MicroRNA expression and clinical outcomes in patients treated with adjuvant chemotherapy after complete resection of non-small cell lung carcinoma. Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Randomized controlled phase III trial of adjuvant chemo-immunotherapy with activated killer T cells and dendritic cells in patients with resected primary lung cancer Postoperative adjuvant chemotherapy for stage I non-small cell lung cancer. Randomised study of adjuvant chemotherapy for completely resected p-stage I–IIIA non-small cell lung cancer Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. A phase 3 randomized trial of immediate combination chemotherapy vs delayed combination chemotherapy in patients with completely resected stage II and III non-small cell carcinoma of the lung. Randomized Clinical Trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in Stage IB Non-Small Cell Lung Cancer (NSCLC): Report of Cancer and Leukemia Group B (CALGB) Protocol 9633. Postoperative adjuvant therapy for stage IB non-small-cell lung cancer. A randomized phase III trial of adjuvant chemotherapy with UFT for completely resected pathological stage I non-small-cell lung cancer: the West Japan Study Group for Lung Cancer Surgery (WJSG)--the 4th study. Adjuvant chemotherapy (AC) in stage IB non-small cell lung cancer (NSCLC): Long-term follow-up of Cancer and Leukemia Group B (CALGB) 9633. Postoperative adjuvant chemotherapy with PVM (Cisplatin + Vindesine + Mitomycin C) and UFT (Uracil + Tegaful) in resected stage I-II NSCLC (non-small cell lung cancer): a randomized clinical trial. West Japan Study Group for lung cancer surgery (WJSG). A randomized trial of postoperative UFT therapy in p stage I, II non-small cell lung cancer: North-east Japan Study Group for Lung Cancer Surgery. Preoperative chemotherapy plus surgery versus surgery plus adjuvant chemotherapy versus surgery alone in early-stage non-small-cell lung cancer. Randomized trial comparing postoperative chemotherapy with vindesine and cisplatin plus thoracic irradiation with irradiation alone in stage III (N2) non-small cell lung cancer. Adjuvant chemotherapy with cyclophosphamide, doxorubicin, and cisplatin in patients with completely resected stage I non-small cell lung cancer. An LCSG Trial. Chemotherapy for patients with non-small cell lung cancer: the surgical setting of the Big Lung Trial. Gefitinib versus placebo in completely resected non-small-cell lung cancer: results of the NCIC CTG BR19 study. Adjuvant Cisplatin and Vinorelbine for Completely Resected Non-small Cell Lung Cancer: Subgroup Analysis of the Lung Adjuvant Cisplatin Evaluation Adjuvant Carboplatin-based Chemotherapy in Resected Stage IIIA-N2 Non-small Cell Lung Cancer Significance of TP53 mutations as predictive markers of adjuvant cisplatin-based chemotherapy in completely resected non-small-cell lung cancer. Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. Prognostic Significance of Mucin and p53 Expression in Stage IB Non-small Cell Lung Cancer: A Laboratory Companion Study to CALGB 9633 Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. MAGRIT phase III trial: MAGE-A3 antigen-specific cancer immunotherapy (ASCI) as adjuvant therapy in patients with completely resected stage IB-IIIA NSCLC. Adjuvant chemotherapy in stage IB non-small cell lung cancer (NSCLC): Update of Cancer and Leukemia Group B (CALGB) protocol 9633. Impact of histology on survival of resected non-small cell lung cancer (NSCLC) receiving adjuvant chemotherapy: subgroup analysis of the adjuvant vinorelbine (NVB) cisplatin (CDDP) versus observation in the ANITA trial. Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. Adjuvant chemotherapy after complete resection in non-small-cell lung cancer. West Japan Study Group for Lung Cancer Surgery. Adjuvant chemotherapy for completely resected stage III non-small-cell lung cancer. Results of a randomized prospective study. The Japan Clinical Oncology Group. A randomized trial comparing adjuvant chemotherapy versus surgery alone for completely resected pN2 non-small cell lung cancer (JCOG9304). A randomized trial of adjuvant chemotherapy with uracil-tegafur for adenocarcinoma of the lung. Postoperative adjuvant cisplatin, vindesine, plus uracil-tegafur chemotherapy increased survival of patients with completely resected p-stage I non-small cell lung cancer. The benefit of adjuvant treatment for resected locally advanced non-small-cell lung cancer. The Lung Cancer Study Group. Adjuvant chemotherapy after radical surgery for non-small-cell lung cancer: a randomized study. Adjuvant radiotherapy versus combined sequential chemotherapy followed by radiotherapy in the treatment of resected nonsmall cell lung carcinoma. A randomized trial of 267 patients Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer. 1173OMAGRIT, A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY TO ASSESS THE EFFICACY OF THE RECMAGE-A3 + AS15 CANCER IMMUNOTHERAPEUTIC AS ADJUVANT THERAPY IN PATIENTS WITH RESECTED MAGE-A3-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC). Quality-of-life outcomes for adjuvant chemotherapy in early-stage non-small-cell lung cancer: results from a randomized trial, JBR.10.
This study determined whether expression levels of a panel of biologically relevant microRNAs can be used as prognostic or predictive biomarkers in patients who participated in the International Adjuvant Lung Cancer Trial ( IALT ) , the largest r and omized study conducted to date of  adjuvant chemotherapy in patients with radically resected non-small cell lung carcinoma ( NSCLC ) . Expression of miR-21 , miR-29b , miR-34a/b/c , miR-155 , and let-7a was determined by quantitative real-time PCR in formalin-fixed paraffin-embedded tumor specimens from 639 IALT patients . The prognostic and predictive values of microRNA expression for survival were studied using a Cox model , which included every factor used in the stratified r and omization , clinicopathologic prognostic factors , and other factors statistically related to microRNA expression . Investigation of the expression pattern of microRNAs in situ was performed . We also analyzed the association of TP53 mutation status and miR-34a/b/c expression , epidermal growth factor receptor and KRAS mutation status , and miR-21 and Let-7a expression . Finally , the association of p16 and miR-29b expression was assessed . Overall , no significant association was found between any of the tested microRNAs and survival , with the exception of miR-21 for which a deleterious prognostic effect of lowered expression was suggested . Otherwise , no single or combinatorial microRNA expression profile predicted response to adjuvant cisplatin-based chemotherapy . Together , our results indicate that the microRNA expression patterns examined were neither predictive nor prognostic in a large patient cohort with radically resected NSCLC , r and omized to receive adjuvant cisplatin-based chemotherapy versus follow-up only PURPOSE Adjuvant cisplatin-based chemotherapy ( ACT ) is now an accepted st and ard for completely resected stage II and III A non-small-cell lung cancer ( NSCLC ) . Long-term follow-up is important to document persistent benefit and late toxicity . We report here up date d overall survival ( OS ) and disease-specific survival ( DSS ) data . PATIENTS AND METHODS Patients with completely resected stage IB ( T2N0 , n = 219 ) or II ( T1 - 2N1 , n = 263 ) NSCLC were r and omly assigned to receive 4 cycles of vinorelbine/cisplatin or observation . All efficacy analyses were performed on an intention-to-treat basis . Results Median follow-up was 9.3 years ( range , 5.8 to 13.8 ; 33 lost to follow-up ) ; there were 271 deaths in 482 r and omly assigned patients . ACT continues to show a benefit ( hazard ratio [ HR ] , 0.78 ; 95 % CI , 0.61 to 0.99 ; P = .04 ) . There was a trend for interaction with disease stage ( P = .09 ; HR for stage II , 0.68 ; 95 % CI , 0.5 to 0.92 ; P = .01 ; stage IB , HR , 1.03 ; 95 % CI , 0.7 to 1.52 ; P = .87 ) . ACT result ed in significantly prolonged DSS ( HR , 0.73 ; 95 % CI , 0.55 to 0.97 ; P = .03 ) . Observation was associated with significantly higher risk of death from lung cancer ( P = .02 ) , with no difference in rates of death from other causes or second primary malignancies between the arms . CONCLUSION Prolonged follow-up of patients from the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy . This benefit appears to be confined to N1 patients . There was no increase in death from other causes in the chemotherapy arm BACKGROUND Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer ( NSCLC ) is not known . We aim ed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC . METHODS 840 patients with stage IB-IIIA NSCLC from 101 centres in 14 countries were r and omly assigned to observation ( n=433 ) or to 30 mg/m(2 ) vinorelbine plus 100 mg/m(2 ) cisplatin ( n=407 ) . Postoperative radiotherapy was not m and atory and was undertaken according to every centre 's policy . The primary endpoint was overall survival . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N95053737 . FINDINGS 367 patients in the chemotherapy group and 431 in the control group received their assigned treatment . 301 ( 36 % ) patients had stage IB disease , 203 ( 24 % ) had stage II disease , and 325 ( 39 % ) had stage IIIA disease . Tolerance to chemotherapy mainly included neutropenia in 335 ( 92 % ) patients and febrile neutropenia in 34 ( 9 % ) ; seven ( 2 % ) toxic deaths were also recorded . Compliance was greater with cisplatin than with vinorelbine ( median dose intensity 89 % [ range 17 - 108 ] vs 59 % [ 17 - 100 ] ) . After a median follow-up of 76 months ( range 43 - 116 ) , median survival was 65.7 months ( 95 % CI 47.9 - 88.5 ) in the chemotherapy group and 43.7 ( 35.7 - 52.3 ) months in the observation group . Adjusted risk for death was significantly reduced in patients assigned chemotherapy compared with controls ( hazard ratio 0.80 [ 95 % CI 0.66 - 0.96 ] ; p=0.017 ) . Overall survival at 5 years with chemotherapy improved by 8.6 % , which was maintained at 7 years ( 8.4 % ) . INTERPRETATION Adjuvant vinorelbine plus cisplatin extends survival in patients with completely resected NSCLC , better defining indication of adjuvant chemotherapy Purpose We conducted a phase III r and omized controlled trial ( RCT ) to investigate the efficacy of postsurgical adjuvant immunotherapy combined with chemotherapy . The immunotherapy targets were residual micrometastases and clones resistant to chemotherapy . Patients and methods Between April 2007 and July 2012 , 103 postsurgical non-small cell lung cancer patients were r and omly assigned to receive either chemo-immunotherapy ( group A ) or chemotherapy ( group B ) . The immunotherapy consisted of the adoptive transfer of autologous activated killer T cells and dendritic cells obtained from the lung cancer patients ’ own regional lymph nodes . Results The 2-year overall survival rates in groups A and B were 93.4 and 66.0 % , and the 5-year rates were 81.4 and 48.3 % , respectively . The differences were statistically significantly better in group A. The hazard ratio ( HR ) was 0.229 ( p = 0.0013 ) . The 2- and 5-year recurrence-free survival rates were 68.5 , 41.4 and 56.8 , 26.2 % in groups A and B , respectively . Those differences were also statistically significant ( log-rank test p = 0.0020 ) . The HR was 0.423 ( p = 0.0027 ) in favor of group A. As for adverse reactions to immunotherapy , of a total of 762 courses , 52 ( 6.8 % ) were accompanied with chills and shivering , and 47 ( 6.2 % ) , with fever ( > 38 ° C ) . Conclusions Immunotherapy has the potential to improve the postsurgical prognosis of lung cancer patients , but a large-scale multi-institutional RCT is awaited for further confirmation of this study OBJECTIVE Surgery constitutes the mainstay of treatment in stage I non-small cell lung cancer ( NSCLC ) . However , a significant fraction of patients after surgical resection die mainly due to systemic relapse . Nonetheless , the best adjuvant treatment to improve survival and decrease relapse rate remains as an ever controversial issue . Therefore , we conducted a r and omized trial to determine whether postoperative adjuvant chemotherapy is beneficial in prolonging survival and decreasing recurrence in patients with completely resected stage I NSCLC . METHODS It was design ed as a r and omized , prospect i ve two-armed study with  surgery only ( control group , 59 patients ) versus surgery plus adjuvant MVP ( mitomycin C , vinblastin and cisplatin ) chemotherapy ( study group , 59 patients ) . RESULTS Data for all the patients were complete . Twenty-four patients in the control group and nine patients in the study group experienced tumor recurrence during the follow-up . Neither histological type nor surgical extent correlated with recurrence . However , the addition of adjuvant MVP chemotherapy could decrease the rate of recurrence and the incidence of cancer-related death after surgery in the patients of stage I NSCLC ( P<0.05 ) . We followed up at least 5 years , and the duration of mean follow-up was 7.3 years . The rates of the loco-regional and distant metastases were 3.4 and 40.7 % in the control group , and 3.4 and 11.9 % in the study group , respectively . The 5- and 10-year survival rates were 74.6 and 56.3 % in the control group , and 81.4 and 65.0 % in the study group , respectively ( P=0.19 , log-rank test ) . The 5- and 10-year disease-free survival rates were 64.8 and 54.8 % in the control group , and 88.8 and 76.8 % in the study group , respectively ( P=0.002 , log-rank test ) . CONCLUSIONS Our results suggest that the addition of adjuvant MVP chemotherapy may reduce the incidence of distant metastasis and prolong the disease-free survival of the patients with stage I NSCLC after surgery We evaluated the therapeutic usefulness of adjuvant chemotherapy in patients with completely resected non-small cell lung cancer ( NSCLC ) . We also examined the relation between DNA ploidy pattern and the response to chemotherapy .  A total of 267 patients with NSCLC ( pathologically documented stage I , II , or IIIA ) underwent complete resection , and DNA ploidy pattern was analysed . Patients with stage I disease ( n=172 ) were r and omly assigned to receive surgery alone ( group A ) or surgery followed by adjuvant chemotherapy ( UFT ( oral anti-cancer drug , a combination of Uracil and Tegaful ) 400 mg day−1 for 1 year after surgery ; group B ) . Stage II or IIIA disease patients ( n=95 ) were r and omly assigned to surgery alone ( group C ) or surgery followed by chemotherapy ( two 28-day courses of cisplatin 80 mg m−2 on day 1 plus vindesine 3 mg m−2 on days 1 and 8 , followed by UFT 400 mg day−1 for at least 1 year ; group D ) . Eight-year overall survival rate in patients with stage I disease was 74.2 % ( 95 % confidence interval ( CI ) : 64.4–84.0 % ) in group B and 57.6 % ( 95 % CI : 46.4–68.8 % ) in group A ( P=0.045 by log-rank test ) . In patients with stage II and IIIA disease , no difference was found between groups C and D. Analysis according to DNA ploidy pattern revealed no difference between the groups . Postoperative chemotherapy with UFT was suggested to be useful in patients with completely resected stage I NSCLC . No difference was seen in relation to DNA pattern in any treatment group BACKGROUND On the basis of a previous meta- analysis , the International Adjuvant Lung Cancer Trial was design ed to evaluate the effect of cisplatin-based adjuvant chemotherapy on survival after complete resection of non-small-cell lung cancer . METHODS We r and omly assigned patients either to three or four cycles of cisplatin-based chemotherapy or to observation . Before r and omization , each center determined the pathological stages to include , its policy for chemotherapy ( the dose of cisplatin and the drug to be combined with cisplatin ) , and its postoperative radiotherapy policy . The main end point was overall survival . RESULTS A total of 1867 patients underwent r and omization ; 36.5 percent had pathological stage I disease , 24.2 percent stage II , and 39.3 percent stage III . The drug allocated with cisplatin was etoposide in 56.5 percent of patients , vinorelbine in 26.8 percent , vinblastine in 11.0 percent , and vindesine in 5.8 percent . Of the 932 patients assigned to chemotherapy , 73.8 percent received at least 240 mg of cisplatin per square meter of body-surface area . The median duration of follow-up was 56 months . Patients assigned to chemotherapy had a significantly higher survival rate than those assigned to observation ( 44.5 percent vs. 40.4 percent at five years [ 469 deaths vs. 504 ] ; hazard ratio for death , 0.86 ; 95 percent confidence interval , 0.76 to 0.98 ; P<0.03 ) . Patients assigned to chemotherapy also had a significantly higher disease-free survival rate than those assigned to observation ( 39.4 percent vs. 34.3 percent at five years [ 518 events vs. 577 ] ; hazard ratio , 0.83 ; 95 percent confidence interval , 0.74 to 0.94 ; P<0.003 ) . There were no significant interactions with prespecified factors . Seven patients ( 0.8 percent ) died of chemotherapy-induced toxic effects . CONCLUSIONS Cisplatin-based adjuvant chemotherapy improves survival among patients with completely resected non-small-cell lung cancer The purpose of this trial ( Lung Cancer Study Group [ LCSG ] 853 ) was to perform a comparative study of immediate combination chemotherapy ( cyclophosphamide , doxorubicin , cisplatin [ CAP ] ) vs delayed combination chemotherapy ( CAP ) administered at the time of first systemic relapse in patients with completely resected stage II and stage III non-small cell cancer of the lung . We r and omly assigned 188 patients with resected stage II or stage III non-small cell lung cancer of the lung ( squamous , 53 % ; nonsquamous , 47 % ) to receive either  immediate or delayed combination chemotherapy . Careful intraoperative staging was performed in all patients . Before r and omization , patients were stratified according to stage -- II ( hilar nodes positive ) vs III ( mediastinal nodes positive or T3)-- and histologic features ( squamous vs nonsquamous ) . Ninety-four patients were r and omized to receive immediate CAP vs 94 patients r and omized to receive delayed CAP .  Prognostic variables such as extent of disease , histologic features , sex , race , TN status , and Karnofsky performance status were equally distributed between r and omized groups . The treatment groups differed with respect to greater than 10 % weight loss . Forty-one percent of patients had stage II disease and 59 % of patients had stage III disease . Median time to recurrence ( 19.5 months ) and survival ( 32.7 months ) did not differ between treatment groups . Immediate combination chemotherapy was associated with a 12 % reduction in risk of recurrence and an 18 % reduction in risk of death , although these rates were not statistically significant . Histologic features , sex , race , Karnofsky performance status , nodal status , and weight change were associated with higher risks of recurrence 7019 Background : The value of adjuvant chemotherapy in resectable lung cancer remains controversial . The International Adjuvant Lung Trial ( IALT ) reported a modest but statistically significant survival advantage with cisplatin-based adjuvant chemotherapy in stages IA to III NSCLC . On the other h and , Adjuvant Lung Project Italy ( ALPI ) failed to demonstrate benefit for adjuvant chemotherapy in patients of similar stage . CALGB 9633 was design ed to test the effectiveness of adjuvant chemotherapy in patients with T2N0M0 , stage IB NSCLC . NCCTG and RTOG also participated . METHODS Within 4 - 8 weeks of resection , patients were r and omized to adjuvant chemotherapy with paclitaxel 200 mg/m2 over 3 hours and carboplatin AUC 6 , each administered on day one every three weeks for four cycles , or to observation .  Eligibility : age > 18 years , histologically documented NSCLC , T2 primary lesion , lobectomy or pneumonectomy , absence of tumor in N1 or N2 nodes sample d at surgery or mediastinoscopy . All p-values are two-sided . RESULTS Between 9/15/96 and 11/26/03 , 344 patients were r and omized . Median follow-up is currently 34 months . Median age was 61 years ( range 34 - 81 years ) , and 64 % were male . Groups were well balanced with regard to age , gender , race , ethnicity , histology , tumor differentiation , and resection type . 80 % underwent mediastinoscopy prior to surgery . Lobectomy was performed in 89 % . Adjuvant chemotherapy was well tolerated , and there were no chemotherapy-related toxic deaths . Grade III or IV neutropenia occurred in 36 % . There have been 36 deaths from any cause among 173 patients in the chemotherapy group compared to 52 deaths among 171 patients in the observation group ( HR=0.62 ; 95 % CI : 0.41 - 0.95 , p=0.028 ) . Overall survival at 4 years is 71 % ( 95 % CI : 62%-81 % ) and 59 % ( 95 % CI : 50%-69 % ) in chemotherapy and observation groups , respectively . There was also a significant advantage in failure-free survival favoring the chemotherapy group ( HR=0.69 ; 95 % CI : 0.48 - 0.98 ; p=0.035 ) . With regard to lung cancer mortality , there have been 19 lung cancer deaths in the chemotherapy group and 34 deaths in the control group ( HR=0.51 ; 95 % CI : 0.29 - 0.89 ; p=0.018 ) . At 4 years , lung cancer mortality was 15 % ( 95 % CI : 8%-21 % ) and 26 % ( 95 % CI : 18%-34 % ) in chemotherapy and control groups , respectively . CONCLUSIONS Adjuvant chemotherapy significantly reduces all-cause and lung cancer mortality in stage IB NSCLC . This is the first r and omized trial to demonstrate significantly improved survival for a carboplatin-based adjuvant chemotherapy regimen in a uniform population with NSCLC . [ Table : see text ] OBJECTIVE Although surgical resection alone is considered adequate treatment in stage IB non-small-cell lung cancer ( NSCLC ) , long-term survival is not satisfactory and the recurrence rate is quite high . The validity of postoperative chemotherapy at stage IB in terms of disease-free and overall survival was assessed in a r and omised trial . METHODS The trial was design ed as a r and omised , two-group study with postoperative adjuvant chemotherapy versus surgery alone as control group . All patients had stage IB disease ( pT2N0 ) assessed after a radical surgical procedure .  Chemotherapy consisted of treatment with cisplatin ( 100 mg/m(2 ) on day 1 ) and etoposide ( 120 mg/m(2 ) on days 1 - -3 ) for a total of six cycles . RESULTS Between January 1988 and December 1994 , 66 patients were included in the study . Thirty-three belonged to the adjuvant chemotherapy group and 33 to the control group . Groups were homogeneous for conventional risk factors . There was no clinical significant morbidity associated to chemotherapy . Patients were followed for a minimum period of 5 years . The rates of locoregional recurrence and distant metastases were 18 and 30 % , respectively , in the adjuvant chemotherapy group and 24 and 43 % , respectively , in the control group . The 5-year disease-free survival rates were 59 % in the adjuvant group and 30 % in the control group ( P = 0.02 ) . The difference in the Kaplan -- Meier survival between the groups was significant as assessed using the log-rank test ( P = 0.04 ) . CONCLUSIONS Our results suggest that adjuvant chemotherapy may reduce recurrences and prolong overall survival in patients at stage IB NSCLC deemed radically operated . Despite being difficult to accept , the use of adjuvant chemotherapy might have better long-term results PURPOSE To examine the efficacy of UFT , an oral 5-fluorouracil derivative agent , as post-operative adjuvant therapy for pathologic ( p- ) stage I non-small-cell lung cancer ( NSCLC ) , because a previous r and omized study had suggested it was efficacious for early-stage NSCLC patients . PATIENTS AND METHODS Patients with completely resected p-stage I , adenocarcinoma or squamous cell carcinoma were eligible . A total of 332 patients were r and omized to the  surgery-alone group ( control group ) and the treatment group ( UFT 400 mg/m(2 ) for 1 year after surgery , UFT group ) after stratification by the histologic types . RESULTS For all patients , the 5- and 8-year survival rates for the UFT group were 82.2 % and 73.0 % , and those for the control group were 75.9 % and 61.2 % , respectively ; no statistically significant improvement of survival was achieved by UFT administration ( P=0.105 ) . For Ad patients , the 5- and 8-year survival rates of the UFT group ( n=120 ) were 85.2 % and 79.5 % , respectively , which seemed better than those of the control group ( n=121 ) ( 79.2 % and 64.0 % , respectively ; P=0.081 ) . For squamous cell carcinoma patients , there was also no difference in survival between the control group ( n=48 ) and the UFT group ( n=43 ) ( P=0.762 ) . For all pT1 patients , the 5- and 8-year survival rates of the UFT group were 83.6 % and 82.1 % , respectively , significantly better than those of the control group ( 77.9 % and 57.6 % , respectively , P=0.036 ) ; UFT was not significantly effective for pT2 patients . For pT1 adenocarcinoma patients , UFT administration markedly improved the survival ( P=0.011 ) . CONCLUSION Post-operative UFT administration did not significantly improve post-operative survival of p-stage I NSCLC patients . Subset analyses suggested that UFT might be effective in pT1N0M0 adenocarcinoma patients 7015 Background : The value of AC in stage IB NSCLC remains controversial . In 2004 , preliminary results of CALGB 9633 demonstrated a statistically significant overall survival ( OS ) advantage for pts r and omized to adjuvant paclitaxel and carboplatin in resected stage IB NSCLC . However , subsequent analyses failed to demonstrate a significant OS advantage for all pts , although an unplanned subset analysis did show improved OS in pts with tumor diameter ≥4 cm ( JCO , 26:5043 , 2008 ) . This report provides up date d OS for CALGB 9633 . Moreover , because the new 2010 AJCC staging system does not recognize 4 cm as a cut point , we correlated results with subgroups incorporated in the new system . METHODS Resected stage IB pts were r and omized to paclitaxel 200 mg/m2 and carboplatin AUC 6 q3wks X4 cycles or observation . OS was the primary endpoint . Because of slow accrual , the accrual target was reduced from 500 to 384 pts , providing 80 % power using a 1-tail logrank with alpha=0.05 . RESULTS Between 1996 - 2003 , 344 pts were r and omized . Median follow-up is 9 yrs . There are now 197  deaths  . While the study remains negative , there is a powerful trend toward improved OS for all pts ( HR=0.80 ; 90 % CI 0.63 - 1.02 ; p=0.062 , 1-tail ) , with a 7 % advantage in 8 yr OS favoring AC ( 51 % vs. 44 % ; p=0.087 ) ; median OS is 8.2/6.6 yrs in chemo/control groups . Subgroup analysis using a 4 cm cut-off continues to show a strong OS signal favoring AC for those with large tumors . In pts with tumors ≥4 cm , the HR for OS is 0.77 ( 90 % CI : 0.57 - 1.04 ; p=0.079 ) ; there is a 10 % improvement in 8 yr OS ( 53 % vs.43 % ; p=0.059 ) ; median OS is 8.9/6.6 yrs in chemo/control groups . In pts with tumors < 4 cm there is little OS difference ( HR=0.89 ; p=0.31 ) . While correlations with the new staging system yield inconclusive findings due to small sample size , it does show that larger tumors derive greater benefit from AC . For example , in 43 pts with tumors > 7 cm ( defined as T3 in the new AJCC system ) , the HR for OS was 0.53 ( 90 % CI : 0.28 - 1.00 ; p=0.051 ) . CONCLUSIONS While not statistically significant , long term follow-up of this underpowered study shows a strong OS signal for all pts and for pts with tumors ≥4 m . Our long-term data justifies AC in resected node negative NSCLC ≥4 cm in diameter OBJECTIVE The West Japan Study Group For Lung Cancer Surgery ( WJSG ) conducted a r and omized controlled trial in order to assess the usefulness of adjuvant chemotherapy for NSCLC . METHODS Patients with completely resected NSCLC ( stages I and II ) were enrolled in the trial . These patients were r and omized into two groups : a surgery alone group ; and a chemotherapy group which received intravenous administration of two courses of 4-week PVM chemotherapy ( 80 mg/m2 of Cisplatin on day 1 , 2 - 3 mg/m2 of Vindesine on day 1 and /or day 8 , and 8 mg/m2 of Mitomycin C on day 1 ) , after which they took 400 mg/day of UFT ( Uracil + Tegaful ) orally for 1 year . RESULTS Among 229 patients registered for the study from August 1988 to July 1990 , 225 were available cases ( 116 patients in the surgery alone group , and 109 patients in the chemotherapy group ) . No bias in prognostic factors could be found between the two groups . The 5-year survival rate was 71.1 % for the surgery-alone group and 76.8 % for the chemotherapy group with no significant difference observed . However , subset analysis demonstrated that PVM therapy improved the post operative survival of pT1N0 patients ( the 5-year survival rate : 75.3 % for the surgery alone group , and 90.7 % for the chemotherapy group P<0.05 ) . CONCLUSIONS It is interesting to find that among pT1N0 patients , who were not regarded as a target of chemotherapy , those receiving chemotherapy showed significantly better prognostic results . These findings suggest the necessity of further studies on the adjuvant chemotherapy , even in the early stages OBJECTIVE A prospect i ve r and omized trial was performed to investigate the prognostic advantage of postoperative adjuvant chemotherapy in patients with resected stage I-II non-small cell lung cancer ( NSCLC ) . PATIENTS AND METHODS From March 1992 to December 1994 , 221 patients with completely resected stage I-II primary NSCLC were enrolled and r and omly assigned to two groups , as follows : 2-year oral administration of Uracil plus Tegafur ( UFT ) ( adjuvant group , 109 patients ) , and surgical treatment alone ( control group , 110 patients ) . RESULTS The overall 5-year survival rates were 79 % for the adjuvant group and 75 % for the control group , and there was no statistical significance . The 5-year disease-free survival rates were 78 % for the adjuvant group and 71 % for the control group , and there was also no statistical significance . There have been seen no severe complications in the adjuvant group . The mean total dosages of UFT were about 75 % of maximum basic amount . CONCLUSIONS The UFT regimen was feasible . However , we have not observed any survival benefit in the adjuvant group . Larger trials are needed to confirm the effect of UFT to patients with resected NSCLC PURPOSE To address whether preoperative chemotherapy plus surgery or surgery plus adjuvant chemotherapy prolongs disease-free survival compared with surgery alone among patients with resectable non-small-cell lung cancer . PATIENTS AND METHODS In this phase III trial , 624 patients with stage IA ( tumor size > 2 cm ) , IB , II , or T3N1 were r and omly assigned to surgery alone ( 212 patients ) , three cycles of preoperative paclitaxel-carboplatin followed by surgery  ( 201 patients ) , or  surgery followed by three cycles of adjuvant paclitaxel-carboplatin  ( 211 patients ) . The primary end point was disease-free survival . RESULTS In the preoperative arm , 97 % of patients started the planned chemotherapy , and radiologic response rate was 53.3 % . In the adjuvant arm , 66.2 % started the planned chemotherapy . Ninety-four percent of patients underwent surgery ;  surgical procedures and postoperative mortality were similar across the three arms . Patients in the preoperative arm had a nonsignificant trend toward longer disease-free survival than those assigned to surgery alone ( 5-year disease-free survival 38.3 % v 34.1 % ; hazard ratio [ HR ] for progression or death , 0.92 ; P = .176 ) . Five-year disease-free survival rates were 36.6 % in the adjuvant arm versus 34.1 % in the surgery arm ( HR 0.96 ; P = .74 ) . CONCLUSION In early-stage patients , no statistically significant differences in disease-free survival were found with the addition of preoperative or adjuvant chemotherapy to surgery . In this trial , in which the treatment decision was made before surgery , more patients were able to receive preoperative than adjuvant treatment This prospect i ve r and omized trial was performed to determine whether postoperative chemotherapy with vindesine and cisplatin could lengthen time to progression and overall survival in stage III ( T1 - 3N2M0 ) non-small cell lung cancer ( NSCLC ) patients . Seventy-two patients were entered ; 36 were r and omized to receive chemotherapy .  Patients were stratified by extent of resection ( complete vs. incomplete ) and histology ( squamous vs. nonsquamous ) . All had surgery and mediastinal irradiation 6 - 7 weeks post-thoracotomy . Incompletely resected patients had intraoperative 125I and /or 192Ir implantation . Vindesine ( 3 mg/m2 ) weekly x 5 , then every 2 weeks x 8 , and cisplatin ( 120 mg/m2 ) days 1 , 29 , 71 , 113 were planned for those r and omized to chemotherapy . No difference in time to progression ( median 9.2 months for radiation + chemotherapy vs. 9.0 months for radiation , P = 0.35 ) or overall survival ( 16.3 months for radiation + chemotherapy vs. 19.1 months for radiation , P = 0.42 ) was found . Postoperative vindesine and cisplatin did not prolong time to progression or survival in this population of stage III NSCLC OBJECTIVE Two recent studies in resectable non-small cell lung cancer by the Lung Cancer Study Group ( LCSG ) suggested an advantage to adjuvant therapy with cyclophosphamide , doxorubicin ( Adriamycin ) , and cisplatin ( CAP ) . Neither study had a no-treatment control arm . The purpose of this study was to compare the CAP regimen with no treatment in patients with resectable early-stage non-small cell lung cancer . METHODS After complete resection , eligible patients with T1N1 or T2N0 non-small cell lung cancer were r and omly assigned to receive or not to receive four courses of CAP at 3-week intervals beginning on day 30 after surgery after stratification for histology , preoperative white blood cell count , and Karnofsky performance status before surgery . The CAP regimen consisted of 400 mg/m2 of cyclophosphamide , 40 mg/m2 of doxorubicin , and 60 mg/m2 of cisplatin . Of the 269 eligible patients entered in the study , 101 had recurrence and 127 had died at the time of analysis . The mean time since r and omization is 6.4 years ; mean follow-up is 3.8 years . There were no differences in time to recurrence or overall survival between the two groups even when analyses were adjusted for prognostic variables . Only 53 % of the eligible patients received all four courses of CAP , and only 57 % of such patients received all four cycles on time . Among the patients who had recurrences , 74 % had their initial recurrence at a distant site . CONCLUSION No survival benefit for CAP vs no-treatment control was found in this study . Therefore , adjuvant therapy with CAP should not be recommended for patients with resected early-stage non-small cell lung cancer . Further trials to test adjuvant therapy are indicated , but investigators should use better antiemetics to improve patient compliance as well as more active cisplatin-based chemotherapy regimens OBJECTIVES The non-small cell lung cancer ( NSCLC ) meta- analysis suggested a survival benefit for cisplatin-based chemotherapy when given in addition to surgery , radical radiotherapy or ' best supportive care ' . However , it included many small trials and trials with differing eligibility criteria and chemotherapy regimens . The aim of the Big Lung Trial was therefore to run a large pragmatic trial to confirm the survival benefits seen in the meta- analysis . METHODS In the surgery setting , a total of 381 patients were r and omised to chemotherapy ( C , 192 patients ) or no chemotherapy ( NoC , 189 patients ) . C was three 3-weekly cycles of cisplatin/vindesine , mitomycin/ifosfamide/cisplatin , mitomycin/vinblastine/cisplatin or vinorelbine/cisplatin . RESULTS Chemotherapy was given before surgery in 3 % of patients whilst 97 % received adjuvant chemotherapy . Baseline characteristics were : median age 61 years , 69 % male , 48 % squamous cell , 93 % WHO PS 0 - 1 , 27 % stage I , 38 % stage II , and 34 % stage III . Complete resection was achieved in approximately 95 % of patients . In the C group , 13 % received no chemotherapy , 21 % one or two cycles , and 64 % all three cycles of their prescribed chemotherapy ( 60 % of the latter with no delays or modification ) . 30 % had grade 3/4 toxicity , mainly haematological , nausea/vomiting and neutropenic fever , and six patients were reported as having a treatment-related death . 198 ( 52 % ) of patients have died , but there is currently no evidence of a benefit in overall survival to the C group : HR 1.02 ( 95 % CI 0.77 - 1.35 ) , P = 0.90 ) . CONCLUSIONS This trial has failed to observe a survival benefit with adjuvant chemotherapy following complete resection of stage I-III NSCLC . However , the hazard ratio and 95 % confidence intervals are consistent with the previously reported meta- analysis and two large recently reported trials , which suggest a small survival benefit with cisplatin-based chemotherapy PURPOSE Survival of patients with completely resected non-small-cell lung cancer ( NSCLC ) is unsatisfactory , and in 2002 , the benefit of adjuvant chemotherapy was not established . This phase III study assessed the impact of postoperative adjuvant gefitinib on overall survival ( OS ) . PATIENTS AND METHODS Patients with completely resected ( stage IB , II , or IIIA ) NSCLC stratified by stage , histology , sex , postoperative radiotherapy , and chemotherapy were r and omly assigned ( 1:1 ) to receive gefitinib 250 mg per day or placebo for 2 years . Study end points were OS , disease-free survival ( DFS ) , and toxicity . RESULTS As a result of early closure , 503 of 1,242 planned patients were r and omly assigned ( 251 to gefitinib and 252 to placebo ) . Baseline factors were balanced between the arms . With a median of 4.7 years of follow-up ( range , 0.1 to 6.3 years ) , there was no difference in OS ( hazard ratio [ HR ] , 1.24 ; 95 % CI , 0.94 to 1.64 ; P = .14 ) or DFS ( HR , 1.22 ; 95 % CI , 0.93 to 1.61 ; P = .15 ) between the arms . Exploratory analyses demonstrated no DFS ( HR , 1.28 ; 95 % CI , 0.92 to 1.76 ; P = .14 ) or OS benefit ( HR , 1.24 ; 95 % CI , 0.90 to 1.71 ; P = .18 ) from gefitinib for 344 patients with epidermal growth factor receptor ( EGFR ) wild-type tumors . Similarly , there was no DFS ( HR , 1.84 ; 95 % CI , 0.44 to 7.73 ; P = .395 ) or OS benefit ( HR , 3.16 ; 95 % CI , 0.61 to 16.45 ; P = .15 ) from gefitinib for the 15 patients with EGFR mutation-positive tumors . Adverse events were those expected with an EGFR inhibitor . Serious adverse events occurred in ≤ 5 % of patients , except infection , fatigue , and pain . One patient in each arm had fatal pneumonitis . CONCLUSION Although the trial closed prematurely and definitive statements regarding the efficacy of adjuvant gefitinib can not be made , these results indicate that it is unlikely to be of benefit Background : To evaluate the impact of adjuvant cisplatin-vinorelbine in completely resected non-small cell lung cancer and identify patients likely to benefit from this regimen in the Lung Adjuvant Cisplatin Evaluation ( LACE ) data base . The overall LACE meta- analysis showed survival benefit with cisplatin-based adjuvant chemotherapy ( 5-year survival benefit of 5.4 % , hazard ratio [ HR ] 0.89 , p = 0.004 ) . Subgroup analysis for the cisplatin-vinorelbine regimen was prespecified in the LACE statistical analysis plan . Patients r and omized to cisplatin-vinorelbine or observation were the largest subgroup ( 41 % ) and the most homogeneous in terms of drug doses and eligibility . Patients and Methods : The LACE-vinorelbine cohort included trials evaluating cisplatin-vinorelbine versus observation .  Overall survival was the primary end point . Other studies r and omizing patients to other chemotherapy or observation ( LACE-other ) were also evaluated . Results : The LACE-vinorelbine cohort included 1888 patients from four studies ( Adjuvant Navelbine International Trialist Association , Big Lung Trial , International Adjuvant Lung Cancer Trial , and National Cancer Institute of Canada Clinical Trials Group JBR.10 ) . Baseline characteristics were similar to the LACE-other but had fewer patients with stage IA ( 2 % versus 11 % ) . Survival improvement at 5 years was 8.9 % with cisplatin-vinorelbine versus observation ( HR 0.80 , 95 % confidence interval : 0.70–0.91 , p < 0.001 ) . Stage was a significant predictor for survival ( test for trend , p = 0.02 ; benefit at 5 years : 14.7 % [ stage III ] , 11.6 % [ stage II ] , and 1.8 % [ stage I ] ) . Similar benefits were seen for disease-free survival ( HR 0.75 [ 0.67–0.85 , p < 0.001 ] , stage III [ HR 0.62 , 0.50–0.76 ] , stage II [ HR 0.69 , 0.57–0.83 ] , and stage I [ HR 0.95 , 0.767ndash;1.19 ] ) . The overall result was statistically superior to LACE-other ( LACE other HR 0.95 , 0.86–1.05 , interaction p = 0.04 ) . Conclusion : In subgroup analyses , adjuvant cisplatin-vinorelbine provides a superior survival benefit and can be recommended in completely resected stages II and III non-small cell lung cancer Instruction : We determined whether adjuvant vinorelbine/paclitaxel plus carboplatin prolonged overall survival among patients with completely resected stage IIIA-N2 non-small cell lung cancer ( NSCLC ) . Methods : We r and omly assigned patients with completely resected stage IIIA-N2 NSCLC to a  control group or to a treatment group with vinorelbine/carboplatin or paclitaxel/carboplatin doublet adjuvant chemotherapy . The primary endpoint was overall survival ; secondary endpoints were disease-free survival and the toxicity and safety of the regimen . Results : This trial was terminated before accumulation of the planned numbers for registration because of the results of bigger clinical trial . Finally , 150 patients underwent r and omization to vinorelbine/paclitaxel plus carboplatin ( 79 patients ) or observation . In the chemotherapy group , 38 patients received vinorelbine plus carboplatin and 41 patients received paclitaxel plus carboplatin . In both groups , the median age was 57 years , 73 % were men , and 28 % had squamous carcinoma . Chemotherapy caused neutropenia in 82 % of the patients ( including grade 3 and 4 neutropenia in 42 % ) , and there were no treatment-related deaths in this trial . After a median follow-up of 29 months ( range , 1–110 months ) , the overall survival was significantly prolonged in the chemotherapy group , when compared with the observation group ( 33 months [ 95 % confidence interval { CI } , 27.4–38.6 ] versus 24 months [ 95 % CI , 15.8–32.2 ] , p = 0.037 ) , as was disease-free survival ( 32 months [ 95 % CI , 21.3–42.7 ] versus 20 months ( 95 % CI , 13.1–26.9 ) , p = 0.020 ) . The 5-year overall survival rates were 31.1 % and 19.1 % , respectively . Conclusions : Although with limitations , this clinical trial showed that adjuvant vinorelbine/paclitaxel plus carboplatin has an acceptable level of toxicity and prolongs disease-free and overall survival among patients with completely resected stage IIIA-N2 NSCLC Adjuvant cisplatin-based chemotherapy only marginally improves survival in patients with completely resected non-small-cell lung cancer ( NSCLC ) . We have evaluated the predictive value of mutations in TP53 , encoding the tumour suppressor p53 , in the International Adjuvant Lung Cancer Trial ( IALT ) , a r and omized trial of adjuvant cisplatin-based chemotherapy against observation . TP53 ( exons 4 - 8 ) was sequenced in 524 archived specimens of IALT patients with a median follow-up of 7.5 years . Predictive analyses were based on Cox models adjusted for clinical and pathological variables . P-values ≤ 0.01 were considered as significant . Mutations were detected in 221 patients ( 42 % ) and had no predictive value for the effect of chemotherapy ( interaction between TP53 and treatment : p = 0.17 for Overall Survival ( OS ) ; p = 0.06 for Disease-Free Interval , ( DFS ) ) . However , among patients with mutations , outcome appeared worse in treatment compared to observation arms ( HR for OS = 1.36 ( 95 % CI [ 0.97 - 1.31 ) , p = 0.08 ; DFS = 1.40 ( 95 % CI [ 1.01 - 1.95 ] ) , p = 0.04 ) . When grouping mutations into classes according to predicted effects on protein structure , the tendency towards worse outcomes was restricted to " structure " mutations affecting residues of the hydrophobic core that are not located at the p53 protein-DNA interface ( HR for death in this class vs wild-type T53 = 1.66 ; 95 % CI [ 1.10 - 2.52 ] , p = 0.02 ) . Overall , TP53 mutations are not significant predictors of outcome in this trial of cisplatin-based chemotherapy , although a specific class of structural mutations may be associated with a tendency towards worse outcomes upon treatment PURPOSE To explore whether population -related pharmacogenomics contribute to differences in patient outcomes between clinical trials performed in Japan and the United States , given similar study design s , eligibility criteria , staging , and treatment regimens . METHODS We prospect ively design ed and conducted three phase III trials ( Four-Arm Cooperative Study , LC00 - 03 , and S0003 ) in advanced-stage , non-small-cell lung cancer , each with a common arm of paclitaxel plus carboplatin . Genomic DNA was collected from patients in LC00 - 03 and S0003 who received paclitaxel ( 225 mg/m(2 ) ) and carboplatin ( area under the concentration-time curve , 6 ) . Genotypic variants of CYP3A4 , CYP3A5 , CYP2C8 , NR1I2 - 206 , ABCB1 , ERCC1 , and ERCC2 were analyzed by pyrosequencing or by PCR restriction fragment length polymorphism . Results were assessed by Cox model for survival and by logistic regression for response and toxicity . Results Clinical results were similar in the two Japanese trials , and were significantly different from the US trial , for survival , neutropenia , febrile neutropenia , and anemia . There was a significant difference between Japanese and US patients in genotypic distribution for CYP3A4 * 1B ( P = .01 ) , CYP3A5 * 3C ( P = .03 ) , ERCC1 118 ( P < .0001 ) , ERCC2 K751Q ( P < .001 ) , and CYP2C8 R139 K ( P = .01 ) . Genotypic associations were observed between CYP3A4 * 1B for progression-free survival ( hazard ratio [ HR ] , 0.36 ; 95 % CI , 0.14 to 0.94 ; P = .04 ) and ERCC2 K751Q for response ( HR , 0.33 ; 95 % CI , 0.13 to 0.83 ; P = .02 ) . For grade 4 neutropenia , the HR for ABCB1 3425C-->T was 1.84 ( 95 % CI , 0.77 to 4.48 ; P = .19 ) . CONCLUSION Differences in allelic distribution for genes involved in paclitaxel disposition or DNA repair were observed between Japanese and US patients . In an exploratory analysis , genotype-related associations with patient outcomes were observed for CYP3A4 * 1B and ERCC2 K751Q . This common-arm approach facilitates the prospect i ve study of population -related pharmacogenomics in which ethnic differences in antineoplastic drug disposition are anticipated Introduction : Cancer and Leukemia Group B 9633 was a phase III trial that r and omized patients with stage IB non-small cell lung cancer to observation or four cycles of carboplatin and paclitaxel . A statistically significant effect in favor of adjuvant chemotherapy was seen for disease-free survival ( DFS ) and overall survival ( OS ) in the subgroup of patients with tumors ≥4 cm . A laboratory companion study was conducted to see whether molecular and clinical factors could provide additional prognostic information . Methods : Formalin-fixed , paraffin-embedded blocks were obtained for 250 of the 344 patients enrolled . Immunohistochemical staining for bcl-2 , p53 , blood group antigen A , and mucin was correlated with DFS and OS . Results : The prevalence of the markers was bcl-2 , 17 % ; p53 , 47 % ; blood group antigen A , 25 % ; and mucin , 45 % . Univariate analysis for DFS showed a statistically significant effect for the presence of mucin ( p = 0.0005 ) and p53 ( p = 0.05 ) and for OS showed a significant effect for mucin ( p = 0.0005 ) . In the multivariate Cox model , there was a statistically significant association between shorter DFS and presence of mucin ( p = 0.002 ; hazard ratio [ HR ] 2.05 ) and p53 ( p = 0.003 ; HR 1.95 ) and between shorter OS and presence of mucin ( p = 0.004 ; HR 2.03 ) and p53 ( p = 0.0005 ; HR 2.30 ) . Of the clinical factors , male gender and larger tumor volume were also significant adverse prognostic factors ( p < 0.05 ) . Conclusions : A statistically significant association between shorter DFS and OS was seen for the patients with p53 protein expression , mucin expression , male gender , and larger tumors in this cohort of patients with stage IB non-small cell lung cancer treated on Cancer and Leukemia Group B 9633 PURPOSE Epidermal growth factor receptor ( EGFR ) -tyrosine kinase inhibitors have proven efficacy in advanced non-small-cell lung cancer ( NSCLC ) . We hypothesized that erlotinib would be efficacious in the adjuvant setting . PATIENTS AND METHODS An international r and omized , double-blind , placebo-controlled study was conducted in patients with completely resected IB to IIIA NSCLC whose tumors expressed EGFR protein by immunohistochemistry or EGFR amplification by fluorescence in situ hybridization . Patients were assigned 2:1 to erlotinib 150 mg once per day or placebo for 2 years . Stratification factors were stage , histology , previous adjuvant chemotherapy , smoking status , EGFR amplification status , and country . The primary end point was disease-free survival ( DFS ) ; key secondary end points were overall survival ( OS ) and DFS and OS in patients whose tumors had EGFR-activating mutations ( EGFRm-positive ) . RESULTS A total of 973 patients were r and omly assigned ( November 26 , 2007 , to July 7 , 2010 ) . There was no statistically significant difference in DFS ( median , 50.5 months for erlotinib and 48.2 months for placebo ; hazard ratio , 0.90 ; 95 % CI , 0.74 to 1.10 ; P = .324 ) . Among the 161 patients ( 16.5 % ) in the EGFRm-positive subgroup , DFS favored erlotinib ( median , 46.4 v 28.5 months ; hazard ratio , 0.61 ; 95 % CI , 0.38 to 0.98 ; P = .039 ) , but this was not statistically significant because of the hierarchical testing procedure . OS data are immature . Rash and diarrhea were common adverse events occurring in 528 ( 86.4 % ) and 319 ( 52.2 % ) patients treated with erlotinib , respectively , versus 110 ( 32.1 % ) and 54 ( 15.7 % ) patients receiving placebo . The most common grade 3 adverse events in patients treated with erlotinib were rash ( 22.3 % ) and diarrhea ( 6.2 % ) . CONCLUSION Adjuvant erlotinib did not prolong DFS  in patients with EGFR-expressing NSCLC or in the EGFRm-positive subgroup . Further evaluation of erlotinib is warranted in the EGFRm-positive subgroup TPS210 Background : Active immunization with MAGE-A3 Antigen-Specific Cancer Immunotherapeutic ( ASCI ) showed clinical activity in a r and omized Phase II study ( NCT00290355 ) in patients with completely resected non-small cell lung cancer ( NSCLC ) and in a r and omized Phase II study ( NCT00086866 ) in metastatic melanoma . METHODS MAGRIT ( NCT00480025 ) is a double-blind , placebo-controlled , r and omized ( 2:1 ;  MAGE-A3 ASCI vs. Placebo )  Phase III trial in patients with pathological stage IB-IIIA NSCLC ( AJCC TNM v6 ) . Tumors of eligible patients have been resected by complete anatomic lobectomy/pneumonectomy and must be MAGE-A3 + . Patients are allowed to receive up to 4 cycles of adjuvant platinum-based chemotherapy ( CT ) , when clinical ly indicated , post-operatively and before study treatment . Adjuvant radiotherapy is not permitted . MAGE-A3 ASCI ( recombinant MAGE-A3 protein and immunostimulant AS15 ) or placebo is administered intramuscularly for a total of 13 doses : 5 doses every 3 weeks followed by 8 doses every 12 weeks . R and omization of patients is performed using a central web-based system , stratified for chemotherapy ( CT vs. no-CT ) and accounting for the following minimization factors : number of CT cycles ( 1 - 4 ) , pathological stage ( IB vs. II vs. IIIA ) , type of lymph node sampling ( minimal vs. systematic radical resection ) , ECOG performance status ( 0 , 1 and 2 ) , and smoking status ( never- , ex- , or current smoker ) . Co- primary endpoints are disease-free survival ( DFS ) in the overall population and DFS in the population that has not received adjuvant CT prior to study treatment . Secondary endpoints include additional clinical efficacy indicators such as overall survival ; safety health-related quality of life ( EQ-5D ) , and validation of a predictive gene signature ( GS ) associated with clinical benefit of the MAGE-A3 ASCI . As of 21 Jan 2011 , 9898 patients were screened , 1579 r and omized ( 2270 targeted ) . 9057 valid tumor sample s have been tested for MAGE-A3 expression , 33 % were positive . At their last meeting ( Sep 2010 ) , The Independent Data Monitoring Committee suggested no safety issue and allowing the trial to continue as planned 7007 Background : In 2004 , preliminary results of CALGB 9633 demonstrated statistically significant evidence that adjuvant chemotherapy with paclitaxel and carboplatin ( PC ) improved disease-free ( DFS ) and overall survival ( OS ) in resected stage IB NSCLC . Indeed , the study was closed early by the DSMB after a planned interim analysis demonstrated a p value for OS less than a prespecified stopping boundary . However , two larger trials , NCIC-JBR10 and ANITA , have shown significant OS advantages with adjuvant chemo , but failed to demonstrate improved survival in the stage IB subset . This report provides more mature data from CALGB 9633 . METHODS InCALGB 9633 , stage IB patients ( pts ) were r and omized following resection to paclitaxel 200 mg/m2 and carboplatin AUC 6 q3wks ×4 cycles or to observation . While initially planned to accrue 500 pts , the accrual rate was < 50 % of expected . Because slow accrual allowed longer observation times for each pt , the accrual target was reduced to 384 pts . OS is the primary endpoint . The re design ed study had 80 % power to detect a hazard ratio ( HR ) of 0.67 after 150 observed deaths using a 1-tailed logrank test conducted at the 0.05 level of significance . RESULTS Between 9/15/96 and 11/26/03 , 344 pts were r and omized . Median follow-up is 54 mo . Demographics and toxicity has been previously reported ( JCO Sup , 22:621a , 2004 ) . The current intent-to-treat analysis shows a significant improvement in DFS  favoring adjuvant chemo ( HR=0.74 ; 90 % 2-sided CI : 0.57 - 0.96 ; p=0.027 ) . There is a trend toward improvement in OS that is not significant ( HR=0.80 ; 90 % CI : 0.60 - 1.07 ; p=0.10 ) . There is , however , a significant advantage in 3-yr survival ( 79 % vs. 70 % ; p=0.045 ) . Five-yr survival is not different ( 60 % vs. 57 % ; p=0.32 ) , although median follow-up is < 5 yrs and CIs are wide . Continued follow-up is planned since only 131 of 150 deaths required for final analysis have been observed . CONCLUSIONS This up date d but " preliminary " analysis no longer shows a significant OS advantage  for adjuvant chemotherapy in stage IB NSCLC . However , the re- design ed study does not have adequate power to detect small differences in OS that may be clinical ly significant . Advantages in DFS and 3-yr survival support continued consideration of adjuvant PC in stage IB NSCLC . [ Table : see text ] BACKGROUND Data issued from the survival outcome in the ANITA trial are reported according to histology in observation ( n=433 ) and adjuvant chemotherapy arms ( n=407 ) . METHODS In the ANITA trial , patients with resected stage IB , stage II and stage IIIA NSCLC were r and omly assigned to vinorelbine plus cisplatin or to observation . In this retrospective analysis , Kaplan-Meier plots and life tables were used to describe survival within each treatment arm and each histological subgroup : observation adenocarcinoma , observation non-adenocarcinoma , chemotherapy adenocarcinoma , chemotherapy non-adenocarcinoma . RESULTS In the observation arm , adenocarcinoma appears to be a poor prognostic factor in patients with resected NSCLC with a median survival of 37.3 months and 45.5 months for non-adenocarcinoma . In the treatment arm , adenocarcinoma may be a predictive factor of efficacy for adjuvant chemotherapy with a larger benefit from adjuvant vinorelbine-cisplatin chemotherapy , even though other histological subtypes also benefit from this treatment . The absolute benefit on survival at 5-years of chemotherapy was 13.9 % in adenocarcinoma and 5.8 % in non-adenocarcinoma . CONCLUSION Efficacy of vinorelbine-cisplatin in adjuvant setting is independent from histology . The poor outcome of adenocarcinoma found in the observation arm was reversed by the positive impact of chemotherapy , possibly due to a higher chemosensitivity of this subtype PURPOSE Adjuvant chemotherapy for resected non-small-cell lung cancer ( NSCLC ) is now accepted on the basis of several r and omized clinical trials ( RCTs ) that demonstrated improved survival . Although there is strong evidence that adjuvant chemotherapy is effective in stages II and IIIA NSCLC , its utility in stage IB disease is unclear . This report provides a mature analysis of Cancer and Leukemia Group B ( CALGB ) 9633 , the only RCT design ed specifically for stage IB NSCLC . PATIENTS AND METHODS Within 4 to 8 weeks of resection , patients were r and omly assigned to adjuvant chemotherapy or observation .  Eligible patients had pathologically confirmed T2N0 NSCLC and had undergone lobectomy or pneumonectomy .  Chemotherapy consisted of paclitaxel 200 mg/m(2 ) intravenously over 3 hours and carboplatin at an area under the curve dose of 6 mg/mL per minute intravenously over 45 to 60 minutes every 3 weeks for four cycles . The primary end point was overall survival . RESULTS Three hundred-forty-four patients were r and omly assigned . Median follow-up was 74 months . Groups were well-balanced with regard to demographics , histology , and extent of surgery . Grade s 3 to 4 neutropenia were the predominant toxicity ; there were no treatment-related deaths . Survival was not significantly different ( hazard ratio [ HR ] , 0.83 ; CI , 0.64 to 1.08 ; P = .12 ) . However , exploratory analysis demonstrated a significant survival difference in favor of adjuvant chemotherapy for patients who had tumors > or = 4 cm in diameter ( HR , 0.69 ; CI , 0.48 to 0.99 ; P = .043 ) . CONCLUSION Because a significant survival advantage was not observed across the entire cohort , adjuvant chemotherapy should not be considered st and ard care in stage IB NSCLC . Given the magnitude of observed survival differences , CALGB 9633 was underpowered to detect small but clinical ly meaningful improvements . A statistically significant survival advantage for patients who had tumors > or = 4 cm supports consideration of adjuvant paclitaxel/carboplatin for stage IB patients who have large tumors PURPOSE We performed a study to determine whether postoperative mild chemotherapy to maintain the patient 's quality of life ( QOL ) and immunoactivity could also prolong survival . SUBJECT AND METHODS From December 1985 to July 1988 , 323 patients with completely resected primary non-small-cell lung cancer ( stage I to III ) were enrolled . The subjects were r and omized into three treatment groups , as follows : cisplatin ( CDDP ) 50 mg/m2 body surface , vindesine ( VDS ) 2 to 3 mg/kg body weight for three courses , and 1-year oral administration of tegafur ( FT ) plus uracil ( UFT ) 400 mg/kg body weight ( CVUft group , 115 patients ) ; 1-year oral administration of UFT 400 mg/kg body weight ( Uft group , 108 patients ) ; or surgical treatment only ( control group , 100 patients ) . RESULTS The overall 5-year survival rates were 60.6 % for the CVUft group and 64.1 % for the Uft group versus 49.0 % for the control group . The results of statistical testing were P = .053 ( log-rank test ) and P = .044 ( generalized Wilcoxon test ) among the three groups , P = .083 ( log-rank ) and P = .074 ( Wilcoxon ) between the CVUft and the control groups , and P = .022 ( log-rank ) and P = .019 ( Wilcoxon ) between the Uft and the control groups , which indicates higher survival rates in the CVUft and the Uft groups compared with the control group . A multivariate statistical analysis on prognostic factors using Cox 's proportional hazards model was performed with the following results : P = .037 , hazards ratio = 0.64 with a 95 % confidence interval ( CI ) of 0.42 to 0.97 ( control v CVUft group ) ; and P = .009 , hazards ratio = 0.55 with a 95 % CI of 0.36 to 0.86 ( control v Uft group ) . CONCLUSION Significantly favorable results were obtained in the CVUft and Uft groups compared with surgery alone . These data showed significant prognostic advantages in the postoperative adjuvant chemotherapy groups Two hundred nine patients with completely resected stage III non-small-cell lung cancer were r and omized to receive postoperative cisplatin and vindesine chemotherapy or no further treatment . Before r and omization , patients were stratified by the histologic characteristics of their tumors ( squamous versus nonsquamous cell carcinoma ) . Prognostic variables such as histology , performance status , extent of operation , and tumor and nodal status of the eligible patients in chemotherapy ( n = 90 ) and control groups ( n = 91 ) were equally distributed . There was no statistically significant difference in disease-free and overall survival between the two groups . The 3-year disease-free survivals of the chemotherapy and control groups were 37 % and 42 % , respectively . The median survival times ( 5-year survival ) were 31 months ( 35 % ) in the chemotherapy group and 37 months ( 41 % ) in the control group . These was no different pattern in the first site of recurrence ( local versus systemic ) between the two groups . This study failed to demonstrate the therapeutic benefits of postoperative cisplatin and vindesine chemotherapy The purpose of this study was to evaluate the efficacy of adjuvant chemotherapy with three courses of cisplatin and vindesine , in comparison to observation only , for N2 non-small cell lung cancer that had been completely resected . Patients with pathologically demonstrated mediastinal lymph node metastasis ( N2 ) , who had undergone complete resection , were r and omized to observation or adjuvant chemotherapy ( cisplatin 80 mg/m2 on day 1 ; vindesine 3 mg/m2 on days 1 and 8 : x3 courses ) . Cycles started within 6 weeks after complete resection and were repeated every 4 weeks . This trial was terminated before accumulation of the planned numbers for registration because of a slow accrual rate . A total of 119 patients were r and omized ( 59 patients in the adjuvant arm and 60 with surgery alone ) . The median survival was 36 months for both groups . Postoperative cisplatin with vindesine chemotherapy was not shown to be efficacious in cases of completely resected N2 non-small cell lung cancer in this setting of timing , dose and agents studied BACKGROUND In a previous phase 3 trial of adjuvant chemotherapy after resection of non-small-cell lung cancer , a combination of uracil and tegafur ( often referred to as UFT ) taken orally was shown to prolong survival . A subgroup analysis disclosed that most patients who benefited had pathological stage I adenocarcinoma . METHODS We r and omly assigned patients with completely resected pathological stage I adenocarcinoma of the lung to receive either oral uracil-tegafur ( 250 mg of tegafur per square meter of body-surface area per day ) for two years or no treatment . R and omization was performed with stratification according to the pathological tumor category ( T1 vs. T2 ) , sex , and age . The primary end point was overall survival . RESULTS From January 1994 through March 1997 , 999 patients were enrolled . Twenty patients were found to be ineligible and were excluded from the analysis after r and omization ; 491 patients were assigned to receive uracil-tegafur and 488 were assigned to observation . The median duration of follow-up for surviving patients was 73 months . The difference in overall survival between the two groups was statistically significant in favor of the uracil-tegafur group ( P=0.04 by a stratified log-rank test ) . Grade 3 toxic effects occurred in 10 of the 482 patients ( 2 percent ) who actually received uracil-tegafur . CONCLUSIONS Adjuvant chemotherapy with uracil-tegafur improves survival among patients with completely resected pathological stage I adenocarcinoma of the lung PURPOSE To evaluate the efficacy of postoperative adjuvant chemotherapy for completely resected p-stage I non-small cell lung cancer ( NSCLC ) . MATERIAL S AND METHODS Patients who underwent complete resection with lymph node dissection for p-stage I NSCLC ( T1N0 , T2N0 , adenocarcinoma or squamous cell carcinoma , were eligible . After surgery , 150 patients were stratified according to tumor size and histologic type , and then r and omly assigned to 1 of 3 groups ( 50 patients each group ) : surgery alone ( control group ) , surgery with chemotherapy ; PVU group ( 2 courses of cisplatin 80 mg/m2 , i.v . x 1 ( day 1 ) , vindesine 3 mg/m2 , i.v . x 1 ( days 1 and 8) and UFT 400 mg/day , p.o . for a period of 2 years ) , and UFT group ( UFT 400 mg/day , p.o . for 2 years ) . RESULTS The 5-year survival rates of the PVU group , the UFT group , and the control group were 87.9 , 67.7 , and 66.3 % , respectively . The difference in 5-year survival between the PVU group and the control group was statistically significant ( p = 0.045 , log rank ) . The 5-year disease-free survival rate of the PVU group ( 81.1 % ) was also significantly better than that of the control group ( 66.5 % ) ( p = 0.042 , log rank ) . According to multivariate analysis using Cox 's proportional hazard model , the only significantly positive factor on outcome was PVU chemotherapy after surgery . CONCLUSION Postoperative PVU chemotherapy is effective for Japanese patients with completely resected p-stage I NSCLC The purpose of this trial was to investigate the impact of systemic combination chemotherapy on survival and recurrence patterns in incompletely resected non-small-cell lung cancer . Incomplete resection was defined as presence of residual tumor in the resection margin or by presence of metastasis in the highest paratracheal lymph node sample d during protocol -directed surgical staging of the mediastinum . One hundred seventy-two patients were r and omized to receive either postoperative radiotherapy ( RT ) alone or postoperative RT plus chemotherapy with CAP ( Cytoxan [ cyclophosphamide ; Bristol Myers , Evansville , IN ] , Adriamycin [ doxorubicin ; Adria Laboratories , Columbus , OH ] , and Platinol [ cisplatin ; Bristol Myers ] ) for 6 months . One hundred sixty-four patients were eligible for analysis at a mean time since r and omization of 3.7 years . The chemotherapy arm showed significantly longer recurrence-free survival ( two-sided Mantel-Haenszel log rank test , P = .004 ) . This difference holds true for nonsquamous patients ( P = .01 ) , and approaches significance for squamous patients as well ( P = .08 ) . There was a 14 % difference in survival rate favoring the chemotherapy arm 1 year after r and omization . Analysis of sites of recurrence showed a significant decrease in distant metastases in the chemotherapy arm . Median survival for the entire group was approximately 17 months , and 35 % are alive 2 years after resection . Toxicity of treatment consisted of esophagitis ( mild-moderate by Eastern Cooperative Oncology Group [ ECOG ] criteria ) and predictable hematologic , gastrointestinal ( GI ) , and skin toxicity expected from CAP PURPOSE The aims of this study were to assess the effect of adjuvant chemotherapy on overall survival , disease-free survival , and relapse pattern , as well as its toxicity in patients who underwent radical surgery for non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS One hundred ten patients with T1 - 3N0 ( World Health Organization [ WHO ] 1981 ) NSCLC underwent radical surgery during the period of 1982 through 1987 . After surgery , the patients were r and omized to receive adjuvant chemotherapy ( n = 54 ) ( cyclophosphamide 400 mg/m2 , doxorubicin 40 mg/m2 , and cisplatin 40 mg/m2 [ CAP ] for six cycles ) or no active treatment ( n = 56 ) . RESULTS After 10 years from the start of the study , 61 % of patients were alive in the chemotherapy group and 48 % were alive in the control group ( P = .050 ) . Seventeen patients ( 31 % ) in the CAP group and 27 patients ( 48 % ) in the control group had a recurrence during the follow-up period ( P = .01 ) . The 5-year survival rate was 67 % in the chemotherapy group and was 56 % in the control group ( P = .050 ) . The patients in the chemotherapy group who completed the planned treatment had a slightly better 5-year survival than those whose chemotherapy was discontinued ( 72.5 % v 50.3 % ; P = .15 ) . Chemotherapy-related gastrointestinal toxicity grade 3 to 4 ( WHO ) occurred in 63 % and was the main reason why patients refused further planned therapy . CONCLUSION Our results suggest that patients with NSCLC at pathologic stage I who have undergone radical surgery benefit from adjuvant chemotherapy Background . The effect of adjuvant chemotherapy after resection of nonsmall cell lung cancer ( NSCLC ) remains an unresolved question PURPOSE Based on 5-year or shorter-term follow-up data in recent r and omized trials , adjuvant cisplatin-based chemotherapy is now generally recommended after complete surgical resection for patients with non-small-cell lung cancer ( NSCLC ) . We evaluated the results of the International Adjuvant Lung Cancer Trial study with three additional years of follow-up . PATIENTS AND METHODS Patients with completely resected NSCLC were r and omly assigned to three or four cycles of cisplatin-based chemotherapy or to observation . Cox models were used to evaluate treatment effect according to follow-up duration . Results The trial included 1,867 patients with a median follow-up of 7.5 years . Results showed a beneficial effect of adjuvant chemotherapy on overall survival ( hazard ratio [ HR ] , 0.91 ; 95 % CI , 0.81 to 1.02 ; P = .10 ) and on disease-free survival ( HR , 0.88 ; 95 % CI , 0.78 to 0.98 ; P = .02 ) . However , there was a significant difference between the results of overall survival before and after 5 years of follow-up ( HR , 0.86 ; 95 % CI , 0.76 to 0.97 ; P = .01 v HR , 1.45 ; 95 % CI , 1.02 to 2.07 ; P = .04 ) with P = .006 for interaction . Similar results were observed for disease-free survival . The analysis of non-lung cancer deaths for the whole period showed an HR of 1.34 ( 95 % CI , 0.99 to 1.81 ; P = .06 ) . CONCLUSION These results confirm the significant efficacy of adjuvant chemotherapy at 5 years . The difference in results beyond 5 years of follow-up underscores the need for the long-term follow-up of other adjuvant lung cancer trials and for a better identification of patients deriving long-term benefit from adjuvant chemotherapy ABSTRACT Aim : Adjuvant chemotherapy ( ACT ) is the st and ard of care for Stage II and IIIA NSCLC , and for high risk Stage IB NSCLC . However , the 5-year disease-free survival remains poor ( 35 - 50 % ) and about half of the patients will not receive ACT for various reasons . This Phase III trial investigated whether the recMAGE-A3 + AS15 cancer immunotherapeutic ( MAGE-A3 CI ) as adjuvant therapy improved disease-free survival ( DFS ) in patients with resected NSCLC . Methods : MAGRIT was a r and omized , double-blind , placebo-controlled trial in patients with completely resected MAGE-A3-positive NSCLC Stages IB , II , and IIIA ( TNM version 6 ) and who did or did not receive ACT .  Patients were r and omly assigned ( 2:1 ) to receive 13 intramuscular injections of MAGE-A3 CI or placebo over a 27-month ( m ) treatment period . The three co- primary endpoints were DFS in the overall and in the no-ACT population and DFS in patients with a potentially predictive gene signature ( GS ) . Results : Out of 13,849 patients screened , 4,210 patients had a MAGE-A3 positive tumour sample and 2,272 patients were r and omised and treated . Overall , 52 % of the patients received ACT ; 47 % , 36 % and 17 % were Stage IB , II and IIIA , respectively . Median age was 63 years and 24 % of patients were females .  Mean relative dose intensity was above 98 % in both groups throughout the treatment period . Median follow-up at the time of final analysis was 38.8 m . Median DFS was 60.5 m and 57.9 m respectively for MAGE-A3 CI and placebo ( HR 1.024 , 95 % CI 0.891 - 1.177 ; p = 0.7379 ) . In patients who did not receive ACT , median DFS was 58.0 m and 56.9 m for MAGE-A3 CI and placebo groups , respectively ( HR 0.970 , 95 % CI 0.797 - 1.179 ; p = 0.7572 ) . The rate of grade ≥ 3 adverse events ( 16 % ) did not differ between treatment groups . Conclusions : Treatment of NSCLC patients with MAGE-A3 CI did not increase DFS compared to placebo in either the overall population or in patients who did not receive ACT . Due to the absence of treatment effect , a GS predictive of clinical benefit to MAGE-A3 CI could not be identified . Funding Source : GlaxoSmithKline Biologicals SA . Disclosure : J.F. Vansteenkiste : Pr Vansteenkiste received GSK fees as Primary investigator for the MAGRIT study ; B. Cho : Dr Cho received consultancy fees from Novartis and Boehringer-ingelheim ; T. De Pas : No conflicts of interest . Fee received from GSK as member of steering committee of the study ; J. Jassem : Dr Jassem received grant and personal fees for Consultancy from GSK ; M. Yoshimura : Pr Yoshimura received GSK fees as Primary investigator for the MAGRIT and PEARL study ; H. Nakayama : Dr Nakayama received GSK fees as Primary investigator for the MAGRIT and PEARL study ; T. Mitsudomi : Dr Mitsudomi received personal fees from GSK for an advisory role ; B. Spiessens : Bart Spiessens is employee of GSK and do own stock options of GSK ; V. Brichard : Dr Birchart is GSK employee and do own Stock options from GSK ; C. Debruyne : Dr Debruyne is GSK employee and do own GSK stock options ; P. Therasse : GSK employee and Stock options owner ; N. Altorki : Dr Altorki received GSK fees for trial conduct of GSK studies . All other authors have declared no conflicts of interest PURPOSE Adjuvant chemotherapy for early stage non-small-cell lung cancer ( NSCLC ) is now the st and ard of care , but there is little information regarding its impact on quality of life ( QOL ) . We report the QOL results of JBR.10 , a North American , intergroup , r and omized trial of adjuvant cisplatin and vinorelbine compared with observation in patients who have completely resected , stages IB to II NSCLC . PATIENTS AND METHODS QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 and a trial-specific checklist at baseline and at weeks 5 and 9 for those who received chemotherapy and at follow-up months 3 , 6 , 9 , 12 , 18 , 24 , 30 and 36 . A 10-point change in QOL scores from baseline was considered clinical ly significant . RESULTS Four hundred eighty-two patients were r and omly assigned on JBR.10 . A total of 173 patients ( 82 % of the expected ) in the observation arm and 186 ( 85 % of expected ) in the chemotherapy arm completed baseline QOL assessment s. The two groups were comparable , with low global QOL scores and significant symptom burden , especially pain and fatigue , after thoracotomy . Changes in QOL during chemotherapy were relatively modest ; fatigue , nausea , and vomiting worsened , but there was a reduction in pain and no change in global QOL . Patients in the observation arm showed considerable improvements in QOL by 3 months . QOL , except for symptoms of sensory neuropathy and hearing loss , in those treated with chemotherapy returned to baseline by 9 months . CONCLUSION The findings of this trial indicate that the negative effects of adjuvant chemotherapy on QOL appear to be temporary , and that improvements ( with a return to baseline function ) are likely in most patients
Abstract The purpose of the present review was to determine whether the use of postoperative adjuvant systemic therapy in patients with completely resected non – small‐cell lung cancer ( NSCLC )  improves survival .
Cancer Care Ontario 's Program in Evidence ‐Based Care review ed the evidence to up date previously published recommendations for patients with completely resected NSCLC .