Prophylactic cranial irradiation versus observation in patients with extensive-disease small-cell lung cancer: a multicentre, randomised, open-label, phase 3 trial. Comparative study of prophylactic cranial irradiation in patients with small cell lung cancer achieving a complete response: a long-term follow-up result. Nine‐year Experience: Prophylactic Cranial Irradiation in Extensive Disease Small‐cell Lung Cancer Prophylactic cranial irradiation in extensive small-cell lung cancer. Prophylactic cranial irradiation could improve overall survival in patients with extensive small cell lung cancer : A retrospective study. Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01). Current Patterns of Care for Patients with Extensive‐Stage SCLC: Survey of U.S. Radiation Oncologists on Their Recommendations Regarding Prophylactic Cranial Irradiation Prophylactic cranial irradiation in extensive disease small-cell lung cancer: short-term health-related quality of life and patient reported symptoms: results of an international Phase III randomized controlled trial by the EORTC Radiation Oncology and Lung Cancer Groups. Value of prophylactic cranial irradiation given at complete remission in small cell lung carcinoma. Decline in tested and self-reported cognitive functioning after prophylactic cranial irradiation for lung cancer: pooled secondary analysis of Radiation Therapy Oncology Group randomized trials 0212 and 0214. Controlled clinical trial of prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Prophylactic cranial irradiation in elderly patients with small cell lung cancer: findings from a North Central Cancer Treatment Group pooled analysis.
BACKGROUND Results from a previous phase 3 study suggested that prophylactic cranial irradiation reduces the incidence of symptomatic brain metastases and prolongs overall survival compared with no prophylactic cranial irradiation in patients with extensive-disease small-cell lung cancer . However , because of the absence of brain imaging before enrolment and variations in chemotherapeutic regimens and irradiation doses , concerns have been raised about these findings . We did a phase 3 trial to reassess the efficacy of prophylactic cranial irradiation in the treatment of extensive-disease small-cell lung cancer . METHODS We did this r and omised , open-label , phase 3 study at 47 institutions in Japan . Patients with extensive-disease small-cell lung cancer who had any response to platinum-based doublet chemotherapy and no brain metastases on MRI were r and omly assigned ( 1:1 ) to receive prophylactic cranial irradiation ( 25 Gy in ten daily fractions of 2·5 Gy ) or observation . All patients were required to have brain MRI at 3-month intervals up to 12 months and at 18 and 24 months after enrolment . R and omisation was done by computer-generated allocation sequence , with age as a stratification factor and minimisation by institution , Eastern Cooperative Oncology Group performance status , and response to initial chemotherapy . The primary endpoint was overall survival , analysed in the intention-to-treat population . This trial is registered with the UMIN Clinical Trials Registry , number UMIN000001755 , and is closed to new participants . FINDINGS Between April 3 , 2009 , and July 17 , 2013 , 224 patients were enrolled and r and omly assigned ( 113 to prophylactic cranial irradiation and 111 to observation ) . In the planned interim analysis on June 18 , 2013 , of the first 163 enrolled patients , Bayesian predictive probability of prophylactic cranial irradiation being superior to observation was 0·011 % , result ing in early termination of the study because of futility . In the final analysis , median overall survival was 11·6 months ( 95 % CI 9·5 - 13·3 ) in the prophylactic cranial irradiation group and 13·7 months ( 10·2 - 16·4 ) in the observation group ( hazard ratio 1·27 , 95 % CI 0·96 - 1·68 ; p=0·094 ) . The most frequent grade 3 or worse adverse events at 3 months were anorexia ( six [ 6 % ] of 106 in the prophylactic cranial irradiation group vs two [ 2 % ] of 111 in the observation group ) , malaise ( three [ 3 % ] vs one [ < 1 % ] ) , and muscle weakness in a lower limb ( one [ < 1 % ] vs six [ 5 % ] ) . No treatment-related deaths occurred in either group . INTERPRETATION In this Japanese trial , prophylactic cranial irradiation did not result in longer overall survival compared with observation in patients with extensive-disease small-cell lung cancer .  Prophylactic cranial irradiation is therefore not essential for patients with extensive-disease small-cell lung cancer with any response to initial chemotherapy and a confirmed absence of brain metastases when patients receive periodic MRI examination during follow-up . FUNDING The Ministry of Health , Labour and Welfare of Japan Between 1981 and 1986 , a total of 46 patients with small cell lung cancer ( SCLC ) achieving a complete response by chemotherapy with or without chest irradiation  were r and omized either to receive prophylactic cranial irradiation ( PCI ) or not . With a median follow-up time of 8.5 years for both groups , only five of 23 patients ( 22 % ) in the PCI group developed brain relapse , while 12 out of 23 ( 52 % ) in the no PCI group did so ( P < 0.05 ) . The frequency of patients developing a sole brain relapse during their whole clinical course was 4 % for the PCI group and 17 % for the no PCI group , however , the difference was not statistically significant . Patient survival was better for the PCI group ( median survival time of 21 months , and 5-year survival rate of 22 % ) as compared with the no PCI group ( median survival time of 15 months , and 5-year survival rate of 13 % ) , showing a marginal significance ( P = 0.097 ) . Late neurologic toxicity was infrequent ; only one developed a mild deterioration among seven long-term disease-free survivors in the PCI group . These results appear to warrant further clinical trials to clarify the utility of  PCI  in patients with SCLC achieving a complete response Background In 2007 , the European Organization for Research and Treatment of Cancer ( EORTC ) study ( Clinical Trials.gov identifier , NCT00016211 ) demonstrated a beneficial effect on overall survival ( OS ) with the use of prophylactic cranial irradiation ( PCI ) for extensive disease ( ED ) small‐cell lung cancer ( SCLC ) . Nevertheless , debate is ongoing regarding the role of PCI , because the patients in that trial did not undergo magnetic resonance imaging ( MRI ) of the brain before treatment . Also , a recent Japanese r and omized trial showed a detrimental effect of PCI on OS in patients with negative pretreatment brain MRI findings . Material s and Methods We examined the medical records of 136 patients with ED SCLC who had initially responded to chemotherapy and undergone PCI from 2007 to 2015 . The outcomes , radiation toxicity , neurologic progression‐free survival , and OS after PCI were analyzed . Survival and correlations were calculated using log‐rank and univariate Cox proportional hazard ratio analyses . Results The median OS and the median neurologic progression‐free survival  after PCI was 12 and 19 months , respectively . No significant survival difference was seen for patients who had undergone MRI before PCI compared with patients who had undergone contrast‐enhanced computed tomography ( P = .20 ) . Univariate analysis for OS did not show a statistically significant effect for known cofactors . Conclusion In the present cohort , PCI was associated with improved survival compared with the PCI arm of the EORTC trial , with a nearly doubled median OS period . Also , the median OS was prolonged by 2 months compared with the irradiation arm of the Japanese trial . Micro‐ Abstract In 2007 , a European Organization for Research and Treatment of Cancer ( EORTC ) study demonstrated a beneficial effect on overall survival ( OS ) with the use of prophylactic cranial irradiation ( PCI ) in extensive disease small‐cell lung cancer . Nevertheless , debate is ongoing regarding the role of PCI , because the patients in that trial did not undergo imaging of the brain before treatment . Also , a recent Japanese r and omized trial showed a detrimental effect of PCI on OS in patients with negative pretreatment brain magnetic resonance imaging findings . Of our patients , 87 % underwent brain imaging before PCI . In the present retrospective analysis , we found that PCI leads to a nearly doubled median OS compared with the irradiation arm of the EORTC trial , with a 2‐month prolonged median OS compared with the irradiation arm of the Japanese trial BACKGROUND We conducted a r and omized trial of prophylactic cranial irradiation in patients with extensive small-cell lung cancer who had had a response to chemotherapy . METHODS Patients between the ages of 18 and 75 years with extensive small-cell lung cancer were r and omly assigned to undergo prophylactic cranial irradiation ( irradiation group ) or receive no further therapy ( control group ) . The primary end point was the time to symptomatic brain metastases . Computed tomography or magnetic resonance imaging of the brain was performed when any predefined key symptom suggestive of brain metastases was present . RESULTS The two groups ( each with 143 patients ) were well balanced regarding baseline characteristics . Patients in the irradiation group had a lower risk of symptomatic brain metastases ( hazard ratio , 0.27 ; 95 % confidence interval [ CI ] , 0.16 to 0.44 ; P<0.001 ) . The cumulative risk of brain metastases within 1 year was 14.6 % in the irradiation group ( 95 % CI , 8.3 to 20.9 ) and 40.4 % in the control group ( 95 % CI , 32.1 to 48.6 ) . Irradiation was associated with an increase in median disease-free survival from 12.0 weeks to 14.7 weeks and in median overall survival from 5.4 months to 6.7 months after r and omization . The 1-year survival rate was 27.1 % ( 95 % CI , 19.4 to 35.5 ) in the irradiation group and 13.3 % ( 95 % CI , 8.1 to 19.9 ) in the control group . Irradiation had side effects but did not have a clinical ly significant effect on global health status . CONCLUSIONS Prophylactic cranial irradiation reduces the incidence of symptomatic brain metastases and prolongs disease-free and overall survival . ( Clinical Trials.gov number , NCT00016211 [ Clinical Trials.gov ] . ) OBJECTIVE To evaluate the effect of prophylactic cranial irradiation ( PCI ) on overall survival ( OS ) in patients with extensive small cell lung cancer ( ESCLC ) . METHODS Between April 2005 and May 2014 , 204 patients with ESCLC who had any response ( according to RECIST 1.1 ) to initial chemotherapy were review ed . All patients had undergone appropriate imaging tests to exclude brain metastases before initial chemotherapy . PCI was performed on 45 patients ( 22.1 % ) and the remaining patients ( 77.9 % ) received no such treatment ( control group ) . Primary endpoint was OS . The incidence of brain metastases , brain metastases-free survival ( BMFS ) , and adverse effects were also evaluated . RESULTS Survival data of the 204 patients were analyzed statistically . PCI significantly prolonged median OS from 12.6 to 16.5 months as compared to the control group ( hazard ratio , HR , 0.63 ; 95 % confidence interval , CI , 0.41 to 0.96 ; p = 0.033 ) . PCI significantly lowered the risk of brain metastases ( HR 0.48 ; 95 % CI 0.30 to 0.76 ; p = 0.001 ) . The 1‑year incidence of brain metastases was 17.1 and 55.9 % in the PCI and control group , respectively . PCI significantly correlated with the increased median BMFS ( p = 0.002 ) . Additionally , multivariate analyses demonstrated that PCI was a favorable independent predictor of OS , BMFS , and the incidence of brain metastases . Acute and chronic adverse effects were generally low grade and well tolerated in patients receiving PCI . CONCLUSION PCI after any response to initial chemotherapy significantly improved OS of ESCLC patients analyzed in this study BACKGROUND We recently published the results of the PCI99 r and omised trial comparing the effect of a prophylactic cranial irradiation ( PCI ) at 25 or 36 Gy on the incidence of brain metastases ( BM ) in 720 patients with limited small-cell lung cancer ( SCLC ) . As concerns about neurotoxicity were a major issue surrounding PCI , we report here midterm and long-term repeated evaluation of neurocognitive functions and quality of life ( QoL ) . PATIENTS AND METHODS At predetermined intervals , the European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-C30 and brain module were used for self-reported patient data , whereas the EORTC-Radiation Therapy Oncology Group Late Effects Normal Tissue-Subjective , Objective , Management , Analytic scale was used for clinicians ' assessment . For each scale , the unfavourable status was analysed with a logistic model including age , grade at baseline , time and PCI dose . RESULTS Over the 3 years studied , there was no significant difference between the two groups in any of the 17 selected items assessing QoL and neurological and cognitive functions . We observed in both groups a mild deterioration across time of communication deficit , weakness of legs , intellectual deficit and memory ( all P < 0.005 ) . CONCLUSION Patients should be informed of these potential adverse effects , as well as the benefit of PCI on survival and BM .  PCI with a total dose of 25 Gy remains the st and ard of care in limited-stage SCLC Introduction : Conflicting data from r and omized clinical trials incite the debate over the appropriate use of prophylactic cranial irradiation ( PCI ) for patients with extensive‐stage SCLC ( ES‐SCLC ) who achieve clinical response to systemic chemotherapy . The current pattern of practice among U.S. radiation oncologists is unknown . Methods : We surveyed practicing U.S. radiation oncologists through a short online question naire . Respondents ' characteristics and their self‐rated knowledge base were analyzed for association with their treatment recommendations . Results : We received 473 responses from practicing U.S. radiation oncologists . More than half of the respondents had been practicing for more than 10 years after completing residency training , and 70 % had treated more than 10 patients with lung cancer per year . Of the respondents , 90 % recommended  brain magnetic resonance imaging ( MRI )  before initiation of PCI and 98 % recommended PCI for patients with ES‐SCLC after systemic chemotherapy . Half of the respondents followed their patients with brain MRI after completion of PCI . One‐third of the respondents prescribed memantine to patients undergoing PCI . Among the respondents , recent graduates ( p = 0.004 ) and physicians practicing in academic centers ( p = 0.005 ) were more likely to prescribe memantine . Self‐rated knowledge base was not associated with any treatment recommendations . Conclusions : Our analysis revealed that among the respondents , there was a very high adherence to current National Comprehensive Cancer Network guidelines , which recommend providing universal PCI and obtaining brain MRI before initiation of PCI for patients with ES‐SCLC with clinical response to systemic chemotherapy . These guidelines and practice patterns are not supported by clinical evidence because patients in the European Organization for Research and Treatment of Cancer trial did not undergo brain MRI before PCI and the Japanese r and omized trial has shown a possible detrimental effect of PCI  on overall survival when brain MRI was incorporated . A critical reevaluation of current guidelines is essential to determine the appropriate management of these patients PURPOSE Prophylactic cranial irradiation ( PCI ) in patients with extensive-disease small-cell lung cancer ( ED-SCLC ) leads to significantly fewer symptomatic brain metastases and improved survival . Detailed effects of PCI on health-related quality of life ( HRQOL ) are reported here . PATIENTS AND METHODS Patients ( age , 18 to 75 years ; WHO < or = 2 ) with ED-SCLC , and any response to chemotherapy  , were r and omly assigned to either observation or PCI .  Health-related quality of life ( HRQOL ) and patient-reported symptoms were secondary end points . The European Organisation for the Research and Treatment of Cancer core HRQOL tool ( Quality of Life Question naire C30 ) and brain module ( Quality of Life Question naire Brain Cancer Module ) were used to collect self-reported patient data . Six HRQOL scales were selected as primary HRQOL end points : global health status ; hair loss ; fatigue ; and role , cognitive and emotional functioning . Assessment s were performed at r and om assignment , 6 weeks , 3 months , and then 3-monthly up to 1 year and 6-monthly thereafter . RESULTS Compliance with the HRQOL assessment was 93.7 % at baseline and dropped to 60 % at 6 weeks . Short-term results up to 3 months showed that there was a negative impact of PCI on selected HRQOL scales . The largest mean difference between the two arms was observed for fatigue and hair loss . The impact of PCI on global health status as well as on functioning scores was more limited . For global health status , the observed mean difference was eight points on a scale 0 to 100 at 6 weeks ( P = .018 ) and 3 months ( P = .055 ) . CONCLUSION PCI should be offered to all responding ED SCLC patients . Patients should be informed of the potential adverse effects from PCI . Clinicians should be alert to these ; monitor their patients ; and offer appropriate support , clinical , and psychosocial care The optimal use of " prophylactic " cranial irradiation ( PCI ) in patients with small cell lung cancer remains undetermined . This study review s the impact of PCI , given at complete remission ( CR ) , on neurologic relapse in 172 consecutive patients with small cell lung cancer treated in three sequential chemotherapy protocol s at the University of Maryl and Cancer Center . In the first study of 38 patients , none received PCI . In the second study of 109 patients , the first 28 achieving CR were r and omized to 3000 rad of PCI in ten fractions ( PCI+ ) or to observation ( PCI- ) . Thereafter , based on interim analysis , all patients achieving CR received PCI . In the third study , to date , 25 patients achieving CR have received PCI . Overall , 169 patients were evaluable for neurologic relapse , and 30 of 90 patients achieving CR received PCI . Among all patients with CR , with adjustment for disease extent , there was a significant delay to any neurologic relapse ( P = 0.01 ) and cerebral metastases ( P = 0.02 ) for PCI+ compared to PCI- patients . Among PCI- patients with CR , cerebral metastases alone occurred in 28 % as the sole site and in 33 % as the initial site , whereas cerebral relapse occurred prior to systemic relapse in only one PCI+ patient with CR . Patient survival however , was not significantly altered by PCI . PCI at CR confers effective and worthwhile local control in the CNS , especially during periods of systemic response , and a small percentage of patients may benefit . Systemic drug resistance still determines overall survival PURPOSE To assess the impact of prophylactic cranial irradiation ( PCI ) on self-reported cognitive functioning ( SRCF ) , a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Question naire ( EORTC QLQ-C30 ) . METHODS AND MATERIAL S Radiation Therapy Oncology Group ( RTOG ) protocol 0214 r and omized patients with locally advanced non-small cell lung cancer to PCI or observation ; RTOG 0212 r and omized patients with limited-disease small cell lung cancer to high- or st and ard-dose PCI .  In both trials ,  Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline ( after locoregional therapy but before PCI or observation ) and at 6 and 12 months . Patients developing brain relapse before follow-up evaluation were excluded . Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling . Fisher 's exact test correlated decline in SRCF with HVLT decline . RESULTS Of the eligible patients pooled from RTOG 0212 and RTOG 0214 , 410 ( 93 % ) receiving PCI and 173 ( 96 % ) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis . Prophylactic cranial irradiation was associated with a higher risk of decline in SRCF at 6 months ( odds ratio 3.60 , 95 % confidence interval 2.34 - 6.37 , P<.0001 ) and 12 months ( odds ratio 3.44 , 95 % confidence interval 1.84 - 6.44 , P<.0001 ) . Decline on HVLT-Recall at 6 and 12 months was also associated with PCI ( P=.002 and P=.002 , respectively ) but was not closely correlated with decline in SRCF at the same time points ( P=.05 and P=.86 , respectively ) . CONCLUSIONS In lung cancer patients who do not develop brain relapse , PCI is associated with decline in HVLT-tested and self-reported cognitive functioning . Decline in HVLT and decline in SRCF are not closely correlated , suggesting that they may represent distinct elements of the cognitive spectrum We conducted a r and omised clinical trial on 211 patients with small-cell lung cancer in complete remission ( CR ) . The aim of this trial was to evaluate the effect of prophylactic cranial irradiation ( PCI ) on overall survival .  Eligible patients were r and omly assigned to receive either PCI ( 100 patients ) or no PCI ( 111 patients ) . Each centre was allowed to use its own PCI protocol as long as the total dose was within the range of 24 - 30 Gy and delivered in less than 3 weeks with fractions of 3 Gy or less . The mean follow-up is 5 years . The survival curves do not differ significantly ( P = 0.25 ) between the two groups . The 4-year overall survival rate ( 95 % confidence interval ) is 22 % [ 15 - 32 % ] in the PCI group versus 16 % [ 10 - 25 % ] in the control group . The relative risk of death in the PCI group compared to the control group is 0.84 ( 95 % CI = [ 0.62 - 1.13 ] ) . The incidence of brain metastasis is lower in the PCI group , but the difference is not statistically significant ( P = 0.14 ) . The 4-year cumulative rate of brain metastasis is 44 % [ 32 - 57 % ] in the PCI group compared to 51 % [ 38 - 63 % ] in the control group . In conclusion , in this study , which had to be closed prematurely , no significant difference was found in terms of the incidence of brain metastases nor in survival BACKGROUND Prophylactic cranial irradiation in patients with small-cell lung cancer decreases the overall rate of brain metastases without an effect on overall survival . It has been suggested that this treatment may increase neuropsychological syndromes and brain abnormalities indicated by computed tomography scans . However , other retrospective data suggested a beneficial effect on overall survival for patients in complete remission . PURPOSE Our purpose was to evaluate the effects of prophylactic cranial irradiation on brain metastasis , overall survival , and late-occurring toxic effects in patients with small-cell lung cancer in complete remission . METHODS We conducted a prospect i ve study of 300 patients who had small-cell lung cancer that was in complete remission . The patients were r and omly assigned to receive either prophylactic cranial irradiation delivering 24 Gy in eight fractions during 12 days ( treatment group ) or no prophylactic cranial irradiation ( control group ) . A neuropsychological examination and a computed tomography scan of the brain were performed at the time of r and om assignment and repeatedly assessed at 6 , 18 , 30 , and 48 months . Patterns of failure were analyzed according to total event rates and also according to an isolated first site of relapse , using a competing-risk approach . RESULTS Two hundred ninety-four patients who did not have brain metastases at the time of r and om assignment were analyzed . The 2-year cumulative rate of brain metastasis as an isolated first site of relapse was 45 % in the control group and 19 % in the treatment group ( P < 10(-6 ) ) . The total 2-year rate of brain metastasis was 67 % and 40 % , respectively ( relative risk = 0.35 ; P < 10(-13 ) ) . The 2-year overall survival rate was 21.5 % in the control group and 29 % in the treatment group ( relative risk = 0.83 ; P = .14 ) . There were no significant differences between the two groups in terms of neuropsychological function or abnormalities indicated by computed tomography brain scans . CONCLUSIONS Prophylactic cranial irradiation given to patients with small-cell lung cancer in complete remission decreases the risk of brain metastasis threefold without a significant increase in complications . A possible beneficial effect on overall survival should be tested with a higher statistical power . IMPLICATION S The results of the trial favor , at present , the indication of prophylactic cranial irradiation for patients who are in complete remission . A longer follow-up and confirmatory trials are needed to fully assess late-occurring toxic effects . The possible effect on overall survival needs to be evaluated with a larger number of patients in complete remission , and a meta- analysis of similar trials is recommended PURPOSE To determine the effect of dose and fractionation schedule of prophylactic cranial irradiation ( PCI ) on the incidence of chronic neurotoxicity ( CNt ) and changes in quality of life for selected patients with limited-disease small-cell lung cancer ( LD SCLC ) . METHODS AND MATERIAL S Patients with LD SCLC who achieved a complete response after chemotherapy and thoracic irradiation  were eligible for r and omization to undergo PCI to a total dose of 25 Gy in 10 daily fractions ( Arm 1 ) vs. the experimental cohort of 36 Gy . Those receiving 36 Gy underwent a secondary r and omization between daily 18 fractions ( Arm 2 ) and twice-daily 24 fractions ( Arm 3 ) . Enrolled patients participated in baseline and follow-up neuropsychological test batteries along with quality -of-life assessment s. RESULTS A total of 265 patients were accrued , with 131 in Arm 1 , 67 in Arm 2 , and 66 in Arm 3 being eligible . There are 112 patients ( 42.2 % ) alive with 25.3 months of median follow-up . There were no significant baseline differences among groups regarding quality -of-life measures and one of the neuropsychological tests , namely the Hopkins Verbal Learning Test . However , at 12 months after PCI there was a significant increase in the occurrence of CNt in the 36-Gy cohort ( p=0.02 ) . Logistic regression analysis revealed increasing age to be the most significant predictor of CNt ( p=0.005 ) . CONCLUSIONS Because of the increased risk of developing CNt in study patients with 36 Gy , a total PCI dose of 25 Gy remains the st and ard of care for patients with LD SCLC attaining a complete response to initial chemoradiation OBJECTIVES To examine the efficacy of prophylactic cranial irradiation ( PCI ) in elderly patients with small cell lung cancer ( SCLC ) ( ≥70 years of age ) from a pooled analysis of four prospect i ve trials . MATERIAL S & METHODS One hundred fifty-five patients with SCLC ( limited stage , LSCLC , and extensive stage , ESCLC ) participated in four phase II or III trials . Ninety-one patients received  PCI ( 30 Gy/15 or 25 Gy/10 ) and 64 patients did  not receive PCI .  Survival was compared in a l and mark analysis that included only patients who had stable disease or better in response to primary therapy . RESULTS Patients who received PCI  had better survival than patients who did not receive PCI ( median survival 12.0 months vs. 7.6 months , 3-year overall survival 13.2 % vs. 3.1 % , HR = 0.53 [ 95 % CI 0.36 - 0.78 ] , p = 0.001 ) . On multivariate analysis of the entire cohort , the only factor that remained significant for survival was stage ( ESCLC vs. LSCLC , p = 0.0072 ) . In contrast , the multivariate analysis of patients who had ESCLC revealed that PCI was the sole factor associated with a survival advantage ( HR = 0.47 [ 95 % CI 0.24 - 0.93 ] , p = 0.03 ) . Grade 3 or higher adverse events ( AEs ) were significantly greater in patients who received PCI ( 71.4 % vs. 47.5 % , p = 0.0031 ) , with non-neuro and non-heme being the specific AE categories most strongly correlated with PCI delivery . CONCLUSIONS PCI was associated with a significant improvement in survival for our entire elderly SCLC patient cohort on univariate analysis . Multivariate analysis suggested that the survival advantage remained significant in patients with ESCLC . PCI was also associated with a modest increase in grade 3 or higher AEs
Background The efficacy of prophylactic cranial irradiation ( PCI ) in treating patients with small cell lung cancer ( SCLC ) has not been clear , and recent r and omized studies have demonstrated conflicting results from previously published findings .
The purpose of this study was to reevaluate the efficacy of PCI in patients with SCLC and to assess factors associated with its efficacy .
Methods We conducted a quantitative meta- analysis to explore the efficacy of PCI in patients with SCLC .