Comparison of clinical outcome of stage I non-small cell lung cancer treated surgically or with stereotactic radiotherapy: results from propensity score analysis. Stereotactic body radiation therapy versus conventional radiation therapy in patients with early stage non-small cell lung cancer: An updated retrospective study on local failure and survival rates Stage I-II non-small-cell lung cancer treated using either stereotactic ablative radiotherapy (SABR) or lobectomy by video-assisted thoracoscopic surgery (VATS): outcomes of a propensity score-matched analysis. A propensity-matched analysis of surgery and stereotactic body radiotherapy for early stage non-small cell lung cancer in the elderly A propensity-matched analysis of wedge resection and stereotactic body radiotherapy for early stage lung cancer. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves Clinical outcomes of stereotactic body radiotherapy for stage I non-small cell lung cancer using different doses depending on tumor size Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer Tumors Greater Than 5 cm: Safety and Efficacy. Patterns of Failure after Stereotactic Body Radiation Therapy or Lobar Resection for Clinical Stage I Non–Small-Cell Lung Cancer Management of Single Malignant Lung Nodules in Elderly Patients (70 Years or Older) Who are Not Candidates for Lobectomy Stereotactic Body Radiation Therapy Versus Surgery for Early Lung Cancer Among US Veterans. Video‐assisted thoracoscopic lobectomy is associated with greater recurrence‐free survival than stereotactic body radiotherapy for clinical stage I lung cancer Comparative effectiveness of 5 treatment strategies for early-stage non-small cell lung cancer in the elderly. Outcomes after stereotactic lung radiotherapy or wedge resection for stage I non-small-cell lung cancer. Outcome in a prospective phase II trial of medically inoperable stage I non-small-cell lung cancer patients treated with stereotactic body radiotherapy. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Stereotactic body radiation therapy for inoperable early stage lung cancer. Stereotactic body radiation therapy for early-stage non-small cell lung cancer: Executive Summary of an ASTRO Evidence-Based Guideline. Analysis of stereotactic radiation vs. wedge resection vs. wedge resection plus Cesium-131 brachytherapy in early stage lung cancer. Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. A comparison of surgical intervention and stereotactic body radiation therapy for stage I lung cancer in high-risk patients: a decision analysis.
OBJECTIVES Guideline -specified curative therapies for a clinical stage I non-small cell lung cancer ( NSCLC ) are either lobectomy or Stereotactic Ablative Radiotherapy ( SABR ) . As outcomes of prospect i ve r and omized clinical trials comparing these modalities are unavailable , we performed a propensity-score matched analysis to create two similar groups in order to compare clinical outcomes . METHODS We selected 577 patients , 96 VATS or open lobectomy were treated at Erasmus University Medical Center Rotterdam and 481 SABR patients were treated at VU University Medical Center Amsterdam with clinical stage I NSCLC . RESULTS Matching of patients according to propensity score result ed in a cohort that consisted of 73 patients in the surgery group and of 73 patients in the SABR group . Median follow-up in the surgery and SABR group was 49 months and 28 months , respectively . Overall survival of patients who underwent surgery was 95 % and 80 % at 12 and 60 months , respectively . For the SABR group this was 94 % at 12 months and 53 % at 60 months . No statistical significant difference ( p=0.089 ) in survival was found between these groups . CONCLUSIONS In this study we found no significant differences in overall survival in propensity matched patients diagnosed with stage I NSCLC treated either surgically or with SABR . After 3 years there seems to be a trend toward improved survival in patients who were treated surgically Abstract Introduction . Stereotactic body radiation therapy ( SBRT ) for early stage non-small cell lung cancer ( NSCLC ) is now an accepted and patient friendly treatment , but still controversy exists about its comparability to conventional radiation therapy ( RT ) . The purpose of this single-institutional report is to describe survival outcome for medically inoperable patients with early stage NSCLC treated with SBRT compared with high dose conventional RT . Material and methods . From August 2005 to June 2012 , 100 medically inoperable patients were treated with SBRT at Odense University Hospital . The thoracic RT consisted of 3 fractions ( F ) of 15–22 Gy delivered in nine days . For comparison a group of 32 medically inoperable patients treated with conventional RT with 80 Gy/35–40  F ( 5 F/week ) in the period of July 1998 to August 2011 were analyzed . All tumors had histological or cytological proven NSCLC T1 - 2N0M0 . Results . The median overall survival was 36.1 months versus 24.4 months for SBRT and conventional RT , respectively ( p = 0.015 ) . Local failure-free survival rates at one year were in SBRT group 93 % versus 89 % in the conventional RT group and at five years 69 % versus 66 % , SBRT and conventional RT respectively ( p = 0.99 ) . On multivariate analysis , female gender and performance status of 0–1 and SBRT predicted improved prognosis . Conclusion . In a cohort of patients with NSCLC there was a significant difference in overall survival  favoring SBRT . Performance status of 0–1 , female gender and SBRT predicted improved prognosis . However , staging procedure , confirmation procedure of recurrence and technical improvements of radiation treatment is likely to influence outcomes . However , SBRT seems to be as efficient as conventional RT and is a more convenient treatment for the patients BACKGROUND Video-assisted thoracoscopic surgery ( VATS ) lobectomy and stereotactic ablative radiotherapy ( SABR ) are both used for early-stage non-small-cell lung cancer . We carried out a propensity score-matched analysis to compare locoregional control ( LRC ) . PATIENTS AND METHODS  VATS lobectomy data from six hospitals were retrospectively accessed ; SABR data were obtained from a single institution data base . Patients were matched using propensity scores based on cTNM stage , age , gender , Charlson comorbidity score , lung function and performance score . Eighty-six VATS and 527 SABR patients were matched blinded to outcome ( 1:1 ratio , caliper distance 0.025 ) . Locoregional failure was defined as recurrence in/adjacent to the planning target volume/surgical margins , ipsilateral hilum or mediastinum . Recurrences were either biopsy-confirmed or had to be PET-positive and review ed by a tumor board . RESULTS The matched cohort consisted of 64 SABR and 64 VATS patients with the median follow-up of 30 and 16 months , respectively . Post-SABR LRC rates were superior at 1 and 3 years ( 96.8 % and 93.3 % versus 86.9 % and 82.6 % , respectively , P = 0.04 ) . Distant recurrences and overall survival ( OS ) were not significantly different . CONCLUSION This retrospective analysis found a superior LRC after SABR compared with VATS lobectomy , but OS did not differ . Our findings support the need to compare both treatments in a r and omized , controlled trial Abstract Elderly patients with early stage non-small cell lung cancer ( NSCLC ) who undergo surgical resection  are at a high risk of treatment-related complications . Stereotactic body radiation therapy ( SBRT ) is considered an alternative treatment option with a favorable safety profile . Given that prospect i ve comparative data on SBRT and surgical treatments are limited , we compared the 2 treatments for early stage NSCLC in the elderly . We retrospectively collected information from the data base at our geriatric institution on patients with clinical stage IA/B NSCLC who were treated with surgery or SBRT .  The patients were matched using a propensity score based on gender , age , T stage , tumor location , pulmonary function ( forced expiratory volume in 1 second [FEV1]% and FEV1 ) , Charlson comorbidity score , and World Health Organization performance score . We compared locoregional control rate , recurrence-free survival ( RFS ) , overall survival ( OS ) , and cancer-specific survival ( CSS ) between the 2 treatment cohorts before and after propensity score matching . A total of 106 patients underwent surgery , and 74 received SBRT . Surgical patients were significantly younger ( 72.6 ± 7.9 vs 82.6 ± 4.1 years , P = 0.000 ) , with a significantly higher rate of adenocarcinoma ( P = 0.000 ) , better Eastern Cooperative Oncology Group performance scores ( P = 0.039 ) , and better pulmonary function test results ( P = 0.034 for predicted FEV1 and P = 0.032 for FEV1 ) . In an unmatched comparison , there were significant differences in locoregional control ( P = 0.0012 ) and RFS ( P < 0.001 ) . The 5-year OS was 69 % in patients who underwent surgery and 44.6 % in patients who underwent SBRT ( P = 0.0007 ) . The 5-year CSS was 73.9 % in the surgery group and 57.5 % in the SBRT group ( P = 0.0029 ) . Thirty-five inoperable or marginally operable surgical patients and 35 patients who underwent SBRT were matched to their outcomes in a blinded manner ( 1:1 ratio , caliper distance = 0.25 ) . In this matched comparison , the follow-up period of this subgroup ranged from 4.2 to 138.1 months , with a median of 58.7 months . Surgery was associated with significantly better locoregional control ( P = 0.0191 ) and RFS ( P = 0.0178 ) , whereas no significant differences were found in OS ( 5-year OS , 67.8 % for surgery vs 47.4 % for SBRT , P = 0.07 ) or CSS ( 67.8 % for surgery vs 58.2 % for SBRT , P = 0.1816).This retrospective analysis found superior locoregional control rates and RFS after surgery compared with SBRT , but there were no differences in OS or CSS .  SBRT is an alternative treatment option to surgery in elderly NSCLC patients who can not tolerate surgical resection because of medical comorbidities . Our findings support the need to compare the 2 treatments in r and omized controlled trials BACKGROUND Patients who present with early stage non-small cell lung cancer and are poor c and i date s for lobar resection may be offered sublobar resection ( commonly wedge ) or stereotactic body radiotherapy ( SBRT ) . However , comparing the relative effectiveness of these techniques is difficult because of differences in patient selection . We performed a propensity-matched analysis to compare the different treatment modalities . We compared the overall recurrence , overall survival , disease-free survival , and recurrence-free survival between treatment groups . METHODS A prospect ively collected data base was review ed for patients who underwent a wedge resection , a wedge plus brachytherapy , or SBRT for clinical stage IA non-small cell lung cancer from 2001 to 2012 . Patients who underwent SBRT were further assessed to confirm operability . Univariate and Cox regression multivariate analysis were performed for predictors of a composite end point of recurrence and mortality . RESULTS There were 164 patients identified , from which 99 were matched by age , sex , and histology . There were 61 women ( 62 % ) and 38 men ( 38 % ) with a median age of 73 years . Thirty-eight patients underwent a wedge resection only , 38 patients underwent a wedge with brachytherapy , and 23 patients had SBRT . Median follow-up was 35 months . Overall recurrence ( local and distant ) was significantly higher after SBRT ( wedge , 9 % ; SBRT , 30 % ; p = 0.016 ) . Although recurrence-free 3 -year survival was significantly better after wedge resection ( 88 % versus 72 % ; p = 0.001 ) , there was no difference between the two groups in disease-free 3-year survival ( 77 % versus 59 % ; p = 0.066 ) . Multivariate regression analysis identified male sex and SBRT as significant predictors for mortality and recurrence . CONCLUSIONS Patients with clinical stage IA non-small cell lung cancer treated by SBRT appear to have higher overall disease recurrence than those treated by wedge resection . However , there was no significant difference in disease-free survival . A r and omized trial is needed to define the role of SBRT in the potentially operable patient Background The results of R and omized Controlled Trials ( RCTs ) on time-to-event outcomes that are usually reported are median time to events and Cox Hazard Ratio . These do not constitute the sufficient statistics required for meta- analysis or cost-effectiveness analysis , and their use in secondary analyses requires strong assumptions that may not have been adequately tested . In order to enhance the quality of secondary data analyses , we propose a method which derives from the published Kaplan Meier survival curves a close approximation to the original individual patient time-to-event data from which they were generated . Methods We develop an algorithm that maps from digitised curves back to KM data by finding numerical solutions to the inverted KM equations , using where available information on number of events and numbers at risk . The reproducibility and accuracy of survival probabilities , median survival times and hazard ratios based on reconstructed KM data was assessed by comparing published statistics ( survival probabilities , medians and hazard ratios ) with statistics based on repeated reconstructions by multiple observers . Results The validation exercise established there was no material systematic error and that there was a high degree of reproducibility for all statistics . Accuracy was excellent for survival probabilities and medians , for hazard ratios reasonable accuracy can only be obtained if at least numbers at risk or total number of events are reported . Conclusion The algorithm is a reliable tool for meta- analysis and cost-effectiveness analyses of RCTs reporting time-to-event data . It is recommended that all RCTs should report information on numbers at risk and total number of events alongside KM curves Background The treatment schedules for stereotactic body radiotherapy ( SBRT ) for lung cancer vary from institution to institution . Several reports have indicated that stage IB patients had worse outcomes than stage IA patients when the same dose was used . We evaluated the clinical outcomes of SBRT for stage I non-small cell lung cancer ( NSCLC ) treated with different doses depending on tumor diameter . Methods Between February 2004 and November 2008 , 124 patients with stage I NSCLC underwent SBRT .  Total doses of 44 , 48 , and 52 Gy were administered for tumors with a longest diameter of less than 1.5 cm , 1.5 - 3 cm , and larger than 3 cm , respectively . All doses were given in 4 fractions . Results For all 124 patients , overall survival was 71 % , cause-specific survival was 87 % , progression-free survival was 60 % , and local control was 80 % , at 3 years . The 3-year overall survival was 79 % for 85 stage IA patients treated with 48 Gy and 56 % for 37 stage IB patients treated with 52 Gy ( p = 0.05 ) . At 3 years , cause-specific survival was 91 % for the former group and 79 % for the latter ( p = 0.18 ) , and progression-free survival was 62 % versus 54 % ( p = 0.30 ) . The 3-year local control rate was 81 % versus 74 % ( p = 0.35 ) . The cumulative incidence of grade 2 or 3 radiation pneumonitis was 11 % in stage IA patients and 30 % in stage IB patients ( p = 0.02 ) . Conclusions There was no difference in local control between stage IA and IB tumors despite the difference in tumor size . The benefit of increasing the SBRT dose for larger tumors should be investigated further PURPOSE The purpose of this study was to determine outcomes of patients with node-negative medically inoperable non-small cell lung cancer ( NSCLC ) whose primary tumors exceeded 5 cm and were treated with stereotactic body radiation therapy ( SBRT ) . METHODS AND MATERIAL S We surveyed our institutional prospect i ve lung SBRT registry to identify treated patients with tumors > 5 cm . Treatment outcomes for local control ( LC ) , locoregional control ( LRC ) , disease-free survival ( DFS ) , and overall survival ( OS ) were assessed by Kaplan-Meier estimates . Toxicities were grade d according to Common Terminology Criteria for Adverse Events version 4 . Mean pretreatment pulmonary function test values were compared to mean posttreatment values . RESULTS From December 2003 to July 2014 , 40 patients met study criteria . Median follow-up was 10.8 months ( range : 0.4 - 70.3 months ) . Median age was 76 years ( range : 56 - 90 years ) , median body mass index was 24.3 ( range : 17.7 - 37.2 ) , median Karnofsky performance score was 80 ( range : 60 - 90 ) , and median Charlson comorbidity index score was 2 ( range : 0 - 5 ) . Median forced expiratory volume in 1 second ( FEV1 ) was 1.41 L ( range : 0.47 - 3.67 L ) , and median diffusion capacity ( DLCO ) was 47 % of predicted ( range : 29%-80 % ) . All patients were staged by fluorodeoxyglucose-positron emission tomography/computed tomography staging , and 47.5 % underwent mediastinal staging by endobronchial ultrasonography . Median tumor size was 5.6 cm ( range : 5.1 - 10 cm ) , median SBRT dose was 50 Gy ( range : 30 - 60 Gy ) in 5 fractions ( range : 3 - 10 fractions ) . Eighteen-month LC , LRC , DFS , and OS rates were 91.2 % , 64.4 % , 34.6 % , and 59.7 % , respectively . Distant failure was the predominant pattern of failure ( 32.5 % ) . Three patients ( 7.5 % ) experienced grade 3 or higher toxicity . Mean posttreatment FEV1 was not significantly reduced ( P=.51 ) , but a statistically significant absolute 6.5 % ( P=.03 ) reduction in DLCO was observed . CONCLUSIONS Lung SBRT for medically inoperable node-negative NSCLC with primary tumors larger than 5 cm is safe and provides excellent local control with limited toxicity . The predominant pattern of failure in this population was distant failure Introduction : The purpose of this study was to compare patterns of failure between lobar resection ( lobectomy or pneumonectomy ) and stereotactic body radiation therapy ( SBRT ) for patients with clinical stage I non – small-cell lung cancer ( NSCLC ) . Methods : From January 2004 to January 2008 , 338 patients underwent definitive treatment for pathologically confirmed clinical stage I NSCLC with lobar resection ( n = 260 ) or SBRT ( n = 78 ) . Most surgical patients underwent  lobectomy ( n = 237 ) . SBRT patients received a biologically effective dose of at least 100 Gy10 . Lobar resection patients were younger , healthier , and had superior pulmonary function , whereas most of the patients in the SBRT group had T1 tumors . Final pathology upstaged 32.7 % of surgery patients , and 20.0 % received adjuvant chemotherapy . No SBRT patients received adjuvant chemotherapy . Results : In an unmatched comparison , 4-year lobar local control ( 98.7 % versus 93.6 % , p = 0.015 ) was greater for lobar resection versus SBRT , respectively , though primary tumor ( 98.7 % versus 95.3 % , p = 0.088 ) , regional ( 82.9 % versus 78.1 % , p = 0.912 ) , and distant control ( 76.1 % versus 54.0 % , p = 0.152 ) were similar . Overall survival ( OS , 63.5 % versus 29.6 % , p < 0.0001 ) was greater for lobar resection , though cause-specific survival ( CSS , 81.3 % versus 75.3 % , p = 0.923 ) was similar . In a T-stage matched comparison of 152 patients , there was no significant difference in patterns of failure or CSS , whereas OS favored surgery . Conclusion : Lobectomy/pneumonectomy or SBRT results in comparable patterns of failure for clinical stage I NSCLC . In this retrospective comparison , OS was superior for surgery , though CSS was similar . R and omized trials are necessary to control for fundamental differences in comorbidity , which impact interpretation of both tumor control and survival Purpose The aim of this study was to evaluate and compare sublobar resection plus intraoperative seed implant ( IOS ) versus stereotactic body radiation therapy ( SBRT ) in patients with single malignant lung nodules in patients 70 years of age or older . Material s and Methods A retrospective chart review was performed and 47 patients with adequate information were selected for analysis . Thirty patients with single malignant lung nodules received SBRT .  Seventeen patients received limited surgical resection plus radioactive seed implantation for solitary malignant lung nodules . Univariate statistical analysis showed a significant difference only for the age in the 2 groups : the mean age in the radioactive seed group , 78.8 years versus 76.1 years in the SBRT group ( 2-sided , P=0.05 ) . Results There was high local control and minimal toxicity with either treatment modality and no significant difference among the 2 groups in terms of local control , survival , and toxicity . However , the distant failure was higher but not statistically significant in the SBRT group ( 9 of 30 patients in SBRT vs. 0 of 17 in IOS , P=0.1 ) . Conclusions Our study has shown excellent outcomes and limited toxicity in both IOS and SBRT for treatment of single malignant lung nodules in patients who are not c and i date s for lobectomy . However , a r and omized trial is needed in this group of elderly patients to determine the most appropriate treatment BACKGROUND Stereotactic body radiation therapy ( SBRT ) has been proposed as a potential alternative to surgery for early lung cancer , although we lack well-powered prospect i ve r and omized data comparing these treatments , and existing studies suffer from incomplete information on confounders that can bias results . Here , we evaluated the comparative effectiveness of surgery  and  SBRT  in lung cancer treatment using a large extensively detailed data base from the Veteran 's Affairs system . METHODS We identified veterans with biopsy-proven clinical stage I non-small cell lung cancer diagnosed between 2006 and 2015 from within the Veteran 's Affairs Informatics and Computing Infrastructure . We compared cancer-specific survival among patients receiving lobectomy , sublobar resection , or SBRT  using univariable and multivariable competing risk analyses . Multivariable analyses adjusted for confounders including preoperative pulmonary function , smoking status , comorbidity , and staging workup procedures . RESULTS In all , 4,069 patients were included ( 449 SBRT , 2,986 lobectomy , 634 sublobar resection ) . Unadjusted analysis found higher immediate postprocedural mortality in the surgery groups compared with the SBRT group . The multivariable analysis considering long-term survival found higher cancer-specific mortality for SBRT compared with lobectomy ( subdistribution hazard ratio 1.45 , 95 % confidence interval : 1.09 to 1.94 , p = 0.01 ) , although no survival difference between SBRT and sublobar resection ( subdistribution hazard ratio 1.25 , 95 % confidence interval : 0.93 to 1.68 , p = 0.15 ) . CONCLUSIONS Among a large cohort of early stage lung cancer patients , we found that lobectomy had improved survival compared with SBRT , although we found no survival difference between sublobar resection and SBRT . Despite these findings , the potential for unmeasured confounding remains and prospect i ve r and omized trials are needed to better compare these treatment modalities Objective Stereotactic body radiotherapy is the st and ard treatment for medically inoperable early‐stage non – small cell lung cancer . Recent data suggest that in operable patients , stereotactic body radiotherapy produces outcomes comparable to those of surgical resection . In veterans with early non – small cell lung cancer , we compared the outcomes of stereotactic body radiotherapy and video‐assisted thoracoscopic lobectomy . Methods We retrospectively review ed data from 183 patients ( 94.0 % male ) with clinical stage I non – small cell lung cancer who underwent stereotactic body radiotherapy ( n = 56 ) or video‐assisted thoracoscopic lobectomy ( n = 127 ) from 2009 to 2014 . Propensity matching was used to produce more comparable groups . Primary end points were tumor control and overall , recurrence‐free , and lung‐cancer – specific survival , as estimated by Kaplan – Meier actuarial analysis . Multivariable analysis was used to identify independent predictors . Results In the overall cohort , the patients who received stereotactic body radiotherapy were older than the patients who received video‐assisted thoracoscopic lobectomy  ( median age , 79.5 vs 64 years ) and had more comorbidities . In the 37 propensity‐matched pairs , the 3‐year actuarial tumor control rate was 54.3 % after stereotactic body radiotherapy and 90.6 % after video‐assisted thoracoscopic lobectomy ( P = .0038 ) . Actuarial lung cancer – specific 3‐year survival was 78.1 % ( stereotactic body radiotherapy ) versus 93.6 % ( video‐assisted thoracoscopic lobectomy ) ( P = .055 ) . One‐year overall , 3‐year overall , and 3‐year recurrence‐free survivals were 89.2 % , 52.9 % , and 38.5 % after stereotactic body radiotherapy and 94.6 % , 85.7 % , and 82.8 % after video‐assisted thoracoscopic lobectomy ( P < .005 for all ) , respectively . In multivariable analysis , stereotactic body radiotherapy independently predicted recurrence and poorer survival . Conclusions In veteran patients with early‐stage non – small cell lung cancer , video‐assisted thoracoscopic lobectomy result ed in better disease control and survival than stereotactic body radiotherapy . Although prior reports suggest that stereotactic body radiotherapy is a suitable alternative to surgery in early‐stage lung cancer , a prospect i ve r and omized trial is needed . Nevertheless , stereotactic body radiotherapy remains a suitable option for medically inoperable patients PURPOSE The incidence of early-stage non-small cell lung cancer ( NSCLC ) among older adults is expected to increase because of demographic trends and computed tomography-based screening ; yet , optimal treatment in the elderly remains controversial . Using the Surveillance , Epidemiology , and End Results (SEER)-Medicare cohort spanning 2001 - 2007 , we compared survival outcomes associated with 5 strategies used in contemporary practice : lobectomy , sublobar resection , conventional radiation therapy , stereotactic ablative radiation therapy ( SABR ) , and observation . METHODS AND MATERIAL S Treatment strategy and covariates were determined in 10,923 patients aged ≥ 66 years with stage IA-IB NSCLC . Cox regression , adjusted for patient and tumor factors , compared overall and disease-specific survival for the 5 strategies . In a second exploratory analysis , propensity-score matching was used for comparison of SABR with other options . RESULTS The median age was 75 years , and 29 % had moderate to severe comorbidities . Treatment distribution was lobectomy ( 59 % ) , sublobar resection ( 11.7 % ) , conventional radiation ( 14.8 % ) , observation ( 12.6 % ) , and SABR ( 1.1 % ) . In Cox regression analysis with a median follow-up time of 3.2 years , SABR was associated with the lowest risk of death within 6 months of diagnosis ( hazard ratio [ HR ] 0.48 ; 95 % confidence interval [ CI ] 0.38 - 0.63 ; referent is lobectomy ) . After 6 months , lobectomy was associated with the best overall and disease-specific survival . In the propensity-score matched analysis , survival after SABR was similar to that after lobectomy ( HR 0.71 ; 95 % CI 0.45 - 1.12 ; referent is SABR ) . Conventional radiation and observation were associated with poor outcomes in all analyses . CONCLUSIONS In this population -based experience , lobectomy was associated with the best long-term outcomes in fit elderly patients with early-stage NSCLC . Exploratory analysis of SABR early adopters suggests efficacy comparable with that of surgery in select population s. Evaluation of these therapies in r and omized trials is urgently needed PURPOSE To compare outcomes between lung stereotactic radiotherapy ( SBRT ) and wedge resection for stage I non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS One hundred twenty-four patients with T1 - 2N0 NSCLC underwent wedge resection ( n = 69 ) or image-guided lung SBRT ( n = 58 ) from February 2003 through August 2008 . All were ineligible for anatomic lobectomy ; of those receiving SBRT  , 95 % were medically inoperable , with 5 % refusing surgery . Mean forced expiratory volume in 1 second and diffusing capacity of lung for carbon monoxide were 1.39 L and 12.0 mL/min/mmHg for wedge versus 1.31 L and 10.14 mL/min/mmHg for SBRT ( P = not significant ) . Mean Charlson comorbidity index and median age were 3 and 74 years for wedge versus 4 and 78 years for SBRT ( P < .01 , P = .04 ) . SBRT was volumetrically prescribed as 48 ( T1 ) or 60 ( T2 ) Gy in four to five fractions . Results Median potential follow-up is 2.5 years . At 30 months , no significant differences were identified in regional recurrence ( RR ) , locoregional recurrence ( LRR ) , distant metastasis ( DM ) , or freedom from any failure ( FFF ) between the two groups ( P > .16 ) . SBRT reduced the risk of local recurrence ( LR ) , 4 % versus 20 % for wedge ( P = .07 ) . Overall survival ( OS ) was higher with wedge but cause-specific survival ( CSS ) was identical . Results excluding synchronous primaries , nonbiopsied tumors , or pathologic T4 disease ( wedge satellite lesion ) showed reduced LR ( 5 % v 24 % , P = .05 ) , RR ( 0 % v 18 % , P = .07 ) , and LRR ( 5 % v 29 % , P = .03 ) with SBRT . There were no differences in DM , FFF , or CSS , but OS was higher with wedge . CONCLUSION Both lung SBRT and wedge resection are reasonable treatment options for stage I NSCLC patients ineligible for anatomic lobectomy .  SBRT  reduced LR , RR , and LRR . In this nonr and omized population of patients selected for surgery versus SBRT ( medically inoperable ) at physician discretion , OS was higher in surgical patients . SBRT and surgery , however , had identical CSS PURPOSE The impact of stereotactic body radiotherapy ( SBRT ) on 3-year progression-free survival of medically inoperable patients with stage I non-small-cell lung cancer ( NSCLC ) was analyzed in a prospect i ve phase II study . PATIENTS AND METHODS Fifty-seven patients with T1NOMO ( 70 % ) and T2N0M0 ( 30 % ) were included between August 2003 and September 2005 at seven different centers in Sweden , Norway , and Denmark and observed up to 36 months . SBRT was delivered with 15 Gy times three at the 67 % isodose of the planning target volume . RESULTS Progression-free survival at 3 years was 52 % . Overall- and cancer-specific survival at 1 , 2 , and 3 years was 86 % , 65 % , 60 % , and 93 % , 88 % , 88 % , respectively . There was no statistically significant difference in survival between patients with T1 or T2 tumors . At a median follow-up of 35 months ( range , 4 to 47 months ) , 27 patients ( 47 % ) were deceased , seven as a result of lung cancer and 20 as a result of concurrent disease . Kaplan-Meier estimated local control at 3 years was 92 % . Local relapse was observed in four patients ( 7 % ) . Regional relapse was observed in three patients ( 5 % ) . Nine patients ( 16 % ) developed distant metastases . The estimated risk of all failure ( local , regional , or distant metastases ) was increased in patients with T2 ( 41 % ) compared with those with T1 ( 18 % ) tumors ( P = .027 ) . CONCLUSION With a 3-year local tumor control rate higher than 90 % with limited toxicity , SBRT emerges as state-of-the-art treatment for medically inoperable stage I NSCLC and may even challenge surgery in operable instances BACKGROUND The st and ard of care for operable , stage I , non-small-cell lung cancer ( NSCLC ) is lobectomy with mediastinal lymph node dissection or sampling . Stereotactic ablative radiotherapy ( SABR ) for inoperable stage I NSCLC has shown promising results , but two independent , r and omised , phase 3 trials of SABR in patients with operable stage I NSCLC ( STARS and ROSEL ) closed early due to slow accrual . We aim ed to assess overall survival for SABR versus surgery by pooling data from these trials . METHODS Eligible patients in the STARS and ROSEL studies were those with clinical T1 - 2a ( < 4 cm ) , N0M0 , operable NSCLC . Patients were r and omly assigned in a 1:1 ratio to SABR or lobectomy with mediastinal lymph node dissection or sampling . We did a pooled analysis in the intention-to-treat population using overall survival as the primary endpoint . Both trials are registered with Clinical Trials.gov ( STARS : NCT00840749 ; ROSEL : NCT00687986 ) . FINDINGS 58 patients were enrolled and r and omly assigned ( 31 to SABR and 27 to surgery ) . Median follow-up was 40·2 months ( IQR 23·0 - 47·3 ) for the SABR group and 35·4 months ( 18·9 - 40·7 ) for the surgery group . Six patients in the surgery group died compared with one patient in the SABR group . Estimated overall survival at 3 years was 95 % ( 95 % CI 85 - 100 ) in the SABR group compared with 79 % ( 64 - 97 ) in the surgery group ( hazard ratio [ HR ] 0·14 [ 95 % CI 0·017 - 1·190 ] , log-rank p=0·037 ) . Recurrence-free survival at 3 years was 86 % ( 95 % CI 74 - 100 ) in the SABR group and 80 % ( 65 - 97 ) in the surgery group ( HR 0·69 [ 95 % CI 0·21 - 2·29 ] , log-rank p=0·54 ) . In the surgery group , one patient had regional nodal recurrence and two had distant metastases ; in the SABR group , one patient had local recurrence , four had regional nodal recurrence , and one had distant metastases . Three ( 10 % ) patients in the SABR  group had grade 3 treatment-related adverse events ( three [ 10 % ] chest wall pain , two [ 6 % ] dyspnoea or cough , and one [ 3 % ] fatigue and rib fracture ) . No patients given SABR  had grade 4 events or treatment-related death . In the surgery group , one ( 4 % ) patient died of surgical complications and 12 ( 44 % ) patients had grade 3 - 4 treatment-related adverse events . Grade 3 events occurring in more than one patient in the surgery group were dyspnoea ( four [ 15 % ] patients ) , chest pain ( four [ 15 % ] patients ) , and lung infections ( two [ 7 % ] ) . INTERPRETATION SABR could be an option for treating operable stage I NSCLC . Because of the small patient sample size and short follow-up , additional r and omised studies comparing SABR with surgery in operable patients are warranted . FUNDING Accuray Inc , Netherl and s Organisation for Health Research and Development , NCI Cancer Center Support , NCI Clinical and Translational Science Award CONTEXT Patients with early stage but medically inoperable lung cancer have a poor rate of primary tumor control ( 30%-40 % ) and a high rate of mortality ( 3-year survival , 20%-35 % ) with current management . OBJECTIVE To evaluate the toxicity and efficacy of stereotactic body radiation therapy in a high-risk population of patients with early stage but medically inoperable lung cancer . DESIGN , SETTING , AND PATIENTS Phase 2 North American multicenter study of patients aged 18 years or older with biopsy-proven peripheral T1-T2N0M0 non-small cell tumors ( measuring < 5 cm in diameter ) and medical conditions precluding surgical treatment . The prescription dose was 18 Gy per fraction x 3 fractions ( 54 Gy total ) with entire treatment lasting between 1(1/2 ) and 2 weeks . The study opened May 26 , 2004 , and closed October 13 , 2006 ; data were analyzed through August 31 , 2009 . MAIN OUTCOME MEASURES The primary end point was 2-year actuarial primary tumor control ; secondary end points were disease-free survival ( ie , primary tumor , involved lobe , regional , and disseminated recurrence ) , treatment-related toxicity , and overall survival . RESULTS A total of 59 patients accrued , of which 55 were evaluable ( 44 patients with T1 tumors and 11 patients with T2 tumors ) with a median follow-up of 34.4 months ( range , 4.8 - 49.9 months ) . Only 1 patient had a primary tumor failure ; the estimated 3-year primary tumor control rate was 97.6 % ( 95 % confidence interval [ CI ] , 84.3%-99.7 % ) . Three patients had recurrence within the involved lobe ; the 3-year primary tumor and involved lobe ( local ) control rate was 90.6 % ( 95 % CI , 76.0%-96.5 % ) . Two patients experienced regional failure ; the local-regional control rate was 87.2 % ( 95 % CI , 71.0%-94.7 % ) . Eleven patients experienced disseminated recurrence ; the 3-year rate of disseminated failure was 22.1 % ( 95 % CI , 12.3%-37.8 % ) . The rates for disease-free survival and overall survival at 3 years were 48.3 % ( 95 % CI , 34.4%-60.8 % ) and 55.8 % ( 95 % CI , 41.6%-67.9 % ) , respectively . The median overall survival was 48.1 months ( 95 % CI , 29.6 months to not reached ) . Protocol -specified treatment-related grade 3 adverse events were reported in 7 patients ( 12.7 % ; 95 % CI , 9.6%-15.8 % ) ; grade 4 adverse events were reported in 2 patients ( 3.6 % ; 95 % CI , 2.7%-4.5 % ) . No grade 5 adverse events were reported . CONCLUSION Patients with inoperable non-small cell lung cancer who received stereotactic body radiation therapy had a survival rate of 55.8 % at 3 years , high rates of local tumor control , and moderate treatment-related morbidity PURPOSE This guideline presents evidence -based recommendations for stereotactic body radiation therapy ( SBRT ) in challenging clinical scenarios in early-stage non-small cell lung cancer ( NSCLC ) . METHODS AND MATERIAL S The American Society for Radiation Oncology convened a task force to perform a systematic literature review on 4 key questions addressing : ( 1 ) application of SBRT to operable patients ; ( 2 ) appropriate use of SBRT in tumors that are central ly located , large , multifocal , or unbiopsied ; ( 3 ) individual tailoring of SBRT in " high-risk " clinical scenarios ; and ( 4 ) SBRT as salvage therapy after recurrence . Guideline recommendations were created using a predefined consensus-building methodology supported by American Society for Radiation Oncology-approved tools for grading evidence quality and recommendation strength . RESULTS Although few r and omized trials have been completed for SBRT , strong consensus recommendations based on extensive , consistent publications were generated for several questions , including recommendations for fractionation for central tumors and surgery versus SBRT in st and ard-risk medically operable patients with early-stage NSCLC . Lower quality evidence led to conditional recommendations on use of SBRT for tumors > 5 cm , patients with prior pneumonectomy , T3 tumors with chest wall invasion , synchronous multiple primary lung cancer , and as a salvage therapy after prior radiation therapy . These areas of moderate- and low- quality evidence highlight the importance of clinical trial enrollment as well as the role of prospect i ve data registries . CONCLUSIONS SBRT has an important role to play in treating early-stage NSCLC , particularly for medically inoperable patients with limited other treatment options . Shared decision-making with patients should be performed in all cases to ensure the patient underst and s the risks related to SBRT , the side effects , and the alternative treatments available PURPOSE The purpose of the study was to evaluate the outcomes for wedge resection ( WR ) , WR plus brachytherapy ( WRB ) , or stereotactic body radiation therapy ( SBRT ) for early stage non-small lung cancer . METHODS AND MATERIAL S Retrospectively collected data of patients treated with WR , WRB , or SBRT ( 1993 - 2012 ) .  Cesium-131 ( Cs131 ) used in WRB group in patients with close or positive margins based on surgical assessment . Kaplan-Meier survival analysis , log-rank test used to compare disease-free survival/overall survival between different groups . Multivariable analysis , using Cox proportional hazards regression analysis , was performed to evaluate the independent effect of age , gender , and treatment procedure on disease-free survival . RESULTS A total of 272 patients were included in the study ( 123 WR , 52 WR+Cs-131 , 97 SBRT ) .  Cs-131 was used with WRs that the surgeons deemed high risk . Local control ( LC ) was similar in the three groups and was achieved in 92.2 % for WR group vs. 96.2 % for WR+Cs-131 and 95.5 % for SBRT ( p = 0.60 ) . On multivariate analysis , although females showed a higher LC , neither LC nor distant metastasis were associated with age or gender ( p = 0.65 and p = 0.41 , respectively ) . Five-year overall survival was 100 % in the WR+B group , 97.7 % in the WR group , and 89.6 % in the SBRT group ( p = 0.02 ) . Toxicity was similar in the three groups . CONCLUSION WR , WR+ Cs-131 , or SBRT are all excellent treatment options for patients with early stage non-small cell lung cancer that are not c and i date s for lobectomy . For high risk WRs , we favor use of Cesim-131 brachytherapy . Until a prospect i ve r and omized comparative study is done to evaluate the best treatment approach for early stage NSCLC , treatment selection should be based on a multidisciplinary team approach PURPOSE To evaluate , in Japan Clinical Oncology Group study 0403 , the safety and efficacy of stereotactic body radiation therapy ( SBRT ) in patients with T1N0M0 non-small cell lung cancer ( NSCLC ) . METHODS AND MATERIAL S Eligibility criteria included histologically or cytologically proven NSCLC , clinical T1N0M0 . Prescribed dose was 48 Gy at the isocenter in 4 fractions . The primary endpoint was the percent ( % ) 3-year overall survival . The threshold % 3-year survival to be rejected was set at 35 % for inoperable patients , whereas the expected % 3-year survival was 80 % for operable patients . RESULTS Between July 2004 and November 2008 , 169 patients from 15 institutions were registered . One hundred inoperable and 64 operable patients ( total 164 ) were eligible . Patients ' characteristics were 122 male , 47 female ; median age 78 years ( range , 50 - 91 years ) ; adenocarcinomas , 90 ; squamous cell carcinomas , 61 ; others , 18 . Of the 100 inoperable patients , the % 3-year OS was 59.9 % ( 95 % confidence interval 49.6%-68.8 % ) . Grade 3 and 4 toxicities were observed in 10 and 2 patients , respectively . No grade 5 toxicity was observed . Of the 64 operable patients , the % 3-year OS was 76.5 % ( 95 % confidence interval 64.0%-85.1 % ) . Grade 3 toxicities were observed in 5 patients . No grade 4 and 5 toxicities were observed . CONCLUSIONS Stereotactic body radiation therapy for stage I NSCLC is effective , with low incidences of severe toxicity . This treatment can be considered a st and ard treatment for inoperable stage I NSCLC . This treatment is promising as an alternative to surgery for operable stage I NSCLC OBJECTIVE We sought to compare the relative cost-effectiveness of surgical intervention and stereotactic body radiation therapy in high risk patients with clinical stage I lung cancer ( non-small cell lung cancer ) . METHODS We compared patients chosen for surgical intervention or SBRT for clinical stage I non-small cell lung cancer . Propensity score matching was used to adjust estimated treatment hazard ratios for the confounding effects of age , comorbidity index , and clinical stage . We assumed that Medicare-allowable charges were $ 15,034 for surgical intervention and $ 13,964 for stereotactic body radiation therapy . The incremental cost-effectiveness ratio was estimated as the cost per life year gained over the patient 's remaining lifetime by using a decision model . RESULTS Fifty-seven patients in each arm were selected by means of propensity score matching . Median survival with surgical intervention was 4.1 years , and 4-year survival was 51.4 % . With stereotactic body radiation therapy , median survival was 2.9 years , and 4-year survival was 30.1 % . Cause-specific survival was identical between the 2 groups , and the difference in overall survival was not statistically significant . For decision modeling , stereotactic body radiation therapy was estimated to have a mean expected survival of 2.94 years at a cost of $ 14,153 and mean expected survival with surgical intervention was 3.39 years at a cost of $ 17,629 , for an incremental cost-effectiveness ratio of $ 7753 . CONCLUSIONS In our analysis stereotactic body radiation therapy appears to be less costly than surgical intervention in high-risk patients with early stage non-small cell lung cancer . However , surgical intervention appears to meet the st and ards for cost-effectiveness because of a longer expected overall survival . Should this advantage not be confirmed in other studies , the cost-effectiveness decision would be likely to change . Prospect i ve r and omized studies are necessary to strengthen confidence in these results
Objective : Stereotactic body radiation therapy is the preferred treatment modality for patients with inoperable early‐stage non – small cell lung cancer .
However , comparative outcomes between stereotactic body radiation therapy and surgery for high‐risk patients remain controversial .
The primary aim of the present meta‐ analysis was to assess overall survival in matched and unmatched patient cohorts undergoing stereotactic body radiation therapy or surgery .
Secondary end points included cancer‐specific survival , disease‐free survival , disease recurrence , and perioperative outcomes .