Citations 2
Adjuvant Nivolumab vs Observation in Resected Non–Small Cell Lung Cancer
Sun, Zhuoxin, Rudin, Charles M., Khullar, Onkar V., Simone, Charles B., Oettel, Kurt, Kozono, David, Sunkara, Rajitha, Faller, Bryan, Hugec, Vladimir, Shipstone, Asheesh, McGary, Eric C., Clarke, Jeffrey M., Talsania, Ashita, Ding, Li, Heymach, J, Raez, Luis E., Malik, Shakun , Stinchcombe, T., Mandrekar, Sumithra J. , Bradley, J.D., Vokes, E., Gandara, David, Staley, Charles, Ramalingam, Suresh S., Chaft, Jamie E. , Sun, Zhuoxin, Rudin, Charles M. , Khullar, Onkar V. , Simone, Charles B. , Oettel, Kurt R., Kozono, David , Sunkara, Rajitha, Faller, Bryan A. , Isbell, James M. , Clarke, Jeffrey M., Govindan, Ramaswamy , Sands, Jacob , Heymach, John V. , Raez, Luis , Stinchcombe, Thomas E. , Gerber, David E. , Gandara, David R. , Ramalingam, Suresh S.
JAMA | June 1, 2026 | Volume: 336 | Issue: 6 | Pages: 464
Importance Preoperative and perioperative nivolumab improve event-free survival in resectable non–small cell lung cancer. The role of adjuvant nivolumab after upfront surgery is unknown. Objective To determine whether adjuvant nivolumab improves disease-free survival and overall survival in patients with resected non–small cell lung cancer with any tumor programmed death-ligand 1 (PD-L1) expression and in those with at least 50% PD-L1 expression. Design, Setting, and Participants This open-label, randomized phase 3 study enrolled participants from May 2016 through September 2019, with median follow-up of 72.6 months at the data cutoff in December 2025. The study was conducted at 378 centers in the US National Clinical Trials Network. Patients were identified through a screening trial. Those with resected tumors at least 4 cm and/or who were lymph node positive (N1/N2) were eligible for inclusion after completion of planned standard adjuvant therapy if the tumor was adenocarcinoma without sensitizing sequence variants in EGFR and ALK or squamous cell carcinoma. Intervention Patients were randomized in a 1:1 ratio to receive nivolumab 480 mg intravenously every 4 weeks for up to 1 year or standard care observation. Main Outcomes and Measures Co–primary end points were disease-free survival in the intention-to-treat population and in those with tumoral PD-L1 expression at least 50%. Overall survival was examined if the corresponding test of disease-free survival was statistically significant. Results A total of 466 patients (median age, 66 years; 241 [52%] male) were assigned to receive nivolumab and 469 (median age, 67 years; 245 [52%] male) to undergo standard care observation. The median duration of follow-up was 72.6 months. The trial was stopped for futility at 75% information. In the intention-to-treat population, median disease-free survival was 71.3 months with nivolumab and 68.8 months with observation (hazard ratio for progression or death, 0.97 [97% CI, 0.79-1.20]; [95% CI, 0.81-1.17]; 1-sided P = .39). In the subset of participants with PD-L1 of at least 50%, median disease-free survival was 89.8 months with nivolumab and 78.5 months with observation (hazard ratio for progression or death, 0.86 [98% CI, 0.55-1.34]; [95% CI, 0.59-1.25]; 1-sided P = .22). Conclusions and Relevance Adjuvant nivolumab was not associated with improved disease-free survival in patients with resected non–small cell lung cancer without sensitizing EGFR and ALK alterations when given after planned adjuvant chemotherapy and/or radiotherapy. Trial Registration Clinicaltrials.gov Identifier: NCT02595944
Validation of Progression-Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials
Wang, Xiaofei , Wang, Xiaoyi , Hodgson, Lydia, George, Stephen L., Foster, Nate R., Ganti, Apar Kishor, Stinchcombe, T., Crawford, Jeffrey, Kratzke, Robert A. , Adjei, Alex A. , Kindler, Hedy L., Pang, Herbert , George, Stephen L. , Ganti, Apar Kishor , Hodgson, Lydia, Sargent, Daniel J. , Stinchcombe, Thomas E. , Crawford, Jeffrey , Kindler, Hedy L. , Vokes, Everett E. , Ganti, Apar K
The Oncologist | February 11, 2017 | Volume: 22 | Issue: 2 | Pages: 189-198
10.1634/theoncologist.2016-0121
Abstract Purpose The aim of this study was to investigate whether progression-free survival (PFS) can be considered a surrogate endpoint for overall survival (OS) in malignant mesothelioma. Materials and Methods Individual data were collected from 15 Cancer and Leukemia Group B (615 patients) and 2 North Central Cancer Treatment Group (101 patients) phase II trials. The effects of 5 risk factors for OS and PFS, including age, histology, performance status (PS), white blood cell count, and European Organisation for Research and Treatment of Cancer (EORTC) risk score, were used in the analysis. Individual-level surrogacy was assessed by Kendall’s tau through a Clayton bivariate Copula survival (CBCS) model. Summary-level surrogacy was evaluated via the association between logarithms of the hazard ratio (log HR)—log HROS and log HRPFS—measured in R2 from a weighted least-square (WLS) regression model and the CBCS model. Results The median PFS for all patients was 3.0 months (95% confidence interval [CI], 2.8–3.5 months) and the median OS was 7.2 months (95% CI, 6.5–8.0 months). Moderate correlations between PFS and OS were observed across all risk factors at the individual level, with Kendall’s tau ranging from 0.46 to 0.47. The summary-level surrogacy varied among risk factors. The Copula R2 ranged from 0.51 for PS to 0.78 for histology. The WLS R2 ranged from 0.26 for EORTC and PS to 0.67 for age. Conclusions The analyses demonstrated low to moderate individual-level surrogacy between PFS and OS. At the summary level, the surrogacy between PFS and OS varied significantly across different risk factors. With a short postprogression survival and a moderate correlation between PFS and OS, there is no evidence that PFS is a valid surrogate endpoint for OS in malignant mesothelioma.