P48.02 NRG Oncology/Alliance LU005: Chemoradiation vs. Chemoradiation Plus Atezolizumab in Limited Stage Small Cell Lung Cancer

Higgins, Kristin; Hu, Chen; Ross, Helen J.; Jabbour, Salma K.; Kozono, David; Owonikoko, Taofeek K.; Movsas, Benjamin; Solberg, T.D.; Xiao, Canhua; Williams, T.M.; Welsh, J.; Simko, Jeffry P.; Wang, X; Mohindra, Nisha; Hsu, Chiu-Hsieh; Stinchcombe, Tom; Bradley, Jeffrey D.

doi:10.1016/j.jtho.2021.01.872

Cited by 3 publications

(1 citation statement)

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“…For locally advanced lung cancer, new treatments have significantly increased the OS in NSCLC based on results of the PACIFIC trial (57), and the mature OS was achieved after 6 years from the beginning of the first patients enrolled (58) l i m i t e d -s t a g e S C L C u n d e r s t a n d a r d c o n c u r r e n t chemoradiotherapy followed by prophylactic cranial irradiation, 5-year OS was still low ranging from 26% to 34% and did not change in the past two decades (4,25). There are several ongoing phase II and III trials investigating the PD-1/PD-L1 consolidation immunotherapy (59)(60)(61)(62). High-level evidence for immunotherapy as concurrent of consolidation treatment has not been reported until now.…”

Section: Previous Meta-analyses Have Assessed Surrogate Endpoints Inmentioning

confidence: 99%

Progression-Free Survival and Time to Progression as Potential Surrogate Endpoints for Overall Survival in Chemoradiotherapy Trials in Limited-Stage Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis

Yang

Wang

et al. 2022

Front. Oncol.

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PurposeTo investigate whether progression-free survival (PFS) or time to progression (TTP) could be a valid surrogate endpoint for overall survival (OS) in patients with limited-stage small-cell lung cancer (LS-SCLC) receiving combined chemoradiotherapy.MethodsLiterature searching was performed in PubMed, Embase, and The Cochrane Library up to 2021. Prediction models were firstly established using data from phase III randomized controlled trials (RCTs) and then externally validated in phase II and retrospective studies. Correlation analysis was evaluated by a weighted linear regression model at both trial and arm levels. Cross-validation was performed to assess the consistency and robustness of the established models.Results37 studies, including 15 phase III RCTs, 12 phase II studies, and 10 retrospective studies, were selected in the final analysis. In trial-level surrogacy, a very good correlation was observed between hazard ratios (HRs) of PFS/TTP and OS (R2 = 0.783, 95% CI 0.771–0.794). In arm-level surrogacy, very good correlations were also observed between 2-year (R2 = 0.823, 95% CI 0.814–0.832), 3-year (R2 = 0.843, 95% CI 0.833–0.850), 5-year (R2 = 0.852, 95% CI 0.843–0.859) PFS/TTP, and 5-year OS. An excellent correlation was observed between 4-year PFS/TTP and 5-year OS (R2 = 0.906, 95% CI 0.901–0.910). Cross-validation demonstrated reasonable overall consistency. External validation in phase II and retrospective studies showed good agreement (R2, 0.728–0.824).ConclusionsPFS/TTP was a valid surrogate endpoint for OS in patients with LS-SCLC receiving combined chemoradiotherapy. The finding provides high-level evidence to support PFS/TTP as the primary endpoint in clinical trials so as to speed up introducing novel agents to the treatment of LS-SCLC.

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Section: Previous Meta-analyses Have Assessed Surrogate Endpoints Inmentioning

confidence: 99%

Progression-Free Survival and Time to Progression as Potential Surrogate Endpoints for Overall Survival in Chemoradiotherapy Trials in Limited-Stage Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis

Yang

Wang

et al. 2022

Front. Oncol.

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Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer

Cheng,

Spigel,

Cho

et al. 2024

N Engl J Med

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Real-world predictors of survival in patients with limited-stage small-cell lung cancer in Manitoba, Canada

Dawe,

Rittberg,

Syed

et al. 2023

Front. Oncol.

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BackgroundAlthough therapy for limited-stage small-cell lung cancer (LS-SCLC) is administered with curative intent, most patients relapse and eventually die of recurrent disease. Chemotherapy (CT) with concurrent radiotherapy (RT) remains the standard of care for LS-SCLC; however, this could evolve in the near future. Therefore, understanding the current prognostic factors associated with survival is essential.ObjectiveThis real-world analysis examines factors associated with long-term survival in patients with LS-SCLC treated with CT in Manitoba, Canada.MethodsA retrospective cohort study was conducted using Manitoba Cancer Registry and CancerCare Manitoba records. Eligible patients were aged >18 years and had cytologically confirmed LS-SCLC diagnosed between January 1, 2004, and December 31, 2018, for which they received CT ± RT. Baseline patient, disease, and treatment characteristics and survival duration, characterized as short (<6 months), medium (6−24 months), and long term (>24 months), were extracted. Overall survival (OS) was estimated at one, two, and five years and assessed using Kaplan-Meier methods and Cox proportional hazards models.ResultsOver the 15-year study period, 304 patients met the eligibility criteria. Long-term survivors comprised 39.1% of the cohort; at diagnosis, this subgroup was younger, more likely to have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, and have normal lactate dehydrogenase, sodium, and hemoglobin levels. OS estimates for the entire cohort at one, two, and five years were 66%, 38%, and 18%, respectively. In the ECOG PS 0 subgroup, OS estimates at one, two, and five years were 85%, 52%, and 24%, respectively; OS estimates were 60%, 35%, and 17%, respectively, for ECOG PS 1−2 and were 47%, 23%, and 10%, respectively, for ECOG PS 3−4. OS was significantly higher among patients with normal serum sodium and hemoglobin levels than those with abnormal levels. Univariable hazard regression models found that ECOG PS, age at diagnosis, receipt of prophylactic cranial irradiation (PCI), and thoracic RT were associated with survival. On multivariable hazard regression, ECOG PS and receipt of PCI were associated with survival.ConclusionSurvival for greater than two years in patients with LS-SCLC treated with CT ± RT was associated with ECOG PS and receipt of PCI.

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P48.02 NRG Oncology/Alliance LU005: Chemoradiation vs. Chemoradiation Plus Atezolizumab in Limited Stage Small Cell Lung Cancer

Cited by 3 publications

References 0 publications

Progression-Free Survival and Time to Progression as Potential Surrogate Endpoints for Overall Survival in Chemoradiotherapy Trials in Limited-Stage Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis

Progression-Free Survival and Time to Progression as Potential Surrogate Endpoints for Overall Survival in Chemoradiotherapy Trials in Limited-Stage Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis

Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer

Real-world predictors of survival in patients with limited-stage small-cell lung cancer in Manitoba, Canada

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