Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026
Comprehensive Patient-Reported Outcomes from NRG Oncology/Alliance LU005: A Randomized Trial of Chemoradiation With or Without Atezolizumab in Limited-Stage SCLC.
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Movsas Benjamin, Hu Chen, Higgins Kristin A, Ross Helen J, Jabbour Salma K, Kozono David, Owonikoko Taofeek K, Xiao Canhua, Shoji Tetsuaki, Faller Bryan A, Mohindra Pranshu, Dib Elie G, Brownstein Jeremy, Chun Stephen G, Kuzma Charles S, Kotecha Rupesh, Onitilo Adedayo, Mulford Deborah, Paulus Rebecca, Bradley Jeffrey D, Bruner Deborah Watkins
Аннотация
INTRODUCTION: NRG-LU005 found no overall survival advantage with the addition of concurrent and adjuvant immunotherapy to chemoradiotherapy (CRT); however, it reported longer overall survival in an exploratory comparison of twice-daily versus once-daily radiation. This planned analysis assessed longitudinal patient-reported outcomes (PROs). The prespecified hypothesis was that clinically meaningful decline (CMD) in longer-term PROs at 15 months would be lower with immunotherapy, as measured by the Functional Assessment of Cancer Therapy: Trial Outcome Index (FACT-TOI).
METHODS: Patients (N = 544) were randomized to receive standard CRT (platinum and etoposide + thoracic RT [45 Gy twice-daily or 66 Gy once-daily]) with or without atezolizumab starting at cycle 2 of chemotherapy. Stratification factors included radiation therapy (RT) schedule, chemotherapy type, sex, and performance status. PROs included validated instruments: FACT-TOI, EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Patient-Reported Outcomes Measurement Information System Fatigue (at baseline, end of CRT, and at 3, 6, 15, and 21 mo). EQ-5D-5L scores were followed through 24 months. CMD and longitudinal trends were evaluated; multivariable logistic regression analysis adjusted for treatment arm, stratification factors, and baseline FACT-TOI.
RESULTS: PRO compliance exceeded 85% at baseline and stabilized at 60% to 68% through 21 months. CMD in FACT-TOI was not meaningfully different between treatment arms at 15 months, though fewer patients in the immunotherapy arm had CMD at 21 months. EQ-5D-5L and Patient-Reported Outcomes Measurement Information System -fatigue scores were similar in both arms. Twice daily-RT was associated with better FACT-TOI than once-daily-RT at all time points. On multivariable logistic regression analysis, significant predictors of lower CMD for FACT-TOI (beyond baseline FACT-TOI) included twice-daily RT (at end-of-CRT, 15, and 21 mo), performance status (at end-of-CRT), cisplatin (at 15 mo), and immunotherapy (at 21 mo).
CONCLUSIONS: The addition of atezolizumab to CRT was not associated with a significant change in CMD in FACT-TOI at 15 months, with similar EQ-5D-5L and fatigue scores. Although not randomized for RT schedule, this analysis suggests that twice-daily RT (versus once-daily RT) was associated with a consistently more favorable PRO trajectory.
CLINICAL TRIAL INFORMATION: ClinicalTrials.gov Identifier: NCT03811002.
METHODS: Patients (N = 544) were randomized to receive standard CRT (platinum and etoposide + thoracic RT [45 Gy twice-daily or 66 Gy once-daily]) with or without atezolizumab starting at cycle 2 of chemotherapy. Stratification factors included radiation therapy (RT) schedule, chemotherapy type, sex, and performance status. PROs included validated instruments: FACT-TOI, EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Patient-Reported Outcomes Measurement Information System Fatigue (at baseline, end of CRT, and at 3, 6, 15, and 21 mo). EQ-5D-5L scores were followed through 24 months. CMD and longitudinal trends were evaluated; multivariable logistic regression analysis adjusted for treatment arm, stratification factors, and baseline FACT-TOI.
RESULTS: PRO compliance exceeded 85% at baseline and stabilized at 60% to 68% through 21 months. CMD in FACT-TOI was not meaningfully different between treatment arms at 15 months, though fewer patients in the immunotherapy arm had CMD at 21 months. EQ-5D-5L and Patient-Reported Outcomes Measurement Information System -fatigue scores were similar in both arms. Twice daily-RT was associated with better FACT-TOI than once-daily-RT at all time points. On multivariable logistic regression analysis, significant predictors of lower CMD for FACT-TOI (beyond baseline FACT-TOI) included twice-daily RT (at end-of-CRT, 15, and 21 mo), performance status (at end-of-CRT), cisplatin (at 15 mo), and immunotherapy (at 21 mo).
CONCLUSIONS: The addition of atezolizumab to CRT was not associated with a significant change in CMD in FACT-TOI at 15 months, with similar EQ-5D-5L and fatigue scores. Although not randomized for RT schedule, this analysis suggests that twice-daily RT (versus once-daily RT) was associated with a consistently more favorable PRO trajectory.
CLINICAL TRIAL INFORMATION: ClinicalTrials.gov Identifier: NCT03811002.