Durvalumab After Sequential Chemoradiotherapy in Stage III, Unresectable NSCLC: The Phase 2 PACIFIC-6 Trial

作者：Marina Chiara Garassino, Julien Mazières, Martin Reck, CHRISTOS CHOUAID, Helge G. Bischoff, Niels Reinmuth, Laura Cove-Smith, Talal Mansy, Diego Luigi Cortinovis, Maria Rita Migliorino, Angelo Delmonte, José Garcia Sánchez, Luis Enrique Chara Velarde, Reyes Bernabé, Luis G Paz-Ares, Ignacio Diaz Perez, Nataliya Trunova, Kayhan Foroutanpour, Corinne Faivre Finn · 发表于：Journal of Thoracic Oncology · 年份：2022 · DOI：10.1016/j.jtho.2022.07.1148 · 被引用次数：131 · 研究领域：Cancer Immunotherapy and Biomarkers、Colorectal Cancer Treatments and Studies、Radiomics and Machine Learning in Medical Imaging

INTRODUCTION: On the basis of the findings of the phase 3 PACIFIC trial (NCT02125461), durvalumab is standard of care for patients with stage III, unresectable NSCLC and no disease progression after concurrent chemoradiotherapy (cCRT). Many patients are considered unsuitable for cCRT owing to concerns with tolerability. The phase 2 PACIFIC-6 trial (NCT03693300) evaluates the safety and tolerability of durvalumab after sequential CRT (sCRT). METHODS: Patients with stage III, unresectable NSCLC and no progression after platinum-based sCRT were enrolled to receive durvalumab (1500 mg intravenously) every 4 weeks for up to 24 months. The primary end point was the incidence of grade 3 or 4 adverse events possibly related to treatment occurring within 6 months. Secondary end points included investigator-assessed progression-free survival (PFS; Response Evaluation Criteria in Solid Tumors version 1.1) and overall survival. RESULTS: Overall, 117 patients were enrolled (59.8% with performance status >0, 65.8% aged ≥65 y, and 37.6% with stage IIIA disease). Median treatment duration was 32.0 weeks; 37.6% of patients remained on treatment at data cutoff (July 15, 2021). Grade 3 or 4 AEs occurred in 18.8% of patients. Five patients had grade 3 or 4 possibly related adverse events within 6 months (incidence: 4.3%; 95% confidence interval: 1.4-9.7), including two pneumonitis cases. Two patients (1.7%) had grade 5 AEs of any cause. Survival data maturity was limited. Median PFS was 10.9 mon...