RT Journal Article
T1 Durvalumab After Sequential Chemoradiotherapy in Stage III, Unresectable NSCLC: The Phase 2 PACIFIC-6 Trial.
A1 Garassino, Marina C
A1 Mazieres, Julien
A1 Reck, Martin
A1 Chouaid, Christos
A1 Bischoff, Helge
A1 Reinmuth, Niels
A1 Cove-Smith, Laura
A1 Mansy, Talal
A1 Cortinovis, Diego
A1 Migliorino, Maria R
A1 Delmonte, Angelo
A1 Sánchez, José Garcia
A1 Chara Velarde, Luis Enrique
A1 Bernabe, Reyes
A1 Paz-Ares, Luis
A1 Perez, Ignacio Diaz
A1 Trunova, Nataliya
A1 Foroutanpour, Kayhan
A1 Faivre-Finn, Corinne
K1 Durvalumab
K1 Immunotherapy
K1 Locally advanced
K1 Non–small-cell lung cancer
K1 Sequential chemoradiotherapy
AB 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). 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. 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 months (95% confidence interval: 7.3-15.6), and 12-month PFS and overall survival rates were 49.6% and 84.1%, respectively. Durvalumab after sCRT had a comparable safety profile with that observed with durvalumab after cCRT in PACIFIC and had encouraging preliminary efficacy in a frailer population.
YR 2022
FD 2022-08-09
LK http://hdl.handle.net/10668/22343
UL http://hdl.handle.net/10668/22343
LA en
DS RISalud
RD Apr 5, 2025