Durvalumab After Sequential Chemoradiotherapy in Stage III, Unresectable NSCLC: The Phase 2 PACIFIC-6 Trial.
Por:
Garassino MC, Mazieres J, Reck M, Chouaid C, Bischoff H, Reinmuth N, Cove-Smith L, Mansy T, Cortinovis D, Migliorino MR, Delmonte A, Sánchez JG, Chara Velarde LE, Bernabe R, Paz-Ares L, Perez ID, Trunova N, Foroutanpour K and Faivre-Finn C
Publicada:
1 dic 2022
Ahead of Print:
9 ago 2022
Resumen:
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 months (95% confidence interval: 7.3-15.6), and 12-month PFS and overall survival rates were 49.6% and 84.1%, respectively. CONCLUSIONS: 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.
Filiaciones:
Garassino MC:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Department of Hematology/Oncology, The University of Chicago, Chicago, Illinois. Electronic address:
Mazieres J:
Centre Hospitalier Universitaire, Université Paul Sabatier, Toulouse, France
Reck M:
Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
Chouaid C:
Service de Pneumologie, Centre Hospitalier Intercommunal de Créteil, Créteil, France
Bischoff H:
Thoraxklinik Heidelberg, Heidelberg, Germany
Reinmuth N:
Asklepios Fachkliniken München-Gauting, German Center for Lung Research, Gauting, Germany
Cove-Smith L:
The Christie NHS Foundation Trust and Manchester University Hospitals Foundation Trust, Manchester, United Kingdom
Mansy T:
South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom
Cortinovis D:
Oncology Unit, ASST-Monza, San Gerardo Hospital, Monza, Italy
Migliorino MR:
San Camillo-Forlanini Hospital, Rome, Italy
Delmonte A:
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori," Meldola, Italy
:
Medical Oncology Department, Hospital Arnau de Vilanova, Fundación para el Fomento de la Investigación Sanitaria i Biomédica de la Comunidad Valenciana (FISABIO), Valencia, Spain
Chara Velarde LE:
Hospital Universitario de Guadalajara, Guadalajara, Spain
Bernabe R:
Hospital Universitario Virgen del Rocío, Seville, Spain
Paz-Ares L:
Universidad Complutense, CiberOnc, CNIO and Hospital Universitario 12 de Octubre, Madrid, Spain
Perez ID:
AstraZeneca, Gaithersburg, Maryland
Trunova N:
AstraZeneca, Gaithersburg, Maryland
Foroutanpour K:
AstraZeneca, Gaithersburg, Maryland
Faivre-Finn C:
The University of Manchester and The Christie NHS Foundation Trust, Manchester, United Kingdom
hybrid
|