| Added by | amaraver |
|---|---|
| Group name | EquipeAM |
| Item Type | Journal Article |
| Title | Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer |
| Creator | Spigel et al. |
| Author | David R. Spigel |
| Author | Corinne Faivre-Finn |
| Author | Jhanelle E. Gray |
| Author | David Vicente |
| Author | David Planchard |
| Author | Luis Paz-Ares |
| Author | Johan F. Vansteenkiste |
| Author | Marina C. Garassino |
| Author | Rina Hui |
| Author | Xavier Quantin |
| Author | Andreas Rimner |
| Author | Yi-Long Wu |
| Author | Mustafa Özgüro?lu |
| Author | Ki H. Lee |
| Author | Terufumi Kato |
| Author | Maike de Wit |
| Author | Takayasu Kurata |
| Author | Martin Reck |
| Author | Byoung C. Cho |
| Author | Suresh Senan |
| Author | Jarushka Naidoo |
| Author | Helen Mann |
| Author | Michael Newton |
| Author | Piruntha Thiyagarajah |
| Author | Scott J. Antonia |
| Abstract | PURPOSE: The phase III PACIFIC trial compared durvalumab with placebo in patients with unresectable, stage III non-small-cell lung cancer and no disease progression after concurrent chemoradiotherapy. Consolidation durvalumab was associated with significant improvements in the primary end points of overall survival (OS; stratified hazard ratio [HR], 0.68; 95% CI, 0.53 to 0.87; P = .00251) and progression-free survival (PFS [blinded independent central review; RECIST v1.1]; stratified HR, 0.52; 95% CI, 0.42 to 0.65; P < .0001), with manageable safety. We report updated, exploratory analyses of survival, approximately 5 years after the last patient was randomly assigned. METHODS: Patients with WHO performance status 0 or 1 (any tumor programmed cell death-ligand 1 status) were randomly assigned (2:1) to durvalumab (10 mg/kg intravenously; administered once every 2 weeks for 12 months) or placebo, stratified by age, sex, and smoking history. Time-to-event end point analyses were performed using stratified log-rank tests. Medians and landmark survival rates were estimated using the Kaplan-Meier method. RESULTS: Seven hundred and nine of 713 randomly assigned patients received durvalumab (473 of 476) or placebo (236 of 237). As of January 11, 2021 (median follow-up, 34.2 months [all patients]; 61.6 months [censored patients]), updated OS (stratified HR, 0.72; 95% CI, 0.59 to 0.89; median, 47.5 v 29.1 months) and PFS (stratified HR, 0.55; 95% CI, 0.45 to 0.68; median, 16.9 v 5.6 months) remained consistent with the primary analyses. Estimated 5-year rates (95% CI) for durvalumab and placebo were 42.9% (38.2 to 47.4) versus 33.4% (27.3 to 39.6) for OS and 33.1% (28.0 to 38.2) versus 19.0% (13.6 to 25.2) for PFS. CONCLUSION: These updated analyses demonstrate robust and sustained OS and durable PFS benefit with durvalumab after chemoradiotherapy. An estimated 42.9% of patients randomly assigned to durvalumab remain alive at 5 years and 33.1% of patients randomly assigned to durvalumab remain alive and free of disease progression, establishing a new benchmark for standard of care in this setting. |
| Publication | Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology |
| Volume | 40 |
| Issue | 12 |
| Pages | 1301-1311 |
| Date | 2022-04-20 |
| Journal Abbr | J Clin Oncol |
| Language | eng |
| DOI | 10.1200/JCO.21.01308 |
| ISSN | 1527-7755 |
| Short Title | Five-Year Survival Outcomes From the PACIFIC Trial |
| Library Catalog | PubMed |
| Extra | PMID: 35108059 PMCID: PMC9015199 |
| Tags | Antibodies, Monoclonal, Carcinoma, Non-Small-Cell Lung, Chemoradiotherapy, clinic, Disease Progression, Humans, Lung Neoplasms |
| Date Added | 2022/08/31 - 14:15:33 |
| Date Modified | 2022/08/31 - 14:15:48 |
| Notes and Attachments | Full Text (Attachment) PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
