AI Article Synopsis
- In the phase 3 PACIFIC trial, durvalumab was found to significantly extend progression-free survival (PFS) and overall survival (OS) in patients with advanced lung cancer who were untreated after chemoradiotherapy.
- A notable proportion of patients experienced symptomatic radiation pneumonitis (PRP), with 19.8% in the durvalumab group and 14.1% in the placebo group, though severe cases were rare.
- Factors such as being treated in Asia, having stage IIIA disease, and certain performance statuses increased the risk of G2+PRP, but the effectiveness of durvalumab persisted regardless of these side effects.
Article Abstract
Introduction: In the placebo-controlled, phase 3 PACIFIC trial, durvalumab significantly prolonged progression-free survival (PFS) ( < 0.0001) and overall survival (OS) ( = 0.00251) in patients with unresectable stage III NSCLC and no progression after platinum-based concurrent chemoradiotherapy (cCRT). Pneumonitis or radiation pneumonitis (PRP) was common in both arms. We report exploratory analyses evaluating the association of symptomatic (grade ≥2) PRP (G2+PRP) with baseline factors and clinical outcomes.
Methods: Patients with WHO performance status of 0 or 1 were randomized (2:1) to 12 months of durvalumab or placebo, 1 to 42 days after cCRT. Associations between baseline factors and on-study G2+PRP in durvalumab-treated patients were investigated using univariate and multivariate logistic regression. PFS and OS were analyzed using Cox proportional hazards models adjusted for time-dependent G2+PRP plus covariates for randomization stratification factors without and with additional baseline factors.
Results: On-study G2+PRP occurred in 94 of 475 (19.8%) and 33 of 234 patients (14.1%) on durvalumab and placebo, respectively (median follow-up, 25.2 mo); grade greater than or equal to 3 PRP was uncommon (4.6% and 4.7%, respectively). Time to onset and resolution of G2+PRP was similar with durvalumab and placebo. Univariate and multivariate analyses identified patients treated in Asia, those with stage IIIA disease, those with performance status of 1, and those who had not received induction chemotherapy as having a higher risk of G2+PRP. PFS and OS benefit favoring durvalumab versus placebo was maintained regardless of time-dependent G2+PRP.
Conclusions: Factors associated with higher risk of G2+PRP with durvalumab after cCRT were identified. Clinical benefit was maintained regardless of on-study G2+PRP, suggesting the risk of this event should not deter the use of durvalumab in eligible patients with unresectable stage III NSCLC.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10918565 | PMC |
| http://dx.doi.org/10.1016/j.jtocrr.2024.100638 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Association of Immune-Related Adverse Events With Efficacy in Consolidation Nivolumab Plus Ipilimumab or Nivolumab Alone After Chemoradiation in Patients With Unresectable Stage III Nonsmall Cell Lung Cancer: An Exploratory Analysis From the Big 10 Cancer Research Consortium Study BTCRC LUN 16-081.
Clin Lung Cancer
December 2024
Indiana University Simon Cancer Center, Indianapolis, IN. Electronic address:
Background: Immunotherapy has been widely incorporated into the treatment of patients with non-small-cell lung cancer (NSCLC). Many of these patients will experience immune-related adverse events (irAEs) without decreased efficacy. We report a retrospective analysis of the association between irAEs and efficacy outcomes from the BTCRC LUN 16-081 randomized phase 2 trial of consolidation nivolumab (N) plus ipilimumab (IPI) vs N alone following chemoradiotherapy in unresectable Stage IIIA/IIIB NSCLC.
View Article and Find Full Text PDFTreatment strategy involving docetaxel plus cisplatin and 5-fluorouracil followed by conversion surgery for locally advanced unresectable/borderline resectable esophageal squamous cell carcinoma.
Dis Esophagus
January 2025
Department of Esophageal Surgery, National Cancer Center, Tokyo, Japan.
Definitive chemoradiotherapy (dCRT) is the standard treatment for unresectable (T4) esophageal squamous cell carcinoma (ESCC), but the prognosis is poor. Borderline resectable (T3br) ESCC has been discussed, but its clinical features and appropriate treatment are unclear. The effects of docetaxel plus cisplatin and 5-fluorouracil (DCF) therapy and subsequent surgery for potentially unresectable ESCC remain controversial.
View Article and Find Full Text PDFTremelimumab plus durvalumab prior to chemoradiotherapy in unresectable, locally advanced non-small cell lung cancer: the Induction trial.
Clin Cancer Res
January 2025
NKI, Amsterdam, Netherlands.
Background: The phase I Induction trial (NCT04287894) assessed the feasibility and safety of induction immunotherapy (IIT) prior to concurrent chemoradiotherapy (cCRT) in patients with locally advanced non-small cell lung cancer (NSCLC).
Methods: Patients with unresectable stage II/III NSCLC were eligible for inclusion. Patients received either one cycle of tremelimumab (75mg) with two cycles of durvalumab (1500mg) in cohort I, one cycle of tremelimumab (300mg) with two cycles of durvalumab in cohort II or one cycle of tremelimumab (300mg) with one cycle of durvalumab in cohort III.
SURGICAL TREATMENT OF GASTRIC STUMP CANCER: A COHORT STUDY OF 51 PATIENTS.
Arq Bras Cir Dig
January 2025
Universidade Estadual de Campinas, Faculty of Medical Sciences, Department of Surgery, Digestive Diseases Surgical Unit - Campinas (SP), Brazil.
Background: Gastric stump neoplasia is defined as a neoplasia that arises in the gastric remnant after at least 5 years of interval from the first gastric resection.
Aims: The aim of this study was to analyze 51 patients who underwent total and subtotal gastrectomy and multi-visceral resections in patients with gastric stump cancer.
Methods: The hospital records of 51 patients surgically treated for gastric stump cancer between 1989 and 2019 were reviewed.
Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120).
J Bras Pneumol
January 2025
. Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS), Brasil.
Objective: The PACIFIC trial established standard therapy for patients with unresectable stage III NSCLC who did not progress after platinum-based concurrent chemoradiation therapy. However, real-world data, particularly from Latin America, remain limited. The LACOG 0120 study aimed to evaluate the efficacy and safety of consolidation therapy with durvalumab in a real-world setting in Brazil.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!