Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133).
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ therapeutic use
Antineoplastic Agents
/ therapeutic use
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Asian People
Double-Blind Method
Female
Humans
Japan
/ epidemiology
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Neoplasm Staging
Placebos
Small Cell Lung Carcinoma
/ drug therapy
Survival Analysis
White People
Asian patients
Cancer immunotherapy
Japan
Programmed death-ligand 1
TECENTRIQ
Journal
Clinical lung cancer
ISSN: 1938-0690
Titre abrégé: Clin Lung Cancer
Pays: United States
ID NLM: 100893225
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
10
05
2019
revised:
20
06
2019
accepted:
26
07
2019
pubmed:
31
8
2019
medline:
26
3
2020
entrez:
31
8
2019
Statut:
ppublish
Résumé
Atezolizumab is effective and well-tolerated in patients with extensive-stage small-cell lung cancer (ES-SCLC), but differences in response to systemic therapy exist between Asian and Caucasian patients. Here, we assess the efficacy and tolerability of atezolizumab in Japanese patients from the IMpower133 trial (NCT02763579). Key eligibility criteria for this multicenter, double-blind, placebo-controlled, randomized study included age ≥ 18 years; histologically or cytologically confirmed ES-SCLC, measurable per Response Evaluation Criteria in Solid Tumors version 1.1; an Eastern Cooperative Oncology Group performance status of 0/1; and no prior systemic treatment for ES-SCLC. Patients were treated with either atezolizumab 1200 mg or placebo with carboplatin (area under the curve of 5 mg/mL/min) and etoposide (100 mg/m In Japanese patients in the intention-to-treat population, the median overall survival in the atezolizumab group (n = 20) was longer than that in the placebo group (n = 22; 14.6 months; 95% confidence interval [CI], 11.8-17.8 months vs. 11.9 months; 95% CI, 8.4-15.8, respectively; hazard ratio, 0.72; 95% CI, 0.31-1.67). The median progression-free survival was 4.5 months (95% CI, 4.2-8.1 months) versus 4.0 months (95% CI, 2.9-5.6 months; hazard ratio, 0.47; 95% CI, 0.23-0.96), respectively. Atezolizumab was generally well-tolerated, with no treatment-related deaths. The addition of atezolizumab to carboplatin and etoposide was effective and well-tolerated in Japanese patients with ES-SCLC. Results are consistent with the primary analysis of the IMpower133 trial.
Sections du résumé
BACKGROUND
Atezolizumab is effective and well-tolerated in patients with extensive-stage small-cell lung cancer (ES-SCLC), but differences in response to systemic therapy exist between Asian and Caucasian patients. Here, we assess the efficacy and tolerability of atezolizumab in Japanese patients from the IMpower133 trial (NCT02763579).
PATIENTS AND METHODS
Key eligibility criteria for this multicenter, double-blind, placebo-controlled, randomized study included age ≥ 18 years; histologically or cytologically confirmed ES-SCLC, measurable per Response Evaluation Criteria in Solid Tumors version 1.1; an Eastern Cooperative Oncology Group performance status of 0/1; and no prior systemic treatment for ES-SCLC. Patients were treated with either atezolizumab 1200 mg or placebo with carboplatin (area under the curve of 5 mg/mL/min) and etoposide (100 mg/m
RESULTS
In Japanese patients in the intention-to-treat population, the median overall survival in the atezolizumab group (n = 20) was longer than that in the placebo group (n = 22; 14.6 months; 95% confidence interval [CI], 11.8-17.8 months vs. 11.9 months; 95% CI, 8.4-15.8, respectively; hazard ratio, 0.72; 95% CI, 0.31-1.67). The median progression-free survival was 4.5 months (95% CI, 4.2-8.1 months) versus 4.0 months (95% CI, 2.9-5.6 months; hazard ratio, 0.47; 95% CI, 0.23-0.96), respectively. Atezolizumab was generally well-tolerated, with no treatment-related deaths.
CONCLUSION
The addition of atezolizumab to carboplatin and etoposide was effective and well-tolerated in Japanese patients with ES-SCLC. Results are consistent with the primary analysis of the IMpower133 trial.
Identifiants
pubmed: 31466854
pii: S1525-7304(19)30209-8
doi: 10.1016/j.cllc.2019.07.005
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antineoplastic Agents
0
Placebos
0
atezolizumab
52CMI0WC3Y
Banques de données
ClinicalTrials.gov
['NCT02763579']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
469-476.e1Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.