Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2019 Dec 27;49(12):1083-1091.
doi: 10.1093/jjco/hyz135.

Subgroup analysis of Japanese patients in a Phase 3 study of atezolizumab in advanced triple-negative breast cancer (IMpassion130)

Hiroji Iwata  1 , Kenichi Inoue  2 , Koji Kaneko  3 , Yoshinori Ito  4 , Koichiro Tsugawa  5 , Ayumi Hasegawa  6 , Shintaro Nakagawa  6 , Hiroyasu Kuratomi  6 , Kenji Tamura  7
Affiliations
Clinical Trial

Subgroup analysis of Japanese patients in a Phase 3 study of atezolizumab in advanced triple-negative breast cancer (IMpassion130)

Hiroji Iwata et al. Jpn J Clin Oncol. .

Erratum in

Abstract

Background: In the randomised Phase 3 IMpassion130 trial, atezolizumab combined with nab-paclitaxel (atezo + nab-P) in 902 patients with triple-negative breast cancer (TNBC) showed prolonged progression-free survival (PFS) in both the intention-to-treat (ITT) population and programmed death-ligand 1 (PD-L1)-positive subgroup compared with placebo plus nab-P (plac + nab-P). This study assessed the efficacy and safety of atezo + nab-P in the IMpassion130 Japanese subpopulation.

Methods: Eligible patients had unresectable locally advanced or metastatic TNBC previously untreated with chemotherapy for metastatic disease. Patients were randomised 1:1 to receive either atezo + nab-P or plac + nab-P. Co-primary endpoints were investigator-assessed PFS and overall survival (ITT population and PD-L1-positive subgroup). These were also assessed in the Japanese subpopulation.

Results: There were 65 Japanese patients (34 atezo + nab-P; 31 plac + nab-P). The PD-L1-positive subgroup included 25 patients (12 atezo + nab-P; 13 plac + nab-P). Median PFS was 7.4 months (atezo + nab-P) versus 4.6 months (plac + nab-P; hazard ratio [HR], 0.47; 95% CI, 0.25-0.90). In the PD-L1-positive subgroup, median PFS was 10.8 months (atezo + nab-P) versus 3.8 months (plac + nab-P; HR, 0.04; 95% CI, <0.01-0.35). Safety results in the Japanese subgroup were consistent with those in the overall population. The Japanese subgroup had a lower incidence of adverse events leading to treatment withdrawal than the overall population. More patients in the atezo + nab-P arm had neutrophil count decreases and stomatitis than patients in the plac + nab-P arm.

Conclusions: Atezo + nab-P efficacy in Japanese patients was consistent with the overall IMpassion130 population. No new safety signals were observed, and tolerability was consistent with that of the overall population.

Keywords: Japanese; atezolizumab; immunotherapy; programmed death-ligand 1; triple-negative breast cancer.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
(A) Investigator-assessed progression-free survival in Japanese patients (ITT) and (B) PD-L1–positive patients. Atezo, atezolizumab; ITT, intention-to-treat; nab-Pac, nab-paclitaxel; NE, not estimable; PD-L1, programmed death-ligand 1.
Figure 2.
Figure 2.
(A) Overall survival in Japanese patients (ITT) and (B) PD-L1–positive patients. Atezo, atezolizumab.
See this image and copyright information in PMC

References

    1. den Brok WD, Speers CH, Gondara L, Baxter E, Tyldesley SK, Lohrisch CA. Survival with metastatic breast cancer based on initial presentation, de novo versus relapsed. Breast Cancer Res Treat 2017;161:549–56. - PubMed
    1. National Comprehensive Cancer Network NCCN clinical practice guidelines in oncology. Breast Cancer 2019;V1 Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. - PubMed
    1. Cardoso F, Senkus E, Costa A et al. 4th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 4). Ann Oncol 2018;29:1634–57. - PMC - PubMed
    1. Gobbini E, Ezzalfani M, Dieras V et al. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer 2018;96:17–24. - PubMed
    1. Yardley DA, Coleman R, Conte P et al. Nab-paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial. Ann Oncol 2018;29:1763–70. - PMC - PubMed

Publication types

MeSH terms