Long-term outcomes of neoadjuvant trastuzumab emtansine + pertuzumab (T-DM1 + P) and docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP) for HER2-positive primary breast cancer: results of the randomized phase 2 JBCRG20 study (Neo-peaks)

Purpose The randomized phase 2 Neo-peaks study examined usefulness of neoadjuvant trastuzumab emtansine + pertuzumab (T-DM1 + P) following docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP) as compared with the standard TCbHP regimen. We previously reported that pCR rate after neoadjuvant th...

Full description

Saved in:
Bibliographic Details
Published in:Breast cancer research and treatment 2024-08, Vol.207 (1), p.33-48
Main Authors: Takano, Toshimi, Masuda, Norikazu, Ito, Mitsuya, Inoue, Kenichi, Tanabe, Yuko, Kawaguchi, Kousuke, Yasojima, Hiroyuki, Bando, Hiroko, Nakamura, Rikiya, Yamanaka, Takashi, Ishida, Kazushige, Aruga, Tomoyuki, Yanagita, Yasuhiro, Tokunaga, Eriko, Aogi, Kenjiro, Ohno, Shinji, Kasai, Hiroi, Kataoka, Tatsuki R., Morita, Satoshi, Toi, Masakazu
Format: Article
Language:English
Subjects:
Anthracycline
Breast cancer
Cancer therapies
Carboplatin
Clinical Trial
ErbB-2 protein
Medical prognosis
Medicine
Medicine & Public Health
Oncology
Patients
Prognosis
Survival
Toxicity
Trastuzumab
UMIN
UMIN000014649
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Purpose The randomized phase 2 Neo-peaks study examined usefulness of neoadjuvant trastuzumab emtansine + pertuzumab (T-DM1 + P) following docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP) as compared with the standard TCbHP regimen. We previously reported that pCR rate after neoadjuvant therapy tended to be higher with TCbHP followed by T-DM1 + P. We conducted an exploratory analysis of prognosis 5 years after surgery. Methods Neoadjuvant treatment with TCbHP (6 cycles; group A), TCbHP (4 cycles) followed by T-DM1 + P (4 cycles; group B), and T-DM1 + P (4 cycles; group C, + 2 cycles in responders) were compared. Group C non-responders after 4 cycles were switched to an anthracycline-based regimen. We evaluated 5-year disease-free survival (DFS), distant DFS (DDFS), and overall survival (OS). Results Data from 203 patients (50, 52, and 101 in groups A–C, respectively) were analyzed. No significant intergroup differences were found for DFS, DDFS, or OS. The 5-year DFS rates (95% CI) were 91.8% (79.6–96.8%), 92.3% (80.8–97.0%), and 88.0% (79.9–93.0%) in groups A–C, respectively. TCbHP followed by T-DM1 + P and T-DM1 + P with response-guided addition of anthracycline therapy resulted in similar long-term prognosis to that of TCbHP. Conclusions In patients who achieved pCR after neoadjuvant therapy with T-DM1 + P, omission of adjuvant anthracycline may be considered, whereas treatment should be adjusted for non-pCR patients with residual disease. T-DM1 + P with response-guided treatment adjustment may be useful for minimizing toxicity. Trial registration number and date of registration UMIN-CTR, UMIN000014649, prospectively registered July 25, 2014. Some of the study results were presented as a Mini Oral session at the ESMO Breast Cancer 2023 (Berlin, Germany, 11–13 May 2023).
ISSN:0167-6806
1573-7217
1573-7217
DOI:10.1007/s10549-024-07333-7