Adjuvant trastuzumab emtansine versus paclitaxel plus trastuzumab for stage I human epidermal growth factor receptor 2–positive breast cancer: 5-year results and correlative analyses from ATEMPT Journal Article


Authors: Tarantino, P.; Tayob, N.; Villacampa, G.; Dang, C.; Yardley, D. A.; Isakoff, S. J.; Valero, V.; Faggen, M.; Mulvey, T.; Bose, R.; Weckstein, D.; Wolff, A. C.; Reeder-Hayes, K.; Rugo, H. S.; Ramaswamy, B.; Zuckerman, D.; Hart, L.; Gadi, V. K.; Constantine, M.; Cheng, K. T.; Garrett, A. M.; Marcom, P. K.; Albain, K.; DeFusco, P.; Tung, N.; Ardman, B.; Nanda, R.; Jankowitz, R. C.; Rimawi, M.; Abramson, V.; Pohlmann, P. R.; Van Poznak, C.; Forero-Torres, A.; Liu, M. C.; Ruddy, K. J.; Waks, A. G.; DeMeo, M.; Burstein, H. J.; Partridge, A. H.; Dell'Orto, P.; Russo, L.; Krause, E.; Newhouse, D. J.; Kurt, B. B.; Mittendorf, E. A.; Schneider, B.; Prat, A.; Winer, E. P.; Krop, I. E.; Tolaney, S. M.; on behalf of the Consortium of the TBCRC Translational Investigators
Article Title: Adjuvant trastuzumab emtansine versus paclitaxel plus trastuzumab for stage I human epidermal growth factor receptor 2–positive breast cancer: 5-year results and correlative analyses from ATEMPT
Abstract: PURPOSELong-term outcomes of patients with stage I human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving adjuvant trastuzumab emtansine (T-DM1) remain undefined, and prognostic predictors represent an unmet need.METHODSIn the ATEMPT phase II trial, patients with stage I centrally confirmed HER2-positive breast cancer were randomly assigned 3:1 to adjuvant T-DM1 for 1 year or paclitaxel plus trastuzumab (TH). Coprimary objectives were to compare the incidence of clinically relevant toxicities between arms and to evaluate invasive disease-free survival (iDFS) with T-DM1. Correlative analyses included the HER2DX genomic tool, multiomic evaluations of HER2 heterogeneity, and predictors of thrombocytopenia.RESULTSAfter a median follow-up of 5.8 years, 11 iDFS events were observed in the T-DM1 arm, consistent with a 5-year iDFS of 97.0% (95% CI, 95.2 to 98.7). At 5 years, the recurrence-free interval (RFI) was 98.3% (95% CI, 97.0 to 99.7), the overall survival was 97.8% (95% CI, 96.3 to 99.3), and the breast cancer-specific survival was 99.4% (95% CI, 98.6 to 100). Comparable iDFS was observed with T-DM1 irrespective of tumor size, hormone receptor status, centrally determined HER2 immunohistochemical score, and receipt of T-DM1 for more or less than 6 months. Although ATEMPT was not powered for this end point, the 5-year iDFS in the TH arm was 91.1%. Among patients with sufficient tissue for HER2DX testing (n = 187), 5-year outcomes significantly differed according to HER2DX risk score, with better RFI (98.1% v 81.8%, hazard ratio [HR], 0.10, P = .01) and iDFS (96.3% v 81.8%, HR, 0.20, P = .047) among patients with HER2DX low-risk versus high-risk tumors, respectively.CONCLUSIONAdjuvant T-DM1 for 1 year leads to outstanding long-term outcomes for patients with stage I HER2-positive breast cancer. A high HER2DX risk score predicted a higher risk of recurrence in ATEMPT.
Keywords: recommendations; open-label; physicians choice; th3resa
Journal Title: Journal of Clinical Oncology
Volume: 42
Issue: 31
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2024-11-01
Language: English
ACCESSION: WOS:001346477100003
DOI: 10.1200/jco.23.02170
PROVIDER: wos
PMCID: PMC11527383
PUBMED: 38935923
Notes: Article -- Source: Wos
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  1. Chau Dang
    271 Dang