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.
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Tarantino Paolo, Tayob Nabihah, Villacampa Guillermo, Dang Chau, Yardley Denise A, Isakoff Steven J, Valero Vicente, Faggen Meredith, Mulvey Therese, Bose Ron, Weckstein Douglas, Wolff Antonio C, Reeder-Hayes Katherine, Rugo Hope S, Ramaswamy Bhuvaneswari, Zuckerman Dan, Hart Lowell, Gadi Vijayakrishna K, Constantine Michael, Cheng Kit, Garrett Audrey Merrill, Marcom P Kelly, Albain Kathy, DeFusco Patricia, Tung Nadine, Ardman Blair, Nanda Rita, Jankowitz Rachel C, Rimawi Mothaffar, Abramson Vandana, Pohlmann Paula R, Van Poznak Catherine, Forero-Torres Andres, Liu Minetta C, Ruddy Kathryn J, Waks Adrienne G, DeMeo Michelle, Burstein Harold J, Partridge Ann H, Dell'Orto Patrizia, Russo Leila, Krause Emma, Newhouse Daniel J, Kurt Busem Binboğa, Mittendorf Elizabeth A, Schneider Bryan, Prat Aleix, Winer Eric P, Krop Ian E, Tolaney Sara M, Consortium of the TBCRC Translational Investigators, TBCRC Translational Investigators
Аннотация
METHODS: In 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.
RESULTS: After 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.
CONCLUSION: Adjuvant 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.