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.

Autor:	Tarantino P; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA.; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy., Tayob N; Harvard Medical School, Boston, MA.; Division of Data Science, Dana-Farber Cancer Institute, Boston, MA., Villacampa G; SOLTI Breast Cancer Research Group, Barcelona, Spain.; Oncology Data Science Vall d'Hebron Institute of Oncology, Barcelona, Spain., Dang C; Memorial Sloan Kettering Cancer Center, New York, NY., Yardley DA; Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN., Isakoff SJ; Harvard Medical School, Boston, MA.; Massachusetts General Hospital, Boston, MA., Valero V; MD Anderson Cancer Center, Houston, TX., Faggen M; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA., Mulvey T; Harvard Medical School, Boston, MA.; Massachusetts General Hospital, Boston, MA., Bose R; Washington University School of Medicine, St Louis, MO., Weckstein D; New Hampshire Oncology Hematology, Manchester, NH., Wolff AC; Johns Hopkins Sidney Kimmel Cancer Center, Washington, DC., Reeder-Hayes K; University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC., Rugo HS; University of California, San Francisco, CA., Ramaswamy B; Ohio State University Comprehensive Cancer Center, Columbus, OH., Zuckerman D; St Luke's Mountain States Tumor Institute, Boise, ID., Hart L; Wake Forest Baptist Health, Winston-Salem, NC., Gadi VK; University of Illinois Cancer Center, Chicago, IL., Constantine M; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA., Cheng K; North Shore-LIJ Cancer Institute, Lake Success, NY., Garrett AM; Northern Light Cancer Care, Brewer, ME., Marcom PK; Duke University School of Medicine, Durham, NC., Albain K; Loyola University Medical Center, Maywood, IL., DeFusco P; Hartford Healthcare Cancer Institute, Hartford, CT., Tung N; Harvard Medical School, Boston, MA.; Beth Israel Deaconess Medical Center, Boston, MA., Ardman B; Lowell General Hospital, Lowell, MA., Nanda R; UChicago Medicine, Chicago, IL., Jankowitz RC; Perelman Center for Advanced Medicine, Philadelphia, PA., Rimawi M; Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX., Abramson V; Vanderbilt-Ingram Cancer Center, Nashville, TN., Pohlmann PR; MD Anderson Cancer Center, Houston, TX.; Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC., Van Poznak C; Rogel Cancer Center, University of Michigan, Ann Arbor, MI., Forero-Torres A; Kirklin UAB Hematology Oncology, Birmingham, AL., Liu MC; Natera, Inc, Austin, TX., Ruddy KJ; Mayo Clinic, Rochester, NY., Waks AG; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA., DeMeo M; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA., Burstein HJ; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA., Partridge AH; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA., Dell'Orto P; IEO European Institute of Oncology, IRCCS, Milan, Italy., Russo L; IEO European Institute of Oncology, IRCCS, Milan, Italy., Krause E; PathAI, Boston, MA., Newhouse DJ; NanoString Technologies, Inc, Boston, MA., Kurt BB; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA., Mittendorf EA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA.; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA., Schneider B; Indiana University School of Medicine, Indianapolis, IN., Prat A; SOLTI Breast Cancer Research Group, Barcelona, Spain.; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain., Winer EP; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA.; Yale Cancer Center, New Haven, CT., Krop IE; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA.; Yale Cancer Center, New Haven, CT., Tolaney SM; Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA.; Harvard Medical School, Boston, MA.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Nov; Vol. 42 (31), pp. 3652-3665. Date of Electronic Publication: 2024 Jun 27.
DOI:	10.1200/JCO.23.02170
Abstrakt:	Purpose: Long-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. 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.
Databáze:	MEDLINE
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