Long-Term Outcomes of Adjuvant Trastuzumab for 9 Weeks or 1 Year for ERBB2-Positive Breast Cancer: A Secondary Analysis of the SOLD Randomized Clinical Trial.

Autor:	Joensuu H; Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland., Fraser J; Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom., Wildiers H; Multidisciplinary Breast Centre, University Hospitals Leuven, Leuven, Belgium., Huovinen R; Turku University Hospital, Turku, Finland., Auvinen P; Department of Oncology, Kuopio University Hospital, Kuopio, Finland., Utriainen M; Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland., Villman KK; Örebro University Hospital, Örebro, Sweden., Halonen P; Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland., Granstam-Björneklett H; Västerås Central Hospital, Västerås, Sweden., Tanner M; Department of Oncology, Tampere University Hospital and Tampere University, Tampere, Finland., Sailas L; Vaasa Central Hospital, Vaasa, Finland.; North Karelia Central Hospital, Joensuu, Finland., Turpeenniemi-Hujanen T; Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland., Yachnin J; Center for Clinical Cancer Studies, Karolinska University Hospital, Stockholm, Sweden., Huttunen T; EstiMates Ltd, Turku, Finland., Neven P; Multidisciplinary Breast Centre, University Hospitals Leuven, Leuven, Belgium., Canney P; Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom., Harvey VJ; Auckland City Hospital, Auckland, New Zealand., Kellokumpu-Lehtinen PL; Department of Oncology, Tampere University Hospital and Tampere University, Tampere, Finland., Lindman H; Department of Immunology, Genetics and Pathology, Uppsala University Hospital, Uppsala, Sweden.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2024 Aug 01; Vol. 7 (8), pp. e2429772. Date of Electronic Publication: 2024 Aug 01.
DOI:	10.1001/jamanetworkopen.2024.29772
Abstrakt:	Importance: The standard adjuvant treatment for patients with ERRB2-positive breast cancer is chemotherapy plus 1 year of trastuzumab. Shorter durations of trastuzumab administration improve cardiac safety, but more information is needed about their effect on survival. Objective: To compare survival outcomes after 9-week vs 1-year administration of trastuzumab with the same adjuvant chemotherapy. Design, Setting, and Participants: This post hoc secondary analysis of an open-label, multicenter, noninferiority-design randomized clinical trial included women aged 18 years or older with early ERBB2-positive, axillary node-negative or axillary node-positive breast cancer who were enrolled from January 3, 2008, to December 16, 2014, at 65 centers in 7 European countries. The current exploratory analysis was conducted after achieving the maximum attainable follow-up data when the last patient enrolled had completed the last scheduled visit in December 2022. Intervention: Chemotherapy consisted of 3 cycles of docetaxel administered at 3-week intervals followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide at 3-week intervals. Trastuzumab was administered in both groups for 9 weeks concomitantly with docetaxel. In the 9-week group, no further trastuzumab was administered after chemotherapy, whereas in the 1-year group, trastuzumab was continued after chemotherapy to complete 1 year of administration. Main Outcomes and Measures: The primary objective was disease-free survival (DFS). Distant DFS and OS were secondary objectives. Survival between groups was compared using the Kaplan-Meier method and log-rank test or univariable Cox proportional hazards regression. Results: Among the 2174 women analyzed, median age was 56 years (IQR, 48-64 years). The median follow-up time was 8.1 years (IQR, 8.0-8.9 years); 357 DFS events and 176 deaths occurred. Trastuzumab for 9 weeks was associated with shorter DFS compared with trastuzumab for 1 year (hazard ratio [HR], 1.36; 90% CI, 1.14-1.62); 10-year DFS was 80.3% in the 1-year group vs 78.6% in the 9-week group. The 5-year and 10-year OS rates were comparable between the 9-week and 1-year groups (95.0% vs 95.9% and 89.1% vs 88.2%, respectively; HR for all time points, 1.20; 90% CI, 0.94-1.54). In multivariable analyses, 9-week treatment was associated with shorter DFS compared with 1-year treatment (HR for recurrence or death, 1.36; 95% CI, 1.10-1.68; P = .005), but there was no between-group difference in OS (HR, 1.22; 95% CI, 0.90-1.64; P = .20). Only 4 patients (0.2%) died of a cardiac cause. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, 1-year vs 9-week adjuvant trastuzumab was associated with improved DFS among patients with ERRB2-positive breast cancer receiving chemotherapy, but there was no significant difference in OS between the groups. Trial Registration: ClinicalTrials.gov Identifier: NCT00593697.
Databáze:	MEDLINE
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