Long term outcome data from the EORTC 75111-10114 ETF/BCG randomized phase II study: Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer, followed by T-DM1 after progression

Breast

Thomas Meyskens¹  Barbara Brouwers²  Etienne Brain³  Giuseppe Curigliano⁴  Hans Wildiers⁵  Berta Sousa⁶  Peter Vuylsteke⁷  Simon Waters⁸  Lissandra Dal Lago⁹  Coralie Poncet⁹  Sandrine Marréaud⁹  Bart Meulemans^1,10 

[1] Corresponding author. Department of General Medical Oncology, University Hospitals Leuven and Department of Oncology, KU Leuven, Herestraat 49, B-Leuven, Belgium.;University of Milano, Milan, Italy;Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal;CHU UCL Namur Sainte Elisabeth, UCLouvain, Namur, Belgium;Department of General Medical Oncology, University Hospitals Leuven and Department of Oncology, KU Leuven, Leuven, Belgium;Department of Medical Oncology, AZ Sint-Jan Hospital, Brugge, Belgium;Department of Medicine, Institut Jules Bordet, Brussels, Belgium;Division of Early Drug Development, Istituto Europeo di Oncologia, IRCCS, Italy;European Organization for Research and Treatment of Cancer (EORTC) - Headquarters, Brussels, Belgium;Velindre Cancer Centre, Cardiff, UK;

关键词: HER2 positive breast cancer;    Older patients;    Frail patients;    Trastuzumab;    Pertuzumab;    Metronomic chemotherapy;   

DOI  :  

来源: DOAJ

【 摘 要 】

Introduction: Older patients are at higher risk of chemotherapy-induced toxicity, raising interest in less toxic anti-HER2 regimens for older persons with HER2-positive (HER2+) metastatic breast cancer (MBC). Patients and methods: This phase II study randomized (1:1) patients with HER2+ MBC, aged 70+ or frail 60+, to first line chemotherapy with metronomic oral cyclophosphamide (M) + Trastuzumab (T) and Pertuzumab (P) or TP alone. T-DM1 was offered in case of progression. Results: In total, 39 and 41 patients were randomized to TP and TPM arm respectively. Median follow-up is 54.0 months. 24-month PFS was 18.7% (95% CI 8.2–32.4) and 28.7% (95% CI 15.8–43.0), respectively. A total of 49 (61.3%) patients died of whom 37 (75.5%) from disease progression; number of deaths per arm was 27 (69.2%) for TP and 22 (53.7%) for TPM. There was no significant difference in OS between the two arms (median OS TP vs TPM: 32.1 vs 37.5 months, p 0.25). Among the 40 patients who have started T-DM1 after disease progression on TP/TPM, PFS rate at 6 months after start of T-DM1 was 43.6% (95% CI: 27.7–58.5) and grade 3 or higher AE occurred in 18 pts (45%). Conclusions: Metronomic chemotherapy-based dual blockade (TPM), followed by T-DM1 after progression, provides an active and relatively well tolerated treatment option in an older/frail HER2+ MBC population, with a median survival of over 3 years. Nevertheless, the majority of this older/frail population died from breast cancer, highlighting the need for well tolerated and efficacious treatments in these patients.

【 授权许可】

Unknown