Phase II randomized trial comparing metronomic anthracycline-containing chemotherapy versus standard schedule in untreated HER2 negative advanced breast cancer: activity and quality of life results of the GOIM 21003 trial

Autor: Laura Orlando, Evaristo Maiello, Michele Orditura, Anna Diana, Giuliano Antoniol, Maria Grazia Morritti, Michele Aieta, Mariangela Ciccarese, Salvatore Pisconti, Roberto Bordonaro, Antonio Russo, Antonio Febbraro, Paola Schiavone, Annamaria Quaranta, Chiara Caliolo, Dario Loparco, Margherita Cinefra, Giuseppe Colucci, Saverio Cinieri
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Breast, Vol 75, Iss , Pp 103725- (2024)
Druh dokumentu: article
ISSN: 1532-3080
DOI: 10.1016/j.breast.2024.103725
Popis: Background: Optimizing chemotherapy to achieve disease and symptoms control is a noteworthy purpose in advanced breast cancer (ABC). We reported the activity and quality of life of a phase II study, comparing metronomic regimen with standard schedule as first line chemotherapy for ABC. Methods: Patients with HER2 negative ABC were randomized to non-pegylated liposomal doxorubicin (NPLD, 60 mg/m2 every 3 weeks) and cyclophosphamide (CTX, 600 mg/m2 every 3 weeks) (Arm A) or NPLD (20 mg/m2 day, on day 1, 8 and 15 every 4 weeks) and metronomic daily oral CTX 50 mg (ARM B). Primary end-points were overall response rate (ORR) and quality of life, secondary progression-free survival (PFS), overall survival (OS) and toxicity. Results: From August 2012 to December 2017, 121 patients were enrolled, 105 evaluable. Median follow-up was 21.3 months. Most patients had hormone receptor positive. ORR was 43 % in arm A and 50 % in arm B. Median PFS was 8.9 months in arm A and 6,4 months in arm B. There was no difference in OS. Total score was not clinically different between the two arms. Grade 4 neutropenia was observed in 12 patients and 16 patients respectively; alopecia G2 in 41 % (77 %) vs 14 (27 %) in arm A and in arm B respectively. One cardiac toxicity was observed (arm A). Conclusions: First line metronomic chemotherapy for HER2 negative ABC had similar clinical activity and quite better tolerability than standard schedule and could be considered a further treatment option when chemotherapy is indicated.
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