Final results of a phase II study of paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer

• Autores: Javier Salvador Bofill, Luis Manso Sánchez, Juan Rafael Haba Rodríguez, Ana Jaén, Eva Ciruelos, M. Codes Manuel de Villena, Juan Miguel Gil Gil, Adolfo Murias Rosales, Antonio Galán, Carlos Jara Sánchez, Juan Bayo Calero, José Manuel Baena Cañada, Joaquín Casal Rubio, Ramón Mel Lorenzo, I. Blancas, Pedro Sánchez Rovira
• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 17, Nº. 2, 2015, págs. 160-166
• Idioma: inglés
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• Resumen

  • Background Efficacy and safety data for combining bevacizumab, gemcitabine, and paclitaxel for locally advanced/metastatic breast cancer are limited.

    Patients and methods AVALUZ trial evaluates the combination of bevacizumab 10 mg/kg, gemcitabine 2,000 mg/m2 plus paclitaxel 150 mg/m2, on days 1 and 15 of each 28-day course in previously untreated HER-2 negative patients.

    Results Median progression-free survival (PES): 12.3 months. The overall response and clinical benefit rate (CR + PR + SD) were 72 % (95 % CI 60.9�82.0 %) and 89 % (95 % CI 80.3�95.3 %), respectively. Median overall survival: 27.4 mo. Baseline circulating tumor cell (CTCs) =2 versus CTCs <2 was associated with lower PFS, p = 0.046. Overall response was significantly greater in patients with intense angiotensin type 1 receptor (AGTR1) expression (99 vs. 60 % [p = 0.021]). The most frequent grade 3/4 adverse events were: neutropenia (10 %); febrile neutropenia (1 %); sensory neuropathy (13 %); and asthenia (6 %). Grade 3 adverse events of interest with bevacizumab included bleeding (1 %) and hypertension (4 %). One patient developed cardiac ischemia (1 %).

    Conclusions Adding bevacizumab to chemotherapy appeared feasible and well tolerated, producing toxicity comparable to other effective combined first-line regimens. Baseline circulating endothelial cells and AGTR1 expression are predictive of PFS and response.