A neoadjuvant, randomized, open-label phase ii trial of afatinib versus trastuzumab versus lapatinib in patients with locally advanced HER2-positive breast cancer

MF Rimawi, SB Aleixo, Ashley Alarcon Rozas, MAIRA CALEFFI, Alicardo Cesar Figueira, Sulene Cunha Souza, Heloisa Arantes, C. Kent Osborne, AA Rozas, João Nunes de Matos Neto, Andre B. Reiriz, Carolina Gutierrez, Martina M. Uttenreuther-Fischer, Flavio Solca

Clinical breast cancer, v. 15, n. 2, p. 101-109, 2015.

Motivo: Produção Colaborador HMV

Setor HMV: Oncologia

Área da saúde: Oncologia

Resumo: BACKGROUND: Chemotherapy is standard neoadjuvant treatment of LA BC. Patients with HER2-positive BC require targeted therapy. Trastuzumab and pertuzumab, which target HER2, with chemotherapy are approved as neoadjuvant therapy, however, treatments with different mechanisms of action might provide a broader range of activity. In this study we evaluated the efficacy and safety of the irreversible ErbB family blocker afatinib, versus trastuzumab or lapatinib in the neoadjuvant treatment of HER2-positive, LA BC. PATIENTS AND METHODS: Treatment-naive, HER2-positive BC patients with stage IIIA, B, C or inflammatory disease were randomized 1:1:1 to daily afatinib (50 mg), lapatinib (1500 mg), or weekly trastuzumab (4 mg/kg loading dose, then 2 mg/kg/wk) for 6 weeks until surgery or follow-up neoadjuvant treatment. The primary end point was objective response rate according to Response Evaluation Criteria in Solid Tumors (version 1.0). RESULTS: Recruitment was stopped early because of slow patient enrollment; 29 patients were randomized to afatinib (n = 10), lapatinib (n = 8), or trastuzumab (n = 11). Objective response was seen in 8 afatinib-, 6 lapatinib-, and 4 trastuzumab-treated patients. Eleven patients had stable disease (best response); 1 lapatinib- and 1 trastuzumab-treated patient had progressive disease. All 10 afatinib-treated patients experienced drug-related adverse events (commonly diarrhea, dermatitis acneiform, and paronychia) versus 6 of 8 lapatinib- (diarrhea and rash) and 5 of 11 trastuzumab-treated patients (vomiting and arthralgia). CONCLUSION: Afatinib demonstrated clinical activity that compared favorably to trastuzumab and lapatinib for neoadjuvant treatment of HER2-positive BC, with a safety profile consistent with epidermal growth factor receptor tyrosine kinase inhibitors.

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