A phase II study of afatinib, an irreversible ErbB family blocker, added to letrozole in patients with estrogen receptor-positive hormone-refractory metastatic breast cancer progressing on letrozole

SpringerPlus - Tập 5 - Trang 1-12 - 2016
Katharina Gunzer1, Florence Joly1,2, Jean-Marc Ferrero3, Joseph Gligorov4,5, Helene de Mont-Serrat6, Martina Uttenreuther-Fischer7, Katy Pelling8, Sven Wind7, Guilhem Bousquet9, Jean-Louis Misset10
1Oncologue-Service de Recherche Clinique, Centre François Baclesse, Caen Cedex 05, France
2Centre Hospitalier Universitaire Côte de Nacre, Caen, France
3Centre Antoine-Lacassagne, Nice, France
4APHP, HUEP-Tenon Hospital, Paris, France
5Institut Universitaire de Cancérologie, UPMC, Paris, France
6Boehringer Ingelheim France S.A.S, Reims, France
7Boehringer Ingelheim Pharma GmbH and Co. KG, Biberach, Germany
8Boehringer Ingelheim Ltd., Bracknell, UK
9Hôpital Saint Louis, Paris, France
10Hôpital Saint-Louis, Paris, France

Tóm tắt

Phase II, open-label study assessing the efficacy and safety of the ErbB family blocker afatinib combined with letrozole in estrogen receptor-positive metastatic breast cancer (MBC) patients who had progressed on letrozole monotherapy. Adult females (N = 28) received oral afatinib (50 [n = 7], 40 [n = 13] or 30 [n = 8] mg/day) plus letrozole 2.5 mg/day in 28-day cycles until disease progression. Primary endpoint was the progression-free rate at or after 16 weeks of afatinib. At 16 weeks, four patients remained on afatinib without progression; two of these were HER2 negative. Fifteen (54 %) patients had a best response of stable disease according to Response Evaluation Criteria in Solid Tumors. Median progression-free survival was 60, 107 and 79 days with 50, 40 and 30 mg/day afatinib, respectively. Diarrhea, asthenia, rash, mucosal inflammation and nausea were the most frequent adverse events. In this small, exploratory study, afatinib combined with letrozole was able to induce disease stabilization in 54 % of hormone-refractory MBC patients previously progressing on letrozole. Clinical trial registration: NCT00708214

Tài liệu tham khảo

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