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.
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.
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DOI：
10.1186/s40064-015-1601-7
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Misset JL
中科院分区：
文献类型：
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作者：
Gunzer K;Joly F;Ferrero JM;Gligorov J;de Mont-Serrat H;Uttenreuther-Fischer M;Pelling K;Wind S;Bousquet G;Misset JL
一项II期、开放标签研究，评估ErbB家族阻滞剂阿法替尼联合来曲唑治疗来曲唑单药治疗后进展的雌激素受体阳性转移性乳腺癌（MBC）患者的疗效和安全性。成年女性（N = 28）接受口服阿法替尼（50 [n = 7]、40 [n = 13]或30 [n = 8] mg/天）联合来曲唑2.5 mg/天，28天为一个周期，直至疾病进展。主要终点为阿法替尼治疗16周时或治疗16周后的无进展率。第16周时，4例患者继续接受阿法替尼治疗，未发生进展;其中2例为HER 2阴性。根据实体瘤缓解评价标准，15例（54%）患者的最佳缓解为疾病稳定。阿法替尼50、40和30 mg/天组的中位无进展生存期分别为60、107和79天。腹泻、乏力、皮疹、粘膜炎症和恶心是最常见的不良事件。在这项小型探索性研究中，阿法替尼联合来曲唑能够在54%既往接受来曲唑治疗后疾病进展的难治性MBC患者中诱导疾病稳定。临床试验注册：NCT 00708214
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