Everolimus (Afinitor®), Trastuzumab (H), and Paclitaxel (P) or Vinorelbine (V) in the Treatment of HER-2+ Metastatic Breast Cancer (MBC) Patients (Pts) Pre-Treated with Lapatinib-Containing Therapy: Pooled Analysis of 2 Phase I Studies.

作者：Fátima Cardoso, Véronique Dièras, Mario Campone, Cristian Massacesi, C. Manlius, P. Thevenaz, Y. Zhang, Guy Jérusalem, Tarek Sahmoud, Fabrice André, Luca Gianni · 发表于：Cancer Research · 年份：2009 · DOI：10.1158/0008-5472.sabcs-09-5064 · 被引用次数：5 · 研究领域：HER2/EGFR in Cancer Research、Advanced Breast Cancer Therapies、Chronic Lymphocytic Leukemia Research

Abstract Introduction: The re-introduction of H-based therapy after progression on a lapatinib-containing regimen has not yet been supported by clear evidence. The aim of this analysis is to describe the safety and efficacy of the regimens everolimus (E) + H, and either P or V in patients pre-treated with lapatinib (L) in relation to those who did not receive previous L (N-L). Methods: Data from pts enrolled in two multicenter phase I studies (NCT00426556 and NTC00426530), with similar study design, were pooled and analyzed according to previous treatment with L. Regimens were: oral E daily (5 or 10mg) or weekly (20 or 30mg) + weekly H 2mg/kg IV, and either P 80mg/m2, IV D1-8-15 q4w (33 pts) or V 25 mg/m2, IV D1-8 q3w (46 pts). Results: Twenty-six (33%) of the overall 79 pts enrolled, received previous L (equally distributed among E dose cohorts). Baseline characteristics of the L and N-L groups, respectively, were: median age: 49 and 53 yo; visceral disease: 85% and 75% of pts; median number of previous chemotherapy lines for metastatic disease: 3 (range: 1-17) and 1 (range: 0-7); prior-taxanes and anthracyclines: 96% and 81% of the L pts, and in 96% and 85% of the N-L pts, respectively; 78 of 79 pts were H-resistant. The 26 pts pretreated with L were all resistant to L and had a median treatment duration of 24 wks (range: 6-123). In the L and N-L groups, the most frequently reported severe toxicities were G3/4 neutropenia in 58% and 75%, febrile neutropenia in 8% and 2%, G3...