拉帕替尼联合卡培他滨治疗HER2阳性进展期或转移性乳腺癌患者的疗效安全性药代动力学和生物标志物发现51例日本患者临床研究治疗结果.pdfVIP

Breast Cancer (2015) 22:192–200 DOI 10.1007/s12282-013-0475-1 ORIGINAL ARTICLE Efficacy, safety, pharmacokinetics and biomarker findings in patients with HER2-positive advanced or metastatic breast cancer treated with lapatinib in combination with capecitabine: results from 51 Japanese patients treated in a clinical study Hiroji Iwata • Hirofumi Fujii • Norikazu Masuda • Hirofumi Mukai • Yuichiro Nishimura • Koichi Katsura • Catherine E. Ellis • Robert C. Gagnon • Seigo Nakamura Received: 19 June 2012 / Accepted: 29 April 2013 / Published online: 21 May 2013 The Author(s) 2013. This article is published with open access at S Abstract Methods Eligible women received lapatinib 1250 mg Background The results from a phase III trial conducted once daily and capecitabine 1000 mg/m2 twice daily on outside of Japan demonstrated a significant improvement in days 1 through 14 of a 21-day cycle. The primary endpoint time to progression (TTP) when lapatinib was combined was the clinical benefit rate (CBR: complete response, with capecitabine compared with capecitabine alone in partial response or stable disease for at least 24 weeks). patients with HER2-positive advanced or metastatic breast Results Lapatinib in combination with capecitabine was cancer. In this clinical study of lapatinib in combination well tolerated in the 51 patients enrolled in this study. CBR with capecitabine, efficacy, safety, pharmacokinetics (PK) was 59 % (95 % CI 44.2, 72.4), and the median TTP in the and biomarkers were investigated in Japanese patients with Kaplan-Meier estimate was 36 weeks (95 % CI 27.1, 48.0). HER2-positive advanced or metastatic breast cancer trea- The majority of drug-related adverse e