演題抄録

FACO International Workshop

開催概要
開催回
第53回・2015年・京都
 

Phase III trial evaluating the addition of bevacizumab to paclitaxel as first-line chemotherapy for HER2-negative metastatic breast cancer: Japanese subgroup data in MERiDiAN study

演題番号 : FWS11-6

[筆頭演者]
Kashiwaba Masahiro:1 
[共同演者]
Takahashi M:2、Nakagami K:3、Okumura Y:4、Nakayama T:5、Sato N:6、Kanatani K:7、Masuda N:8

1:Iwate Medical University, Morioka, Japan、2:Hokkaido Cancer Center, Sapporo, Japan、3:Shizuoka General Hospital, Shizuoka, Japan、4:Kumamoto City Hospital, Kumamoto, Japan、5:Osaka Medical Center, Osaka, Japan、6:Niigata Cancer Center, Niigata, Japan、7:Chugai Pharmaceutical Co. Ltd, Tokyo, Japan、8:NHO Osaka National Hospital, Osaka, Japan

 

[Background] MERiDiAN is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate safety and efficacy of the addition of bevacizumab (BEV) to paclitaxel compared to placebo plus paclitaxel (PTX) as first-line treatment of patients with HER2-negative metastatic breast cancer (MBC), and to prospectively elucidate the roles of plasma VEGF-A (pVEGF-A) as predictive efficacy biomarker of BEV. The Co-primary endpoints were progression-free survival (PFS) by investigators assessment in the intent-to-treat (ITT) patient population and PFS in the pVEGF-A high population.
[Method] Key eligible criteria were HER2-negative adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease; no prior chemotherapy for MBC; ECOG performance status 0-1. Mandatory blood samples for the determination of pVEGF-A levels were collected from all patients. Following the determination of pVEGF-A expression levels, patients were randomized in a 1:1 ratio to one of two treatment arms. Stratification factors were pVEGF-A level, prior adjuvant chemotherapy, hormone receptor status and geographic region. Patients received PTX 90 mg/m2 weekly for 3 weeks followed by a 1-week rest and 10 mg/kg of BEV /placebo every 2 weeks until progression disease or treatment-limiting toxicity.
[Result] 481 patients were randomized (BEV+PTX: 242, placebo+PTX: 239 in ITT patient population; BEV+PTX: 124, placebo+PTX: 120 in patients with high baseline pVEGF-A level). 54 patients were enrolled from Japan (BEV+PTX: 30, placebo+PTX: 24). The study met both its co-primary endpoints, showing a statistically significant PFS benefit with BEV plus PTX for the ITT population and the population with high pVEGF-A, compared to placebo plus PTX. More detail results of ITT patient population and subgroup in Japanese patients will be presented in this congress.

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