A Phase II Trial of Vinflunine As Monotherapy or in Combination with Trastuzumab as First-Line Treatment of Metastatic Breast Cancer

被引：20

作者：

Yardley, Denise A. ^{[1
,2
]}

McCleod, Michael ^{[3
]}

Schreiber, Fred ^{[4
]}

Murphy, Patrick ^{[2
]}

Patton, Jeffrey ^{[2
]}

Thompson, Dana S. ^{[2
]}

Shastry, Mythili ^{[1
]}

Rubin, Mark ^{[3
]}

Melnik, Marianne ^{[5
]}

Burris, Howard A. ^{[1
,2
]}

Hainsworth, John D. ^{[1
,2
]}

机构：

[1] Sarah Cannon Res Inst, Nashville, TN 37203 USA

[2] Tennessee Oncol PLLC, Nashville, TN USA

[3] Florida Canc Specialists, Ft Myers, FL USA

[4] Watson Clin, Lakeland, FL USA

[5] Grand Rapids Clin Oncol Program, Grand Rapids, MI USA

来源：

CANCER INVESTIGATION | 2010年 / 28卷 / 09期

关键词：

Vinflunine; Trastuzumab; Metastatic breast cancer; Phase II; HER2; SOLID TUMORS; FIRST-LINE; INTRAVENOUS VINORELBINE; CLINICAL DEVELOPMENT; PLUS VINORELBINE; CELL CARCINOMA; SINGLE-AGENT; IN-VITRO; CHEMOTHERAPY; THERAPY;

D O I：

10.3109/07357907.2010.496755

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

We investigated the microtubulin inhibitor vinflunine-with trastuzumab in human epidermal growth factor receptor-2 (HER2)-positive patients-as first-line metastatic breast cancer therapy. HER2-negative patients received vinflunine on day 1; HER2-positive patients received vinflunine/trastuzumab every 21 days. Forty-eight patients in each treatment group were planned; the sponsor terminated the study early. Thirty-two evaluable patients (vinflunine, 11; vinflunine/trastuzumab, 21) were enrolled. In HER2-positive patients, vinflunine/trastuzumab produced an objective response rate (33%), clinical benefit rate (71%), and progression-free survival (6.2 months). Grade-3/4 neutropenia occurred in 14 (44%) patients; gastrointestinal toxicities were common and six patients were hospitalized for treatment-related toxicity. The vinflunine/trastuzumab combination was active and well tolerated, but our results do not suggest advantages over taxane/trastuzumab or vinorelbine/trastuzumab.

引用

页码：925 / 931

页数：7

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