Docetaxel and Continuous-Infusion Fluorouracil Versus Epirubicin, Cisplatin, and Fluorouracil for Advanced Gastric Adenocarcinoma: A Randomized Phase II Study

Author:

Thuss-Patience Peter C.1,Kretzschmar Albrecht1,Repp Michael1,Kingreen Dorothea1,Hennesser Dirk1,Micheel Simone1,Pink Daniel1,Scholz Christian1,Dörken Bernd1,Reichardt Peter1

Affiliation:

1. From the Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charité, Universitätsmedizin Berlin, Campus Virchow-Klinkum; HELIOS-Klinikum Berlin, Robert-Rössle-Klink, Charité Campus Buch; and Onkologische Schwerpunktpraxis Tiergarten, Berlin; Städtisches Klinikum St. Georg, Leipzig; and Vinzenz-Pallotti-Krankenhaus, Hämato-onkologische Ambulanz, Bergisch-Gladbach, Germany

Abstract

Purpose A combination of docetaxel and fluorouracil (DF) was evaluated in an outpatient setting and compared with epirubicin, cisplatin, and fluorouracil (ECF), which served as an internal control arm to avoid selection bias. Patients and Methods Patients with metastatic or locally advanced gastric adenocarcinoma without prior chemotherapy were randomly assigned to receive either ECF (epirubicin 50 mg/m2 day 1, cisplatin 60 mg/m2 day 1, and fluorouracil 200 mg/m2 days 1 through 21, every 3 weeks) or DF (docetaxel 75 mg/m2 day 1, and fluorouracil 200 mg/m2 days 1 through 21, every 3 weeks). Results Ninety patients were randomly assigned. Toxicity was rarely severe. Major toxic effects included diarrhea, stomatitis, and leukopenia in the DF arm and nausea, vomiting, and leukopenia in the ECF arm. Forty-three of 45 patients in each arm were assessable. In the DF arm, two patients (4.4%, intent to treat) experienced a confirmed complete tumor remission as best response, and 15 patients (33.3%) experienced a confirmed partial remission (overall response rate [ORR], 37.8%; 95% CI, 25.9% to 51.9%). Two patients (4.4%) in the ECF arm showed confirmed complete remission, and 14 (31.1%) showed confirmed partial remission (ORR, 35.6%; 95% CI, 24.8% to 48.7%). For the DF and ECF arms, the median survival was 9.5 and 9.7 months, and the median time to tumor progression 5.5 and 5.3 months, respectively. Conclusion DF can be safely given in an ambulant setting. Compared with ECF, the dual combination of DF shows promising efficacy and may be an alternative treatment option that avoids cisplatin.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3