A phase II study of capecitabine plus oxaliplatin (XELOX): a new first-line option in metastatic colorectal cancer.

International journal of gastrointestinal cancer Pub Date : 2005-01-01 DOI:10.1385/ijgc:35:2:103

Thomas Makatsoris, Haralabos P Kalofonos, Gerasimos Aravantinos, Christos Papadimitriou, Efstathios Kastritis, Sotirios K Rigatos, Nikolaos Xiros, Theodore Petsas, Theofanis Economopoulos, Athanassios K Sakadamis, George Fountzilas

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引用次数: 21

Abstract

Background: Capecitabine and oxaliplatin are both effective and well-tolerated monotherapies for the treatment of advanced colorectal cancer (CRC). Oxaliplatin has also been shown to be very effective when combined with 5-FU/LV in the first-line setting.

Aim of the study: Assess the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with previously untreated advanced CRC.

Methods: Fifty-three patients with measurable disease received capecitabine 1,000 mg/m2 twice daily on d 1-14 and oxaliplatin 130 mg/m2 on d 1, every 3 wk. Of these, 52 were evaluable for safety and 49 for antitumor response.

Results: There was a low rate of grade 1/2 adverse events; grade 3/4 events included leukopenia (10%), neutropenia (6%), thrombocytopenia (2%), nausea/vomiting (4%), and diarrhea (4%). The overall response rate was 39% (95% CI, 25-54%) and median time to disease progression was 7.8 mo.

Conclusions: XELOX is an active and well-tolerated first-line treatment for advanced CRC. Randomized phase III studies are ongoing to compare XELOX with FOLFOX in view of the comparable efficacy and safety but superior convenience of XELOX therapy.

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卡培他滨联合奥沙利铂(XELOX)的II期研究:转移性结直肠癌的新一线选择。

背景:卡培他滨和奥沙利铂是治疗晚期结直肠癌(CRC)的有效且耐受性良好的单药治疗方法。奥沙利铂在一线与5-FU/LV联合使用时也显示出非常有效。研究目的:评估卡培他滨联合奥沙利铂(XELOX)治疗先前未治疗的晚期结直肠癌患者的疗效和安全性。方法:53例可测量疾病患者接受卡培他滨1000mg /m2，每日2次，第1-14天，奥沙利铂130mg /m2，第1天，每3周。其中52个可评估安全性，49个可评估抗肿瘤反应。结果:1/2级不良事件发生率低;3/4级事件包括白细胞减少(10%)、中性粒细胞减少(6%)、血小板减少(2%)、恶心/呕吐(4%)和腹泻(4%)。总缓解率为39% (95% CI, 25-54%)，中位疾病进展时间为7.8个月。结论:XELOX是一种治疗晚期结直肠癌的有效且耐受性良好的一线治疗药物。目前正在进行随机III期研究，比较XELOX和FOLFOX的疗效和安全性，但XELOX治疗的便利性更强。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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International journal of gastrointestinal cancer

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