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卡培他滨联合奥沙利铂(XELOX)的II期研究:转移性结直肠癌的一种新一线治疗方案

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

作者信息

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

机构信息

Hellenic Cooperative Oncology Group (HECOG), Data Office, Athens, Greece.

出版信息

Int J Gastrointest Cancer. 2005;35(2):103-9. doi: 10.1385/ijgc:35:2:103.

DOI:10.1385/ijgc:35:2:103
PMID:15879624
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.

摘要

背景

卡培他滨和奥沙利铂都是治疗晚期结直肠癌(CRC)有效的且耐受性良好的单一疗法。奥沙利铂在一线治疗中与5-氟尿嘧啶/亚叶酸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CRC患者的疗效和安全性。

方法

53例有可测量病灶的患者在第1 - 14天每天两次接受1000 mg/m²的卡培他滨治疗,在第1天接受130 mg/m²的奥沙利铂治疗,每3周重复一次。其中52例可进行安全性评估,49例可进行抗肿瘤反应评估。

结果

1/2级不良事件发生率较低;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%),疾病进展的中位时间为7.8个月。

结论

XELOX是一种治疗晚期CRC的有效的一线治疗方案,且耐受性良好。鉴于XELOX疗法具有相当的疗效和安全性,但便利性更佳,正在进行随机III期研究以比较XELOX与FOLFOX。

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本文引用的文献

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XELOX (capecitabine plus oxaliplatin): active first-line therapy for patients with metastatic colorectal cancer.XELOX方案(卡培他滨联合奥沙利铂):转移性结直肠癌患者的一线有效治疗方案。
J Clin Oncol. 2004 Jun 1;22(11):2084-91. doi: 10.1200/JCO.2004.11.069.
2
Treatment of advanced colorectal carcinoma with oxaliplatin and capecitabine: a phase II trial.奥沙利铂联合卡培他滨治疗晚期结直肠癌:一项II期试验
Cancer. 2004 Feb 1;100(3):531-7. doi: 10.1002/cncr.11925.
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A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer.
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BMC Cancer. 2015 Oct 24;15:786. doi: 10.1186/s12885-015-1712-0.
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Eur J Cancer. 2002 Feb;38 Suppl 2:15-20. doi: 10.1016/s0959-8049(01)00415-4.
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Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group.伊立替康联合氟尿嘧啶和亚叶酸用于转移性结直肠癌。伊立替康研究组。
N Engl J Med. 2000 Sep 28;343(13):905-14. doi: 10.1056/NEJM200009283431302.