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一项 S-1-奥沙利铂与卡培他滨-奥沙利铂治疗晚期胃癌的随机 II 期试验。

A randomized phase II trial of S-1-oxaliplatin versus capecitabine-oxaliplatin in advanced gastric cancer.

机构信息

Department of Medical Oncology, Yonsei University College of Medicine, Seoul, South Korea.

出版信息

Eur J Cancer. 2012 Mar;48(4):518-26. doi: 10.1016/j.ejca.2011.12.017. Epub 2012 Jan 12.

DOI:10.1016/j.ejca.2011.12.017
PMID:22243774
Abstract

PURPOSE

S-1 or capecitabine plus oxaliplatin are considered active and tolerable in gastric cancer patients. We conducted a randomized phase II trial in gastric cancer patients to compare the activity and safety of these combinations.

METHODS

The patients received S-1 at 80 mg/m2 for 14 days, followed by a 7-day rest period within a 3-week schedule in the S-1/oxaliplatin (SOX) arm, and capecitabine at 2000 mg/m2 for 14 days, followed by a 7-day rest period within a 3-week schedule in the capecitabine/oxaliplatin (CAPOX) arm. Oxaliplatin 130 mg/m2 was administered every 3 weeks in both arms.

RESULTS

One hundred twenty-nine patients were randomly assigned to SOX (N=65) or CAPOX (N=64). The median time to progression and the overall survival were 6.2 and 12.4 months with SOX, respectively; and 7.2 and 13.3 months with CAPOX, respectively. The overall response rates were 40% and 44% for SOX and CAPOX, respectively. The most frequent grade 3 or 4 toxicities were thrombocytopenia (15.4%) for SOX and neutropenia (18.8%) for CAPOX. The median time to 10% deteriorations in global health scores was similar in both arms (SOX, 4.3 months, CAPOX, 4.9 months).

CONCLUSION

Both the SOX and CAPOX regimens were equally active and well tolerated in advanced gastric cancer patients.

摘要

目的

S-1 或卡培他滨联合奥沙利铂在胃癌患者中被认为具有活性且可耐受。我们在胃癌患者中进行了一项随机 II 期试验,以比较这两种联合用药的疗效和安全性。

方法

患者在 SOX 组中接受 S-1 80mg/m2,14 天为一个疗程,随后是 7 天的休息期,每 3 周一个疗程;在 CAPOX 组中接受卡培他滨 2000mg/m2,14 天为一个疗程,随后是 7 天的休息期,每 3 周一个疗程。在两个治疗组中,奥沙利铂的剂量均为 130mg/m2,每 3 周给药一次。

结果

129 例患者被随机分配至 SOX(n=65)或 CAPOX(n=64)组。SOX 组的中位无进展生存期和总生存期分别为 6.2 个月和 12.4 个月;CAPOX 组的中位无进展生存期和总生存期分别为 7.2 个月和 13.3 个月。SOX 和 CAPOX 的总缓解率分别为 40%和 44%。SOX 组最常见的 3 级或 4 级毒性为血小板减少症(15.4%),CAPOX 组为中性粒细胞减少症(18.8%)。两组患者的全球健康评分恶化至 10%的中位时间相似(SOX,4.3 个月;CAPOX,4.9 个月)。

结论

SOX 和 CAPOX 方案在晚期胃癌患者中均具有同等的疗效和良好的耐受性。

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