A phase II study of S-1 and oxaliplatin (SOx) combination chemotherapy as a first-line therapy for patients with advanced gastric cancer
A phase II study of S-1 and oxaliplatin (SOx) combination chemotherapy as a first-line therapy for patients with advanced gastric cancer
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DOI：
10.1007/s10637-010-9507-2
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发表时间：
2012-02-01
影响因子：
3.4
通讯作者：
Kang, Jung Hun
中科院分区：
文献类型：
--
作者：
Oh, Sung Yong;Kwon, Hyuk-Chan;Kang, Jung Hun
背景姑息性化疗已被证明对复发或转移性胃癌患者有生存益处。5-氟尿嘧啶（5-FU）和顺铂已广泛用于多种组合。我们进行了一项II期研究，联合化疗与新的药物，S-1和奥沙利铂（SOx），在进展期胃癌患者的努力，以评估这种方案的疗效和毒性。方法组织学证实的复发或转移性胃癌患者口服S-1 80 mg/m2/d，第1-28天;奥沙利铂85 mg/m2，静脉滴注90 min，第1、15和29天。每6周重复治疗一次。患者最多接受4个周期。结果2006年2月至2008年5月共41例患者入组本研究。男女比例为28比13。患者中位年龄为61岁（范围：36 - 74岁），85.4%（35/41）的患者体能状态（ECOG）评分为1分。中位化疗周期数为3（范围：1 - 4）。根据我们的意向治疗分析结果，22例患者（53.7%）达到部分缓解（95% CI，38 - 70%）。15例患者（36.6%）病情稳定，1例患者（2.4%）在治疗过程中进展。3例患者在评价前失访。从化疗开始，中位至进展时间和总生存时间分别为4.6个月（95% CI，3.4 - 5.8个月）和7.8个月（95% CI，6.9 - 8.7个月）。共评估了114个周期的毒性。主要血液学毒性包括2级贫血（41.2%）、1 - 2级中性粒细胞减少（28.1%）和1级血小板减少（23.7%）。仅发生1个周期的血小板减少性发热。观察到的非血液学毒性为3级呕吐（12.2%）和3级腹泻（4.9%）。在研究期间，我们的患者人群中未发生治疗相关死亡。结论SOX方案治疗晚期胃癌有效率高，耐受性好，可作为晚期胃癌的一线治疗方案。
Background Palliative chemotherapy has been shown to have a survival benefit for patients with recurrent or metastatic gastric cancer. 5-fluorouracil (5-FU) and cisplatin have been widely used in a variety of combinations. We conducted a phase II study of combination chemotherapy with new agents, S-1 and oxaliplatin (SOx), in advanced gastric cancer patients in an effort to evaluate the efficacy and toxicity of this regimen. Method Histologically confirmed recurrent or metastatic gastric cancer were treated by the oral administration of S-1 80 mg/m(2)/day on days 1-28, and oxaliplatin 85 mg/m(2) administered as a 90-min intravenous infusion on days 1, 15, and 29. Treatment courses were repeated every 6 weeks. Patients received a maximum of four cycles. Results From Feb 2006 to May 2008, 41 patients were enrolled in this study. The ratio of males to females was 28 to 13. The median patient age was 61 years (range, 36-74 years), and 85.4% (35/41) of the patients had a performance status (ECOG) of 1. The median number of chemotherapy cycles administered was 3 (range, 1-4). According to the results of our Intent-to-Treat analysis, 22 patients (53.7%) achieved a partial response (95% CI, 38-70%). 15 patients (36.6%) evidenced a stable disease, and 1 patient (2.4%) progressed during the course of the treatment. 3 patients were lost to follow-up prior to evaluation. The median time to progression and overall survival time were 4.6 months (95% CI, 3.4-5.8 months) and 7.8 months (95% CI, 6.9-8.7 months) from the start of the chemotherapy, respectively. A total of 114 cycles were assessed for toxicity. The major hematologic toxicities included grade 2 anemia (41.2%), grade 1-2 neutropenia (28.1%), and grade 1 thrombocytopenia (23.7%). Only 1 cycle of neutropenic fever occurred. The non-hematological toxicities observed were grade 3 vomiting (12.2%) and grade 3 diarrhea (4.9%). No treatment-related deaths occurred in our patient population during the study period. Conclusion The SOx regimen evidenced a relatively high response rate and was well tolerated as a first-line therapy for advanced gastric cancer.