替吉奥胶囊联合奥沙利铂治疗晚期结直肠癌的临床观察

Clinical Observation of Treatment for Advanced Colorectal Cancer with S-1 Plus Oxaliplatin

目的观察替吉奥胶囊联合奥沙利铂治疗晚期结直肠癌的近期疗效和毒性反应。方法 2011年5月-12月,将30例晚期结直肠癌患者根据体表面积来确定初始剂量,体表面积<1.25 m2者,替吉奥胶囊40 mg/次,2次/d;体表面积1.25～1.50 m2者,替吉奥胶囊50 mg/次,2次/d;体表面积>1.50 m2者,替吉奥胶囊60 mg/次,2次/d。早饭后和晚饭后分别口服1次,第1～4天服用奥沙利铂注射液130 mg/m2,静脉滴注,第1、21天重复,此为1个月周期。连用2周期后,按美国国立癌症研究所拟定的药物不良反应的分级评价标准3.0版本评价不良反应,按实体瘤治疗疗效评价标准评价疗效。结果 30例患者中,完全缓解1例(3.3%),部分缓解7例(23.3%),稳定12例(40%),进展10例(33.3%),疾病控制率为66.6%。不良反应主要是血液学毒性、胃肠道反应、皮肤色素沉着及外周神经毒性;1例Ⅳ度骨髓抑制,3例3度贫血,2例3度腹泻,2例3度皮肤色素沉着,2例3度恶心、呕吐,其余且均在Ⅰ～Ⅱ度骨髓抑制。结论替吉奥胶囊联合奥沙利铂方案治疗晚期结直肠癌可获得较高的疾病控制率,不良反应可控。

Objective To evaluate the efficacy and safety of the combination of S-1 and oxaliplatin （SOX） in treating advanced colorectal cancer. Methods Between May and December 2011, 30 patients were enrolled in this study. S- 1 40 mg/m2 was orally administered twice daily at the following doses on the basis of body surface area （BSA）： BSA 〈 1.25 m2, 40 mg; 1.25 ~〈 BSA 〈 1.50, 50 rag; BSA 1〉 1.50, 60 mg for 14 days, which was followed by a 7-day rest. Oxaliplatin 130 mg/m2 was administered （i.v.） on day 1. The regimen was repeated every 3 weeks, The Response Evaluation Criteria in Solid Tumors guidelines were used to evaluate tumor responses, and the National Cancer Institute--Common Toxicity Criteria （version 3.0） were used to assess toxicity after two cycles of treatment, and response evaluable criteria solid tumors （RECIST） was used to evaluate the efficacy, Results In the 30 patients, there were one complete response （3.3%）, 7 partial responses （23.3%）, 12 cases of stable disease （40%） and 10 cases of progression （33.3%）. The most common toxic effects were hematologic toxicity, gastrointestinal toxicity, cutaneous pigmentation and peripheral neurotoxicity. Among them, 1 patient had grade 1V bone marrow depression, 3 had grade III anemia, 2 had grade RI diarrhea, 2 had grade III cutaneous pigmentation, 2 had grade III nausea and vomiting. The rest of patients had grade I or Ⅱ adverse events. Conclusion These data indicate the SOX regimen is effective and well tolerated in patients with advanced coloreactal cancer.