SOX方案一线化疗后替吉奥维持治疗晚期胃癌的临床观察

Clinical efficacy of S-1 maintenance chemotherapy after first-line SOX regimen in the treatment of advanced gastric cancer

目的评价替吉奥维持化疗在SOX方案(替吉奥+奥沙利铂)一线化疗后评估疾病无进展的晚期胃癌患者中的疗效及安全性。方法 67例晚期胃癌患者在接受SOX方案一线化疗6个周期后疗效评估疾病无进展。据患方意愿接受观察29例(观察组),接受替吉奥维持化疗38例(维持组)。维持化疗方案为:替吉奥40~60 mg口服2次/d,d1-21,每5周为1个周期,均每2个周期按照RECIST 1.1评价近期疗效,采用NCI-CTCAE 4.0评价化疗不良反应。观察组如无相关临床症状恶化则每2个月进行相关检查评估,并采用电话随访方式确定生存情况。结果观察组及维持组中位至肿瘤进展时间(time to progression,TTP)分别为8.2个月和9.8个月(P=0.026),中位生存时间(overall survival,OS)分别为14.6个月和17.4个月(P=0.019)。维持组常见不良反应主要为Ⅰ~Ⅱ度中性粒细胞减少、贫血、皮肤色素沉着、恶心、食欲不振和疲乏等,无化疗相关死亡事件发生。结论 SOX方案一线化疗6个周期后评估继续临床获益的晚期胃癌患者生存期较长,接受单药替吉奥维持化疗耐受性良好,一线化疗耐受性佳的患者更可能从维持化疗中获益。

Objective To investigate the efficacy and safety of S-1 maintenance chemotherapy after first-line SOX regimen（ S-1 ＋ oxaliplatin） in advanced gastric cancer（ AGC） patients.Methods Sixty-seven AGC patients who showed no disease progression after 6 cycles of first-line SOX regimen chemotherapy were enrolled.According to patients＇ decision,29 cases participated in the control group（ optimal supportive care） and 38 cases participated in the maintenance group（ S-1 40-60 mg,twice daily for 21 d; 35 d a cycle）.For both groups,the short-term efficacy was assessed by RECIST 1.1 for every 2 cycles,and chemotherapy toxicity was evaluated by NCI-CTCAE 4.0.If there was no obvious deterioration of clinical symptoms,the patients in the control group was evaluated every 2 months,and their survival status were determined by phone interview.Results The median time to progression（ TTP） was 8.2 months for the control group and 9.8 months for the maintenance group（ P = 0.026）.The median overall survival time（ OS） was 14.6 months and17.4 months for the two groups respectively（ P = 0.019）.The most frequent treatment-related adverse events were grade Ⅰ-Ⅱ neutropenia,anemia,chromatosis,nausea,anorexia and fatigue in the maintenance group.No death occurred in relation to the chemotherapy.Conclusions S-1 maintenance chemotherapy improves the overall survival time of AGC patients after 6-month firstline SOX regimen treatment.Patients who showed high tolerance to first-line chemotherapy are more likely to benefit from the maintenance therapy.