GS方案一线化疗后替吉奥维持治疗晚期胰腺癌的疗效和安全性

Efficacy and safety of maintenance chemotherapy with S-1 following treatment with gemcitabine and S-1 for advanced pancreatic cancer

目的观察晚期胰腺癌GS方案(吉西他滨+替吉奥)一线化疗疾病控制后替吉奥单药维持治疗的疗效和安全性。方法 41例晚期胰腺癌患者经GS方案化疗达疾病控制后随机分为替吉奥组20例和对照组21例,替吉奥组继续替吉奥原剂量维持治疗直至疾病进展,对照组仅定期复查,每2个周期评价疗效。观察两组疗效及不良反应。结果替吉奥组中位无进展生存期为6.8个月,中位总生存期为8.9个月;对照组中位无进展生存期为4.1个月,中位总生存期为5.7个月,两组比较差异均有统计学意义(P<0.05)。两组患者常见不良反应主要为骨髓抑制和消化道反应,以Ⅰ~Ⅱ度为主,其中替吉奥组白细胞降低、延迟性腹泻、恶心呕吐及手足综合征发生率与对照组比较差异有统计学意义(P<0.05)。结论 GS方案一线化疗后替吉奥维持治疗晚期胰腺癌具有良好的疗效与耐受性,值得临床推广应用。

Objective To observe efficacy and side effects of S-1 maintenance chemotherapy for patients with advanced pancreatic cancer initially treated with gemcitabine and S-1. Methods A total of 41 patients with advanced pancreatic cancer received gemcitabine and S-1 as first-line therapy,and then they were randomly divided into a group that received maintenance therapy with S-1 alone until progression of disease （n=20）, and a control group that was merely observed （n=21）. Every two cycles, efficacy and adverse reactions were compared between the two groups. Results Median progression-free survival was 6.8 months in the S-1 group and 4.1 months in the control group. Median overall survival was 8.9 months in the S-1 group and 5.7 months in the control group. The differences between the two groups were significant （P〈0.05）, The main adverse reactions included bone marrow aplasia and gastrointestinal reactions, most of which were grade I -I. Patients in the S-1 group showed significantly higher rates of low leucocyte neutrophil,nausea/vomiting and hand-foot syndrome （P〈0.05）. Conclusions Maintenance chemotherapy with S-1 alone following initial therapy with gemcitabine and S-1 is safe and effective in patients with advanced pancreatic cancer.