替吉奥联合奥沙利铂一线治疗晚期胆道系统肿瘤的临床研究

Clinical trial of S-1 combined with oxalipaltin as the first line chemotherapy in patients with advanced biliary tract cancer

目的探讨替吉奥联合奥沙利铂一线治疗晚期胆道系统肿瘤（BTC）的疗效和安全性。方法 26例晚期胆道系统恶性肿瘤患者采用替吉奥联合奥沙利铂化疗方案,替吉奥40mg/m^2,早晚2次口服,第1-14天,奥沙利铂130mg/m^2,第1天,每21天为1个周期,共6个周期。结果 26例患者均可评价疗效与安全性,其中完全缓解1例（3.85%）,部分缓解9例（30.77%）,病情稳定11例（42.31%）,疾病进展5例（23.08%）,总有效率34.62%,肿瘤控制率80.77%。中位无进展生存和总生存分别为8.6个月（95%CI：7.1-10.1个月）和12.2个月（95%CI：9.4-15.0个月）。主要毒副作是白细胞下降、厌食、恶心和呕吐及外周神经毒性,多为Ⅰ-Ⅱ度,均可耐受,无治疗相关性死亡。结论替吉奥联合奥沙利铂治疗晚期胆系恶性肿瘤疗效显著,具有较好的耐受性,有可能成为晚期胆道系统恶性肿瘤的一线化疗方案。

Objectives To evaluate the efficacy and safety of combination chemotherapy with S-1 and oxaliplatin （ L-OHP） in patients with advanced biliary tract cancer（ BTC） .Methods Twenty-six patients with advanced BTC were eligible.The chemother-apy regimen consisted of S-1（40mg/m^2 p.o,bid,d1-14） and L-OHP （130mg/m^2,d1）,repeated every 3 weeks,A maximum of 6 treatment cycles were given.Results 26 patients were assessed for efficacy and safety.Of all patients,Com-plete response was ob-served in one patient （ 3.85%） , partial response in 9 （ 30.77%） , stable disease in 11 （ 42.31%） , progressive disease in 5 （23.08%）,the overall response rate was 34.62% and the disease control rate was 80.77%.With a median follow-up of 16 months,the median progression-free survival （PFS） and overall survival （OS） were 8.6 months （95% CI 7.1-10.1） and 12.2 months （95%CI 9.4-15.0）,respectively.The most common toxicities were leukopenia,anorexia,nausea/vomiting and peripheral sensory neuropathy,mostly one or two degree,and were tolerated.There were no treatment-related deaths.Conclusions Combina-tion chemo-therapy with S-1 and L-OHP was an effective and well tolerated first line regimen for advanced BTC.