改良吉西他滨联合白蛋白结合型紫杉醇方案一线治疗不可切除进展期胰腺癌的临床研究

Clinical study of modified gemcitabine plus nab-paclitaxel in first-line treatment of unresectable advanced pancreatic cancer

目的探讨2周AG方案[吉西他滨(1000 mg/m^(2),d1)+白蛋白结合型紫杉醇(125 mg/m^(2),d1),14 d为1个周期]与3周AG方案[吉西他滨(1000 mg/m^(2),d1、d8)+白蛋白结合型紫杉醇(125 mg/m^(2),d1、d8),21 d为1个周期]治疗不可切除进展期胰腺癌的疗效性及安全性。方法回顾性收集接受AG方案治疗的不可切除进展期胰腺癌患者142例。其中76例接受2周AG方案(2周方案组),66例接受3周AG方案(3周方案组)。研究终点为总生存期(overall survival,OS)和无进展生存期(progression free survival,PFS),次要研究终点为客观缓解率(overall response rate,ORR)和3/4级不良反应发生率。结果2周方案组和3周方案组患者中位OS(8.7个月vs 8.5个月)和中位PFS(4.7个月vs 4.6个月)比较,差异均无统计学意义(均P>0.05)。两组ORR分别为26.1%和22.7%(P>0.05)。2周方案组最常见3/4级不良反应为中性粒细胞减少(27.6%)、周围神经毒性(17.1%)、感染性发热(14.5%)、血红蛋白减少(11.8%)及血小板减少(11.8%)。3周方案组最常见3/4级不良反应为中性粒细胞减少(39.4%)、周围神经病变(31.8%)、感染性发热(18.1%)及血红蛋白减少(16.7%)。2周方案组3/4级周围神经毒性发生率低于3周方案组(P<0.05),其余3/4级不良反应发生率比较,差异均无统计学意义(均P>0.05)。结论对于不可切除的进展期胰腺癌患者,使用2周AG方案与3周AG方案生存获益相当且不良反应较低。

Objective To compare the efficacy and safety of biweekly gemcitabine plus nab-paclitaxel(gemcitabine 1000 mg/m^(2) d1+nab-paclitaxel 125 mg/m^(2) d1,14 d as one cycle)and 3-weekly gemcitabine plus nab-paclitaxel(gemcitabine 1000 mg/m^(2) d1,d8+nab-paclitaxel 125 mg/m^(2) d1,d8,21 d as one cycle)in the treatment of unresectable advanced pancreatic cancer.Methods The clinical data of 142 unresectable advanced pancreatic cancer patients who received gemcitabine plus nab-paclitaxel chemotherapy were retrospectively collected.Among them,76 patients received biweekly gemcitabine plus nab-paclitaxel(biweekly group),and 66 patients received 3-weekly gemcitabine plus nab-paclitaxel(3-weekly group).The primary endpoints were overall survival(OS)and progression free survival(PFS).The secondary endpoints were objective response rate(ORR)and grade 3/4 adverse events(AEs).Results There were no significant differences in median OS(8.7 months vs 8.5 months)and median PFS(4.7 months vs 4.6 months)between the biweekly group and the 3-weekly group(both P>0.05).The ORR were 26.1%and 22.7%in the biweekly group and the 3-weekly group,respectively(P>0.05).Moreover,the most common grade 3/4 AEs in the biweekly group were neutropenia(27.6%),peripheral neurotoxicity(17.1%),febrile neutropenia(14.5%),anemia(11.8%),and thrombocytopenia(11.8%).The most common grade 3/4 AEs in the 3-weekly group were neutropenia(39.4%),peripheral neurotoxicity(31.8%),febrile neutropenia(18.1%),and anemia(16.7%).The incidence of grade 3/4 peripheral neurotoxicity in the biweekly group was significantly lower than that in the 3-weekly group(P<0.05),and there was no significant difference in other adverse events(all P>0.05).Conclusions Compared with the 3-weekly gemcitabine plus nab-paclitaxel treatment,the biweekly gemcitabine plus nab-paclitaxel has similar efficacy and less AEs in the treatment of unresectable advanced pancreatic cancer.