吉西他滨联合奥沙利铂与吉西他滨单药辅助治疗体力状态良好的可切除胰腺癌的比较  

A retrospective study of gemcitabine combined with oxaliplatin vs. gemcitabine alone as adjuvant chemotherapy of resectable pancreatic cancer patients with good performance status

作　　者：马韬[1] 何昌玉[1] 蒋金玲[1] 杨晨[1] 奚文崎[1] 叶正宝[1] 张俊[1] 朱正纲[1] MA Tao;HE Changyu;JIA NG Jinling;YA NG Chen;XI Wenqi;YE Zhengbao;ZHANG Jun;ZHU Zhenggang(Department of Oncology,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,200025,China)

机构地区：[1]上海交通大学医学院附属瑞金医院肿瘤科,上海200025

出　　处：《内科理论与实践》2018年第3期158-164,共7页Journal of Internal Medicine Concepts & Practice

摘　　要：目的:比较GEMOX方案(吉西他滨联合奥沙利铂)和吉西他滨单药方案用于美国东部肿瘤协作组(ECOG)评分0～1分、可切除胰腺癌辅助化学治疗(化疗)的疗效及安全性,并探索与无病生存(DFS)期和总生存(OS)期相关的独立预后因素。方法:回顾性分析103例ECOG评分0～1分的可切除胰腺癌患者,其中68例给予GEMOX方案辅助化疗:吉西他滨1 000 mg/m^2以固定速率(FDR)静脉滴注100 min,第1天,奥沙利铂85 mg/m^2静脉滴注,第2天,每2周重复,共8周期;35例接受吉西他滨单药化疗:吉西他滨1 000 mg/m^2第1、8和15天静脉滴注30 min,每28 d重复,共6周期。比较2种辅助化疗方案的DFS期、OS期及毒性差异,并通过单因素及多因素生存分析探讨预后因素。结果:GEMOX组和吉西他滨单药组的中位DFS期分别为370 d和520 d(P=0.815),中位OS期分别为803 d和888 d(P=0.428),差异均无统计学意义。2种辅助化疗方案的毒性多为Ⅰ、Ⅱ度且易于控制,GEMOX组呕吐(30.8%比10.5%,P=0.019)及外周神经毒性发生率(38.5%比0%,P<0.001)显著高于吉西他滨单药组;丙氨酸转氨酶(ALT)/天冬氨酸转氨酶(AST)升高2组发生率相似,分别为47.7%和44.7%,但吉西他滨单药组Ⅲ度以上ALT/AST升高发生率显著高于GEMOX组(7.9%比0%,P=0.048)。生存分析显示,分化差(P=0.002)、R1切缘(P<0.001)、淋巴结转移(P=0.028)、术后CA19-9≥90 U/m L(P=0.005)及未能完成全部辅助化疗疗程者(P=0.002)中位DFS期显著缩短;而分化差(P=0.001)、R1切缘(P<0.001)、术后CA19-9≥90 U/m L(P=0.003)及未能完成全部疗程者(P=0.001)等因素也预示中位OS期显著缩短。结论:对体力状态良好的胰腺癌患者切除术后,为期4个月的GEMOX方案,与为期6个月的吉西他滨单药化疗生存获益相似,GEMOX方案可视为辅助化疗的备选方案之一。分化差、R1切缘、术后CA19-9≥90 U/m L及未能完成全部辅助化疗疗程等因素是DFS期和OS期的独立不良预后因素。Objective To compare the efficacy and safety of gemcitabine combined with oxaliplatin（GEMOX） vs.gemcitabine alone in patients with resectable pancreatic cancer and Eastern Cooperative Oncology Group（ECOG） perfor-mance status（PS） score 0-1, and to investigate the independent prognostic factors related to disease-free survival（DFS） and overall survival（OS）. Methods One hundred and three patients with resectable pancreatic cancer treated with GEMOX and gemcitabine as adjuvant chemotherapy were retrospectively analyzed. Of them 68 patients were treated with GEMOX：gemcitabine 1 000 mg/m^2 at a fixed-dose rate（FDR） for 100 min as intravenous（i.v.） infusion on day 1 and oxaliplatin at an i.v. dose of 85 mg/m^2 on day 2 in a single cycle of 2 weeks for a total of 8 cycles; 35 patients were treated with gemc-itabine alone at a dose of 1 000 mg/m^2 for 30 min as i.v. infusion on days 1, 8 and 15 in a cycle of 28 days, with a total of6 cycles. The DFS, OS and toxicity of the two chemotherapy regimens were compared, and the prognostic factors were an-alyzed via univariate and multivariate survival analysis. Results The median DFS of GEMOX and gemcitabine alone groups were 370 days and 520 days, respectively（P=0.815）, while the median OS was 803 days and 888 days, respectively（P=0.428）, both having no significant difference. Grade 1 to 2 toxicity occurred in both of the regimens, and were easy to control. The incidence of vomiting（30.8% vs. 10.5%, P=0.019） and peripheral neuropathy（38.5% vs. 0%, P〈0.001） of GEMOX was substantially higher than that in gemcitabine alone. The incidences of alanine aminotransferase（ALT）/aspartate aminotransferase（AST） increase were 47.7% and 44.7%, respectively. However, the incidence of grade 3 or 4 ALT/AST increase was significantly higher in gemcitabine alone than in GEMOX（7.9% vs. 0%, P =0.048）. Survival analysis showed that patients with poorly differentiated tumors（P=0.002）, R1 resection margin（P〈0.001）, lymph node metast

关 键 词：胰腺癌 辅助化疗 吉西他滨联合奥沙利铂方案 吉西他滨单药 预后指标 体力状态 

分 类 号：R735.9[医药卫生—肿瘤]