吉西他滨联合奥沙利铂或替吉奥对比吉西他滨单药治疗晚期胰腺癌临床观察

Comparison between gemcitabine plus oxaliplatin or S-1 and singleagent gemcitabine in the treatment of advanced pancreatic cancer

目的：在真实临床背景下，比较吉西他滨联合奥沙利铂或替吉奥对比吉西他滨单药治疗晚期胰腺癌的疗效和不良反应。方法87例晚期胰腺癌患者分为三组：吉西他滨单药组（ G组）23例，吉西他滨1000 mg · m-2，静滴30 min，第1、8天。吉西他滨联合奥沙利铂组（GM组）33例，在G组基础上联合奥沙利铂130 mg· m-2，第1天。吉西他滨联合替吉奥胶囊组（ GS组）31例，在G组基础上联合口服替吉奥胶囊80／100／120 mg· d-1，每天2次，第1～14天；三组均每21 d为一周期。每2～3个周期进行评价。结果三组比较，其有效率（RR）、疾病控制率（DCR）和临床受益率（CBR）均未取得统计学意义（P＞0．0167）；GM组和GS组的中位无进展生存（PFS）和中位总生存时间（OS）均明显高于G组，差异有统计学意义（P＜0．0167）；而GM组和GS组比较，虽后者略显优势，但差异无统计学意义（P＞0．0167）。三组患者的主要不良反应为血液学毒性和消化道反应，联合化疗组的末梢神经损害和皮疹发生率略高于单药组，但差异不显著（ P＞0．05）。结论在真实临床背景下，GM方案和GS方案较吉西他滨单药治疗晚期胰腺癌可获得更好的生存期，且不良反应可以耐受，二者均可作为首选治疗方案。

Objective To compare the efficacy and adverse reactions of gemcitabine plus oxaliplatin or S-1 with single-agent gemcit-abine in the treatment of advanced pancreatic cancer in a real clinical setting.Methods 87 patients were divided into three groups. Twenty-three cases were included in single-agent gemcitabine group （ G group） , and they were treated with gemcitabine 1 000 mg· m-2 for a 30-minute infusion on days 1 and 8.Thirty-three cases were included in gemcitabine plus oxaliplatin group （GM group）, which were given oxaliplatin 130mg· m-2 in the first day on the basis of the G Group.The rest 31 cases were included in gemcitabine plus S-1 capsules group （ GS group） , which were given S-1 capsules 80/100/120 mg· d-1 , twice a day on days 1~14 on the basis of the G Group.Three groups were repeated every 21 days.Assessment was done after every 2~3 cycles.Results Among the three groups, the total effective rates （RR）, disease control rates （DCR） and clinical benefit response rates （CBR） were not statistically significant （P 〉0.0167）.The median PFS and median OS in GM group and GS group were significantly higher than the G group （P〈0.0167） .Between GM group and GS group, although the latter was slightly better, but the difference had no statistical significance （P〉0.0167）.The main adverse reactions of the three groups were hematologic and gastrointestinal toxicities.The incidences of pe-ripheral nerve damage and skin rashes in the combined chemotherapy group were slightly higher than those in the single-agent chemo-therapy group, but the differences were not significant （P〉0.05）.Conclusions In a real clinical setting, compared with the single-agent gemcitabine, GM and GS regimens can achieve better survival time in the treatment of advanced pancreatic cancer, and adverse reactions can be tolerated.Both GM and GS regimens can be used as the first-line regimen.