吉西他滨为基础的化疗方案治疗进展期胰腺癌的临床研究

背景与目的:进展期胰腺癌预后差.吉西他滨可以改善胰腺癌患者的生存质量,但吉西他滨联合方案疗效是否优于单药,还存在争议,国内更缺乏相关的临床研究.本研究目的是比较吉西他滨为基础的联合化疗方案与吉西他滨单药治疗进展期胰腺癌的疗效.方法:回顾性分析2000～2005年收治的40例经临床或病理确诊的进展期胰腺癌临床资料,其中吉西他滨单药组15例,吉西他滨剂量为1 000 mg/m2,每周1次,连用7周,休息2周,之后每周1次,连用3周,4周重复;吉西他滨联合治疗组25例,联合化疗方案包括吉西他滨1 000 mg/m2,每周1次,连用2周,分别联合:(1)氟尿嘧啶425～600 mg/m2,静脉滴注或持续静脉泵入,d1-5,3周重复;(2)顺铂60～75 mg/m2,分第1、2天,3周重复;(3)奥沙利铂85～130 mg/m2,d1,3周重复;(4)卡培他滨l000 mg/m2,2次/天,d1-14,3周重复.采用Kaplan-Meier生存曲线分析患者的生存期,并比较两组间的临床受益反应、中位疾病进展时间、中位生存时间和不良反应.结果:吉西他滨联合组与单药组患者的临床受益反应均得到改善(56.0% vs.46.7%),但疾病控制率、中位生存时间、临床受益反应在两组之间差异无统计学意义(P＞0.05),不良反应的发生率也相似(P＞0.05).对Ⅲ～Ⅳ期患者进行分层分析,发现吉西他滨联合组疾病控制率高于单药组(75.0% vs.45.5%),但无统计学意义(P=0.13).结论:吉西他滨联合方案与单药治疗进展期胰腺癌相比,疗效、临床受益反应、中位生存时间两组相似.

Efficacy of gemcitabine-based chemotherapy on advanced pancreatic cancer

BACKGROUND & OBJECTIVE: Advanced pancreatic cancer has a poor prognosis. Gemcitabine (GEM) can improve the quality of life of pancreatic cancer patients. However, the efficacy of gemcitabine-based combination chemotherapy is uncertain. This study was to compare the efficacy of GEM-based combination therapy and GEM alone on advanced pancreatic cancer. METHODS: Clinical data of 40 patients with pathologically or clinically diagnosed advanced pancreatic cancer were analyzed. Of the 40 patients, 15 were treated with GEM (1,000 mg/m(2)) alone weekly for 7 weeks followed by a 2-week rest, then received cycles of 3-week administration with 1-week rest; 25 were treated with GEM (1,000 mg/m(2)) weekly for 2 weeks plus 5-fluorouracil (5-FU) (425-600 mg/m(2)) as bolus at Day 1-5 or 120-hour infusion every 21 days, or cisplatin (DDP) (30-37.5 mg/m(2)) at Day 1-2 every 21 days, or oxaliplatin (85-130 mg/m(2)) at Day 1 every 21 days, or capecitabine (1,000 mg/m(2)) twice a day at Day 1-14 every 21 days, respectively. The survival was analyzed by Kaplan-Meier method. Median time to progression (mTTP), clinical benefit response (CBR), disease control rate, median overall survival (mOS) and toxicity were assessed according to World Health Organization criteria. RESULTS: The rate of CBR was 56.0% in GEM-combination group and 46.7% in GEM alone group. There were no significant differences in disease control rate, mOS, CBR, and adverse events between the two groups (all P>0.05). However, for the patients with stage III-IV advanced pancreatic cancer, the disease control rate was higher in GEM-combination group than in GEM alone group (75.0% vs. 45.5%, P=0.13). CONCLUSION: GEM-combination regimens and GEM alone have similar efficacy, and lead to similar clinical benefit response and mOS for the patients with advanced pancreatic cancer.