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目的 评价吉西他滨单药以及与顺铂联合治疗局部晚期或转移性胰腺癌的疗效、临床受益反应、生存时间和毒性反应。方法 4 2例患者随机分为吉西他滨单药组 (A组 2 0例 )和吉西他滨+顺铂联合组 (B组 2 2例 )。A组 :吉西他滨 10 0 0mg/m2 ,每周 1次 ,连用 7周 ,休息 1周 ;随后相同剂量每周 1次 ,连用 3周 ,休息 1周。B组 :吉西他滨 10 0 0mg/m2 ,每周 1次 ,连用 3周 ,顺铂 6 0mg/m2 ,第15天给药 ,休息 1周 ,每 4周重复 ,连续用药 3个周期。结果 4 2例患者中 ,可评价客观疗效者 34例(A组 16例 ,B组 18例 ) ,可评价临床受益反应 (CBR)者 36例 (A组 16例 ,B组 2 0例 ) ,可进行毒性反应评估者 4 0例 (A组 19例 ,B组 2 1例 )。A组 :PR 1例 (6 .3% ) ,MR 4例 (2 5 .0 % ) ,SD 7例 (43.8% ) ,PD 4例 (2 5 .0 % ) ;B组 :PR 2例 (11.0 % ) ,MR 3例 (16 .7% ) ,SD 8例 (44 .4 % ) ,PD 5例 (2 7.8% )。PR +MR +SD率A组为 75 .0 % ,B组为 72 .2 %。CBR有效率A组为 87.5 % (14 /16 ) ,B组为 70 .0 % (14 /2 0 )。两组3个月生存率均为 10 0 % ,6个月生存率分别为 81.3%和 6 1.6 % ,12个月生存率分别为 31.3%和11.1%。B组Ⅲ、Ⅳ度血液学毒性反应发生率略高于A组 ,两组相比 ,差异无显著性。结论 吉西他滨单药以及与顺铂
Objective To evaluate the efficacy, clinical benefit response, survival time and toxicity of gemcitabine monotherapy and cisplatin in the treatment of locally advanced or metastatic pancreatic cancer. Methods Forty two patients were randomly divided into gemcitabine monotherapy group (20 cases in group A) and gemcitabine + cisplatin combination group (22 cases in group B). Group A: gemcitabine 10 0mg / m2, once a week, once every 7 weeks, rest for 1 week; then the same dose once a week, once every 3 weeks, rest for 1 week. Group B: gemcitabine 10 0mg / m2, once a week for 3 weeks, cisplatin 60mg / m2, the first 15 days of administration, rest for 1 week, repeated every 4 weeks for 3 cycles. Results Among the 42 patients, objective response was evaluated in 34 patients (16 in group A and 18 in group B), 36 patients were evaluated for clinical benefit response (16 in group A and 20 in group B) Toxicity assessment can be 40 cases (19 cases in group A, 21 patients in group B). In group A, there were 1 case of PR (6.3%), 4 cases of MR (25.0%), 7 cases of SD (43.8%) and 4 cases of PD 11.0%), MR 3 cases (16.7%), SD 8 cases (44.4%) and PD 5 cases (2 7.8%). PR + MR + SD rate of 75.0% in group A, 72.2% in group B. The effective rate of CBR was 87.5% (14/16) in group A and 70.0% (14/20) in group B. The 3-month survival rates of both groups were 100%. The 6-month survival rates were 81.3% and 61.6%, respectively. The 12-month survival rates were 31.3% and 11.1% respectively. The incidence of grade Ⅲ and Ⅳ hematologic toxicities in group B was slightly higher than that in group A, and there was no significant difference between the two groups. Conclusion Gemcitabine monotherapy as well as with cisplatin