吉西他滨单药或与顺铂联合治疗胰腺癌的临床疗效评价

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炎的疗效。临床受益反应,生存时间和毒性反应。方法 42例患者随机分为吉西他滨单药组（A组20例）和吉西他滨 顺铂联合组（B组22例）,A组;吉西他滨1000mg/m^2,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1000mg/m^2,每周1次,连用3周,顺铂60mg/m^2,第15天给药,休息1周,每4周重复,边境用药3个周期。结果 42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20例）,可进行毒性反应评估者40例（A组19例,B组21例）,A组：PR1例（6.3%)。MR4例（25.0%),SD7例（43.8%)。PD4例（25.0%)。B组;PR2例（11.0%)。MR3例（16.7%),SD8例（44.4%),PD5例（27.8%)。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%(14/20)。两组3个月生存率均为100%,6个月生存率分别为81.3%和61.6%。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联合一线治疗局部晚期或转移性胰腺癌有一定的客观疗效。可明显改善患者的生活质量。延长了生存时间,患者耐受良好。

Gemcitabine or gemcitabine plus cisplatin for in 42 patients with locally advanced or metastatic pancreatic cancer

OBJECTIVE: A multi-center randomized phase III clinical trial was designed to evaluate the efficacy, clinical benefit response (CBR) and toxicity profile of germcitabine (GEM) or GEM plus cisplatin (CDDP) for locally advanced (LAPC) or metastatic pancreatic cancer (MPC). METHODS: From July 2000 to May 2001, 42 untreated patients with LAPC or MPC were collected and randomized into two groups: Arm A-GEM 20 patients and Arm B-GEM + CDDP 22 patients. Eligibility criteria were: cytologically and pathologically proven pancreatic carcinoma, Karnosky performance status (KPS) 60 - 80, age 18 - 75 yrs, adequate hematological, renal and liver function, measurable disease, and controllable pain. For Arm A patients, weekly dose of GEM 1 000 mg/m(2)/w for 7 times followed by a week rest. Then weekly GEM at the same dose for 3 times every 4 weeks. Arm B patients were given weekly dose of GEM 1 000 mg/m(2)/w for 3 times every 4 weeks combined with CDDP 60 mg/m(2) on D15 for 3 cycles. RESULTS: Thirty-four patients were available for objective response (Arm A 16 and Arm B 18) and 36 (Arm A 16 and Arm B 20) for CBR evaluation. In Arm A and Arm B, PR 1 (6.3%) and 2 (11%), MR 4 (25%) and 3 (16.7%), SD 7 (43.8%) and 8 (44.4%), PD 4 (25%) and 5 (27.8%), PR + MR 31.3% and 27.8%, PR + MR + SD 75% and 72.2% were observed. Positive CBR was 14/16 (87.5%) in Arm A and 14/20 (70.0%) in Arm B. The negative results was 2/16 (12.5%) in Arm A and 6/20 (30.0%) in Arm B. The median time of disease progression was not yet available at present. The 3-month survival rate of both Arm A and B was 100%, the 6-month survival rates of Arm A and B were 81.3% and 61.6% and the 12-month survival rates of Arm A and B was 31.3% and 11.1%, with median survivals of 273 and 217 days. The incidence of hematological and non-hematological toxicity of Arm A was lower than that of Arm B without statistical significance. The toxicity ranging from being mild to moderate was manageable. CONCLUSION: GEM or GEM plus CDDP is able to lead to a moderate objective response rate, also significantly improve the quality of life in patients with locally advanced or metastatic pancreatic cancer patients, prolonging the survival time with tolerable toxicity.