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.