A systematic overview of chemotherapy effects in pancreatic cancer.

A systematic review of chemotherapy trials in several tumour types was performed by The Swedish Council of Technology Assessment in Health Care (SBU). The procedures for the evaluation of the scientific literature are described separately (Acta Oncol 2001; 40:155-65). The conclusions of this overview in pancreatic cancer are based on 10 randomised studies with, and 18 randomised studies without, an untreated control group. Altogether, 4,028 patients were included in the phase III studies. Furthermore, 32 phase II studies or retrospective analyses including 1,404 patients have been evaluated. The conclusions reached can be summarized into the following points: There is no convincing evidence that pancreatic cancer patients benefit from adjuvant chemotherapy treatment, with or without concomitant radiotherapy. Adjuvant chemotherapy in patients with pancreatic cancer should thus not be used routinely. In locally advanced/metastatic pancreatic cancer, six randomised trials comparing combination chemotherapy with an untreated control group were retrieved. In three trials, two of which were performed recently, chemotherapy provided statistically significant prolongation in median survival in the range of three to nine months. The three other trials, all reported in the early 80s, essentially showed no difference in survival between the treatment groups. In the locally advanced/metastatic setting there are also several randomised trials comparing various chemotherapy regimens. Except for an improvement in median survival of one to two months from gemcitabine compared with 5-FU, no differences were observed. There is no convincing evidence that a large fraction of pancreatic cancer patients will benefit from palliative chemotherapy. The few open-design studies that have explored the influence on symptom relief/quality of life indicate that between 20-35% of the patients get clinical benefit, but usually short-lived. Recently performed randomised studies, all using adequate methodology, indicate that the beneficial effects observed in advanced pancreatic cancer are similar to those of accepted therapy in other cancer types. However, due to the limited positive effects, palliative chemotherapy in pancreatic cancer can only be recommended selectively and should preferably be used within controlled clinical trials exploring new treatment combinations or concepts.