Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile .
There is no clear evidence to support one regimen over another .
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer .
Multicenter randomized phase III trial comparing protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin in inoperable pancreatic cancer.
PURPOSE To compare protracted venous infusion ( PVI ) fluorouracil ( 5-FU ) with PVI 5-FU plus mitomycin ( MMC ) in patients with advanced pancreatic cancer in a multicenter , prospect ively r and omized study . PATIENTS AND METHODS Two hundred eight patients were r and omized to PVI 5-FU ( 300 mg/m(2)/d for a maximum of 24 weeks ) or  PVI 5-FU plus MMC  ( 7 mg/m(2 ) every 6 weeks for four courses ) . The major end points were tumor response , survival , toxicity , and quality of life ( QOL ) . RESULTS The two treatment groups were balanced for baseline demographic factors , and 62 % had metastatic disease . The overall response rate was 8.4 % ( 95 % confidence interval [ CI ] ) 3.2 % to 13.7 % for patients treated with PVI 5-FU alone compared with 17.6 % ; 95 % CI 10.3 % to 25.1 % for PVI 5-FU plus MMC ( P = .04 ) . Median failure-free survival was 2.8 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC ( P = .14 ) . Median survival was 5.1 months for PVI 5-FU and 6.5 months for PVI 5-FU plus MMC ( P = .34 ) . Toxicities in both arms were mild . There was an increased incidence of neutropenia in the 5-FU plus MMC arm ( P < .01 ) , although no differences in infection were seen . No patients developed hemolytic uremic syndrome . Global QOL improved significantly after 24 weeks of treatment compared with baseline for patients receiving 5-FU plus MMC , although there was no statistically significant difference in QOL between arms . CONCLUSION PVI 5-FU plus MMC result ed in a superior response rate in comparison with PVI 5-FU alone in advanced pancreatic cancer , but this did not translate into a survival advantage . These results emphasize the importance of chemotherapy in this setting and the continuing value of the fluoropyrimidines in pancreatic cancer
Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile .
There is no clear evidence to support one regimen over another .
PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer .