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 .
A randomized phase III study of radiotherapy alone or with 5-fluorouracil and mitomycin-C in patients with locally advanced adenocarcinoma of the pancreas: Eastern Cooperative Oncology Group study E8282.
PURPOSE The median survival time of patients with locally advanced adenocarcinoma of the pancreas is 8 - 10 months . Radiation therapy has been used to improve local control and palliate symptoms . This r and omized study was undertaken to determine whether the addition of 5-fluorouracil ( 5-FU ) and mitomycin-C ( MMC ) to radiation therapy improves outcome in this patient population . PATIENTS AND METHODS One hundred fourteen patients were r and omized to receive 59.4 Gy external beam radiotherapy in 1.8 Gy fractions alone or in combination with 5-FU ( 1,000 mg/m2/day for 4 days by continuous infusion Days 2 - 5 and 28 - 31 ) and MMC ( 10 mg/m2 on Day 2 ) . RESULTS One hundred four patients were evaluable for efficacy . Hematologic and nonhematologic toxicities were more common in the combination arm . The response rates were 6 % in the radiation therapy arm and 9 % in the combination arm . There were no differences in median disease-free survival time ( DFS ) or overall survival time ( OS ) between the combination and radiation therapy alone arms : 5.1 vs. 5.0 months , respectively , for DFS ( p = 0.19 ) and 8.4 vs. 7.1 months , respectively , for OS ( p = 0.16 ) . CONCLUSION The addition of 5-FU and MMC to radiotherapy increased toxicity without improving DFS or OS in patients with locally advanced pancreatic cancer . Alternative drugs for radiosensitization may improve outcome
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 .