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 .
Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer.
PURPOSE To compare the effectiveness and tolerability of gemcitabine plus cisplatin with single-agent gemcitabine as first-line chemotherapy for locally advanced or metastatic pancreatic cancer . PATIENTS AND METHODS Patients with advanced adenocarcinoma of the pancreas were r and omly assigned to receive either gemcitabine 1,000 mg/m2 and cisplatin 50 mg/m2 given on days 1 and 15 of a 4-week cycle ( GemCis arm ) or gemcitabine alone at a dose of 1,000 mg/m2 on days 1 , 8 , and 15 of a 4-week regimen ( Gem arm ) . The primary end point was overall survival ; secondary end points were progression-free survival , response rate , safety , and quality of life . RESULTS One hundred ninety-five patients were enrolled and showed baseline characteristics well balanced between treatment arms . Combination treatment in the GemCis arm was associated with a prolonged median progression-free survival ( 5.3 months v 3.1 months ; hazard ratio [ HR ] = 0.75 ; P = .053 ) . Also , median overall survival was superior for patients treated in the GemCis arm as compared with the Gem arm ( 7.5 v 6.0 months ) , an advantage which did not , however , reach statistical significance ( HR = 0.80 ; P = .15 ) . Tumor response rates were comparable between treatment arms ( 10.2 % v 8.2 % ) . The rate of stable disease was , however , greater in the combination arm ( 60.2 % v 40.2 % ; P < .001 ) . Grade 3 to 4 hematologic toxicity did not exceed 15 % in both treatment arms . CONCLUSION These results support the efficacy and safety of an every-2-weeks treatment with gemcitabine plus cisplatin .  Median overall survival and progression-free survival were more favorable in the combination arm as compared with gemcitabine alone , although the difference did not attain statistical significance
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 .