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• W4233475710 abstract "Purpose: The purpose of this study was to compare the efficacy and toxicity of concurrent gemcitabine-based chemoradiation to concurrent 5-FU-based chemoradiation among patients with unresectable pancreatic cancer. Patients and Methods: Between 9/96 and 5/00, 114 patients with localized unresectable adenocarcinoma of the pancreas were treated with concurrent chemoradiation. Unresectable disease was defined as helical thin-slice computed tomography evidence of low-density tumor in contact with the superior mesenteric artery (SMA) or celiac artery, or occlusion of the portal venous confluence. Fifty-four medically fit patients were selected to receive gemcitabine in 7 weekly cycles (250–500mg/m2) with concurrent radiotherapy (median 30Gy, range 30–33Gy/10–11fx). The remaining patients 60 received continuous infusion 5-FU (200–300 mg/m2) with concurrent radiotherapy (30Gy/10fx). Radiotherapy was delivered to the primary tumor and regional lymphatics; the field size was not dependent on primary tumor size or chemotherapy used. Patients receiving gemcitabine had a similar mean performance status (88% vs 86%), distribution of tumor grade (31% vs 43% poorly differentiated), and percent median weight loss (all p=NS). However, patients receiving gemcitabine had a significantly larger median maximum cross sectional tumor area (TA, 8.8 cm2 vs 5.7 cm2, p=0.046) and were significantly younger (68 vs 60 years, p<0.001). Severe acute toxicity (ST) was defined as hospital admission >5 days, gastric or duodenal mucosal ulceration with bleeding, >3 dose deletions of gemcitabine or discontinuation of 5-FU, or toxicity resulting in surgical intervention or death. Kaplan-Meier analysis was used to calculate the 1-year actuarial overall survival (OS), local progression on imaging (LP), and distant metastasis, (DM). The pretreatment and preoperative imaging was reviewed in resected patients. Results: Patients receiving gemcitabine developed significantly more ST during treatment, (24% vs 2%, p<0.0001) than those receiving 5-FU. ST was based on hospital admission (53%), dose deletions (29%), and ulceration (18%) in patients receiving gemcitabine and hospital admission in patients receiving 5-FU. Administration of gemcitabine did not significantly improve median OS duration (11 months vs 9 months), 1-year OS rate (42% vs 28%), LP rate (73% vs 61%), or DM rate (56% vs 47%) compared to patients treated with 5 FU (all p=NS). Five patients who received gemcitabine and none of the patients who received 5-FU underwent margin negative pancreaticoduodenectomy after a response to therapy. Four of these patients had a short (<1cm) segment of low density tumor abutting the SMA. The other patient was felt to have pancreatitis-related inflammatory changes discontiguous with the tumor surrounding the SMA that resolved after chemoradiation. Poor differentiation predicted for a worse OS, (p=0.01) and TA > 10cm showed a trend toward worse OS (p= 0.06), but other factors such as KPS and weight loss > 10% and age did not influence OS. Conclusions: Despite a selection bias in favor of patients receiving gemcitabine, there was a significantly higher severe toxicity rate than with 5-FU. No statistically significant improvement in the 1-year OS, LP or DM rate has been seen with the use of concurrent gemcitabine but the tumors were significantly larger. A small number of patients with minimal arterial involvement who met our definition of unresectable disease had margin-negative resections after response to gemcitabine-based chemoradiation. This possible improvement and the high rate of severe toxicity define a very narrow therapeutic index with gemcitabine and radiotherapy administered this way." @default.
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• W4233475710 date "2001-11-01" @default.
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• W4233475710 title "Is the therapeutic index better with gemcitabine-based chemoradiation than with 5-FU- based chemoradiation in locally advanced pancreatic cancer" @default.
• W4233475710 doi "https://doi.org/10.1016/s0360-3016(01)01876-4" @default.
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