-------------------------------------- Resectable Neoadjuvant 5FU 300 mg/m2/day C.I. with radiation (30 Gy 10 fractions 5 days a week). JCO 16:3843, 1998 -------------------------------------- Resectable Adjuvant 5FU 500 mg/m2/day x 6 days with radiation (40 Gy) Arch Surg 120: 899, 1985 -------------------------------------- Unresectable Locally Advanced 5FU 200 mg/m2 C.I. per 24 hrs q Monday to Friday concurrently with XRT. -------------------------------------- Metastatic SINGLE AGENT GEMCITIBINE Gemcitibine 1000 mg/m2 weekly for up to 7 weeks Follow by 1 rest week Then Weekly X 3 Q4weeks until progression J Clin Oncol 15:2403-13, 1997 ------------------------------------------------------------ other approaches... IRINOTECAN + GEMZAR (IRINOGEM) (Phase I & II complete, Phase III started) Irinotecan 100 mg/m2 DAYS 1 & 8 of 21 cycle Gemcitibine 1000 mg/m2 DAYS 1 & 8 of 21 cycle ------------------------------------------------------------ TWICE-WEEKLY GEMCITBINE + XRT (phase I) Gemcitabine 40 mg/m2 by 30-minute intravenous infusion each Monday and Thursday for 5 weeks concurrent with 50.4 Gy of radiation to the pancreas J Clin Oncol 1999 Jul;17(7):2208-12 ------------------------------------------------------------ PEF-G Regimen (Phase II) CISPLATIN 40 mg/m2 day 1 EPIRUBICIN 40 mg/m2 day 1 GEMCITABINE 600 mg/m2 over 1 hour days 1, 8 Q 4 weeks 5FU 200 mg/m2 QD as a protracted venous infusion JCO 19:2679, 2001 ------------------------------------------------------------
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, prospectively randomized study.
PATIENTS AND METHODS: Two hundred eight patients were randomized to PVI 5-FU (300 mg/m2/d for a maximum of 24 weeks) or PVI 5-FU plus MMC (7 mg/m2 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 resulted 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. |