Gemcitabine following radiotherapy with concurrent 5-fluorouracil for nonmetastatic adenocarcinoma of the pancreas

Gemcitabine has been shown to be an active agent in the treatment of pancre atic cancer. This study was conducted to prospectively examine the toleranc e and early efficacy of adjuvant gemcitabine following radiotherapy with co ncurrent 5-fluorouracil (5-FU) for nonmetastatic pancreatic adenocarcinoma, Twenty-three patients, median age 64 years, were treated with combined mod ality therapy. Nine patients underwent tumor resection before chemoradiatio n; 14 patients with locally unresectable tumors received definitive chemora diation. Radiotherapy utilized four fields to the tumor and lymphatics to 4 5 Gy, plus a lateral boost to 50.4 Gy, Concurrent 5-FU 500 mg/m(2)/day was administered on days 1-3 and 29-31, followed by 4 months of gemcitabine 1,0 00 mg/m(2)/week for 3 weeks (fourth week break). Adjuvant gemcitabine was w ell tolerated. Eighty-three percent of the patients completed three to four cycles, The primary dose-limiting toxicity was leukopenia, which was obser ved in 10 patients (43%), Nonhematologic toxicities were reported in five p atients (22%), There were no cases of gemcitabine-induced radiation recall and there have been no deaths attributed to treatment toxicity, Median foll ow-up for the 23 patients was 12 months (range, 5-50); the actuarial median survival was 13 months. This report confirms that adjuvant gemcitabine fol lowing radiotherapy with concurrent 5-FU for nonmetastatic pancreatic adeno carcinoma can be safely administered. (C) 2001 Wiley-Liss, Inc.