Treatment of advanced adenocarcinomas of the exocrine pancreas and the gallbladder with 5-fluorouracil, high dose levofolinic acid and oral hydroxyurea on a weekly schedule: Results of a Multicenter Study of the Southern Italy Oncology Group (G.O.I.M.)

Vittorio Gebbia, Evaristo Majello, Antonio Testa, Giuseppe Pezzella, Serravezza Giuseppe, Francesco Giotta, Fernando Riccardi, Santo Fortunato, Giuseppe Colucci, Nicolò Gebbia, Ernesto Durini, Francesco Giuliani, Giuseppe Pisconti, Roberto Valenza, Rosalba Cifarelli

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND. To date there is no established chemotherapeutic treatment for patients with unresectable locally advanced and/or metastatic carcinomas of the exocrine pancreas or the gallbladder. A multicenter Phase II trial has been performed by the Southern Italy Oncology Group with the aim of evaluating the clinical effectiveness and tolerability of weekly 5- fluorouracil (5-FU) in modulation with intravenous (i.v.) high dose levofolinic acid and oral hydroxyurea. METHODS. A total of 70 patients fulfilling the standard eligibility for a Phase II study were enrolled in the trial. Forty patients had advanced pancreatic adenocarcinoma and 30 had advanced gallbladder carcinoma. The treatment schedule was: levofolinic acid, 100 mg/M2, in 500 mL of normal saline over 2-hour infusion followed by 5- FU, 600 mg/m2 i.v. bolus, and oral hydroxyurea, 1000 mg/m2, for 1 day every week for 6 consecutive weeks followed by 15 days of rest. RESULTS. Among the 40 patients with pancreatic adenocarcinoma, 5 (12.5%; 95% confidence level [CL], 85-16.5%) showed a partial response with a median duration of 5.6+ months, and 13 had stable disease. Twenty-two patients progressed. Median survival was 5.8 months. Among patients with advanced gallbladder carcinoma, 9 of 30 had a partial response (30%; 95% CL, 26-54%) with a median duration of 6.5 months, and 8 (27%) had stabilization of disease. Thirteen patients showed progressive disease. Median overall survival was 8 months. Toxicity was mild, with Grade 1 to 2 leukopenia and gastrointestinal toxicity the most frequent side effects. No chemotherapy-related deaths were observed. CONCLUSIONS. 5-FU in modulation with i.v. levofolinic acid and oral hydroxyurea on a weekly schedule is well tolerated by the vast majority of patients with locally advanced and/or metastatic carcinoma of the pancreas or the gallbladder. Although response rate and overall survival for patients with pancreatic adenocarcinoma are far from acceptable, the 30% overall response rate achieved in patients with advanced gallbladder carcinoma suggests that 5-FU in modulation with levofolinic acid and hydroxyurea is active in this neoplasm. The combination of modulated 5-FU with other antineoplastic drugs seems worthy of clinical testing in further controlled trials.

Original languageEnglish
Pages (from-to)1300-1307
Number of pages8
JournalCancer
Volume78
Issue number6
DOIs
Publication statusPublished - Sep 15 1996

Keywords

  • 5- fluorouracil
  • chemotherapy
  • gallbladder carcinoma
  • hydroxyarea
  • levofolinic acid
  • pancreatic carcinoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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