Bi-weekly chemotherapy with cisplatin, epirubicin, folinic acid and 5-fluororacil continuous infusion plus g-csf in advanced gastric cancer: a multicentric phase II study.

Alessandra Felici, Paolo Carlini, Enzo Maria Ruggeri, Teresa Gamucci, Camillo Franco Pollera, Salvatore De Marco, Anna Maria Fariello, Luca Moscetti, Alain Gelibter, Ennio Adami, Isabella Sperduti, Francesco Cognetti

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: It has been demonstrated that the 3-weekly PELF regimen is superior to FAM and FAMTX in advanced gastric cancer. The aim of this multicentric phase II study was to evaluate the efficacy and tolerability of a PELF regimen, given every 2 weeks as a first-line therapy in patients with unresectable or metastatic gastric carcinoma. METHODS: Fifty-nine patients were treated with the following schedule: cisplatin (40 mg/m2, day 1), epirubicin (30 mg/m2, day 1), 5-fluorouracil (400 mg/m2 bolus, followed by 600 mg/m2, 22 h continuous infusion, day 1 and 2) and folinic acid (100 mg/m2, 2-h infusion, day 1 and 2). G-CSF (5 microg/kg) was administered on day 6, 8, 10, and 12. Cycles were repeated every 2 weeks for a maximum of twelve courses. RESULTS: Of the 52 evaluable patients, three (5.8%) complete responses, and 15 (28.8%) partial responses were observed, for an overall response rate of 34.6%. The median duration of response was 8 months. Nineteen patients had stable disease and 15 progressed on therapy. At a median follow-up of 12 months, the median time to progression was 8 months and the median survival duration was 13 months, with a 1-year survival rate of 53.5%. Grade 3 or 4 observed toxicities were: neutropenia in 26 patients (44%), thrombocytopenia in four patients (6.7%), and mucositis in seven patients (11.9%). Conclusions: The bi-weekly PELF regimen seems to be feasible with an acceptable toxicity profile and an activity comparable to the 3-weekly schedule.

Original languageEnglish
Pages (from-to)59-64
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Volume57
Issue number1
Publication statusPublished - Jan 2006

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

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