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
| Autor: | Alain Gelibter, C. F. Pollera, Paolo Carlini, Alessandra Felici, Salvatore De Marco, Francesco Cognetti, Anna Maria Fariello, Isabella Sperduti, Enzo Maria Ruggeri, Teresa Gamucci, Ennio Adami, Luca Moscetti |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Time Factors medicine.medical_treatment Leucovorin Phases of clinical research Adenocarcinoma Toxicology Gastroenterology Disease-Free Survival Drug Administration Schedule Folinic acid Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor medicine Mucositis Humans Pharmacology (medical) Neoplasm Metastasis Infusions Intravenous Survival rate Aged Epirubicin Pharmacology Aged 80 and over Chemotherapy business.industry Middle Aged medicine.disease Recombinant Proteins PELF Regimen Surgery Oncology Tolerability Female Fluorouracil Cisplatin business medicine.drug |
| Zdroj: | Scopus-Elsevier |
| ISSN: | 0344-5704 |
| Popis: | 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 μg/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. |
| Databáze: | OpenAIRE |
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