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A phase I and II trial of epirubicin, cisplatin, 24‐hour infusion 5 fluorouracil and sodium folinate in patients with advanced esophagogastric carcinomas
Author(s) -
KARAPETIS Christos S,
CHEONG Kerry A,
YIP Desmond,
STRICKLAND Andrew H,
STEER Christopher,
MARX Gavin,
YIP Sonia,
CHRYSTAL Kathryn,
HARPER Peter G
Publication year - 2010
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/j.1743-7563.2010.01340.x
Subject(s) - epirubicin , medicine , regimen , fluorouracil , chemotherapy , neutropenia , gastroenterology , febrile neutropenia , cisplatin , mucositis , toxicity , survival rate , surgery , cyclophosphamide
Aim: Advanced esophagogastric carcinoma has a poor prognosis. Palliative chemotherapy provides a survival advantage and improved quality of life. Epirubicin, cisplatin and continuous infusional 5‐fluorouracil (5‐FU) (ECF) is a well‐established chemotherapy regimen but a continuous chemotherapy infusion is not always feasible or acceptable. Methods: We conducted a phase I and II trial of a modified version of ECF, utilizing 5‐FU as a 24‐h infusion on day 1 and day 8 of a 21‐day cycle, administered with sodium folinate as a modulator of 5‐FU (ECSF). In the phase I study the dose of 5‐FU was increased in successive cohorts from 1250 mg/m 2 , 1500 mg/m 2 , and 1750 mg/m 2 to 2000 mg/m 2 per 24 h. Results: Dose limiting toxicity of febrile neutropenia was encountered at 2000 mg/m. The recommended dose for 5‐FU was 1750 mg/m 2 . Overall 29 patients were treated with ECSF of whom 27 were evaluable for toxicity. The response rate was 45% on an intention‐to‐treat analysis with a complete response rate of 3%. The median response rate was 4.1 months and the median survival was 10.7 months. A total of 23 patients (72%) obtained clinical benefit with improvement in dysphagia or weight gain. central venous catheter (CVC) complications were observed in 12 (41%) patients. Conclusion: ECSF was associated with a response rate and survival similar to that reported with standard ECF. ECSF may provide an alternative regimen to standard ECF when a continuous ambulatory infusion pump is not feasible or not preferred by the patient. CVC complications are a limitation.