A phase I and II trial of epirubicin, cisplatin, 24-hour infusion 5 fluorouracil and sodium folinate in patients with advanced esophagogastric carcinomas.

Abstract:

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.

journal_name

Asia Pac J Clin Oncol

authors

Karapetis CS,Cheong KA,Yip D,Strickland AH,Steer C,Marx G,Yip S,Chrystal K,Harper PG

doi

10.1111/j.1743-7563.2010.01340.x

subject

Has Abstract

pub_date

2010-12-01 00:00:00

pages

298-305

issue

4

eissn

1743-7555

issn

1743-7563

journal_volume

6

pub_type

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