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J Thorac Oncol. 2010 Jan;5(1):122-8. doi: 10.1097/JTO.0b013e3181c1ffd5.

Phase I/II study of docetaxel/cisplatin/fluorouracil combination chemotherapy against metastatic esophageal squamous cell carcinoma.

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1
Department of Gastroenterology, Keiyukai Sapporo Hospital, Sapporo, Japan.

Abstract

INTRODUCTION:

More effective regimens are urgently needed for squamous cell carcinoma of esophagus (SCCE), therefore, we conducted a phase I/II trial of a combination of docetaxel, platinum, and fluorouracil (TPF) for treating metastatic SCCE.

METHODS:

This phase I/II trial (n = 12/39) was conducted in our institute from April 2005 to June 2008. Progression-free survival (PFS) and overall survival were analyzed by the Kaplan-Meier method.

RESULTS:

The recommended dose of docetaxel was determined to be 50 mg/m in phase I. In phase II with a mean follow-up period of 13.3 months, the objective response rate was 66.6%, a median survival period of 13 months and PFS of 7 months was achieved, and the 1-year survival and PFS rates were 52.9% and 19.6%, respectively. Grade 3/4 toxicities of leukopenia, neutropenia, and anorexia were observed in 53.8%, 43.6%, and 25.6%, respectively.

CONCLUSIONS:

A TPF regimen against metastatic SCCE was well tolerated and achieved a favorable objective response rate and survival benefit compared with other recently reported regimens. Randomized phase III trials of the TPF regimen are warranted and urgently required.

PMID:
19898259
DOI:
10.1097/JTO.0b013e3181c1ffd5
[Indexed for MEDLINE]
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