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Cancer Chemother Pharmacol. 2010 Nov;66(6):1159-65. doi: 10.1007/s00280-010-1447-1. Epub 2010 Sep 28.

Biweekly docetaxel, cisplatin, and 5-fluorouracil (DCF) chemotherapy for advanced esophageal squamous cell carcinoma: a phase I dose-escalation study.

Author information

  • 1Department of Surgical Oncology, Gifu Graduate School of Medicine, 1-1, Yanagido, Gifu city, Gifu 501-1194, Japan. yoshihirotana11@hotmail.com

Abstract

BACKGROUND AND PURPOSE:

The optimal chemotherapeutic protocol for the treatment of esophageal cancer has not yet been established. A dose-escalation study of docetaxel combined with cisplatin and 5-fluorouracil (5-FU) was performed to determine the optimal dose in patients with advanced esophageal squamous cell carcinoma.

PATIENTS AND METHOD:

We studied a total of 18 patients who had previously untreated thoracic esophageal squamous cell carcinoma with T4 tumors and/or metastasis. The patients received an infusion of docetaxel at different dose levels (levels 1, 2, 3: 30, 35, 40 mg/m(2), respectively) and an infusion of cisplatin (40 mg/m(2)) on days 1 and 15 plus a continuous infusion of 5-FU (400 mg/m(2)/day) on days 1-5 and 15-19.

RESULTS:

Dose-limiting toxicities (DLT) included febrile neutropenia and leukopenia. DLT occurred in 2 of 6 patients at level 1, 2 and in 3 of 6 patients at level 3. The response rate was 88.9%, including a complete response rate of 33.3%.

CONCLUSIONS:

To minimize toxicity and maximize dose intensity, we elected to investigate a biweekly regimen. The maximum tolerated dose was level 3, and the recommended dose was determined to be docetaxel 35 mg/m(2) with cisplatin 40 mg/m(2) plus 5-FU 400 mg/m(2), administered biweekly. This regimen was tolerable and highly active. A phase II study has been started.

PMID:
20878160
PMCID:
PMC2955920
DOI:
10.1007/s00280-010-1447-1
[PubMed - indexed for MEDLINE]
Free PMC Article
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