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

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 sq...

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Bibliographic Details
Published in:Cancer chemotherapy and pharmacology 2010-11, Vol.66 (6), p.1159-1165
Main Authors: Tanaka, Yoshihiro, Yoshida, Kazuhiro, Sanada, Yuichi, Osada, Shinji, Yamaguchi, Kazuya, Takahashi, Takao
Format: Article
Language:English
Subjects:
5-Fluorouracil
Adult
Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Biological and medical sciences
Cancer Research
Carcinoma, Squamous Cell - drug therapy
Carcinoma, Squamous Cell - secondary
chemotherapy
cisplatin
Cisplatin - administration & dosage
Clinical Trial Report
Docetaxel
Dose-Response Relationship, Drug
Drug Administration Schedule
Esophageal carcinoma
Esophageal Neoplasms - drug therapy
Esophageal Neoplasms - pathology
Esophagus
Female
Fluorouracil - administration & dosage
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Male
Maximum Tolerated Dose
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Oncology
Pharmacology. Drug treatments
Pharmacology/Toxicology
Taxoids - administration & dosage
Treatment Outcome
Tumors
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Summary: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/m², respectively) and an infusion of cisplatin (40 mg/m²) on days 1 and 15 plus a continuous infusion of 5-FU (400 mg/m²/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/m² with cisplatin 40 mg/m² plus 5-FU 400 mg/m², administered biweekly. This regimen was tolerable and highly active. A phase II study has been started.
ISSN:0344-5704
1432-0843
DOI:10.1007/s00280-010-1447-1