Multicenter Phase I/II Study of Docetaxel, Cisplatin and Fluorouracil Combination Chemotherapy in Patients with Advanced or Recurrent Squamous Cell Carcinoma of the Esophagus

• Published in: Oncology Vol. 80; no. 5-6; pp. 307 - 313
• Main Authors: Yamasaki, Makoto, Miyata, Hiroshi, Tanaka, Koji, Shiraishi, Osamu, Motoori, Masaaki, Peng, Y.F., Yasuda, Takushi, Yano, Masahiko, Shiozaki, Hitoshi, Mori, Masaki, Doki, Yuichiro
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland Karger 01.01.2011; S. Karger AG
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Cancer; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - secondary; Chemotherapy; Cisplatin - administration & dosage; Clinical Study; Disease-Free Survival; Drug Administration Schedule; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - pathology; Esophagus; Female; Fluorouracil - administration & dosage; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Liver Neoplasms - drug therapy; Liver Neoplasms - secondary; Lung Neoplasms - drug therapy; Lung Neoplasms - secondary; Lymphatic Metastasis; Male; Medical sciences; Middle Aged; Recurrence; Side effects; Taxoids - administration & dosage; Treatment Outcome; Tumors; Chemotherapy; Squamous cell carcinoma of esophagus; Cisplatin; Docetaxel; Fluorouracil; Antineoplastic agent; Relapse; Multicenter study; Esophageal disease; Esophagus squamous cell carcinoma; Cancerology; Taxane derivatives; Phase II trial; Advanced stage; Antimitotic; Platinum II Complexes; Human; Drug combination; Enzyme; Fluoropyrimidine derivatives; Transferases; Enzyme inhibitor; Malignant tumor; Thymidylate synthase; Alkylating agent; Treatment; Antimetabolic; Methyltransferases; Phase I trial; Pyrimidine derivatives; Digestive diseases; Combined treatment; Cancer
• ISSN: 0030-2414; 1423-0232; 1423-0232
• DOI: 10.1159/000329806

Objective: Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC. Methods: The study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m 2 , cisplatin at 70 mg/m 2 on day 1, and daily fluorouracil at 700 mg/m 2 on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II. Results: The recommended dose was determined to be 70 mg/m 2 in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19. Conclusion: DCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC.