Multicenter phase I/II study of docetaxel, cisplatin and fluorouracil combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the esophagus

Makoto Yamasaki, Hiroshi Miyata, Koji Tanaka, Osamu Shiraishi, Masaaki Motoori, Y. F. Peng, Takushi Yasuda, Masahiko Yano, Hitoshi Shiozaki, Masaki Mori, Yuichiro Doki

Research output: Contribution to journalArticlepeer-review

74 Citations (Scopus)

Abstract

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/m2, cisplatin at 70 mg/m2 on day 1, and daily fluorouracil at 700 mg/m2 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/m2 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.

Original languageEnglish
Pages (from-to)307-313
Number of pages7
JournalOncology
Volume80
Issue number5-6
DOIs
Publication statusPublished - Aug 2011
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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