Phase I/II trial of 2-weekly docetaxel combined with cisplatin plus fluorouracil in metastatic esophageal cancer (JCOG0807)

Japan Esophageal Oncology Group/Japan Clinical Oncology Group

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

We carried out a phase I/II trial of adding 2-weekly docetaxel to cisplatin plus fluorouracil (CF) therapy (2-weekly DCF regimen) in esophageal cancer patients to investigate its safety and antimetastatic activity. Patients received 2-weekly docetaxel (30 mg/m<sup>2</sup> [dose level (DL)1] or 40 mg/m<sup>2</sup> [DL2] with a 3 + 3 design in phase I, on days 1 and 15) in combination with fixed-dose CF (80 mg/m<sup>2</sup> cisplatin, day 1; 800 mg/m<sup>2</sup> fluorouracil, days 1-5) repeated every 4 weeks. The primary endpoint was dose-limiting toxicity (DLT) in phase I and central peer review-based response rate in phase II. At least 22 responders among 50 patients were required to satisfy the primary endpoint with a threshold of 35%. Sixty-two patients were enrolled in phase I and II. In phase I, 10 patients were enrolled with DLT of 0/3 at DL1 and 2/7 in DL2. Considering DLT and treatment compliance, the recommended phase II dose was determined as DL1. In phase II, the response rate was 62% (P < 0.0001; 95% confidence interval, 48-75%); median overall survival and progression-free survival were 11.1 and 5.8 months, respectively. Common grade 3/4 adverse events were neutropenia (25%), anemia (36%), hyponatremia (29%), anorexia (24%), and nausea (11%). No febrile neutropenia was observed. Pneumonitis caused treatment-related death in one patient. The 2-weekly DCF regimen showed promising antimetastatic activity and tolerability. A phase III study comparing this regimen with CF therapy is planned by the Japan Clinical Oncology Group. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001737.

Original languageEnglish
Pages (from-to)1189-1195
Number of pages7
JournalCancer Science
Volume105
Issue number9
DOIs
Publication statusPublished - 2014 Sep 1

Fingerprint

docetaxel
Esophageal Neoplasms
Fluorouracil
Cisplatin
Febrile Neutropenia
Peer Review
Medical Oncology
Hyponatremia
Anorexia
Therapeutics
Neutropenia
Nausea
Disease-Free Survival
Registries
Anemia
Pneumonia
Japan
Clinical Trials
Confidence Intervals
Safety

Keywords

  • 2-weekly docetaxel
  • Chemotherapy
  • DCF therapy
  • Metastatic esophageal cancer
  • Phase I/II

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase I/II trial of 2-weekly docetaxel combined with cisplatin plus fluorouracil in metastatic esophageal cancer (JCOG0807). / Japan Esophageal Oncology Group/Japan Clinical Oncology Group.

In: Cancer Science, Vol. 105, No. 9, 01.09.2014, p. 1189-1195.

Research output: Contribution to journalArticle

Japan Esophageal Oncology Group/Japan Clinical Oncology Group. / Phase I/II trial of 2-weekly docetaxel combined with cisplatin plus fluorouracil in metastatic esophageal cancer (JCOG0807). In: Cancer Science. 2014 ; Vol. 105, No. 9. pp. 1189-1195.
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AU - Tsubosa, Yasuhiro

AU - Mizusawa, Junki

AU - Kii, Takayuki

AU - Kato, Ken

AU - Tsushima, Takahiro

AU - Chin, Keisho

AU - Tomori, Akihisa

AU - Okuno, Tatsuya

AU - Taniki, Toshikatsu

AU - Ura, Takashi

AU - Matsushita, Hisayuki

AU - Kojima, Takashi

AU - Doki, Yuichiro

AU - Kusaba, Hitoshi

AU - Fujitani, Kazumasa

AU - Taira, Koichi

AU - Seki, Shiko

AU - Nakamura, Tsutomu

AU - Kitagawa, Yuukou

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