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

• Published in: Cancer science 2014-09, Vol.105 (9), p.1189-1195
• Main Authors: Hironaka, Shuichi, Tsubosa, Yasuhiro, Mizusawa, Junki, Kii, Takayuki, Kato, Ken, Tsushima, Takahiro, Chin, Keisho, Tomori, Akihisa, Okuno, Tatsuya, Taniki, Toshikatsu, Ura, Takashi, Matsushita, Hisayuki, Kojima, Takashi, Doki, Yuichiro, Kusaba, Hitoshi, Fujitani, Kazumasa, Taira, Koichi, Seki, Shiko, Nakamura, Tsutomu, Kitagawa, Yuko
• Format: Article
• Language: English
• Subjects: 2‐weekly docetaxel; 5-Fluorouracil; Adult; Aged; Anorexia; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer therapies; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - secondary; Chemotherapy; Cisplatin; Cisplatin - administration & dosage; Clinical trials; DCF therapy; Drug dosages; Esophageal cancer; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - mortality; Esophageal Neoplasms - pathology; Esophagus; Female; Fluorouracil - administration & dosage; Gastric cancer; Humans; Hyponatremia; Kaplan-Meier Estimate; Male; Maximum Tolerated Dose; Medical research; Metastases; Metastasis; metastatic esophageal cancer; Middle Aged; Nausea; Neutropenia; Oncology; Original; Patients; phase I/II; Pneumonitis; Studies; Taxoids - administration & dosage; Toxicity; Treatment Outcome
• ISSN: 1347-9032; 1349-7006
• DOI: 10.1111/cas.12486

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/m2 [dose level (DL)1] or 40 mg/m2 [DL2] with a 3 + 3 design in phase I, on days 1 and 15) in combination with fixed‐dose CF (80 mg/m2 cisplatin, day 1; 800 mg/m2 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