A Phase 1/2 Study of Definitive Chemoradiation Therapy Using Docetaxel, Nedaplatin, and 5-Fluorouracil (DNF-R) for Esophageal Cancer

作者：Ohnuma Hiroyuki; Sato Yasushi; Hirakawa Masahiro; Okagawa Yutaka; Osuga Takahiro; Hayashi Tsuyoshi; Sato Tsutomu; Miyanishi Koji; Kobune Masayoshi; Takimoto Rishu; Sagawa Tamotsu; Hori Masakazu; Someya Masanori; Nakata Kensei; Sakata Koh ichi; Takayama Tetsuji; Kato Junji^*

来源：International Journal of Radiation Oncology, Biology, Physics, 2015, 93(2): 382-390.

DOI：10.1016/j.ijrobp.2015.05.041

Purpose: Patient survival in esophageal cancer (EC) remains poor. The purpose of this study was to investigate a regimen of definitive chemoradiation therapy (CRT) that exerts good local control of EC. We performed a phase 1/2 study to assess the safety and efficacy of CRT with docetaxel, nedaplatin, and 5-fluorouracil (DNF-R).
Methods and Materials: Eligible patients presented with stage IB to IV EC. Patients received 2 cycles of docetaxel (20, 30, or 40 mg/m 2) and nedaplatin (50 mg/m 2) on days 1 and 8 and a continuous infusion of 5-fluorouracil (400 mg/m(2) /day) on days 1 to 5 and 8 to 12, every 5 weeks, with concurrent radiation therapy (59.4 Gy/33 fractions). The recommended dose (RD) was determined using a 3 + 3 design.
Results: In the phase 1 study, the dose-limiting toxicities were neutropenia and thrombocytopenia. The RD of docetaxel was determined to be 20 mg/m 2. In the phase 2 study, grade 3 to 4 acute toxicities included neutropenia (42.8%), febrile neutropenia (7.14%), thrombocytopenia (17.9%), and esophagitis (21.4%). Grade 3 to 4 late radiation toxicity included esophagostenosis (10.7%). The complete response rate was 82.1% (95% confidence interval: 67.9-96.3%). Both the median progression-free survival and overall survival were 41.2 months.
Conclusions: DNF-R showed good tolerability and strong antitumor activity, suggesting that it is a potentially effective therapeutic regimen for EC.

• 出版日期2015-10-1