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

Abstract

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{sup 2}) and nedaplatin (50 mg/m{sup 2}) on days 1 and 8 and a continuous infusion of 5-fluorouracil (400 mg/m{sup 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{sup 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 strongmore » antitumor activity, suggesting that it is a potentially effective therapeutic regimen for EC.« less

Authors:
; ; ; ; ; ; ; ; ;  [1];  [2]; ; ; ;  [3];  [4];  [1]
  1. Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo (Japan)
  2. Division of Gastroenterology, Hokkaido Cancer Center, Sapporo (Japan)
  3. Department of Radiology, Sapporo Medical University School of Medicine, Sapporo (Japan)
  4. Department of Gastroenterology and Oncology, University of Tokushima, Tokushima (Japan)
Publication Date:
OSTI Identifier:
22458786
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 93; Journal Issue: 2; Other Information: Copyright (c) 2015 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ESOPHAGUS; NEOPLASMS; PATIENTS; RADIATION DOSES; RADIOTHERAPY; SAFETY; TOXICITY; URACILS

Citation Formats

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, and Kato, Junji, E-mail: jkato@sapmed.ac.jp. A Phase 1/2 Study of Definitive Chemoradiation Therapy Using Docetaxel, Nedaplatin, and 5-Fluorouracil (DNF-R) for Esophageal Cancer. United States: N. p., 2015. Web. doi:10.1016/J.IJROBP.2015.05.041.
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, E-mail: jkato@sapmed.ac.jp. A Phase 1/2 Study of Definitive Chemoradiation Therapy Using Docetaxel, Nedaplatin, and 5-Fluorouracil (DNF-R) for Esophageal Cancer. United States. doi:10.1016/J.IJROBP.2015.05.041.
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, and Kato, Junji, E-mail: jkato@sapmed.ac.jp. Thu . "A Phase 1/2 Study of Definitive Chemoradiation Therapy Using Docetaxel, Nedaplatin, and 5-Fluorouracil (DNF-R) for Esophageal Cancer". United States. doi:10.1016/J.IJROBP.2015.05.041.
@article{osti_22458786,
title = {A Phase 1/2 Study of Definitive Chemoradiation Therapy Using Docetaxel, Nedaplatin, and 5-Fluorouracil (DNF-R) for Esophageal Cancer},
author = {Ohnuma, Hiroyuki and Sato, Yasushi and Hirakawa, Masahiro and Okagawa, Yutaka and Osuga, Takahiro and Hayashi, Tsuyoshi and Sato, Tsutomu and Miyanishi, Koji and Kobune, Masayoshi and Takimoto, Rishu and Sagawa, Tamotsu and Hori, Masakazu and Someya, Masanori and Nakata, Kensei and Sakata, Koh-ichi and Takayama, Tetsuji and Kato, Junji, E-mail: jkato@sapmed.ac.jp},
abstractNote = {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{sup 2}) and nedaplatin (50 mg/m{sup 2}) on days 1 and 8 and a continuous infusion of 5-fluorouracil (400 mg/m{sup 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{sup 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.},
doi = {10.1016/J.IJROBP.2015.05.041},
journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 2,
volume = 93,
place = {United States},
year = {2015},
month = {10}
}