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Title: Phase II Study of Chemoradiotherapy With 5-Fluorouracil and Cisplatin for Stage II-III Esophageal Squamous Cell Carcinoma: JCOG Trial (JCOG 9906)

Abstract

Purpose: In this Phase II study, we evaluated the efficacy and toxicity of chemoradiotherapy (CRT) with cisplatin (CDDP) and 5-fluorouracil (5-FU) for Stage II-III esophageal squamous cell carcinoma (ESCC). Patients and Methods: Patients with clinical Stage II-III (T1N1M0 or T2-3N0-1M0) thoracic ESCC were enrolled between April 2000 and March 2002. Chemotherapy comprised two courses of protracted infusion of 5-FU (400 mg/m{sup 2}/day) on Days 1-5 and 8-12, and 2-h infusion of CDDP (40 mg/m{sup 2}) on Days 1 and 8; this regimen was repeated every 5 weeks. Concurrent radiotherapy involved 60-Gy irradiation (30 fractions) for 8 weeks with a 2-week break. Responders received two courses of 5-FU (800 mg/m{sup 2}/day) on Days 1-5 and CDDP (80 mg/m{sup 2}) on Day 1. Final analysis was conducted in March 2007. Survival and late toxicities were monitored for 5 years. Results: The characteristics of the 76 patients enrolled were as follows: median age, 61 years; male/female, 68/8; performance status 0/1, 59/17 patients; Stage IIA/IIB/III, 26/12/38 patients. Of the 74 eligible patients, 46 (62.2%) achieved complete response. Median survival time was 29 months, with 3- and 5-year survival rates of 44.7% and 36.8%, respectively. Acute toxicities included Grade 3/4 esophagitis (17%), nausea (17%), hyponatremiamore » (16%), and infection without neutropenia (12%). Late toxicities comprised Grade 3/4 esophagitis (13%), pericardial (16%) and pleural (9%) effusion, and radiation pneumonitis (4%), causing 4 deaths. Conclusions: CRT is effective for Stage II-III ESCC with manageable acute toxicities and can provide a nonsurgical treatment option. However, further improvement is required for reduction in late toxicity.« less

Authors:
 [1];  [1]; ;  [2];  [3];  [4];  [5];  [6];  [7];  [3]
  1. Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo (Japan)
  2. Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba (Japan)
  3. Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo (Japan)
  4. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Shizuoka (Japan)
  5. Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Osaka (Japan)
  6. Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Hokkaido (Japan)
  7. Department of Internal Medicine, Saku Central Hospital, Nagano (Japan)
Publication Date:
OSTI Identifier:
21590427
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 81; Journal Issue: 3; Other Information: DOI: 10.1016/j.ijrobp.2010.06.033; PII: S0360-3016(10)00884-9; Copyright (c) 2011 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; CARCINOMAS; CHEMOTHERAPY; COMBINED THERAPY; DEATH; ESOPHAGUS; FLUOROURACILS; INFUSION; IRRADIATION; NAUSEA; PLATINUM COMPLEXES; PNEUMONITIS; RADIOTHERAPY; SURGERY; SURVIVAL TIME; TOXICITY; ANTIMETABOLITES; AZINES; BODY; COMPLEXES; DIGESTIVE SYSTEM; DISEASES; DRUGS; HETEROCYCLIC COMPOUNDS; HYDROXY COMPOUNDS; INTAKE; MEDICINE; NEOPLASMS; NUCLEAR MEDICINE; ORGANIC COMPOUNDS; ORGANIC FLUORINE COMPOUNDS; ORGANIC HALOGEN COMPOUNDS; ORGANIC NITROGEN COMPOUNDS; ORGANS; PYRIMIDINES; RADIOLOGY; SYMPTOMS; THERAPY; TRANSITION ELEMENT COMPLEXES; URACILS

Citation Formats

Kato, Ken, Muro, Kei, Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Minashi, Keiko, Ohtsu, Atsushi, Ishikura, Satoshi, Boku, Narikazu, Takiuchi, Hiroya, Komatsu, Yoshito, Miyata, Yoshinori, and Fukuda, Haruhiko. Phase II Study of Chemoradiotherapy With 5-Fluorouracil and Cisplatin for Stage II-III Esophageal Squamous Cell Carcinoma: JCOG Trial (JCOG 9906). United States: N. p., 2011. Web. doi:10.1016/j.ijrobp.2010.06.033.
Kato, Ken, Muro, Kei, Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Minashi, Keiko, Ohtsu, Atsushi, Ishikura, Satoshi, Boku, Narikazu, Takiuchi, Hiroya, Komatsu, Yoshito, Miyata, Yoshinori, & Fukuda, Haruhiko. Phase II Study of Chemoradiotherapy With 5-Fluorouracil and Cisplatin for Stage II-III Esophageal Squamous Cell Carcinoma: JCOG Trial (JCOG 9906). United States. https://doi.org/10.1016/j.ijrobp.2010.06.033
Kato, Ken, Muro, Kei, Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Minashi, Keiko, Ohtsu, Atsushi, Ishikura, Satoshi, Boku, Narikazu, Takiuchi, Hiroya, Komatsu, Yoshito, Miyata, Yoshinori, and Fukuda, Haruhiko. 2011. "Phase II Study of Chemoradiotherapy With 5-Fluorouracil and Cisplatin for Stage II-III Esophageal Squamous Cell Carcinoma: JCOG Trial (JCOG 9906)". United States. https://doi.org/10.1016/j.ijrobp.2010.06.033.
@article{osti_21590427,
title = {Phase II Study of Chemoradiotherapy With 5-Fluorouracil and Cisplatin for Stage II-III Esophageal Squamous Cell Carcinoma: JCOG Trial (JCOG 9906)},
author = {Kato, Ken and Muro, Kei and Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi and Minashi, Keiko and Ohtsu, Atsushi and Ishikura, Satoshi and Boku, Narikazu and Takiuchi, Hiroya and Komatsu, Yoshito and Miyata, Yoshinori and Fukuda, Haruhiko},
abstractNote = {Purpose: In this Phase II study, we evaluated the efficacy and toxicity of chemoradiotherapy (CRT) with cisplatin (CDDP) and 5-fluorouracil (5-FU) for Stage II-III esophageal squamous cell carcinoma (ESCC). Patients and Methods: Patients with clinical Stage II-III (T1N1M0 or T2-3N0-1M0) thoracic ESCC were enrolled between April 2000 and March 2002. Chemotherapy comprised two courses of protracted infusion of 5-FU (400 mg/m{sup 2}/day) on Days 1-5 and 8-12, and 2-h infusion of CDDP (40 mg/m{sup 2}) on Days 1 and 8; this regimen was repeated every 5 weeks. Concurrent radiotherapy involved 60-Gy irradiation (30 fractions) for 8 weeks with a 2-week break. Responders received two courses of 5-FU (800 mg/m{sup 2}/day) on Days 1-5 and CDDP (80 mg/m{sup 2}) on Day 1. Final analysis was conducted in March 2007. Survival and late toxicities were monitored for 5 years. Results: The characteristics of the 76 patients enrolled were as follows: median age, 61 years; male/female, 68/8; performance status 0/1, 59/17 patients; Stage IIA/IIB/III, 26/12/38 patients. Of the 74 eligible patients, 46 (62.2%) achieved complete response. Median survival time was 29 months, with 3- and 5-year survival rates of 44.7% and 36.8%, respectively. Acute toxicities included Grade 3/4 esophagitis (17%), nausea (17%), hyponatremia (16%), and infection without neutropenia (12%). Late toxicities comprised Grade 3/4 esophagitis (13%), pericardial (16%) and pleural (9%) effusion, and radiation pneumonitis (4%), causing 4 deaths. Conclusions: CRT is effective for Stage II-III ESCC with manageable acute toxicities and can provide a nonsurgical treatment option. However, further improvement is required for reduction in late toxicity.},
doi = {10.1016/j.ijrobp.2010.06.033},
url = {https://www.osti.gov/biblio/21590427}, journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 3,
volume = 81,
place = {United States},
year = {Tue Nov 01 00:00:00 EDT 2011},
month = {Tue Nov 01 00:00:00 EDT 2011}
}