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

Journal Article · Tue Nov 01 04:00:00 EDT 2011 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2010.06.033· OSTI ID:21590427

Kato, Ken ^[1]; Muro, Kei ^[1]; Minashi, Keiko; Ohtsu, Atsushi ^[2]; Ishikura, Satoshi ^[3]; Boku, Narikazu ^[4]; Takiuchi, Hiroya ^[5]; Komatsu, Yoshito ^[6]; Miyata, Yoshinori ^[7]; Fukuda, Haruhiko ^[3]

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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)

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.

• OSTI ID: 21590427
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 3 Vol. 81; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

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ANTIMETABOLITES
AZINES
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CARCINOMAS
CHEMOTHERAPY
COMBINED THERAPY
COMPLEXES
DEATH
DIGESTIVE SYSTEM
DISEASES
DRUGS
ESOPHAGUS
FLUOROURACILS
HETEROCYCLIC COMPOUNDS
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PLATINUM COMPLEXES
PNEUMONITIS
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RADIOTHERAPY
SURGERY
SURVIVAL TIME
SYMPTOMS
THERAPY
TOXICITY
TRANSITION ELEMENT COMPLEXES
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