A phase II trial of chemoradiotherapy for stage I esophageal squamous cell carcinoma: Japan Clinical Oncology Group Study (JCOG9708).
OBJECTIVE
The study objective was to evaluate the efficacy and toxicity of chemoradiotherapy with 5-fluorouracil (5-FU) plus cisplatin in patients with Stage I esophageal squamous cell carcinoma (ESCC). The primary endpoint was proportion of complete response (%CR).


METHODS
Patients with Stage I (T1N0M0) ESCC, aged 20-75 years, without indication of endoscopic mucosal resection were eligible. Treatment consisted of cisplatin 70 mg/m(2) (day 1) and 5-FU 700 mg/m(2)/day (days 1-4) combined with 30 Gy radiotherapy (2 Gy/day, 5 days/week, days 1-21). The cycle was repeated twice with 1-week split. Salvage surgery was recommended for residual tumor or local recurrence.


RESULTS
From December 1997 to June 2000, 72 patients were enrolled. No ineligible patient or major protocol violation was observed. There were 63 CRs for %CR of 87.5% [95% confidence interval (CI): 77.6-94.1]. Six patients with residual tumor successfully underwent esophagectomy. There was no Grade 4 toxicity. Four-year survival proportion was 80.5% (95% CI: 71.3-89.7), and 4-year major relapse-free survival proportion was 68% (95% CI: 57.3-78.8) (mucosal recurrence removed by endoscopy was not counted as an event).


CONCLUSIONS
High CR proportion and survival proportion with mild toxicity suggest that this regimen could be considered as a candidate of new standard treatment to be compared with surgery in patients with Stage I ESCC.
Kato
Hoichi
H
Research Center for Innovative Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. asato@east.ncc.go.jp
Sato
Akihiro
A
Fukuda
Haruhiko
H
Kagami
Yoshikazu
Y
Udagawa
Harushi
H
Togo
Akihiko
A
Ando
Nobutoshi
N
Tanaka
Otsuo
O
Shinoda
Masayuki
M
Yamana
Hideaki
H
Ishikura
Satoshi
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D016896:Treatment Outcome; D055815:Young Adult
D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D002945:Cisplatin; D005472:Fluorouracil