A phase I trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) for advanced esophageal carcinoma: Kitasato digestive disease & oncology group trial (KDOG 0501).
OBJECTIVE
A dose-escalation study of docetaxel combined with cisplatin, 5-fluorouracil, and concurrent radiotherapy (DCF-R) was performed to determine the optimal dose in patients with advanced esophageal carcinoma.


METHODS
A total of 19 patients who had previously untreated thoracic esophageal carcinoma with T4 tumors and/or M1 lymph-node metastasis were studied. The Patients received an infusion of docetaxel (levels 1, 2, 3, 2.5: 20, 30, 40, 35 mg/m(2)) and an infusion of cisplatin (40 mg/m(2)) on days 1, 15, 29, and 43 plus a continuous infusion of 5-fluorouracil (400mg/m(2)/day) on days 1-5, 15-19, 29-33, and 43-47. And patients received 61.2 Gy/34 fractions/7 weeks of concurrent radiotherapy.


RESULTS
Dose-limiting toxicities (DLTs) were febrile neutropenia and grade 4 leukopenia lasting 3 days. DLT occurred in 2 of 6 patients at level 2, 3 of 4 patients at level 3, and 2 of 6 patients at level 2.5. The main toxicities were myelotoxicity and esophagitis. The overall response rate was 89.5%, including a complete response rate of 42.1%.


CONCLUSIONS
The maximum-tolerated dose was level 3, because 50% or more of the patients had DLTs. Therefore, level 2.5 was recommended for phase II studies. This regimen was tolerable and highly active.
Higuchi
Katsuhiko
K
Department of Gastroenterology, and Kitasato University School of Medicine, Kanagawa, Japan. k.higu@kitasato-u.ac.jp
Koizumi
Wasaburo
W
Tanabe
Satoshi
S
Sasaki
Tohru
T
Katada
Chikatoshi
C
Ishiyama
Hiromichi
H
Hayakawa
Kazushige
K
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil