title: Definitive chemoradiation therapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) in advanced esophageal cancer: a phase 2 trial (KDOG 0501-P2).
abstract: OBJECTIVE
  A previous phase 1 study suggested that definitive chemoradiation therapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) is tolerable and active in patients with advanced esophageal cancer (AEC). This phase 2 study was designed to confirm the efficacy and toxicity of DCF-R in AEC.
  
  
  METHODS
  Patients with previously untreated thoracic AEC who had T4 tumors or M1 lymph node metastasis (M1 LYM), or both, received intravenous infusions of docetaxel (35 mg/m(2)) and cisplatin (40 mg/m(2)) on day 1 and a continuous intravenous infusion of 5-fluorouracil (400 mg/m(2)/day) on days 1 to 5, every 2 weeks, plus concurrent radiation. The total radiation dose was initially 61.2 Gy but was lowered to multiple-field irradiation with 50.4 Gy to decrease esophagitis and late toxicity. Consequently, the number of cycles of DCF administered during radiation therapy was reduced from 4 to 3. The primary endpoint was the clinical complete response (cCR) rate.
  
  
  RESULTS
  Characteristics of the 42 subjects were: median age, 62 years; performance status, 0 in 14, 1 in 25, 2 in 3; TNM classification, T4M0 in 20, non-T4M1LYM in 12, T4M1LYM in 10; total scheduled radiation dose: 61.2 Gy in 12, 50.4 Gy in 30. The cCR rate was 52.4% (95% confidence interval [CI]: 37.3%-67.5%) overall, 33.3% in the 61.2-Gy group, and 60.0% in the 50.4-Gy group. The median progression-free survival was 11.1 months, and the median survival was 29.0 months with a survival rate of 43.9% at 3 years. Grade 3 or higher major toxicity consisted of leukopenia (71.4%), neutropenia (57.2%), anemia (16.7%), febrile neutropenia (38.1%), anorexia (31.0%), and esophagitis (28.6%).
  
  
  CONCLUSIONS
  DCF-R frequently caused myelosuppression and esophagitis but was highly active and suggested to be a promising regimen in AEC. On the basis of efficacy and safety, a radiation dose of 50.4 Gy is recommended for further studies of DCF-R.
authors.affiliation: Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa, Japan. Electronic address: k.higu@kitasato-u.ac.jp.
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Higuchi
authors.affiliation: Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Shouko
authors.initials: S
authors.lastname: Komori
authors.affiliation: Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanabe
authors.affiliation: Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Chikatoshi
authors.initials: C
authors.lastname: Katada
authors.affiliation: Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa, Japan.
authors.forename: Mizutomo
authors.initials: M
authors.lastname: Azuma
authors.affiliation: Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Hiromichi
authors.initials: H
authors.lastname: Ishiyama
authors.affiliation: Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa, Japan.
authors.forename: Tohru
authors.initials: T
authors.lastname: Sasaki
authors.affiliation: Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishido
authors.affiliation: Department of Surgery, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Natsuya
authors.initials: N
authors.lastname: Katada
authors.affiliation: Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Kazushige
authors.initials: K
authors.lastname: Hayakawa
authors.affiliation: Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa, Japan.
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
mesh_terms: D000368:Aged; D000740:Anemia / Q000209:etiology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D004941:Esophagitis / Q000517:prevention & control; D005240:Feasibility Studies; D064147:Febrile Neutropenia; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D015182:Lymphatic Irradiation / Q000379:methods; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D011879:Radiotherapy Dosage; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil