title: Phase I/II study of divided-dose docetaxel, cisplatin and fluorouracil for patients with recurrent or metastatic squamous cell carcinoma of the esophagus.
abstract: Squamous cell carcinoma of the esophagus (SCCE) has a poor prognosis compared with other gastrointestinal cancers. Many patients present with locoregional unresectable or metastatic disease at the time of diagnosis. For these patients with metastatic esophageal cancer, chemotherapy is generally indicated. The aim of this phase I/II study was to evaluate the efficacy and safety of the combined use of docetaxel, cisplatin (CDDP) and 5-fluorouracil (5-FU)(DCF) in patients with recurrent/metastatic SCCE. This study adopted divided doses of docetaxel and CDDP in order to reduce the toxicities of the treatment. The dose of docetaxel was escalated using the following protocol in the phase I stage: level 1, 30 mg/m2; level 2, 35 mg/m2 and level 3, 40 mg/m2, which was intravenously infused for 2 hours on days 1 and 8. CDDP was administered at a dose of 12 mg/m2 infused for 4 hours on days 1-5. The 5-FU was administered at a dose of 600 mg/m2 continuously infused from day 1 to 5. This regimen was repeated every 4 weeks. The study subjects were nine patients (phase I) and 48 patients (phase II). The recommended dose was determined as level 3 in phase I. In the phase II stage, the overall response rate was 62.5%, with a complete response rate of 12.5%. The median progression-free survival was 6 months, and the median overall survival was 13 months. Grade 3/4 toxicities of leukopenia, neutropenia and febrile neutropenia occurred in 64.6%, 68.8% and 14.6% of the patients, while grade 3/4 non-hematological toxicities were relatively rare. No treatment-related death was recorded. This modified DCF regimen with divided doses can be a tolerable and useful regimen of definitive chemotherapy for unresectable SCCE because of its high efficacy, although adequate care for severe neutropenia must be administered.
authors.affiliation: Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ojima
authors.affiliation: Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Nakamori
authors.affiliation: Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Katsuda
authors.affiliation: Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Hayata
authors.affiliation: Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Matsumura
authors.affiliation: Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Iwahashi
authors.affiliation: Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Yamaue
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000077277:Esophageal Squamous Cell Carcinoma; D004947:Esophagus / Q000473:pathology; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D012107:Research Design; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: DCF; chemotherapy; esophageal cancer