title: Multicenter Phase 2 Study of Cisplatin and 5-Fluorouracil With Concurrent Radiation Therapy as an Organ Preservation Approach in Patients With Squamous Cell Carcinoma of the Cervical Esophagus.
abstract: To clarify, in a multicenter, single-arm, phase 2 study (UMIN Clinical Trials Registry no. UMIN000001439), the clinical profile of chemoradiotherapy (CRT) for cervical esophageal cancer.
  
  
  
  Patients with operable cervical esophageal cancer, excluding candidates for endoscopic resection, were enrolled. Protocol treatment consisted of CRT and adjuvant chemotherapy (CT). First, patients received concurrent CRT with 5-fluorouracil (5-FU) plus cisplatin (CDDP). Chemotherapy consisted of 5-FU at 700 mg/m2intravenous on days 1 to 4 and CDDP at 70 mg/m2intravenous on day 1, repeated every 4 weeks for 2 cycles. Radiation therapy consisted of 60 Gy in 30 fractions. After completion of CRT, 2 additional cycles of CT with 5-FU (800 mg/m2, days 1-5) and CDDP (80 mg/m2, day 1) were repeated at a 4-week interval. The primary endpoint was 3-year overall survival.
  
  
  
  Thirty patients were enrolled across 8 institutions in Japan, consisting of 26 men and 4 women with a median age of 64.5 years (range, 50-75 years). No grade 4 hematologic toxicity was seen in the CRT phase, and 1 grade 4 thrombocytopenia was seen in the CT phase. Grade 3 nonhematologic acute toxicities in the CRT phase were nausea (10%), mucositis (13.3%), and dysphagia (13.3%). No treatment-related death in either phase occurred. Overall complete response rate was 73%, and 3-year overall and laryngectomy-free survival were 66.5% and 52.5%, respectively. Regarding T4 disease, 3-year overall and laryngectomy-free survival were 58.3% and 38.5%, respectively.
  
  
  
  This study, the first prospective study for cervical esophageal cancer, showed that CRT has sufficient efficacy and safety for use as an alternative to surgery for these patients.
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan. Electronic address: szenda@east.ncc.go.jp.
authors.forename: Sadamoto
authors.initials: S
authors.lastname: Zenda
authors.affiliation: Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kojima
authors.affiliation: Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kato
authors.affiliation: Department of Radiation Oncology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Sachiko
authors.initials: S
authors.lastname: Izumi
authors.affiliation: Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Aichi, Japan.
authors.forename: Taijiro
authors.initials: T
authors.lastname: Ozawa
authors.affiliation: Department of Medical Oncology and Hematology, Kobe University Hospital, Hyogo, Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Kiyota
authors.affiliation: Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Chikatoshi
authors.initials: C
authors.lastname: Katada
authors.affiliation: Department of Gastrointestinal Endoscopy and Oncology, Shizuoka Cancer Center Hospital, Shizuoka, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Tsushima
authors.affiliation: Division of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Akimoto
authors.affiliation: Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Aichi, Japan.
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Hasegawa
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Kanamaru
authors.affiliation: Department of Surgery, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Daiko
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D002423:Cause of Death; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003680:Deglutition Disorders / Q000209:etiology*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000401:mortality / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D059351:Organ Sparing Treatments / Q000379:methods*; D011446:Prospective Studies; D016896:Treatment Outcome; D014839:Vomiting / Q000209:etiology
chemical_list: D002945:Cisplatin; D005472:Fluorouracil