title: Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus.
abstract: BACKGROUND
  The efficacy of conventional treatment with surgery and radiation for cancer of the esophagus is limited. The median survival is less than 10 months, and less than 10 percent of patients survive for 5 years. Recent studies have suggested that combined chemotherapy and radiation therapy may result in improved survival.
  
  
  METHODS
  This phase III prospective, randomized, and stratified trial was undertaken to evaluate the efficacy of four courses of combined fluorouracil (1000 mg per square meter of body-surface area daily for four days) and cisplatin (75 mg per square meter on the first day) plus 5000 cGy of radiation therapy, as compared with 6400 cGy of radiation therapy alone, in patients with squamous-cell carcinoma or adenocarcinoma of the thoracic esophagus. The trial was stopped after the accumulated results in 121 patients demonstrated a significant advantage for survival in the patients who received chemotherapy and radiation therapy.
  
  
  RESULTS
  The median survival was 8.9 months in the radiation-treated patients, as compared with 12.5 months in the patients treated with chemotherapy and radiation therapy. In the former group, the survival rates at 12 and 24 months were 33 percent and 10 percent, respectively, whereas they were 50 percent and 38 percent in the patients receiving combined therapy (P less than 0.001). Seven patients in the radiotherapy group and 25 in the combined-therapy group were alive at the time of the analysis. The patients who received combined treatment had fewer local (P less than 0.02) and fewer distant (P less than 0.01) recurrences. Severe and life-threatening side effects occurred in 44 percent and 20 percent, respectively, of the patients who received combined therapy, as compared with 25 percent and 3 percent of those treated with radiation alone.
  
  
  CONCLUSIONS
  Concurrent therapy with cisplatin and fluorouracil and radiation is superior to radiation therapy alone in patients with localized carcinoma of the esophagus, as measured by control of local tumors, distant metastases, and survival, but at the cost of increased side effects.
authors.affiliation: Radiation Oncology Department, Oakwood Hospital, Dearborn, Mich. 48123.
authors.forename: A
authors.initials: A
authors.lastname: Herskovic
authors.forename: K
authors.initials: K
authors.lastname: Martz
authors.forename: M
authors.initials: M
authors.lastname: al-Sarraf
authors.forename: L
authors.initials: L
authors.lastname: Leichman
authors.forename: J
authors.initials: J
authors.lastname: Brindle
authors.forename: V
authors.initials: V
authors.lastname: Vaitkevicius
authors.forename: J
authors.initials: J
authors.lastname: Cooper
authors.forename: R
authors.initials: R
authors.lastname: Byhardt
authors.forename: L
authors.initials: L
authors.lastname: Davis
authors.forename: B
authors.initials: B
authors.lastname: Emami
mesh_terms: D000230:Adenocarcinoma / Q000628:therapy; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000628:therapy; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000191:economics; D004938:Esophageal Neoplasms / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D011897:Random Allocation; D015996:Survival Rate
chemical_list: D002945:Cisplatin; D005472:Fluorouracil