title: Efficacy and toxicity of nedaplatin and 5-FU with radiation treatment for advanced esophageal carcinomas.
abstract: BACKGROUND
  Nedaplatin, a new analog of cisplatin, has been developed and marketed in recent years in Japan. In this study, we evaluated the efficacy and toxicity of a regimen of nedaplatin and 5-FU with radiation in patients with advanced esophageal carcinomas.
  
  
  METHODS
  Between June 1999 and December 2002, 42 patients with advanced and unresectable thoracic esophageal squamous cell carcinomas (SCCs) were enrolled into this study. Twenty-five of these 42 patients were considered to have inoperable tumors due to distant organ metastasis, distant lymph node metastasis, severe organ dysfunction and rejection of surgery by the patients. The remaining 17 patients received neoadjuvant treatment followed by surgery. The clinical responses of the primary tumors were evaluated.
  
  
  RESULTS
  Response and toxicity could be assessed in 22 of the 25 patients with unresectable esophageal SCCs. Two of these 22 achieved a complete response (CR), 15 had a partial response (PR) and 5 showed no change (NC). The overall response rate (CR + PR) was 77%. The one- and 2-year survival rates were 30.7% and 10.2%, respectively, with a median survival time (MST) of 10.1 months. Of the 17 patients who received neoadjuvant treatment, 14 underwent subsequent surgery. Preoperatively, 2 of these 17 patients achieved a CR, 10 had a PR and 5 showed NC. The overall response rate for all 39 patients was 74%. The pathological complete response (pCR) rate of the 14 patients who underwent surgery was 28.6%. Their one- and 2-year survival rates were 48.2% and 12.1%, respectively, with an MST of 12.2 months. Toxicity was evaluated in the 39 patients whose responses were assessed. Toxicity higher than grade 3 occurred in 8 out of 39 (20.5%) patients, and 6 (15.4%), 3 (7.7%) and one (2.6%) had grade 3 leukopenia, thrombocytopenia and anemia, respectively.
  
  
  CONCLUSIONS
  In conclusion, this study indicates that combination chemoradiotherapy with nedaplatin and 5-FU is safe and efficacious for patients with advanced esophageal carcinomas. We recommend further evaluation of this treatment regimen in such patients.
authors.affiliation: Department of Surgery I, Gunma University Faculty of Medicine, 3-39-22, Showamachi, Maebashi, Gunma, 371-8511, Japan. hiroyuki@po.wind.ne.jp
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kato
authors.forename: Minoru
authors.initials: M
authors.lastname: Fukuchi
authors.forename: Ryokuhei
authors.initials: R
authors.lastname: Manda
authors.forename: Masanobu
authors.initials: M
authors.lastname: Nakajima
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Miyazaki
authors.forename: Makoto
authors.initials: M
authors.lastname: Sohda
authors.forename: Norihiro
authors.initials: N
authors.lastname: Masuda
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Fukai
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Tsukada
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kuwano
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds; C053989:nedaplatin; D005472:Fluorouracil