title: Randomized phase II trial of concomitant chemoradiotherapy using weekly carboplatin or daily low-dose cisplatin for squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  This randomized, phase II study aimed to compare concomitant chemoradiotherapy using weekly carboplatin or daily low-dose cisplatin as a treatment for squamous cell carcinoma of the head and neck.
  
  
  METHODS
  One hundred nineteen patients with moderate- to advanced-stage disease were eligible for the study. Fifty-three patients had stage II disease, 28 had stage III, and the remaining 38 had stage IV disease. Primary tumor sites included the larynx (N = 63), oropharynx (N = 30), hypopharynx (N = 23), and oral cavity (N = 3). Each patient received either a weekly carboplatin dose (100 mg/m(2)) in one arm or daily cisplatin (4 mg/m(2)) in the other arm for the initial 4 weeks of radiotherapy. The radiotherapy dose of 65 Gy was given in 26 fractions over 45 days, dependent on a good tumor response at 40 Gy. For ty-nine (81.7%) of 60 patients treated with carboplatin and 41 (69.5%) of 59 patients treated with cisplatin received the full dose of radiotherapy. Surgical-resection was optionally used for the remaining patients.
  
  
  RESULTS
  The median follow-up time was 63 months. The local control rate at 5 years was 56.2% for the carboplatin-treated arm and 35.5% for the cisplatin-treated arm, respectively. The 5-year overall survival rate did not significantly differ between treatments: 71.4% for carboplatin and 66.0% for cisplatin. Hematologic toxicity was more frequent in the carboplatin-treated arm. No difference was observed in surgical complications or in radiation-related adverse effects.
  
  
  CONCLUSIONS
  These findings suggest that weekly carboplatin treatment is preferable to daily low-dose cisplatin. This could be because the total dose of cisplatin was too low to be effective.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Kita 15, Nishi 7, Kitaku, Sapporo 060-8638, Japan. ak-homma@med.hokudai.ac.jp
authors.forename: Akihiro
authors.initials: A
authors.lastname: Homma
authors.forename: Hiroki
authors.initials: H
authors.lastname: Shirato
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Furuta
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nishioka
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Oridate
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Tsuchiya
authors.forename: Tatsumi
authors.initials: T
authors.lastname: Nagahashi
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Aoyama
authors.forename: Yukio
authors.initials: Y
authors.lastname: Inuyama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Fukuda
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D011879:Radiotherapy Dosage; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin; D002945:Cisplatin