title: Long-term results of a phase III randomized trial of postoperative radiotherapy with or without carboplatin in patients with high-risk head and neck cancer.
abstract: BACKGROUND
  The role of postoperative radiotherapy and carboplatin in squamous cell carcinoma of the head and neck (SCCHN) has not been established.
  
  
  METHODS
  Patients with macroscopically resected stage III/IV SCCHN with high-risk pathologic features (> or =3 lymph nodes, extracapsular extension, perineural or angiolymphatic invasion, or involved margins) were randomized to receive postoperative radiotherapy alone (arm A) or the same radiotherapy plus carboplatin 100 mg/m intravenously once weekly during radiation (arm B). The primary endpoint was 2-year disease-free survival.
  
  
  RESULTS
  Seventy-six patients were randomized, of whom 72 were eligible and analyzable (36 in each arm). The study was prematurely closed because of slow accrual. With a median follow-up of 5.3 years, the disease-free survival at 2 and 5 years was 71% and 53% in arm B versus 58% (P = .27) and 49% (P = .72) in arm A. The overall survival at 2 and 5 years was 74% and 47% in arm B versus 51% (P = .04) and 41% (P = .61) in arm A. Serious toxicities were infrequent in both arms.
  
  
  CONCLUSIONS
  We could not demonstrate a benefit with the addition of carboplatin to postoperative radiotherapy, possibly because of insufficient sample size.
authors: Division of Hematology-Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA 15232, USA. argirisae@upmc.edu
authors: Athanassios
authors: A
authors: Argiris
authors: Michalis V
authors: MV
authors: Karamouzis
authors: Jonas T
authors: JT
authors: Johnson
authors: Dwight E
authors: DE
authors: Heron
authors: Eugene
authors: E
authors: Myers
authors: David
authors: D
authors: Eibling
authors: Elmer
authors: E
authors: Cano
authors: Susan
authors: S
authors: Urba
authors: Jack
authors: J
authors: Gluckman
authors: Jennifer R
authors: JR
authors: Grandis
authors: Yun
authors: Y
authors: Wang
authors: Sanjiv S
authors: SS
authors: Agarwala
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care; D012307:Risk Factors; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin