title: Concomitant cisplatin and hyperfractionated radiotherapy in locally advanced head and neck cancer: 10-year follow-up of a randomized phase III trial (SAKK 10/94).
abstract: OBJECTIVE
  To compare the long-term outcome of treatment with concomitant cisplatin and hyperfractionated radiotherapy versus treatment with hyperfractionated radiotherapy alone in patients with locally advanced head and neck cancer.
  
  
  METHODS
  From July 1994 to July 2000, a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to receive either hyperfractionated radiotherapy alone (median total dose, 74.4 Gy; 1.2 Gy twice daily; 5 days per week) or the same radiotherapy combined with two cycles of cisplatin (20 mg/m(2) for 5 consecutive days during weeks 1 and 5). The primary endpoint was the time to any treatment failure; secondary endpoints were locoregional failure, metastatic failure, overall survival, and late toxicity assessed according to Radiation Therapy Oncology Group criteria.
  
  
  RESULTS
  Median follow-up was 9.5 years (range, 0.1-15.4 years). Median time to any treatment failure was not significantly different between treatment arms (hazard ratio [HR], 1.2 [95% confidence interval {CI}, 0.9-1.7; p = 0.17]). Rates of locoregional failure-free survival (HR, 1.5 [95% CI, 1.1-2.1; p = 0.02]), distant metastasis-free survival (HR, 1.6 [95% CI, 1.1-2.5; p = 0.02]), and cancer-specific survival (HR, 1.6 [95% CI, 1.0-2.5; p = 0.03]) were significantly improved in the combined-treatment arm, with no difference in major late toxicity between treatment arms. However, overall survival was not significantly different (HR, 1.3 [95% CI, 0.9-1.8; p = 0.11]).
  
  
  CONCLUSIONS
  After long-term follow-up, combined-treatment with cisplatin and hyperfractionated radiotherapy maintained improved rates of locoregional control, distant metastasis-free survival, and cancer-specific survival compared to that of hyperfractionated radiotherapy alone, with no difference in major late toxicity.
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital, and University of Bern, Switzerland, 3010 Bern, Switzerland. pirus.ghadjar@insel.ch
authors.forename: Pirus
authors.initials: P
authors.lastname: Ghadjar
authors.forename: Mathew
authors.initials: M
authors.lastname: Simcock
authors.forename: Gabriela
authors.initials: G
authors.lastname: Studer
authors.forename: Abdelkarim S
authors.initials: AS
authors.lastname: Allal
authors.forename: Mahmut
authors.initials: M
authors.lastname: Ozsahin
authors.forename: Jacques
authors.initials: J
authors.lastname: Bernier
authors.forename: Michael
authors.initials: M
authors.lastname: Töpfer
authors.forename: Frank
authors.initials: F
authors.lastname: Zimmermann
authors.forename: Michael
authors.initials: M
authors.lastname: Betz
authors.forename: Christoph
authors.initials: C
authors.lastname: Glanzmann
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Aebersold
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000556:secondary; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods; D016001:Confidence Intervals; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016609:Neoplasms, Second Primary / Q000473:pathology; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000379:methods; D017211:Treatment Failure
chemical_list: D011838:Radiation-Sensitizing Agents; D002945:Cisplatin