title: Radiotherapy alone or with concomitant daily low-dose carboplatin in locally advanced, unresectable head and neck cancer: definitive results of a phase III study with a follow-up period of up to ten years.
abstract: OBJECTIVE
  Radiotherapy is the conventional treatment for locally advanced inoperable head and neck squamous cell carcinoma. However, the poor therapeutic results justify the development of radiochemotherapy combinations. In an attempt to improve local control and survival in patients with stage III and IV unresectable head and neck squamous cell carcinoma and based on the results of our previous dose escalation study, we undertook a prospective multicentric randomized trial.
  
  
  METHODS
  From November 1992 through December 1995, a total of 164 patients were randomized to receive radiotherapy alone (arm I) or combined (arm II) with daily low-dose carboplatin.
  
  
  RESULTS
  The 3, 5 and 10-year local-regional recurrence-free survival rates were better in arm II (21.7%, 15.1% and 15.1%, respectively) than in arm I (15%, 10.7% and 10.7%), but without statistical significance (P = 0.11). The 3, 5 and 10-year disease-free survival rates showed the same positive trend for arm II (16%, 6.8% and 6.8% vs. 9%, 5.5% and 5.5%, in arm I, respectively), again without statistical significance (P = 0.09). Instead, a statistical advantage was found in overall survival rates at 3, 5 and 10-years (28.9%, 9% and 5.5% in arm II and 11.1%, 6.9% and 6.9% in arm I, respectively) (P = 0.02). The 3, 5 and 10-year local-regional recurrence-free survival rates in stage IV disease were statistically better in arm II (21.5%, 15.9% and 15.9%) than in arm I (12.8%, 7.7% and 7.7%, respectively) (P = 0.04).
  
  
  CONCLUSIONS
  Long-term results in both treatment arms of the trial appear less positive than most published series. However, our findings do not exclude that carboplatin may be beneficial, but the benefit in local control must be lower than the 15% assumed to dimension the trial.
authors.affiliation: Radiation Oncology Unit of University of Turin, Ospedale S Luigi Gonzaga, Orbassano, Italy. mariagrazia.ruoredda@unito.it
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Ruo Redda
authors.forename: Riccardo
authors.initials: R
authors.lastname: Ragona
authors.forename: Umberto
authors.initials: U
authors.lastname: Ricardi
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Beltramo
authors.forename: Monica
authors.initials: M
authors.lastname: Rampino
authors.forename: Pietro
authors.initials: P
authors.lastname: Gabriele
authors.forename: Simona
authors.initials: S
authors.lastname: Allis
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: La Porta
authors.forename: Gregorio
authors.initials: G
authors.lastname: Moro
authors.forename: Antonella
authors.initials: A
authors.lastname: Melano
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Gabriele
authors.forename: Mariella
authors.initials: M
authors.lastname: Tessa
authors.forename: Piero
authors.initials: P
authors.lastname: Fossati
authors.forename: Roberto
authors.initials: R
authors.lastname: Orecchia
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin