title: Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up.
abstract: In 1986, we initiated a multicenter, randomized trial to compare induction chemotherapy with cisplatin and 5-fluorouracil followed by locoregional treatment (surgery and radiotherapy or radiotherapy alone) with locoregional treatment alone in patients with head and neck squamous cell carcinoma. Here we report the long-term results of the trial. A total of 237 patients with nonmetastatic stage III or IV head and neck carcinoma were randomly assigned to receive four cycles of neoadjuvant chemotherapy followed by locoregional treatment (group A) or locoregional treatment alone (group B). Among all patients, overall survival at 5 and 10 years was 23% (95% confidence interval [CI] = 15.3% to 30.9%) and 19% (95% CI = 11.6% to 26.4%), respectively, for those in group A and 16% (95% CI = 9.6% to 23.4%) and 9% (95% CI = 3.5% to 14.7%), respectively, for those in group B (P = .13). Among operable patients, we observed no difference between group A and group B in overall survival at 5 and 10 years (group A, 31% [95% CI = 14.9% to 47.3%] and 22.7% [95% CI = 7.1% to 38.3%], respectively; group B, 43.3% [95% CI = 25.6% to 61.0%] and 14.2% [95% CI = 0.1% to 28.3%], respectively; P = .73). Among inoperable patients, overall survival at 5 and 10 years was 21% (95% CI = 12.3% to 30.1%) and 16% (95% CI = 7.7% to 23.9%), respectively, for group A and 8% (95% CI = 1.5% to 12.3%) and 6% (95% CI = 0.1% to 9.1%), respectively, for group B (log-rank P = .04). Four cycles of neoadjuvant chemotherapy is a promising approach for treating patients with inoperable advanced head and neck cancer but not for treating patients with operable disease.
authors.affiliation: Radiotherapy Department, Ospedale Ca' Foncello, Treviso, Italy.
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Zorat
authors.forename: Adriano
authors.initials: A
authors.lastname: Paccagnella
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Cavaniglia
authors.forename: Lucio
authors.initials: L
authors.lastname: Loreggian
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gava
authors.forename: Carlo Alberto
authors.initials: CA
authors.lastname: Mione
authors.forename: Fanny
authors.initials: F
authors.lastname: Boldrin
authors.forename: Carlo
authors.initials: C
authors.lastname: Marchiori
authors.forename: Francesco
authors.initials: F
authors.lastname: Lunghi
authors.forename: Antonella
authors.initials: A
authors.lastname: Fede
authors.forename: Alessandro
authors.initials: A
authors.lastname: Bordin
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Da Mosto
authors.forename: Vanna Chiarion
authors.initials: VC
authors.lastname: Sileni
authors.forename: Antonio
authors.initials: A
authors.lastname: Orlando
authors.forename: Antonio
authors.initials: A
authors.lastname: Jirillo
authors.forename: Luigi
authors.initials: L
authors.lastname: Tomio
authors.forename: Giovanni Luigi
authors.initials: GL
authors.lastname: Pappagallo
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Ghi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D020360:Neoadjuvant Therapy / Q000379:methods*; D009367:Neoplasm Staging; D016017:Odds Ratio; D018714:Radiotherapy, Adjuvant; D012074:Remission Induction; D016019:Survival Analysis; D016896:Treatment Outcome