Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up.
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.
Zorat
Pier Luigi
PL
Radiotherapy Department, Ospedale Ca' Foncello, Treviso, Italy.
Paccagnella
Adriano
A
Cavaniglia
Giancarlo
G
Loreggian
Lucio
L
Gava
Alessandro
A
Mione
Carlo Alberto
CA
Boldrin
Fanny
F
Marchiori
Carlo
C
Lunghi
Francesco
F
Fede
Antonella
A
Bordin
Alessandro
A
Da Mosto
Maria Cristina
MC
Sileni
Vanna Chiarion
VC
Orlando
Antonio
A
Jirillo
Antonio
A
Tomio
Luigi
L
Pappagallo
Giovanni Luigi
GL
Ghi
Maria Grazia
MG
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