title: Randomized trial of neoadjuvant chemotherapy in oropharyngeal carcinoma. French Groupe d'Etude des Tumeurs de la Tête et du Cou (GETTEC).
abstract: The objective of the study was to evaluate the effect of neoadjuvant chemotherapy on the survival of patients with oropharyngeal cancer. Patients with a squamous cell carcinoma of the oropharynx for whom curative radiotherapy or surgery was considered feasible were entered in a multicentric randomized trial comparing neoadjuvant chemotherapy followed by loco-regional treatment to the same loco-regional treatment without chemotherapy. The loco-regional treatment consisted either of surgery plus plus radiotherapy or of radiotherapy alone. Three cycles of chemotherapy consisting of Cisplatin (100 mg/m2) on day 1 followed by a 24-hour i.v. infusion of fluorouracil (1000 mg/m2/day) for 5 days were delivered every 21 days. 2-3 weeks after the end of chemotherapy, local treatment was performed. The trial was conducted by the Groupe d'Etude des Tumeurs de la Tête Et du Cou (GETTEC). A total of 318 patients were enrolled in the study between 1986 and 1992. Overall survival was significantly better (P = 0.03) in the neoadjuvant chemotherapy group than in the control group, with a median survival of 5.1 years versus 3.3 years in the no chemotherapy group. The effect of neoadjuvant chemotherapy on event-free survival was smaller and of borderline significance (P = 0.11). Stratification of the results on the type of local treatment, surgery plus radiotherapy or radiotherapy alone, did not reveal any heterogeneity in the effect of chemotherapy.
authors.affiliation: Département de chirurgie cervico-faciale, Institut Gustave Roussy, Villlejuif, France.
authors.forename: C
authors.initials: C
authors.lastname: Domenge
authors.forename: C
authors.initials: C
authors.lastname: Hill
authors.forename: J L
authors.initials: JL
authors.lastname: Lefebvre
authors.forename: D
authors.initials: D
authors.lastname: De Raucourt
authors.forename: B
authors.initials: B
authors.lastname: Rhein
authors.forename: P
authors.initials: P
authors.lastname: Wibault
authors.forename: P
authors.initials: P
authors.lastname: Marandas
authors.forename: B
authors.initials: B
authors.lastname: Coche-Dequeant
authors.forename: M
authors.initials: M
authors.lastname: Stromboni-Luboinski
authors.forename: H
authors.initials: H
authors.lastname: Sancho-Garnier
authors.forename: B
authors.initials: B
authors.lastname: Luboinski
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D020360:Neoadjuvant Therapy; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D016016:Proportional Hazards Models; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D002945:Cisplatin; D005472:Fluorouracil