Patients with head and neck cancer represent 11% of the malignant tumours diagnosed in French males (Ménégoz et al, 1998). While most small tumours can be cured, a majority of the tumours are advanced and despite progress in surgery and radiotherapy, the prognosis remains poor. In the past years, systemic chemotherapy has been used in an attempt to improve the results of loco-regional treatment. Clinical trials have shown a high response rate with a combination of Cisplatinum (CDDP) and 5 Fluoro-Uracil (5FU) in head and neck carcinoma sites (Decker et al, 1983;Weaver et al, 1985;Calais et al, 1988).In 1986, we decided to investigate the efficiency of neoadjuvant chemotherapy in a single tumour site: the oropharynx with survival as the main study end-point, and event-free survival as a secondary endpoint.
MATERIALS AND METHODSAll patients with a biopsy-proven squamous cell carcinoma of all sites of the oropharynx except for the posterior wall and the anterior surface of epiglottis, classified as T2 to T4, N 0 to N 2b , and M 0 (UICC-AJC, 1986) were eligible if curative treatment, either radiotherapy or surgery, was considered feasible. Patients older than 69, younger than 18 or in whom chemotherapy was contraindicated, or who had previously been treated, or with multiple tumours were excluded. Patients were randomized by telephone to receive either neoadjuvant chemotherapy or no chemotherapy. Randomization was stratified on the centre and on the local treatment which was either surgery followed or not by radiotherapy, or radiotherapy alone.The treatment planned consisted, in the study arm, of 3 chemotherapy cycles followed, if possible, by surgery and systematic radiotherapy, or if surgery was impossible by radiotherapy alone. Post-randomization consent was obtained from each patient in accordance with the law in use in France at the time of the trial.A total of 318 patients treated in 6 centres were included in the trial between 1986 and 1992.
ChemotherapyChemotherapy consisted of Cisplatin (100 mg/m 2 ) given in a 1-hour i.v. infusion on day 1 followed by a 24-hour i.v. infusion of fluorouracil (1000 mg/m 2 /day) for 5 days. This treatment was repeated on day 22 unless tumour progression exceeded 25%, and repeated on day 43 only if tumour regression had been observed. 2-3 weeks after the end of chemotherapy, local treatment (surgery and/or radiotherapy) was performed.
SurgeryThe operative procedure in both groups consisted of a commando procedure i.e. oropharyngeal composite resection with segmental Summary 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 locoregional treatment without chemotherapy. The loco-regional treatment consisted either of surgery plus radiotherapy or...
