A randomized EORTC study on the effect of preoperative polychemotherapy in pyriform sinus carcinoma treated by pharyngolaryngectomy and irradiation. Results from 5 to 10 years.

226 patients with an operable epidermoid carcinoma of the pyriform sinus were entered in this clinical trial; 187 cases were considered evaluable, they were distributed as follows: 16 T2, 171 T3, 44 N0, 103 N1 and 40 N3 (UICC TNM Classification 1979). The 89 patients of the chemotherapy group received a 3 day course of Vincristine (1.5 mg/m2), Bleomycin (15 mg), Methotrexate (80 mg). Both the chemotherapy group and the 98 patients of the control group went through the surgical procedure of total laryngectomy with pharyngectomy and radical neck dissection. Radiotherapy was administered postoperatively according to tumor margins and nodal involvement. On examination of the surgical specimen, no evidence of tumor regression was observed in the chemotherapy group. The 3 and 5 year survivals are respectively 45% and 35% in both groups. Node metastasis was studied after N size, N status, capsular rupture (PR +) and revealed early and extensive nodal involvement with 25% capsular ruptures in N0 patients, up to 70% rate in N3. Capsular rupture is also associated with a significantly lower survival and a higher incidence of distant metastases.

RCT Entities:   Population Interventions Outcomes