Long‐Term Results of a Phase II Trial of Induction Chemotherapy with Uracil‐Ftegafur (UFT), Vinorelbine, and Cisplatin (UFTVP) followed by Radiotherapy Concomitant with UFT and Carboplatin (RT/UFTJ) in a Primary Site Preservation Setting for Resectable Locally Advanced Squamous Cell Carcinoma of Larynx and Hypopharynx

Objective: We present long-term results of a phase II trial of induction chemotherapy (IC) with uracilftegafur (UFT) 200 mg/m2 orally days 1 to 21, vinorelbine 25 mg/m2 intravenously (IV) days 1 and 8, and cisplatin 100 mg/m2 IV day 1 (UFTVP) each for 21 days for 4 courses, followed by radiotherapy concomitant with UFT 100 mg/m2 orally daily and carboplatin (area under the curve [AUC] = 0.5 IV weekly) (RT/ UFTJ), without surgery to the primary site if response, in patients (pts) with resectable locally advanced squamous cell carcinoma of the larynx and hypopharynx. The primary endpoint was clinical complete response (CR) to induction UFTVP, and secondary endpoints were long-term overall survival (OS) and survival with primary site preservation (SPP). Results: Between 1994 and 1997, 37 pts were included. CR to IC was 54% (95% confidence interval [CI] 43–65%). Main toxicity of UFTVP was G 3,4 neutropenia (73% of pts, 16% developed febrile neutropenia). After IC, primary site was treated with RT in 29 pts: 20 of them received RT/UFTJ (main toxicity mucositis G 3,4 70%). No pt died during treatment. Actuarial 5-year OS and SPP were 57% and 37%, respectively. Conclusions: This approach has significant activity and acceptable toxicity for achieving promising long-term OS and SPP and deserves further investigation.