VINORELBINE PLUS CISPLATIN IN RECURRENT OR PREVIOUSLY UNTREATED UNRESECTABLE SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK

Despite considerable progress achieved in the management of head and n eck carcinomas (HNC) in the last decade, the prognosis of patients wit h advanced squamous cell HNC is still dismal. On the basis of the repo rted good activity of a new vinca alkaloid derivative, i.e., vinorelbi ne (VNR), we tested the combination of cisplatin and VNR in a series o f patients with recurrent or previously untreated unresectable squamou s cell HNC. Thirty-five patients with recurrent or previously untreate d unresectable squamous cell HNC were treated with a combination of ci splatin 80 mg/m(2) on day 1, plus vinorelbine 25 mg/m(2) i.v. push on days 1 and 8. This cycle was repeated every 3 weeks. Analysis of respo nse rates was carried out separately for previously untreated patients , and those with recurrent disease after surgery and/or radiotherapy. In the group of 20 patients with recurrent disease the overall respons e rate was 55% (95% CL 44-66%), with 3 patients (15%) showing a comple te response with a mean duration of 6.2+ months and 8 patients showing a partial response with a mean duration of 8.6+ months. In the group of patients with previously untreated unresectable disease, 13 patient s (87%, 95% CL 78-96%) had a major objective response with a complete response rate of 27%. This regimen was quite well tolerated, with meye losuppresion and vomiting being the most frequent toxicities. The occu rrence of an acute pain syndrome following vinorelbine administration in 4 patients is noteworthy. In conclusion, this combination is active in advanced squamous cell head and neck carcinoma. However, although it may be reccomended in recurrent carcinoma, the complete response ra te achieved in previously untreated patients is lower than that report ed with other more intensive regimens.