NEOADJUVANT CHEMOTHERAPY WITH CISPLATIN-VINDESINE-5-FLUOSOURACIL AND FOLINIC ACID FOR LOCALLY ADVANCED HEAD AND NECK-CARCINOMA

The aim of this study was to establish the feasibility, evaluate the r esponse rate, and assess the impact on local control and survival in l ocally advanced (bulky nodal) squamous cell carcinoma of the head and neck (SCCHN) patients treated with neoadjuvant chemotherapy consisting of cisplatin Followed by continuous infusion of vindesine and fluorou racil with intermittent i.v. folinic acid. Eligibility criteria includ ed histologically proven SCCHN, previously untreated locally advanced stage III-IV with measurable or evaluable disease, no distant metastas es, an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2, patient age of at least 18 years, and adequate bone marr ow, hepatic, and renal functions. The protocol consisted of three cycl es (day 1, day 21, day 42) of Cisplatin (CDDP) 100 mg/m(2)/day i.v. on day immediately followed by 4 days (96 h) of continuous infusion of v indesine 0.8 mg/m(2)/day and 5-fluorouracil (5-FU) 600-700 mg/m(2)/day with folinic acid 150 mg/m(2) i.v. every 6 h x 16 doses before locore gional treatment with radiotherapy preceded by radical surgery when ap propriate. Twenty-nine patients were enrolled in this study, and 28 we re evaluable For activity; an objective response rate of 55% (four com plete responses, 12 partial responses) was achieved. Leukopenia and mu cositis were the most frequent and severe toxicities. The addition of vindesine did not improve the activity of the CDDP-FU-folinic acid com bination, but this may be partly because of the particularly poor prog nosis of the present patient population, with 75% of stage IV bulky no dal disease (N2c-N3).