HIGH RESPONSE RATES FOLLOWING PACLITAXEL 5-FU AND SIMULTANEOUS RADIOTHERAPY IN ADVANCED HEAD AND NECK-CARCINOMA/

The main stay of treatment fur head and neck cancer patients with adva nced disease has been chemotherapy with Cisplatin/5-FU and simultaneou s applied radiotherapy, With this multimodality treatment including ra dical surgery after two cycles of neoadjuvant chemotherapy and 40 Cy r adiotherapy we reported 60% complete omission after 5 years for patien ts with stage III/IV of head and neck cancer. Paclitaxel, a new plant product, has demonstrated significant antineoplastic activity in head and neck tumors (ECOG-Study: 40% RR). Therefore we performed a trial w ith Taxol/5-FU and simultaneous radiation in an neoadjuvant and postop erative adjuvant setting of stage III/V squamous cell carcinoma of the head and neck with pre-existent contraindication against Cisplatin. P atients and Methods: 30 patients with a primarily inoperable stage III /IV of SCC of the head and neck were enrolled to receive day 1 and 29 Taxol 175 mg/m(2) as a 3-hour-infusion, followed by 120-hour-cvi of 10 00 mg/m(2)/d 5-FU. Locally irradiation was given ad 40 Gy (2. Gy/d/day 1-26). Radical surgery followed about day 56. Postoperatively patient s received again 2 cycles of Taxol/5-FU and simultaneous irradiation w ith 30 Cy. Results: So far 30 patients were treated and all patients r eached a CR after complete treatment, ongoing for 23/30 patients for 6 till 34 months: 1 patients developed a second neoplasia. and 3 patien ts gloved a local relapse. The principal toxicity was moderate (neutro penia, peripheral neuropathy, arthralgia/myalgia) and sensible with su pportive care (e. g. PEG). Conclusions: The results suggest that the t reatment of SCC of the head and neck with Taxol/5-FU and simultaneous radiation and radical surgery is a highly effective schedule and compa rable with the treatment with Cisplatin/5-FU.