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The purpose of the study was to assess response rate, clinical outcome, organ/function preservation and toxicity in head and neck cancer patients treated with induction chemotherapy followed by concomitant chemoradiotherapy and, when necessary, limited surgery. The study design was a phase II non-randomized trial in hospitalized patients setting. The treatment plan consisted of 3 cycles of induction chemotherapy with cisplatin, fluorouracil (5-FU), l-leucovorin and interferon alpha2b (PFL-IFN) followed by 7 cycles of 5-FU, hydroxyurea and concomitant radiation for 5 days (FHX) for a total radiation dose of 70 Gy. 13 Cis-retinoic acid was added to treatment regimen for chemoprevention and a systematic prophylaxis of mucositis was administered to all patients during FHX. Conservative surgical resection was reserved to patients with no optimal response (PR > or =70%), whereas radical surgery was performed as salvage treatment. Twenty-six patients were treated at one institution: more than 90% had stage IV disease and only 19.2% had laryngeal cancer. Eighty-one percent of patients had performance status 0 and 23.1% of patients had >5% weight loss at the start of treatment. Nineteen patients were analyzed for response to PFL-IFN: 3/19 (15.8%) patients achieved a CR and 7/19 (36.8%) achieved a PR for an ORR of 52.6%. FHX was administered on protocol to 12 patients: 6 patients (50%) had CR, 1 patient (8.3%) had PR for an ORR of 58.3%, 2 patients (16.7%) had SD and 3 patients (25%) had PD. At the completion of FHX, no patient underwent local therapy according to treatment plan. At a median follow-up time of 13.5 months (range 1-28+) at June 2001, among 26 patients enrolled 12 (46.1%) were still alive and 9 (75%) of them were progression-free. The median duration of response was 9 months (range 0-25+), the median progression-free survival was 10.5 months (range 0-28+), the median overall survival time was 9 months (range 1-22). The toxicity was significant and consisted mainly of mucositis and, to a lesser extent, neutropenia/thrombocytopenia. In the present study, the low serum levels of leptin and the high serum levels of proinflammatory cytokines in advanced stage cancer patients were confirmed. In conclusion, this sequential induction chemotherapy and chemoradiotherapy program has been found moderately active and significantly toxic; moreover, the long overall treatment duration must be taken into consideration. For these reasons, this regimen could not be recommended for a phase III randomized study.