OBJECTIVE: We undertook a prospective phase II study to assess the feasibility 
and activity of a new induction chemotherapy regimen followed by 
hyperfractionated irradiation in locally advanced squamous cell head and neck 
cancer.
METHODS: 25 patients with locally advanced head and neck cancer were treated 
with 4 cycles of vinorelbine (20 mg i.v. day 1, 3), cisplatin (60 mg/m(2) i.v. 
day 1) and 5-fluorouracil (200 mg/m(2) continuous i.v. infusion day 1-21) (ViFuP 
regimen) followed by bifractionated radiotherapy (bidRT) up to 74.4 Gy in 62 
fractions of 1.2 Gy twice daily.
RESULTS: Chemotherapy was well tolerated, 6 patients developed grade 3 and one 
patient grade 4 neutropenia. Response to chemotherapy was observed in 19 
patients (76%) including three complete responses and 16 partial responses. 
Planned bidRT was completed in 25 patients and all but one received planned 
bidRT dose without interruptions. Radiotherapy was well tolerated, mucositis was 
the most common side effect (grade 3-12 patients, grade 4-1 patient). At 
evaluation after the completion of bidRT, 13 patients had complete response 
(52%), 7 partial response (28%), 2 stable disease and 3 tumor progression. At 
the median follow-up of 18.2 months, 11 patients were alive and free of disease, 
and 14 patients had died (12 of tumor). Late xerostomy was observed in all but 
one 3-month survivors. Late mandibular necrosis was seen in 1 patient.
CONCLUSIONS: bidRT preceded by ViFuP seems a feasible and active combination in 
locally advanced head and neck cancer. Good patient compliance did not 
compromise the delivery of planned dose of bidRT. However, short median duration 
of response (14.6 months) and moderate median overall survival (18.7 months) 
indicate the need for more intensive therapeutic strategies. On the basis of 
these results, modifications of our treatment schedule (shortening the overall 
treatment time by reduction of chemotherapy cycles and the use of chemotherapy 
concomitantly with irradiation) are planned for the future study.