REIRRADIATION OF SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK COMBINED WITH PACLITAXEL TWICE A WEEK - RESULTS OF A PHASE-I II STUDY/

Purpose: To define the maximum tolerated dose (MTD) and the dose-limit ing toxicity (DLT) of paclitaxel using a twice-a-week schedule concurr ent with a reirradiation in the head and neck region. Patients and Met hods: Nineteen patients with histologically proven relapsed squamous c ell carcinoma of the head and neck were enrolled. Twelve of them were pretreated with surgery and adjuvant irradiation or radio-chemotherapy , 6 patients had undergone definitive radio-chemotherapy, 1 definitive irradiation alone. In 15 cases the recurrent carcinoma were unresecta ble and 4 patients had a R1 status after salvage-surgery. Radiotherapy doses in the first line treatment ranged between 56 and 96.9 Cry (mea n 67 Cry). Paclitaxel was given concurrently to the reirradiation twic e a week as a 2-h-infusion. The chemotherapy dose was escalated in coh orts of 3 patients in 6 steps (20/30/35/40/45/50 mg/m(2), each 8 singl e doses). Depending on prior radiotherapy the patients were irradiated after 3D-planning with a conventional fractionation regime (2.0 Gy to 30 to 46 Gy). Results: Eighteen patients completed the protocol. The MTD was reached at the dose level VI (50 mg/m(2)). The dose limiting t oxicity was a mucositis III degrees CTC in the irradiated area for mor e than 7 days. All further side effects were below grade III CTC. The response rate of the 15 measurable tumors was 80% (1x CR, 9x PR, 2x NC ). Conclusion: With the described schedule is in adequately monitored patients an outpatient setting possible. The results justify a phase-I I study to evaluate the response rates.