Combined radiochemotherapy with docetaxel in patients with unresectable locally advanced head and neck tumors

Background: As the treatment with Docetaxel in metastatic head and neck can cer resulted in an encouraging response rate, the following phase-I study e xamined the effects of a combined radiochemotherapy with weekly Docetaxel i n patients with inoperable advanced head and neck tumors. Patients and Methods: Six patients with Stage IV head and neck cancer were included into the study. Within the treatment regimen the primary tumor and the involved lymph nodes were irradiated up to a total dose of 70 Gy, the non involved cervical and supraclavicular lymph nodes received 50 Gy in con ventional fractionation. Simultaneously Docetaxel was given 1 hour before r adiotherapy. The initial dose was 15 mg/m(2). Results: A dose escalation was impossible because of several dose limiting toxicities (NCI-CTC) already in the first dose level. Two patients showed s kin reactions Grade 4, 2 patients pulmonary complications Grade 4, 2 patien ts neurologic side effects Grade 3 and 1 a thrombocytopenia Grade 3. The re sponse rate resulted in 3 complete and 1 partial remission, I death, 1 pati ent was not evaluable. Conclusion: Unexpectedly already in the first dose level several dose limit ing toxicities were evaluated. For that reason the treatment scheme is not feasible.