PHASE-II STUDY OF CARBOPLATIN AND CONTINUOUS-INFUSION BLEOMYCIN FOLLOWED BY CISPLATIN AND 5-FLUOROURACIL IN RECURRENT HEAD AND NECK-CANCER

Background: Recurrent squamous cell carcinoma of the head and neck is poorly responsive to most chemotherapy regimens. Carboplatin and bleom ycin are effective single agents with non-overlapping toxicity; theref ore, we sought to explore the efficacy of this regimen in a phase II s tudy. In the second stage of the study, patients who did not respond t o carboplatin and bleomycin were given treatment with cisplatin and 5- fluorouracil (5-FU). Patients and methods: Patients with recurrent squ amous cell carcinoma of the head and neck were treated with carboplati n 400 mg/m(2) followed by bleomycin 15 units intravenously as a contin uous infusion for 4 days. Patients with no tumor response after 3 cycl es of carboplatin and bleomycin were crossed-over to receive cisplatin 100 mg/m(2) and 5-FU 1000 mg/m(2)/day continuous infusion for 5 days. Results: Among the 20 carboplatin-bleomycin patients evaluable for to xicity, no cases of grade 4 granulocytopenia were reported and grade 3 or 4 thrombocytopenia developed in only three patients. Three partial responses occurred among the 19 patients (16%) [95% C.I. 0% to 32%] e valuable for response to carboplatin-bleomycin. None of the II patient s crossed-over to cisplatin and 5-FU had a major response. Conclusion: The combination of carboplatin and bleomycin is well tolerated in pat ients with recurrent head and neck cancer, but the activity does not a ppear to be superior to the activity of either agent alone. Patients w ho did not respond to carboplatin and bleomycin were also resistant to the cisplatin and 5-FU regimen.