A PHASE-II STUDY OF PIRARUBICIN IN PATIENTS WITH ADVANCED RECURRENT HEAD AND NECK SQUAMOUS-CELL CARCINOMA

Background: Head and neck squamous carcinoma (HNSCC) is a chemotherapy -sensitive tumour, but this sensitivity is not reflected in an impact on survival. The study of new drugs is therefore indicated. Pirarubici n (4'-O-tetrahydropyranyl-doxorubicin) has a higher preclinical index than doxorubicin, with low cardiotoxicity in animal models. Patients a nd methods: Twenty-six patients with squamous cell carcinoma of the he ad and neck and documented progression after or during previous chemot herapy were entered into the study. Two patients were ineligible for e valuation. Pirarubicin was given at a dose of 70 mg/m(2) every 3 weeks . Results: Partial remission was seen in 1 of the 24 evaluable patient s. The predominant toxicity was bone marrow depression, with leucopeni a in 62% of the patients. One patient died due to a gastrointestinal h aemorrhage during a period with WHO grade IV thrombocytopenia. Conclus ion: On the basis of these results, pirarubicin cannot be recommended as second-line treatment in patients with recurrent and metastatic HNS CC. Its possible relevance for first-line treatment cannot be judged f rom these data.