Phase-II-Studie mit Pirarubicin bei vorbehandelten progredienten Kopf-Hals-Malignomen

Abstract

Sixteen heavily pretreated patients (pts) (4 surgery + chemotherapie + radiotherapy; 4 chemotherapy + radiotherapy: 6 surgery + radiotherapy; 2 chemotherapy) and one previously untreated patient, who refused surgery and or radiotherapy, all with progressive disease, with advanced squamous cell carcinoma of the head and neck were included in a phase II study with pirarubicin 60 mg/m2 i.v. day 1 every 3-4 weeks (CT). All pts received at least one course of CT. 15 pts were evaluable for response, all 17 pts were evaluable for toxicity. Female (male ratio 1/16; mean age 56 (42-68) yrs, mean performance status 70% (50-70). Seventeen pts received a mean of 3 (1-8) courses, 2 pts had received only one course of CT. Response and toxicity were assessed according to WHO classification. Results after 1-8 courses of CT: 1 (7%) complete remission; 1 (7%) partial remission; 9 (60%) no change; 4 (26%) progressive disease. No toxicity of grade IV was observed. Mean duration of remission 16 weeks. Median survival time 7 (1-10) months. 9 pts died and 8 pts are alive; six of them had progressive disease.