MODULATION OF CISPLATIN ANTITUMOR-ACTIVITY BY SHORT INFUSIONAL HIGH-DOSE CYTOSINE-ARABINOSIDE IN ADVANCED PRETREATED HEAD AND NECK-CARCINOMA - A PHASE-II STUDY

The aim of the present study, which included 24 pretreated patients (b oth with radiotherapy and/or cisplatin-containing chemotherapy) with h istological grade I/II head and neck cancer, was to investigate whethe r the enhancing action of cytosine arabinoside on cisplatin antinumor activity might be evidenced without excessive hematological toxicity w ith the administration of short infusional high-dose cytosine arabinos ide, applied before cisplatin. Cytosine arabinoside was administered o n day 1 of the treatment cycle at 0h and 12h at the dosage of 500 mg/m (2) (1 hour infusion), and cisplatin at 6h and 18h of the same day wit h a dose of 20 mg/m(2). On days 2, 3 and 4, only cisplatin 30 mg/m(2)/ 24h was administered. 19 patients were evaluable for activity includin g 14 patients pretreated with cisplatin-containing chemotherapy. 2/19 achieved complete response (CR), 2/19 a partial response (PR), 8/19 ha d stable disease and 7/19 progressive disease. Objective responses (2 CR and 1 PR) were evidenced in 3/14 patients previously resistant to c isplatin at the same dosage as in the present regimen. WHO grade IV to xicity for granulocytes was recorded in only one patient.