RANDOMIZED PHASE-II STUDY OF METHOTREXATE (MTX) VERSUS METHOTREXATE PLUS LONIDAMINE (MTX+LND) IN RECURRENT AND OR METASTATIC CARCINOMA OF THE HEAD AND NECK/

Between March 1990 and March 1992, 89 patients with recurrent and/or m etastatic squamous cell cancer of the head and neck were randomised to receive either intravenous methotrexate (MTX) at a weekly dose of 40 mg/m(2) plus lonidamine (LND) given orally at a starting dose of 75 mg three times daily for 3 days and then at a dose of 150 mg three times daily (arm MTX+LND) or methotrexate alone (arm MTX) at the same doses as arm MTX+LND. Complete remissions were observed in 10.5% of the pat ients in arm MTX+LND, and partial remissions in another 15.8%, yieldin g a 26.3% response rate. In arm MTX, only partial remissions were obse rved, yielding an overall response rate of 18.2%. Haematological toxic ity was mild in both groups. Mild testicular pain (21%) and myalgias ( 31%) occurred only in patients treated with LND.