Randomised 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 metastatic squamous cell cancer of the head and neck were randomised to receive either intravenous methotrexate (MTX) at a weekly dose of 40 mg/m2 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 patients in arm MTX + LND, and partial remissions in another 15.8%, yielding a 26.3% response rate. In arm MTX, only partial remissions were observed, yielding an overall response rate of 18.2%. Haematological toxicity was mild in both groups. Mild testicular pain (21%) and myalgias (31%) occurred only in patients treated with LND.
Colella
E
E
Regina Elena National Cancer Institute, Rome, Italy.
Merlano
M
M
Blengio
F
F
Angelini
F
F
Ausili Cefaro
G P
GP
Scasso
F
F
Lo Russo
V
V
Cirulli
S
S
Giannarelli
D
D
Cognetti
F
F
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000556:secondary; D006801:Humans; D007191:Indazoles / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local
D007191:Indazoles; C016371:lonidamine; D008727:Methotrexate