PHASE-II TRIAL OF COMBINATION THERAPY WITH CONTINUOUS-INFUSION PALA AND BOLUS-INJECTION 5-FU

  • 1 January 1982
    • journal article
    • research article
    • Vol. 66  (2) , 299-303
Abstract
Patients (57) were treated with continuous infusion of PALA [N-(phosphonoacetyl)-L-aspartate] at a dose of 850 mg/m2 per day .times. 5 and i.v. bolus injection of 5-FU [5-fluorouracil] at a dose of 300 mg/m2 per day .times. 5, which was given at the end of each 24-h PALA infusion; the treatment interval was 28 days. The overall response rate among 43 evaluable patients was 14%. Two of 21 patients (10%) with colorectal carcinoma, 2 of 8 patients with pancreatic carcinoma, and 2 of 4 patients with breast carcinoma achieved partial responses lasting 2-12 mo. One of the responding patients with colon cancer and 2 with breast cancer had failed to respond to prior therapy with 5-FU; 1 of the responding patients with breast cancer had previously received an inadequate trial of a similar regimen. Toxic effects were mild to moderate and were confined to oral mucositis in most patients. This regimen evidently offers little enhancement of the antitumor activity of 5-FU in patients with colorectal cancer previously treated with 5-FU. Investigation of other infusion techniques for the PALA and 5-FU combination is recommended, with particular attention to the treatment of colorectal, pancreatic and breast carcinomas.