A Study of Infusional Cisplatin and Infusional Fluorouracil for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Mid-Atlantic Oncology Program Study

A combination of cisplatin administered as a 24-hour infusion and fluorouracil administered as a 5-day infusion was used to treat 97 patients with non-small-cell lung (NSCLC) cancer in a phase II trial. Thirty patients had stage IIIB disease; 67 patients, stage IV disease (new international classification). Patients with stage IIIB disease also received thoracic radiation after chemotherapy. The regimen was well tolerated, with 24 % or less grade 3 or greater toxicities of all types. One toxic death was attributed to fluid overload. The response rate, partial and complete, was 43 % (95% THE RATIONALE FOR combining cisplatin and fluorouracil in this study is based on both laboratory and clinical observations. Schabel et al' noted a 60 % long-term survival in L1210-bearing mice treated with this combination, whereas each single agent produced only a modest prolongation of median survival. Therapeutic synergism of the combination in P388 leukemia has also been documented. 2 In addition, a biochemical-physical basis for synergy of this combination in a human ovarian cancer cell line was described by Scanlon et al.3 The primary impetus for the use of the infu-sional fluorouracil and cisplatin in non-small-cell lung cancer (NSCLC) was the clinical report by Decker et al ' on the effects of this regimen in squamous cell carcinoma of the head and neck