CISPLATIN, DOXORUBICIN, MITOMYCIN-C, AND 5-FLUOROURACIL FOR THE TREATMENT OF METASTATIC NONSMALL CELL LUNG-CANCER - LIMITED ACTIVITY OF AN AGGRESSIVE CHEMOTHERAPY REGIMEN

We conducted a Phase II study to determine the efficacy of cisplatin, doxorubicin, mitomycin C, and 5-fluorouracil in patients with untreate d non-small cell lung cancer. Patients were accrued through the Connec ticut Oncology Association (COA), an organization composed of communit y and university oncologists. Thirteen COA oncologists enrolled 30 pat ients over 12 months and 26 were eligible for the final analysis. Pati ents received cisplatin 75 mg/m2, doxorubicin 30 mg/m2, mitomycin C 6. 5 mg/m2, and 5-fluorouracil 750 mg/m2 on day 1. The treatment was repe ated every 4 weeks, with mitomycin C given during the first 3 cycles a nd then every other cycle. There were 5 (19%) partial responses, lasti ng 1.3-7.3 months. The median time to progression was 10.3 months (0.3 -12.5 months). Median survival was 7.5 months (0.3-34 months). The maj or toxicities were related to myelosuppression and there was one septi c death. This study demonstrates the limited efficacy of an aggressive regimen using ''active'' agents in patients with advanced non-small c ell lung cancer.