RANDOM PROSPECTIVE-STUDY OF CYCLOPHOSPHAMIDE, DOXORUBICIN, AND METHOTREXATE (CAM) COMBINATION CHEMOTHERAPY VERSUS SINGLE-AGENT SEQUENTIAL CHEMOTHERAPY IN NON-SMALL CELL LUNG-CANCER

Abstract

A group of 104 patients with unresectable non-small cell lung cancer were randomized to receive combination chemotherapy with cyclophosphamide, doxorubicin and methotrexate (CAM) or single-agent sequential chemotherapy with the same 3 agents. CAM combination chemotherapy produced a 22% objective response rate, including 2 complete remissions, compared to a 9% response rate, including 1 complete remission, produced by single-agent therapy (P = 0.16). The median survival time was 32 wk (range, 3-116) for CAM, compared to 25 wk (range, 4-179+) for sequential single agents (P = 0.24). Overall survival was 31% (1-yr), 16% (1 1/2-yr) and 5% (2-yr), with no difference between the study arms. Although there was no statistically significant survival advantage for the CAM arm, both arms had survival superior to that in historical controls, presumably because of better patient selection. Cyclophosphamide, doxorubicin and methotrexate apparently are, at best, marginally active as single agents. New drugs with more efficacy are needed before combination chemotherapy can be expected to result in any meaningful prolongation of survival in non-small cell lung cancer.