cis-Dichlorodiammineplatinum(II) alone followed by adriamycin plus cyclophosphamide at progression versus cis-dichlorodiammineplatinum(II), adriamycin, and cyclophosphamide in combination for adenocarcinoma of the lung.

Forty-one patients with proven metastatic adenocarcinoma of the lung were randomized into two comparable groups after stratification for performance status and presence of measurable or evaluable disease. Treatment 1 consisted of cis-dichlorodiammineplatinum(II) (P) at a dose of 15 mg/m2/day by iv push on Days 1--5 every 4 weeks. Upon progression or the onset of renal toxic effects, patients were crossed over to cyclophosphamide (C) at a dose of 400 mg/m2, and adriamycin (A) at a dose of 40 mg/m2, both given by iv push on Day 1 every 4 weeks. Treatment 2 (CAP-I) consisted of C-A in the same doses as above plus concurrent P, 40 mg/m2 by IV push on Day 1 every 4 weeks. Eight patients receiving P developed serum creatinine values greater than or equal to 1.5 mg/100 ml versus one patient receiving CAP-I (P = 0.05). Objective regressions occurred in two of 22 patients with P, five of 17 with C-A, and eight of 19 with CAP-I (P = 0.025; CAP-I versus P). There was a significant increase in the median duration of regression in patients responding to C-A following P (267 days) versus patients responding to CAP-I (95 days). The improved rate of response with CAP-I and the prolonged duration of response with C-A following P suggest a potentiating effect between P and C-A whether given simultaneously or sequentially.

RCT Entities:   Population Interventions Outcomes