SUPERIORITY OF 3-DRUG COMBINATION CHEMOTHERAPY VERSUS CISPLATIN-ETOPOSIDE IN ADVANCED NONSMALL CELL LUNG-CANCER - A RANDOMIZED TRIAL BY THEITALIAN ONCOLOGY GROUP FOR CLINICAL RESEARCH

To evaluate the efficacy of a three-drug regimen vs. a two-drug CDDP b ased combination in the treatment of NSCLC, we conducted a three-arm r andomized parallel trial comparing (a) CDDP (120 mg/m(2) day 1) + etop oside (100 mg/m(2) days 1-3) every 3 weeks (PE - arm A); (b) CDDP (120 mg/m(2) every 4 weeks) + mitomycin (8 mg/m(2) days 1, 29, 71) + vinde sine (3 mg/m(2) days 1, 8, 15, 22 every 2 weeks) (MVP - arm B); and (c ) CDDP (120 mg/m(2) pay 1) + mitomycin (6 mg/m(2) day 1) + ifosfamide (3 g/m(2) day 2) every 3 weeks (MIC - arm C). From May 1989 to April 1 992, 393 consecutive previously untreated patients with NSCLC Stage II IB and IV entered the trial; 373 were evaluable for survival and 360 f or response. The response rate was significantly better for both the t hree-drug regimens compared with PE (Table 3). Logistic regression mod el showed a significantly better response in patients with a good P.S. and in Stage IIIB. Main toxicity consisted of myelosuppression: neutr openia Grade III-IV was recorded in 14% (arm A), 15% (arm B) and 21% ( arm C). Thrombocytopenia Grade III-IV was worst in arm C: 10% vs. 5% ( arm A) and 3% (arm B). Nephrotoxicity Grade III-IV was more common in arm C: 3.5%. Toxic deaths were 11 (3%: three in arm A, five in arm B, three in arm C). From our data, the three-drug containing regimens, MV P and MIG, appear more active than the two-drug combination PE in trea tment of advanced NSCLC.