Superiority of three-drug combination chemotherapy versus cisplatin-etoposide in advanced non-small cell lung cancer: a randomized trial by the italian oncology group for clinical research

• Published in: Lung cancer (Amsterdam, Netherlands) Netherlands), 1995-04, Vol.12, p.S125-S132
• Main Authors: Crinòc, Lucio, Clerici, Maurizia, Figoli, Franco, Barduagni, Mario, Carlini, Paolo, Ceci, Guido, Cortesi, Enrico, Carpi, Amelia, Santini, Alessandra, Di Costanzo, Francesco, Boni, Corrado, Meacci, Marialuisa, Corgna, Enrichetta, Santucci, Antonella, Ballatori, Enzo, Tonato, Maurizio
• Format: Article
• Language: English
• Subjects: Advanced non-small cell lung cancer; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Cisplatin - administration & dosage; Cisplatin - adverse effects; Cisplatin-based chemotherapy; Etoposide - administration & dosage; Etoposide - adverse effects; Female; Humans; Ifosfamide - administration & dosage; Ifosfamide - adverse effects; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Male; Mitomycin - administration & dosage; Mitomycin - adverse effects; Survival Rate; Treatment Outcome; Vindesine - administration & dosage; Vindesine - adverse effects
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/0169-5002(95)00428-4

To evaluate the efficacy of a three-drug regimen vs. a two-drug CDDP based combination in the treatment of NSCLC, we conducted a three-arm randomized parallel trial comparing (a) CDDP (120 mg/m 2 day 1) + etoposide (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) + vindesine (3 mg/m 2 days 1, 8, 15, 22 every 2 weeks) (MVP —arm B); and (c) CDDP (120 mg/m 2 day 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 1992, 393 consecutive previously untreated patients with NSCLC Stage IIIB and IV entered the trial; 373 were evaluable for survival and 360 for response. The response rate was significantly better for both the three-drug regimens compared with PE (Table 3). Logistic regression model showed a significantly better response in patients with a good P.S. and in Stage IIIB. Main toxicity consisted of myelosuppression: neutropenia 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, MVP and MIC, appear more active than the two-drug combination PE in treatment of advanced NSCLC.