title: 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.
abstract: 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/m2 day 1) + etoposide (100 mg/m2 days 1-3) every 3 weeks (PE--arm A); (b) CDDP (120 mg/m2 every 4 weeks) + mitomycin (8 mg/m2 days 1, 29, 71) + vindesine (3 mg/m2 days 1, 8, 15, 22 every 2 weeks) (MVP--arm B); and (c) CDDP (120 mg/m2 day 1) + mitomycin (6 mg/m2 day 1) + ifosfamide (3 g/m2 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.
authors.affiliation: Medical Oncology Division, Policlinico Hospital, Perugia, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Crinò
authors.forename: M
authors.initials: M
authors.lastname: Clerici
authors.forename: F
authors.initials: F
authors.lastname: Figoli
authors.forename: M
authors.initials: M
authors.lastname: Barduagni
authors.forename: P
authors.initials: P
authors.lastname: Carlini
authors.forename: G
authors.initials: G
authors.lastname: Ceci
authors.forename: E
authors.initials: E
authors.lastname: Cortesi
authors.forename: A
authors.initials: A
authors.lastname: Carpi
authors.forename: A
authors.initials: A
authors.lastname: Santini
authors.forename: F
authors.initials: F
authors.lastname: Di Costanzo
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D016896:Treatment Outcome; D014751:Vindesine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D016685:Mitomycin; D005047:Etoposide; D002945:Cisplatin; D014751:Vindesine; D007069:Ifosfamide