title: Etoposide v etoposide and cisplatin in the treatment of advanced non-small cell lung cancer: a FONICAP randomized study.
abstract: A multicenter Italian Cooperative Study Group (FONICAP) conducted a prospective, randomized trial comparing cisplatin and etoposide (VP-16) with single-agent etoposide. The national study accrued 216 patients with measurable or evaluable non-small cell lung cancer (NSCLC) with either unresectable stage III, or distant metastasis (stage IV). One hundred patients were evaluable for response in the single-agent arm, and 93 in the two-drug combination arm. The overall response rates for the etoposide group and cisplatin/etoposide (VP-16) group were 7% and 26%, respectively (P less than 0.005). Five patients (5.6%) in the combination arm and 1 (1%) in the single agent arm had a complete response. The overall median survival was 236 days for the two-drug arm and 178 days on the single-drug arm (P = 0.2). Treatment-related toxicity (nausea and vomiting, leukopenia, anemia, hearing-loss, peripheral neuropathy, serum creatinine elevation) was significantly more pronounced in the combined arm. The addition of cisplatin to etoposide gave a small non-statistically significant improvement in terms of performance status and thoracic symptoms.
authors.affiliation: Forza Operativa Nazionale per il Cancro del Polmone (FONICAP), Italy.
authors.forename: R
authors.initials: R
authors.lastname: Rosso
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoni
authors.forename: F
authors.initials: F
authors.lastname: Salvati
authors.forename: C
authors.initials: C
authors.lastname: Gallo-Curcio
authors.forename: A
authors.initials: A
authors.lastname: Rubagotti
authors.forename: V
authors.initials: V
authors.lastname: Fusco
authors.forename: I
authors.initials: I
authors.lastname: Brunetti
authors.forename: M
authors.initials: M
authors.lastname: DePalma
authors.forename: A R
authors.initials: AR
authors.lastname: Crucsiani
authors.forename: L
authors.initials: L
authors.lastname: Portalone
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D005047:Etoposide / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation
chemical_list: D005047:Etoposide; D002945:Cisplatin