title: Treatment of non-small cell lung cancer with ifosfamide (IFO)+ 4'-epiadriamycin (EPI)+platinum vs. IFO+EPI: a GETLAC Study. Grupo de Estudio y Tratamiento Latinoamericano del Cáncer Study.
abstract: 203 patients with inoperable non-small cell lung cancer (NSCLC) were randomized to receive ifosfamide (IFO) 2.5 g/m2 days 1-2 + epirubicin (EPI) 70 mg/m2 day 1 with cisplatin (DDP) 70 mg/m2 day 1 (arm IEP), or without cisplatin (arm IE). For uroprophylaxis, mesna i.v. 20% of IFO dose, hour 0 and 3, and oral, 40% of IFO dose, hour 6 and 9, days 1-2 was given. Cycles were repeated every 28 days. Four cycles were required for evaluation purposes. After completion of chemotherapy, external beam irradiation 40 Gy was given over 4 weeks for stage III B responders. Most of the patients with stable disease, partial response or complete response (CR) received 6 cycles. The median follow-up of the trial is 30 months. There were no differences in overall response rates: arm IEP: 52% (2% CR); arm IE: 51% (13.5% CR). Median time to progression was 6 months (arm IEP) and 4 months (arm IE) (p = 0.4844). Toxicity ranged from mild to moderate. Nephrotoxicity was not seen; only 6 patients had neurotoxic side effects of short duration. Median survival according to treatment was 12 months for IEP arm (12% at 2 years) and 10 months for IE arm (21% at 2 years). IFO/mesna+EPI or IFO/mesna, EPI plus DDP appeared to be an active and well tolerated combination for the treatment of NSCLC, with a good survival time.
authors.affiliation: Policlínico Bancario, Buenos Aires, Argentina.
authors.forename: N
authors.initials: N
authors.lastname: Brocato
authors.forename: M F
authors.initials: MF
authors.lastname: Bruno
authors.forename: C E
authors.initials: CE
authors.lastname: Araujo
authors.forename: J C
authors.initials: JC
authors.lastname: Cervellino
authors.forename: C
authors.initials: C
authors.lastname: Pirisi
authors.forename: G
authors.initials: G
authors.lastname: Temperley
authors.forename: C
authors.initials: C
authors.lastname: Sparrow
authors.forename: C
authors.initials: C
authors.lastname: Savulsky
authors.forename: L R
authors.initials: LR
authors.lastname: Balbiani
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage*; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D015996:Survival Rate
chemical_list: D015251:Epirubicin; D002945:Cisplatin; D007069:Ifosfamide