N. Brocato et al., TREATMENT OF NONSMALL CELL LUNG-CANCER WITH IFOSFAMIDE (IFO) PLUS 4'-EPIADRIAMYCIN (EPI) PLUS PLATINUM VS IFO- A GETLAC STUDY(EPI ), Oncology, 52(1), 1995, pp. 24-31
203 patients with inoperable non-small cell lung cancer (NSCLC) were r
andomized to receive ifosfamide (IFO) 2.5 g/m(2) days 1-2 + epirubicin
(EPI) 70 mg/m(2) day 1 with cisplatin (DDP) 70 mg/m(2) day 1 (arm IEP
), or without cisplatin (arm IE). For uroprophylaxis, mesna i.v. 20% o
f IFO dose, hour 0 and 3, and oral, 40% of IFO dose, hour 6 and 9, day
s 1-2 was given. Cycles were repeated every 28 days. Four cycles were
required for evaluation purposes. After completion of chemotherapy, ex
ternal beam irradiation 40 Gy was given over 4 weeks for stage III B r
esponders. Most of the patients with stable disease, partial response
or complete response (CR) received 6 cycles. The median follow-up of t
he trial is 30 months. There were no differences in overall response r
ates: arm IEP: 52% (2% CR); arm IE: 51% (13.5% CR). Median time to pro
gression was 6 months (arm IEP) and 4 months (arm IE) (p = 0.4844). To
xicity ranged from mild to moderate. Nephrotoxicity was not seen; only
6 patients had neurotoxic side effects of short duration. Median surv
ival according to treatment was 12 months for IEP arm (12% at 2 years)
and IO months for IE arm (21% at 2 years). IFO/mesna + EPI or IFO/mes
na, EPI plus DDP appeared to be an active and well tolerated combinati
on for the treatment of NSCLC, with a good survival time.