For patients with either limited or extensive small-cell lung cancer (SCLC), dose intensification of VICE chemotherapy affords a significant survival advantage without increasing the danger of sepsis or drug-related death, W.P. Steward, MD, said at the Eighth Annual European Cancer Conference (ECCO-8).
The findings stem from a 17-center, double-blind, randomized trial conducted by the European SCLC Study Group.
The 300 previously untreated patients enrolled in this trial were first randomized to receive six courses of the VICE regimen (ifosfamide, 5 mg/m² on day 1; carbo-platin, 300 mg/m² on day 1; etoposide(Drug information on etoposide) 120 mg/m² on days 1 and 2; oral etoposide on day 3; and vincristine, 0.5 mg on day 14) either at the usual 4-week intervals or on an accelerated every-3-week schedule.
In a second randomization, patients were assigned to treatment with either GM-CSF, 200 mg/m²/day, or placebo for 14 days between courses. Approximately two fifths of patients in both treatment arms had extensive-stage disease.
Dose intensification did indeed prove feasible, said Dr. Steward, of the National Cancer Institute of Canada, Clinical Trials Unit. A 27% greater dose intensity was achieved in the group that received the more aggressive VICE regimen.
Somewhat surprisingly, among patients treated at three-week intervals, the incidence of febrile neutropenia was no higher than that of the group treated every 4 weeks, and the rate of treatment-related death was actually lower. The use of GM-CSF appeared to have no effect on the dose intensity delivered in both groups, Dr. Steward said.
The complete response rate was 50% in both treatment groups, with a 90% overall response rate in the dose-intensified arm and a 77% response rate in the standard arm, a difference that did not reach significance. However, the survival advantage with dose intensification proved to be highly significant.
"The median survival was 15 months in the intensive arm, compared with 12 months in the fixed arm, and the 2-year survival rate was 33% in the intensive arm and 20% in the fixed arm," Dr. Steward said. These differences held whether patients received GM-CSF or placebo.
"We feel that the intensification of this chemotherapy regimen provides a useful survival benefit, with no increased risk of sepsis or toxic death," Dr. Steward said. "For patients, there is the benefit that chemotherapy is completed earlier and they have a longer survival without the need for continued chemotherapy, although there is a slight penalty to pay in that there is an increased transfusion requirement in the intensified arm."
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