Search

We compared an aprepitant regimen with a control regimen of ondansetron + dexamethasone given for 4 days.

Patients (pts) with SCLC and≤3 adverse prognostic features (Manchester system) were randomised in a multicentre prospective study to 6 courses of VICE chemotherapy (ifosfamide 5g/m2, carboplatin 300mg/m2, etoposide 120mg/m2iv dl, 2 & 240mg/m2po d3, vincristine 0.5mg/m2d14) every 3 or 4 weeks (“intensified” & “standard” arms respectively). Pts received 14 days of granulocyte-macrophage colonystimulating factor (GM-CSF) or placebo (250μg/m2/d) between each course in a double-blind fashion. Endpoints are to determine the effects of dose-intensity and GM-CSF on outcome.301 pts were entered from 17 centres in Europe (70% from 4 centres) up to 1/94. Sixty-three percent had≤1 adverse prognostic feature and 41% had extensive stage disease (similar distribution in “fixed” and “intensive” arms). Overall, 30% greater dose-intensity was administered to pts in the “intensive” arm. Preliminary outcome assessments are: “fixed” arm—documented sepsis—28 pts, OR 76% (52% CR), 8—month survival 63%; “intensive” arm—documented sepsis-11 pts, OR 87% (47% CR), 8—month survival 75%. Detailed outcome analysis with assessment of the effects of GM-CSF will be performed in 6/95 with a minimum follow up of 1 year.