RANDOMIZED TRIAL WITH OR WITHOUT GRANULOCYTE-COLONY-STIMULATING FACTOR AS ADJUNCT TO INDUCTION VNCOP-B TREATMENT OF ELDERLY HIGH-GRADE NON-HODGKINS-LYMPHOMA

Age is an important prognostic parameter, especially in patients with advanced high-grade non-Hodgkin's lymphoma (HG-NHL) who require more i ntensive and extensive therapy for any possible chance of cure. We inv estigated the potential of granulocyte colony-stimulating factor (G-CS F) for reducing myelotoxicity, which is the most important dose-limiti ng factor for chemotherapy. Between March 1993 and June 1995, 158 prev iously untreated patients 60 years and older with HG-NHL were included in a cooperative randomized comparative trial and treated with a comb ination therapy including VNCOP-B (cyclophosphamide, mitoxantrone, vin cristine, etoposide, bleomycin, and prednisone) with or without G-CSF. G-CSF was administered at 5 mu g/kg/d throughout the treatment starti ng on day 3 of every week for 5 consecutive days. Of the 158 patients registered for the trial, 149 patients were evaluable: 77 received VNC OP-B plus G-CSF and 72 received VNCOP-B alone. The overall response ra te was 81.5%, with complete response in 59%: 60% in the VNCOP-B plus G -CSF group, and 58% in the VNCOP-B group. At 30 months (median 24 mont hs), 68% of all complete responders were alive without disease in the G-CSF group and 65% in the control group. Neutropenia occurred in 18 o ut of 77 (23%) of the G-CSF treated patients and in 40 out of 72 (55.5 %) of the controls (P =.00005). Clinically relevant infections occurre d in 4 out of 77 (5%) of the G-CSF group and in 15 out of 72 (21%) of the controls (P =.004). The delivered dose intensity was higher in pat ients receiving G-CSF (95% v 85%), but the difference was not statisti cally significant. Our data show that VNCOP-B is a feasible and effect ive regimen in elderly HG-NHL patients, and that the use of G-CSF redu ces infection and neutropenia rates without producing any significant modifications to the dose intensity, CR rate, and relapse-free surviva l curve. (C) 1997 by The American Society of Hematology.