Treatment with NEUPOGEN® significantly reduced the median time to ANC recovery and the median duration of fever, antibiotic use, and hospitalization following induction chemotherapy. In the NEUPOGEN®-treated group‚ the median time from initiation of chemotherapy to ANC recovery (ANC ≥ 500/mm³) was 20 days (vs 25 days in the control group, p = 0.0001), the median duration of fever was reduced by 1.5 days (p = 0.009), and there were statistically significant reductions in the durations of IV antibiotic use and hospitalization. During consolidation therapy (DAV 2+5+5), patients treated with NEUPOGEN® also experienced significant reductions in the incidence of severe neutropenia, time to neutrophil recovery, the incidence and duration of fever, and the durations of IV antibiotic use and hospitalization. Patients treated with a further course of standard (DAV 2+5+5) or high-dose cytosine arabinoside consolidation also experienced significant reductions in the duration of neutropenia.

There were no statistically significant differences between NEUPOGEN® and placebo groups in complete remission rate (69% NEUPOGEN® vs 68% placebo, p = 0.77), disease-free survival (median 342 days NEUPOGEN® [n = 178], 322 days placebo [n = 177], p = 0.99), time to progression of all randomized patients (median 165 days NEUPOGEN®, 186 days placebo, p = 0.87), or overall survival (median 380 days NEUPOGEN®, 425 days placebo, p = 0.83).

Cancer Patients Receiving Bone Marrow Transplant

In two separate randomized‚ controlled trials‚ patients with Hodgkin's disease (HD) and non-Hodgkin's lymphoma (NHL) were treated with myeloablative chemotherapy and autologous bone marrow transplantation (ABMT). In one study (n = 54)‚ NEUPOGEN® was administered at doses of 10 or 30 mcg/kg/day; a third treatment group in this study received no NEUPOGEN®. A statistically significant reduction in the median number of days of severe neutropenia (ANC < 500/mm³) occurred in the NEUPOGEN®-treated group versus the control group (23 days in the control group‚ 11 days in the 10 mcg/kg/day group‚ and 14 days in the 30 mcg/kg/day group [11 days in the combined treatment groups‚ p = 0.004]). In the second study (n = 44‚ 43 patients evaluable)‚ NEUPOGEN® was administered at doses of 10 or 20 mcg/kg/day; a third treatment group in this study received no NEUPOGEN®. A statistically significant reduction in the median number of days of severe neutropenia occurred in the NEUPOGEN®-treated group versus the control group (21.5 days in the control group and 10 days in both treatment groups‚ p < 0.001). The number of days of febrile neutropenia was also reduced significantly in this study (13.5 days in the control group‚ 5 days in the 10 mcg/kg/day group‚ and 5.5 days in the 20 mcg/kg/day group [5 days in the combined treatment groups‚ p < 0.0001]). Reductions in the number of days of hospitalization and antibiotic use were also seen‚ although these reductions were not statistically significant. There were no effects on red blood cell or platelet levels.

In a randomized‚ placebo-controlled trial‚ 70 patients with myeloid and nonmyeloid malignancies were treated with myeloablative therapy and allogeneic bone marrow transplant followed by 300 mcg/m²/day of a Filgrastim product. A statistically significant reduction in the median number of days of severe neutropenia occurred in the treated group versus the control group (19 days in the control group and 15 days in the treatment group‚ p < 0.001) and time to recovery of ANC to ≥ 500/mm³ (21 days in the control group and 16 days in the treatment group‚ p < 0.001).

In three nonrandomized studies (n = 119)‚ patients received ABMT and treatment with NEUPOGEN®. One study (n = 45) involved patients with breast cancer and malignant melanoma. A second study (n = 39) involved patients with HD. The third study (n = 35) involved patients with NHL‚ acute lymphoblastic leukemia (ALL)‚ and germ cell tumor. In these studies‚ the recovery of the ANC to ≥ 500/mm³ ranged from a median of 11.5 to 13 days.

Bookmark this page: