This study showed a trend in favor of Neumega, particularly in the subgroup of patients with prior chemotherapy. Open-label treatment with Neumega has been continued for up to four consecutive chemotherapy cycles without evidence of any adverse effect oh the rate of neutrophil recovery or red blood cell transfusion requirements. Some patients continued to maintain platelet nadirs >20,000/mL for at least four sequential cycles of chemotherapy without the need for transfusions, chemotherapy dose reduction, or changes in treatment schedules.

Platelet activation studies done on a limited number of patients showed no evidence of abnormal spontaneous platelet activation, or an abnormal response to ADP. In an unblinded, retrospective analysis of the two placebo-controlled studies, 19 of 69 patients (28%) receiving Neumega 50 mg/kg and 34 of 67 patients (51%) receiving placebo reported at least one hemorrhagic adverse event which involved bleeding.

In a randomized, double-blind, placebo-controlled, Phase 2 study conducted in 80 women with high-risk breast cancer who received 0 (n=26), 25 mg/kg (n=28), or 50 mg/kg (n=26) Neumega following myeloablative chemotherapy and autologous bone marrow transplantation, the incidence of platelet transfusions and time to neutrophil and platelet engraftment were similar in the Neumega and placebo-treated arms. The study showed a statistically significant increased incidence in edema, conjunctival bleeding, hypotension, and tachycardia in patients receiving Neumega as compared to placebo.

In long term follow-up of patients, the distribution of survival and progression-free survival times was similar between patients randomized to Neumega therapy and those randomized to receive placebo.

REFERENCES

(1) Du, X. and Williams, D., Interleukin 11: review of molecular, cell biology and clinical use. Blood. 1997;89(11):3897-3908.

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