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| |  Growth Factor Reduces Need For Platelet Transfusions In Breast Cancer Patients WASHINGTON, MD -- October 30, 1997 -- Women with high-risk breast cancer undergoing dose-intensive chemotherapy were able to significantly reduce the need for platelet transfusions when treated with a platelet growth factor, recombinant human interleukin-11 (Neumega(R)/rhIL-11), following chemotherapy, according to a study published in today's Journal of Clinical Oncology. A multi-center, randomized, placebo-controlled study led by Claudine Isaacs, MD, division of hematology/oncology, Lombardi Cancer Center, Georgetown University Medical Center, evaluated the role of rhIL-11 in adult women over 18 years of age with high-risk and advanced breast cancer (stage 2, 3 or 4) and an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2. "Conventional chemotherapy, particularly for high-risk, primary breast cancer patients, still results in high recurrence rates," Dr. Isaacs said. "This has led oncologists to examine the role of dose-intensive chemotherapy as a means of improving patient outcomes." Prospective clinical studies have demonstrated a positive relationship between dose-intensity and response rates among patients who receive adjuvant therapy for primary breast cancer. However, the use of dose-intensive chemotherapy may be limited by bone marrow suppression, including thrombocytopenia (or platelet loss), placing patients at risk for bleeding complications. Platelet loss may also force significant chemotherapy dose reductions and treatment delays in patients undergoing chemotherapy and thus may have a negative impact on treatment outcomes in some patients. At present, platelet transfusion is the only available treatment for patients with thrombocytopenia. The present study demonstrated significantly more (68 percent, 27 of 40) patients randomized to receive rhIL-11 avoided platelet transfusions and completed two cycles of planned chemotherapy, compared with those randomized to receive placebo (41 percent, 15 of 37). Among patients who had no prior chemotherapy, 73 percent (19 of 26) in the rhIL-11 group avoided platelet transfusion in contrast to 59 percent (13 of 22) in the placebo group. Similarly, among patients who had received prior chemotherapy, 64 percent (seven of 11) treated with rhIL-11 avoided platelet transfusions compared with 12.5 percent (one of eight) placebo patients. In the first cycle of chemotherapy, time to platelet recovery was similar for both study arms. In the second cycle, time to recovery and duration of thrombocytopenia were shorter for the rhIL-11 patients than for placebo patients. Adverse events associated with rhIL-11 were reversible, predominantly mild to moderate and likely related to fluid retention. Seventy-seven female patients were enrolled in the multi-center study. Patients received two sequential cycles of dose-intensive chemotherapy, which consisted of cyclophosphamide (3,200 mg/m2) and doxorubicin (75 mg/m2) plus granulocyte colony-stimulating factor (G-CSF; 5 micrograms/kg/d). Patients were randomized to blinded treatment with placebo or 50 micrograms/kg/d rhIL-11 administered subcutaneously for 10 or 17 days after the two chemotherapy cycles. "Using rhIL-11 may have a profound impact on the treatment of many cancer patients," Dr. Isaacs explained. "As a result, physicians may improve their patients' chances for successful outcomes by incorporating rhIL-11 and dose-intensive chemotherapy into their arsenal of treatments for patients with breast cancer, and possibly other cancers." rhIL-11, manufactured by Genetics Institute, Inc., Cambridge, MA, is the recombinant form of human interleukin-11, a naturally-occurring platelet growth factor. rhIL-11 is a unique platelet growth factor that stimulates the production of blood platelets, the cells essential to the blood-clotting process.
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