Randomized placebo-controlled study of recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in patients with breast cancer receiving dose-intensive cyclophosphamide and doxorubicin
| Autor: | Kathleen J. Beach, Nicholas J. Robert, M W Schuster, B Cai, M Graham, F A Bailey, John Loewy, James A. Kaye, Beth Overmoyer, Claudine Isaacs |
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| Rok vydání: | 1997 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty Cyclophosphamide medicine.medical_treatment Population Placebo-controlled study Breast Neoplasms Platelet Transfusion Placebo Gastroenterology Breast cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans education Aged Chemotherapy education.field_of_study business.industry Cancer Middle Aged Interleukin-11 medicine.disease Thrombocytopenia Recombinant Proteins Surgery Platelet transfusion Oncology Doxorubicin Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 15:3368-3377 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.1997.15.11.3368 |
| Popis: | PURPOSE Thrombocytopenia may compromise cancer treatment, causing chemotherapy dose reductions, schedule alterations, or the need for platelet transfusions. We evaluated the efficacy and safety of recombinant human interleukin-11 (rhIL-11; Neumega, Genetics Institute, Inc, Cambridge, MA), a novel thrombopoietic growth factor, in reducing the need for platelet transfusions in patients who undergo dose-intensive chemotherapy. PATIENTS AND METHODS Women with advanced breast cancer received cyclophosphamide (3,200 mg/m2) and doxorubicin (75 mg/m2) plus granulocyte colony-stimulating factor (G-CSF; 5 microg/kg/d). Patients were randomized to blinded treatment with placebo or 50 microg/kg/d rhIL-11 subcutaneously for 10 or 17 days after the first two chemotherapy cycles. RESULTS Seventy-seven patients were randomized and constitute the intent-to-treat (ITT) population. Sixty-seven patients (the assessable subgroup) either completed both cycles without a major protocol violation (n = 62) or received a platelet transfusion before treatment was discontinued after the first cycle. In the ITT population, rhIL-11 significantly decreased the requirement for platelet transfusions; 27 of 40 (68%) patients who received rhIL-11 did not require transfusions, compared with 15 of 37 (41%) in the placebo group (P = .04). Treatment with rhIL-11 significantly reduced the total number of platelet transfusions required in the assessable subgroup (P = .03) and the time to platelet recovery to more than 50,000/microL in the second cycle (P = .01). Most adverse events associated with rhIL-11 were reversible, mild to moderate in severity, and likely related to fluid retention. CONCLUSION rhIL-11 is safe and effective in reducing treatment-associated thrombocytopenia and the need for platelet transfusions in patients who undergo dose-intensive chemotherapy, and thus may permit chemotherapy to be administered as planned at intended doses and thereby maximize the potential for a successful outcome. |
| Databáze: | OpenAIRE |
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