Abstract:
In a series of controlled clinical trials, r-HuEPO increased hematocrit and decreased transfusion requirements after the first month of therapy in anemic cancer patients undergoing chemotherapy. The present open label Phase IV study, conducted mainly in community-based oncology practices, was undertaken to confirm the results of these controlled clinical trials, to familiarize physicians with a dose level (150 U/kg tiw) somewhat higher than that used in CRF and HIV, and to reflect actual practices used in treating anemic cancer patients receiving chemotherapy. Approximately 520 physicians enrolled over 2000 patients from July to December 1993. Baseline characteristics of the 1101 patients for whom data are complete are shown in a table. These characteristics are similar to those for the patients treated in the controlled clinical trials in terms of age, mean initial hematocrit and transfusion requirements. The study population includes patients diagnosed with various tumor types including hematologic and nonhematologic. Patients with myeloid malignancies, such as the acute leukemias, were excluded. The chemotherapy regimens administered included cisplatin (N=223), carboplatin (N=209) and nonplatinum (N=669) agents. Patients are treated for 4 months at a starting dose of r-HuEPO (PROCRIT [Epoetin alfa]) of 150 U/kg sc tiw. If response is not satisfactory after 8 weeks, the dose can be increased to 300 U/kg tiw. Effectiveness is being evaluated by improvement in hematocrit over time, transfusion requirements and quality of life as measured by a linear analog scale. The study is in progress and the results of this nationwide trial remain preliminary.
Keywords: Anemia/CHEMICALLY INDUCED/*THERAPY Antineoplastic Agents/*ADVERSE EFFECTS Erythropoietin/THERAPEUTIC USE Female Human Male Middle Age Neoplasms/*DRUG THERAPY Recombinant Proteins/THERAPEUTIC USE ABSTRACT CLINICAL TRIAL, PHASE IV
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
