Document 1077
 DOCN  M9471077
 TI    Phase IV clinical evaluation of recombinant human erythropoietin
       (r-HuEPO) in anemic cancer patients receiving chemotherapy (Meeting
       abstract).
 DT    9409
 AU    Bukowski R; Glaspy J; Steinberg D; Taylor CW; Vadhan-Raj S; Sarokhan B;
       Lonczak L; Cleveland Clinic Foundation, Cleveland, OH
 SO    Proc Annu Meet Am Soc Clin Oncol; 13:A1594 1994. Unique Identifier :
       AIDSLINE ICDB/94601587
 AB    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.
 DE    Anemia/CHEMICALLY INDUCED/*THERAPY  Antineoplastic Agents/*ADVERSE
       EFFECTS  Erythropoietin/THERAPEUTIC USE  Female  Human  Male  Middle Age
       Neoplasms/*DRUG THERAPY  Recombinant Proteins/THERAPEUTIC USE  MEETING
       ABSTRACT  CLINICAL TRIAL, PHASE IV

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       protected by Copyright Law (Title 17, U.S.Code).