NEW YORK—Preliminary data from a pilot study show that use of recombinant human erythropoietin(Drug information on erythropoietin) (epoetin alfa, Epogen, Procrit) in breast cancer patients receiving adjuvant chemotherapy increases hemoglobin levels and improves quality of life, especially energy and activity.
The study is also examining the effects of epoetin on cognitive function in these women, said Joyce O’Shaughnessy, MD, associate director, US Oncology Research, Baylor-Charles A. Sammons Cancer Center, Dallas. She discussed the data in a presentation at the Chemotherapy Foundation Symposium XIX (abstract 74).
The 100 women in the study are being assessed for cognitive function at baseline just before cycle 4 of chemotherapy and 6 months after treatment ends. Two tests are used to evaluate executive control function, a frontal lobe function that involves multitasking or "putting together simple tasks into a complex sequential behavior," she said.
The EXIT 25 test asks 25 questions to determine executive control function, while CLOX is a simpler tool. The rationale for using both was to determine whether the simpler CLOX could substitute for EXIT 25 in future studies. Quality of life was measured with the FACT-An and the Linear Analog Scale, and mood with the Profile of Mood States.
Dr. O’Shaughnessy noted that past studies of cognitive function in breast cancer patients receiving adjuvant chemotherapy failed to stratify for menopausal and hormone therapy status. This is important, she said, because chemotherapy-induced menopause or estrogen-therapy withdrawal can also lead to impaired memory and concentration.
"We stratified the women by menopausal status as well as whether they had recently stopped hormone replacement therapy," she said. "We really tried to control that variable as best we could."
All patients in the study received four cycles of anthracycline-based chemotherapy. Adriamycin/cyclophosphamide (AC) was the most common chemotherapy regimen in the trial, Dr. O’Shaughnessy said. Adriamycin-taxane regimens were also used. Patients were randomized in a double-blind fashion to receive 40,000 units per week of epoetin given subcutaneously from the beginning of chemotherapy or placebo.
