Preventing Anemia Maintains QOL During Adjuvant Chemo

April 1, 2003

SAN ANTONIO-Once-weekly treatment with recombinant human erythropoietin (epoetin alfa, Epogen, Procrit), given concurrently with adjuvant chemotherapy for breast cancer, maintains or improves hemoglobin levels while attenuating decreases in quality of life (QOL), interim trial results show.

SAN ANTONIO—Once-weekly treatment with recombinant human erythropoietin (epoetin alfa, Epogen, Procrit), given concurrently with adjuvant chemotherapy for breast cancer, maintains or improves hemoglobin levels while attenuating decreases in quality of life (QOL), interim trial results show.

The findings suggest that epoetin can be protective against chemotherapy-associated anemia and QOL decrements in these patients, Julie R. Gralow, MD, said at the 25th Annual San Antonio Breast Cancer Symposium (abstract 539).

With results available for 721 of approximately 1,800 patients, it appears as if a prophylactic approach to anemia is warranted, said Dr. Gralow, associate professor of medical oncology, University of Washington School of Medicine, Seattle. "To be reimbursed for epoetin alfa, typically we have to wait until the patient is already anemic and has a low energy level," she said. "This is a proof of principle that we can prevent anemia from occurring in these patients."

Previous investigations showed that epoetin improves hemoglobin levels and QOL in breast cancer patients after they become anemic on chemotherapy or chemoradiation. For example, a large, community-based trial of breast cancer patients with anemia and impaired QOL on chemotherapy showed that epoetin increased hemoglobin by a mean of approximately 2 g/dL, while QOL improved significantly (P < .05) (Gabrilove et al: J Clin Oncol 19:2875-2882, 2001).

The next step was to consider giving hematologic support before anemia arises. Dr. Gralow and her colleagues undertook an open-label, nonrandomized, multicenter, community-based study to evaluate once-weekly epoetin in women with stage I-III breast cancer receiving standard adjuvant chemotherapy (an-thracycline with or without a taxane) for 3 to 6 months. They performed hematologic and quality-of-life assessments, then compared the results with historical controls taken from an earlier study of women with early-stage breast cancer who received adjuvant chemotherapy and no hematologic support (Lawless et al: Blood 96:390b [abstract 5447], 2000).

For 721 evaluable patients (mean age, 53.5 years), mean hemoglobin level at baseline was 12.3 g/dL (comparable to 12.1 g/dL in the historical controls). Subcutaneous epoetin was given at 40,000 U/wk for up to 24 weeks, with dose adjustments up to 60,000 U if needed.

The mean final hemoglobin level among the women in the current study was 13.2 g/dL, or a mean increase of 0.9 g/dL from baseline (P < .05). Among the historical controls, there was a mean decrease in hemoglobin levels of 2.0 g/dL after four treatment cycles of adjuvant chemotherapy without epoetin.

Quality of life, measured using the Linear Analog Scale Assessment (LASA), improved significantly (P < .05) in measures of energy and activity from baseline to last observation (mean increases of 4.9 mm and 4.4 mm, respectively) (see Figure). Investigators also noted an improvement in overall quality of life by LASA, although this did not reach statistical significance. In addition, there was a nonsignificant improvement in quality of life measured by the Functional Assessment in Cancer Therapy-Anemia subscale (FACT-An).

"Starting early with epoetin, you actually slightly improve some parameters like energy and activity," Dr. Gralow said. A prospective, randomized trial is warranted to confirm these results, she said. The study was supported by Ortho Biotech Products. L.P.