Epoetin Eases Fatigue, Ups Cancer Patients’ QOL

ASCO—Fatigue can severely affect a patient’s daily life, even as long as 2 years after chemotherapy (see box ). But three studies presented at ASCO show that epoietin alfa (Procrit) can successfully treat the anemia that contributes to chemotherapy-related fatigue and improve patients’ quality of life (QOL).

Survey Shows Fatigue Common, Debilitating

To learn more about the impacts of cancer-related fatigue on cancer patients’ lives, the Fatigue Coalition of the US Department of Health and Human Services surveyed 379 patients who had received chemotherapy.

In his ASCO presentation, Gregory A. Curt, MD, said that 301 of the patients surveyed (76%) reported experiencing persistent debilitating fatigue (defined as fatigue at least monthly). Most of the these patients complained that fatigue kept them from leading a normal life, forcing them to alter their daily routines.

Fatigue affects patients’ ability to remember things, keep dates straight, and concentrate. The symptom often forces patients to miss work and to change their job status in some way, by accepting fewer responsibilities, taking more personal or vacation days, or quitting altogether.

“Perhaps worst of all,” Dr. Curt said, “is the emotional impact of fatigue.” Patients report feeling a loss of control, hopelessness, and loneliness. With physical exhaustion comes mental exhaustion and a lack of motivation. These feelings become so debilitating that 19% of patients in the coalition survey reported an urge to die.

Charles S. Cleeland, MD, of M.D. Anderson Cancer Center, reported on two nonrandomized multicenter studies of epoietin alfa in 4,382 anemic cancer patients, designed to determine an appropriate target hemoglobin (Hb) level. Patients had a starting hemoglobin of 9.2 and 9.3 g/dL. Quality of life was assessed before and after treatment.

A rate of change analysis showed the greatest incremental improvement in quality of life occurred at Hb levels in the 11 to 13 g/dL range. “An increase in hemoglobin from 11 to 12 g/dL was associated with the greatest quality of life improvements,” he said, with a trail off in increasing benefit at 13 g/dL. “These two studies demonstrate the positive relationship between Hb and quality of life ratings,” Dr. Cleeland concluded.

Another study of 302 anemic patients receiving chemotherapy evaluated the safety and efficacy of epoietin given subcutaneously once a week at a dose of 40,000 units. The usual regimen is 10,000 units three times a week. If Hb did not rise by more than 1 g/dL after 4 weeks, the weekly dose was increased to 60,000 units.

Mean Hb level rose from 9.4 to 11.6 g/dL, reported Janice L. Gabrilove, MD, of M.D. Anderson, an increase comparable to that of previous studies of the three times weekly schedule. There was a significant reduction in both the percentage of patients transfused and the number of units transfused. Patients reported a significant improvement in quality of life and were able to tolerate the drug well. “The greatest incremental benefit in quality of life was obtained by treating patients to an Hb of about 12 g/dL,” she said.

T. J. Littlewood, MD, of Oxford University, reporting for the European Epoietin Alfa Study Group, described a double-blind, placebo-controlled randomized multicenter study of epoietin in 369 anemic cancer patients with nonmye-loid malignancies receiving non-platinum-containing chemotherapy. From baseline to study end, the mean increase in Hb in the drug group was 2.2 g/dL vs 0.5 g/dL in the placebo group. “We can increase hemoglobin,” he said, “but does this translate into a reduced need to transfuse and an improved quality of life?”

The answer to both questions was yes. From the end of week 4 to the end of the study, 37.5% of placebo patients required transfusion vs only 23% of epoietin-treated patients, and epoietin-treated patient scored significantly better on all six quality of life scales. “Overall, the placebo patients had a worsening in quality of life,” Dr. Littlewood said, “as opposed to the patients receiving the drug, who had an overall improvement in quality of life.”

Discussant Thomas Witzig, MD, of the Mayo Clinic, said the results raise four questions for future studies: “When do we start epoietin (ie, upfront before patients become anemic)? When do we stop epoietin? Does it have any effect on survival? And what can we add to epoietin to further improve quality of life?”