NoBlood

Jan B. Wade · #1 (**permalink**) 04-26-2005, 05:43 AM

Erythropoietin Study Defends Use in Cancer Anemia

By Tom Ewing, MedPage Today Staff Writer Reviewed by Robert Jasmer, MD; Assistant Professor of Medicine, University of California, San Francisco April 06, 2005 Also covered by: Forbes, MSN, Yahoo!

MedPage Today Action Points

Consider the use of erythropoietin in treating appropriately selected anemic cancer patients as a means of improving their hematologic response and reducing their need for blood transfusion.

Review
COLOGNE, Germany, April 6- A meta-analysis of 27 randomized trials of treatment with erythropoietin in patients with cancer offered suggestive but inconclusive evidence of a survival benefit, contrary to two recent trials that reported excess mortality.

The meta-analysis was reported in the April 6 issue of the Journal of the National Cancer Institute by a team of German and American researchers. It included randomized, controlled trials published between 1993 and 2002.

However, the meta-analysis did not include the results of two recently published randomized controlled trials in 2003 in which patients treated with erythropoietin had worse survival than untreated patients. Those two studies were published after the cutoff point for inclusion in the systematic review.

"The primary findings of our study are that cancer patients treated with erythropoietin had a reduced need for red blood cell transfusion and an increased hematologic response compared with untreated patients," said Andreas Engert, M.D., of the University of Cologne and colleagues. "There is insufficient evidence to conclude that erythropoietin increases the risk of hypertension or thromboembolic events and suggestive but inconclusive evidence that erythropoietin may improve overall survival."

Improved survival had been an assumption, without confirmatory data, until the two 2003 studies reported statistically significantly worse tumor control and survival rates. One trial with 351 patients was for head-and-neck cancer patients and the other for 939 breast-cancer patients, both groups treated for anemia.

Possible reasons for the disparity with the meta-analysis, the researchers said, include higher target hemaglobin levels, higher risk of thromboembolic complications, and the possibility that erythropoietin may stimulate tumor growth. Adjusted survival data in the meta-analysis was hazard ratio (HR)= 0.81, 95% CI = 0.67 to 0.99; unadjusted data: HR = 0.84, 95% CI = 0.69 to 1.02.

The new meta-analysis attempted to assess the association between erythropoietin treatment and the need for blood transfusion, adverse events, and survival among anemic cancer patients. Analysis of the 27 trials, which compared erythropoietin treatment vs. no treatment in a total of 3,287 adult cancer patients, showed:

Cancer patients treated with erythropoietin had a lower relative risk of needing a blood transfusion than did untreated patients.

Erythropoietin-treated patients with baseline hemoglobin levels lower than 10 g/dl were more likely to have a hematologic response than were untreated patients.

The relative risk for thromboembolic complications in patients treated with the hormone was not significantly increased compared with untreated patients.

Based on the analysis, the researchers concluded that erythropoietin treatment may reduce the need for blood transfusion and improve hematologic response among anemic cancer patients. On the other hand, it is their view that the hormone may be used routinely outside of clinical trials to increase hemoglobin levels and to reduce the need for transfusion in patients with falling hemoglobin levels approaching 10 g/dl.

Primary source: Journal of the National Cancer Institute
Source reference:
Bohlius J, et al. Recombinant Human Erythropoietin and Overall Survival in Cancer Patients: Results of a Comprehensive Meta-Analysis. J Natl Cancer Inst. 2005;97:489-98