Abstract
Background: Anemia is a frequent condition in patients receiving chemotherapy. ESA are effective to control this condition, but a recently published meta-analysis and warnings from regulatory agencies have pointed to a possible increase in mortality in these patients.
Objective: Our aim was to evaluate the safety of ESA when used according to label indications, that is, for patients with chemotherapy induced anemia (rather than cancer induced anemia) with Hb<11g/dl.
Methods: We performed a systematic review and meta-analysis of all randomized controlled trials comparing the use of ESA versus placebo (or no treatment) in patients with chemotherapy induced anemia, for whom ESAs where indicated if Hb dropped below 11g/dl. The primary end-point was mortality. We searched several databases, including MEDLINE, EMBASE, LILACS and CENTRAL, among others. All suitable papers were retrived and data regarding the quality of the studies and mortality rates were extracted. Then, we performed a meta-analysis of these trials, using RevMan 5.0 software.
Results: â–¡There were 17 studies, with 3788 patients, meeting our inclusion criteria. There were 566 deaths among the 2208 patients that received ESA and 488 among the 1580 on control groups. The meta-analysis showed no increase in mortality rates associated with the use of ESA (Relative risk (RR) = 0.95; IC 95% 0.88 to 1.03; P=0.22). Also, there was no heterogeneity in the analysis (I2=0%), showing that the results were consistent among the studies. When we analised the Hb cut-off point in 10g/dl, the meta-analysis results were similar (RR=0.97; IC 95% 0.87 to 1.07; P 0.52; I2=0%).
Conclusion: When used as indicated on label, that is, for patients with chemotherapy induced anemia with Hb<11g/dl ESA are NOT associated with higher mortality rates and remain a safe option for these patients.
Disclosures: No relevant conflicts of interest to declare.
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