Prospective Clinical and Epidemiological Evaluation of rHuEPO in the Routine Care of a Network of Hematological Centers.

The expected effects of rHuEPO treatments on the quality of life of patients exposed to chemotherapeutic regimens have favored its widespread clinical utilization, even in the absence of a solid consensus on the criteria for assuring an optimal cost-effectiveness and safety profile.

A prospective multicenter outcomes-oriented observational protocol adopted by a network of 29 hematological centers has explored specifically the relationship between the yield of rHuEPO, therapy and the levels of endogenous EPO in a cohort of 478 consecutively diagnosed patients (55% males), with NHL (43%), CLL (16%), MM (41%), in first (287, 60%) and successive (191, 40%) chemotherapy line. Over the 12 months follow-up, 4/252 and 32/226 patients with Hb > 11 g/dl and < 11 g/dl died; up to 20% of those with inadequate EPO levels did not receive rHuEPO, while 16/35 (46%) of those with adequate EPO levels were prescribed rHuEPO. At a multivariate analysis, only patients with baseline Hb levels between 10 and 11 g/dl and in first line chemotherapy regimen, but not those with levels < 10 g/dl or in > 1^st. line therapy benefited from rHuEPO.

Conclusions: While providing an informative epidemiological profile of the patients exposed to rHu EPO during chemotherapy and of the care they receive in the routine practice of specialized centers, the study documents some of the areas of uncertain practice, and confirms the need of prospective, controlled trials in the specific value of rHu EPO in well-characterized subpopulations on chemotherapy for hematological malignancies.