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Once Weekly Epoetin Beta Regimen Effectively Treats Chemotherapy-Induced Anaemia

Epoetin beta given once weekly is an effective and safe treatment for anaemia in patients with lymphoproliferative malignancy and defective endogenous erythropoietin production, say Italian researchers.

The guidelines of the American Society of Clinical Oncology and the American Society of Haematology recommend epoetin as a treatment option for patients having chemotherapy-associated anaemia (Hb <10 g/dL) and advise subcutaneous administration of 150 U/kg three times weekly.

In a previous uncontrolled, non-randomised community-based study, results indicated that epoetin alpha administered at 40,000 IU produced therapeutic effects similar to a conventional regimen. Because a once-weekly regimen offers potential cost savings, Mario Cazzola, MD, Division of Haematology, IRCCS Policlinico S. Matteo, Pavia and colleagues conducted a prospective, randomised trial to compare the efficacy of once weekly and thrice weekly regimens.

The researchers randomised a population of 241 anaemic patients with multiple myeloma, low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukaemia, to receive epoetin beta once weekly (119 patients, 30 000 IU dosage) or three times weekly (122 patients, 10 000 dosage) over 16 weeks.

Epoetin beta was administered by patients using the RecoPenŽ (F. Hoffmann-La Roche) subcutaneous self-injection delivery system. Dosage was doubled for patients in either regimen group who failed to respond to therapy after 4 weeks. For patients responding with an Hb increase greater than 2 g/dL within 4 weeks, the dosage was reduced by half.

The primary efficacy criterion was the time-adjusted area under the Hb-time curve (Hb AUC5-16), which showed that the once weekly regimen was clinically comparable to the thrice-weekly regimen [difference = - 0.20 g/dL (90% confidence interval - 0.52-0.11)].

Furthermore, therapeutic response rates were high and similar in both groups (72% in the once weekly regimen and 75% in the thrice-weekly regimen).

Data also showed that lower serum erythropoietin was associated with greater likelihood of treatment response (P = 0.002), indicating predictive value of baseline serum erythropoietin.

"Tailoring this treatment modality to subjects with defective endogenous Epo production represents a rational use of epoetin from both a medical and a community perspective," the researchers conclude.

The study was promoted and supported by F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Br J Haematol 2003 Aug;122:3:386-393. "Once-weekly epoetin beta is highly effective in treating anaemic patients with lymphoproliferative malignancy and defective endogenous erythropoietin production"

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