Effects of 40,000 IU Bi-Weekly (BIW) Induction Dose of Epoetin Alfa Followed by 40,000 IU Once Weekly (QW) in Low-Risk Myelodysplastic Syndrome (MDS) Patients.

Reviewer: Tracy d'Entremont, MD
OncoLink
Last Modified: December 9, 2002

Presenter: Maria A. A. Spiriti
Presenter's Affiliation: Italian Fatigue-QoL/MDS Cooperative Group, Italy
Type of Session: Poster

Background

Anemia is a serious problem in MDS and other hematologic malignancies.
>50% of patients with MDS will have anemia at presentation and up to 90% will suffer from it at some point in time during their disease.
>80% of patients with MDS will require transfusions
Anemia in MDS affects functional impairment and causes a decrease QoL
Previous clinical trials demonstrated that Epo Alfa can increase Hgb levels and decrease or eliminate transfusion requirements. Doses of Epo in previous trials averaged approximately 70,000 IU/wk SQ and demonstrated a RR of 37%
This trial was developed to determine if a lower dose of epo would be as efficacious.

Materials and Methods

This is an open-labelled prospective multicenter study conducted over 24 weeks.
Patients enrolled had low risk MDS (RA, RARS, or RAEB)
Epoetin alfa 40,000 IU was given sc BIW for 4 weeks.
Evaluation was performed at four weeks, for those not responding, therapy was continued at the same dose. For those patients responding, the dose was decreased to 40,000 IU QW for 20 weeks.
Evaluations were performed at four week intervals.
A major response was defined as Hgb rise >/= 2 g/dl
A minor response was defined as Hgb rise between 1 and 2 g/dl.
QOL was assessed using the FACT-An at baseline and at 4 week intervals.

Results

Response in transfusion-independent patients was 75%, including 47% with major response and 28% witn minor response.
Response in transfusion dependent patients was 59%.
Mean increases in FACT-An and FACT-An Fatigue subscale scores were 8 and 6 respectively.
Treatment was well tolerated with no relevant adverse events except in 1 patient who discontinued treatment due to hypertension

Author's Conclusions

Our data provide encouraging results regarding the benefits of 40,000 IU BIW induction followed by 40,000 IU QW in correcting anemia, reducing transfusion requirements, and improving quality of life in low-risk MDS patients.

Clinical/Scientific Implications

This data is extremely helpful to clinicians caring for patients with MDS. Most patients with MDS are elderly patients with MediCare coverage. Often times these patients need to get their injections in physicians' offices in order to have them covered. This data allows patients to be treated with EPO in the office only once a week which is far more convenient for patients and physicians.

Oncolink's ASH Coverage made possible by an unrestricted Educational Grant from Ortho Biotech.