Correction of disease related anaemia of B-chronic lymphoproliferative disorders by recombinant human erythropoietin: Maintenance is necessary to sustain response

Thirty three B-chronic lymphoproliferative disorder (B-CLD) patients [22 wi th B-chronic lymphocytic leukemia (B-CLL), 5 with small lymphocytic lymphom a (SLL) and 6 with lymphoplasmacytic lymphoma (LPL)] with anaemia (Ht <32%) of no other cause but their disease, received recombinant human erythropoi etin (r-HuEPO). The treatment protocol provided r-HuEPO in a dose of 150 U/ kg sc. thrice weekly for 3 mo. After 1.5 mo of r-HuEPO administration, if r esponse was not satisfactory, r-HuEPO dose escalation was utilised by givin g incremental doses of 50 U/kg more than the previous dose up to a maximum dose of 300 U/kg tiw. After maximal response, half of the responding patien ts discontinued therapy, while the other half received maintenance therapy at a dose of 150 U/kg sc./w. Oral iron was given throughout the study. Pret reatment EPO levels were determined in all patients. A complete response (C R) was defined when Ht was >38% and a partial response (PR) when there was an increase of the Ht >6% from the initial value was achieved. Sixteen of the 22 B-CLL patients had Rai stage III disease and 6 stage IV, with a median duration of anaemia 27 months (6-38); twelve of them were rec eiving chlorambucil while the rest were on no treatment. Of the SLL and LPL group, 4 patients had Ann Arbor stage III disease and 7 stage IV with a me dian duration of anaemia 24 months (5-36); 8 patients were on chlorambucil. Complete response was achieved in 50% of the B-CLL group and 54% of the SL L and LPL group, with an overall response rate of 77 and 81% respectively. All patients on maintenance therapy had a continuous response, while all pa tients. in whom rHuEPO was discontinued, relapsed. No correlation was found between patients: with low or high pretreatment serum EPO levels; those re ceiving concomitant therapy or not; those with B-symptoms or not; those wit h a non-diffuse or diffuse bone marrow infiltration pattern: and with splen omegaly or not. Life quality was significantly improved and no major side e ffects were encountered. We conclude from our study that r-HuEPO is very ef fective in correcting disease-related anaemia in B-CLD, resulting in down-s taging of Rai stage III patients and that maintenance therapy is necessary. Whether the correction of anaemia improves patients' overall survival, sti ll remains to be seen.