A prospective comparison between treatment with phlebotomy alone and with interferon-alpha in patients with polycythemia vera

Abstract

Interferon alpha (alpha-IFN) is increasingly used for the treatment of patients affected by polycythemia vera (PV). As prior studies are difficult to interpret in view of the lack of appropriate controls, we undertook a randomized comparison of lymphoblastoid alpha-IFN (alpha n-1 IFN) treatment against venesection treatment alone. In a crossover trial, we treated 22 PV patients alternatively for 5 months each with 3 MU/day sc of alpha n-1 IFN and phlebotomy alone. During IFN treatment, red blood cell count and hematocrit level were well controlled in both trial groups, reducing or eliminating the need for phlebotomy in all patients; furthermore, platelet number and white blood cell count declined during alpha-IFN therapy. In addition, the number of symptomatic patients was greatly reduced, and in six patients a reduction in splenic size was observed. Finally, the only patient with chromosomal abnormalities showed a complete cytogenetic conversion after 5 months of alpha-IFN therapy. Thus, for the first time, our results provide the unequivocal demonstration that alpha-IFN is superior to phlebotomy in controlling the pathologic expansion of erythroid elements and all the clinical aspects of this disease.

Alfa-interferon in the treatment of essential thrombocythemia: clinical results and evaluation of its biological effects on the hematopoietic neoplastic clone

“…We have found a decrease in megakaryocytic concentration in ET patients, 2 and a reduction in the abnormal proliferation of erythroid elements in cases of PV. 39 In both patient categories, a reduction in spleen size has also frequently been seen. With the improvement of hematological parameters, clinical symptoms have also progressed positively.…”

Polycythemia Vera: Perspectives for Future Clinical Trials

“…65-100% of patients treated with doses of 9-21 MU per week reached complete or almost complete hematological remission [36][37][38][39][40][41][42]. In single cases, disappearance of a chromosomal abnormality suggests a preferential efficacy on the abnormal done [43,44).…”

A review of the therapeutic agents used in the management of polycythaemia vera

“…In addition, Sacchi carried a randomised crossover trial comparing IFN-a to venesection alone. IFN-a was superior in controlling blood counts and symptoms [29].…”