The objectives of this study are to continue the follow-up of patients entered into prospective Phase II and III therapeutic studies of polycythemia vera. Longer term follow-up to compare mortality and incidence of complications in the three treatment groups (phlebotomy, chlorambucil and 32P) of the PVSG-01 study will permit assessment of optimal therapy. The natural history of polycythemia vera is being characterized and the long term effects of myelosuppressive therapy such as leukemia and cancer determined. Recently, a randomized study had been completed which tested the effect of platelet and anti-aggregating agents plus phlebotomy vs 32-P, the best myelosuppressive treatment. The results were of major significance in that an increased incidence of thrombosis occurred with the anti-aggregating agents suggesting that such agents were not of any benefit. Trials of new agents, such as Hydrea, for treatment of polycythemia and its major symptoms, are being utilized to test its efficacy in management of polycythemia vera. This drug, a non-alkylating myelosuppressive agent, has been highly effective in the treatment of polycythemia vera and its long term effects are being followed, not only with regard to its leukemogenic and oncogenic potential, but for its use as a hemoglobin stimulant of fetal hemoglobin in sickle cell anemia. As of 3/84, 134 patients on the 01 protocol and 104 on the 08 protocol are still being followed. We would like to complete the follow-up on patients on the 01 protocol to the point where 90-95% of the patients have died as well as to continue to accumulate data concerning the long term effects of Hydrea on survival and oncogenesis. To complete this goal, we would like to continue to support a small statistical operation at the current Central Office of the Polycythemia Vera Study Group for the further follow-up and analysis of the patients on these existing protocols of the Polycythemia Vera Study Group.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA010728-17
Application #
3555935
Study Section
Cancer Regional Studies Review Committee (CRS)
Project Start
1985-02-01
Project End
1987-12-31
Budget Start
1986-01-01
Budget End
1986-12-31
Support Year
17
Fiscal Year
1986
Total Cost
Indirect Cost
Name
Mount Sinai School of Medicine
Department
Type
Schools of Medicine
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10029
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Wanless, I R; Peterson, P; Das, A et al. (1990) Hepatic vascular disease and portal hypertension in polycythemia vera and agnogenic myeloid metaplasia: a clinicopathological study of 145 patients examined at autopsy. Hepatology 12:1166-74
Swolin, B; Weinfeld, A; Westin, J (1988) A prospective long-term cytogenetic study in polycythemia vera in relation to treatment and clinical course. Blood 72:386-95
Stoll, D B; Peterson, P; Exten, R et al. (1988) Clinical presentation and natural history of patients with essential thrombocythemia and the Philadelphia chromosome. Am J Hematol 27:77-83
Iland, H J; Laszlo, J; Case Jr, D C et al. (1987) Differentiation between essential thrombocythemia and polycythemia vera with marked thrombocytosis. Am J Hematol 25:191-201
Kaplan, M E; Mack, K; Goldberg, J D et al. (1986) Long-term management of polycythemia vera with hydroxyurea: a progress report. Semin Hematol 23:167-71
Murphy, S; Iland, H; Rosenthal, D et al. (1986) Essential thrombocythemia: an interim report from the Polycythemia Vera Study Group. Semin Hematol 23:177-82
Berk, P D; Goldberg, J D; Donovan, P B et al. (1986) Therapeutic recommendations in polycythemia vera based on Polycythemia Vera Study Group protocols. Semin Hematol 23:132-43
Wasserman, L R (1986) Polycythemia Vera Study Group: a historical perspective. Semin Hematol 23:183-7
Ellis, J T; Peterson, P; Geller, S A et al. (1986) Studies of the bone marrow in polycythemia vera and the evolution of myelofibrosis and second hematologic malignancies. Semin Hematol 23:144-55

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