Table 5.
Studies on Potential Long-Term Consequences of Hydroxyurea Use in Patients with Polycythemia Vera
| Investigator/year | Number of patients, follow-up | Intervention | Comparator | Rate of AML and MDS transformation |
|---|---|---|---|---|
| Fruchtman SM et al, 199724 | 51 patients, 795 weeks | Hydroxyurea (prospective) | Phlebotomy | 6.0% vs 1.5%a |
| Finazzi G et al, 200512 | 1638 patients, 2.8 years (4393 person-years) | Retrospective | No association with the use of single-agent hydroxyurea | |
| Kiladjian J-J et al, 201147 | 285 patients under 65 years of age, 16.3 years | Hydroxyurea (randomized) | Pipobroman | 10 years: 6.6% vs 13% 15 years: 16.5% vs 34.1% 20 years: 24.2% vs 52.1% (P = .004) “Pipobroman is leukemogenic and is unsuitable for first-line therapy [in PV].” |
| Tefferi A et al, 201348 | 1545 patients, 6.9 years | Retrospective | No association with single-agent hydroxyurea | |
a
No significant difference.
AML indicates acute myeloid leukemia; MDS, myelodysplastic syndromes; PV, polycythemia vera.