Main trials in polycythemia vera (PV).
| Trial . | Patients . | Endpoint . | Experimental treatments . | P . | ||
|---|---|---|---|---|---|---|
| Abbreviations: PV, polycythemia vera; ET, essential thrombocythemia; O/E, observed events to the events expected in an age- and sex-matched reference population; AML, acute myeloid leukemia; RR, relative risk; Pts,patients; HU, hydroxyurea; n.r, not reported; n.s., not significant; max, maximum follow-up; pts, patients. | ||||||
| *plus phlebotomy and dipyridamole | ||||||
| PVSG-0112 | 431 pts; 18 yrs (max) | 32 P | Phlebotomy | Chlorambucil | ||
| Median survival | 11.8 yrs | 13.9 yrs | 8.9 yrs | 0.02 | ||
| Thrombosis | 30% | 34% | 25% | 0.08 | ||
| Acute Leukemia | 10% | 1.5% | 13% | < 0.0012 | ||
| EORTC13 | 293 pts. 8 yrs (median) | 32 P | Busulfan | |||
| 10-year survival | 55% | 70% | 0.02 | |||
| Vascular deaths | 18% | 5% | n.r. | |||
| Najean et al14 | 461 pts; Age > 65 yrs 16 yrs (max) | 32 P | 32 P+HU | |||
| Median survival | 10.9 yrs | 9.3 yrs. | n.s. | |||
| Najean et al15 | 292 pts; Age <65 yrs 16 yrs (max) | HU | Pipobroman | |||
| 14-year survival | 70% | 70% | n.s. | |||
| Myelofibrosis | 17% | 2.1% | 0.03 | |||
| PVSG-0516 | 166 pts; 1.2 yrs (median) | ASA (900 mg/d)* | 32 P | |||
| Thrombosis | 8% | 2% | n.r. | |||
| Hemorrhage | 7% | 0% | 0.02 | |||
| GISP17 | 112 pts; 1.4 yrs (median) | ASA (40 mg/d) | Placebo | |||
| Thrombosis | 5% | 7.7% | n.s. | |||
| Hemorrhage | 1.7% | 1.9% | n.s. | |||
| Trial . | Patients . | Endpoint . | Experimental treatments . | P . | ||
|---|---|---|---|---|---|---|
| Abbreviations: PV, polycythemia vera; ET, essential thrombocythemia; O/E, observed events to the events expected in an age- and sex-matched reference population; AML, acute myeloid leukemia; RR, relative risk; Pts,patients; HU, hydroxyurea; n.r, not reported; n.s., not significant; max, maximum follow-up; pts, patients. | ||||||
| *plus phlebotomy and dipyridamole | ||||||
| PVSG-0112 | 431 pts; 18 yrs (max) | 32 P | Phlebotomy | Chlorambucil | ||
| Median survival | 11.8 yrs | 13.9 yrs | 8.9 yrs | 0.02 | ||
| Thrombosis | 30% | 34% | 25% | 0.08 | ||
| Acute Leukemia | 10% | 1.5% | 13% | < 0.0012 | ||
| EORTC13 | 293 pts. 8 yrs (median) | 32 P | Busulfan | |||
| 10-year survival | 55% | 70% | 0.02 | |||
| Vascular deaths | 18% | 5% | n.r. | |||
| Najean et al14 | 461 pts; Age > 65 yrs 16 yrs (max) | 32 P | 32 P+HU | |||
| Median survival | 10.9 yrs | 9.3 yrs. | n.s. | |||
| Najean et al15 | 292 pts; Age <65 yrs 16 yrs (max) | HU | Pipobroman | |||
| 14-year survival | 70% | 70% | n.s. | |||
| Myelofibrosis | 17% | 2.1% | 0.03 | |||
| PVSG-0516 | 166 pts; 1.2 yrs (median) | ASA (900 mg/d)* | 32 P | |||
| Thrombosis | 8% | 2% | n.r. | |||
| Hemorrhage | 7% | 0% | 0.02 | |||
| GISP17 | 112 pts; 1.4 yrs (median) | ASA (40 mg/d) | Placebo | |||
| Thrombosis | 5% | 7.7% | n.s. | |||
| Hemorrhage | 1.7% | 1.9% | n.s. | |||