Randomized clinical trials in polycythemia vera.
| Study . | Patents and Follow-Up . | Treatments and Main Results . | P . | |||
|---|---|---|---|---|---|---|
| PVSG-014 | 431 pts; 18 yrs (max) | 32P | 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 | ||
| EORTC11 | 293 pts.; 8 yrs (median) | 32P | Busulfan | |||
| 10-year survival | 55% | 70% | 0.02 | |||
| Vascular deaths | 18% | 5% | n.r. | |||
| Najean et al.12 | 461 pts; 16 yrs (max) | 32P | 32P+Hydroxyurea | |||
| Age > 65 yrs | Median survival | 10.9 yrs | 9.3 yrs. | n.s. | ||
| Najean et al.14 | 292 pts; 16 yrs (max) | Hydroxyurea | Pipobroman | |||
| Age <65 yrs | 14-year survival | 70% | 70% | n.s. | ||
| Myelofibrosis | 17% | 2.1% | 0.03 | |||
| PVSG-057 | 166 pts; 1.2 yrs (median) | ASA (900 mg/d)* | 32P | |||
| Thrombosis | 8% | 2% | n.r. | |||
| Hemorrhage | 7% | 0% | 0.02 | |||
| GISP21 | 112 pts; 1.4 yrs (median) | ASA (40 mg/d) | Placebo | |||
| Thrombosis | 5% | 7.7% | n.s. | |||
| Hemorrhage | 1.7% | 1.9% | n.s. | |||
| Abbrevations: n.r, not reported; n.s., not significant; max, maximum follow-up; pts, patients | ||||||
| Study . | Patents and Follow-Up . | Treatments and Main Results . | P . | |||
|---|---|---|---|---|---|---|
| PVSG-014 | 431 pts; 18 yrs (max) | 32P | 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 | ||
| EORTC11 | 293 pts.; 8 yrs (median) | 32P | Busulfan | |||
| 10-year survival | 55% | 70% | 0.02 | |||
| Vascular deaths | 18% | 5% | n.r. | |||
| Najean et al.12 | 461 pts; 16 yrs (max) | 32P | 32P+Hydroxyurea | |||
| Age > 65 yrs | Median survival | 10.9 yrs | 9.3 yrs. | n.s. | ||
| Najean et al.14 | 292 pts; 16 yrs (max) | Hydroxyurea | Pipobroman | |||
| Age <65 yrs | 14-year survival | 70% | 70% | n.s. | ||
| Myelofibrosis | 17% | 2.1% | 0.03 | |||
| PVSG-057 | 166 pts; 1.2 yrs (median) | ASA (900 mg/d)* | 32P | |||
| Thrombosis | 8% | 2% | n.r. | |||
| Hemorrhage | 7% | 0% | 0.02 | |||
| GISP21 | 112 pts; 1.4 yrs (median) | ASA (40 mg/d) | Placebo | |||
| Thrombosis | 5% | 7.7% | n.s. | |||
| Hemorrhage | 1.7% | 1.9% | n.s. | |||
| Abbrevations: n.r, not reported; n.s., not significant; max, maximum follow-up; pts, patients | ||||||
plus phlebotomy and dypiridamole