Published and presented prospective trials of IFN products in PV and ET
| Clinical trial (reference) . | Study type; follow-up . | IP starting dose . | n . | Patient population . | Age, y (range) . | ORR% (CR%) . | Molecular response (%) . | AE . |
|---|---|---|---|---|---|---|---|---|
| Masarova et al10 | Single institution; 83 mo | PEG 450-90 µg/wk | 40 ET | New diagnosis and previously treated | 53 (43-62) | PV 79 (77) | 63 | Grade III/IV AE: 69% |
| 43 PV | ET 80 (73) | CR 18 | Discontinuation TEAE: 22% | |||||
| Major VTE: 8 | ||||||||
| Transformations: MF (6) AML (1) | ||||||||
| Kiladjian et al15 | Multicenter; 31.4 mo | PEG 90 µg/wk | 40 PV | New diagnosis | 49 | 100 (94.6) | 89.6 | Grade III AE 3% |
| CR 24.1 | Any AE: 94% | |||||||
| Discontinuation TEAE 24.3% No VTE | ||||||||
| Silver20 | Long-term data; 13 y | rIFNα 1 MU/TIW | 55 PV | Phlebotomy and HU | 50 (24-80) | NA | Discontinuation TEAE 15% | |
| No VTE | ||||||||
| Gisslinger et al19 | Multicenter; 80 wk | RoPEG 50-540 µg q 2 wk | 51 PV | New diagnosis and previously treated | 56 (35-82) | 90(47) | PR 47 | All AE: 88% |
| CR 21 | Discontinuation TEAE 20% | |||||||
| Major vascular events: 2 | ||||||||
| Gisslinger et al18 | Multicenter | RoPEG 50-500 µg q 2 wk | 127 PV | Untreated or previously treated (<3 y) | 60 (30-85) | 43.1% | — | — |
| Yacoub et al, current study | Multicenter; 12 mo | PEG 45 µg/wk | 65 ET | Previously treated | 64 (20-85) | ET 69 (43) | 41.3 | Grade III/IV: 39% |
| 50 PV | PV 60 (22) | Discontinuation TEAE 13.9% | ||||||
| Mascarenhas et al21 | Multicenter; 12 mo | PEG 45 µg/wk | 39 ET | New diagnosis <5 y | 60 (19-79) | 78 (35.4) | NR | Grade III/IV: 37% |
| 43 PV | PV 86 (28) | Discontinuation TEAE 12.5% | ||||||
| ET 69 (43) |
| Clinical trial (reference) . | Study type; follow-up . | IP starting dose . | n . | Patient population . | Age, y (range) . | ORR% (CR%) . | Molecular response (%) . | AE . |
|---|---|---|---|---|---|---|---|---|
| Masarova et al10 | Single institution; 83 mo | PEG 450-90 µg/wk | 40 ET | New diagnosis and previously treated | 53 (43-62) | PV 79 (77) | 63 | Grade III/IV AE: 69% |
| 43 PV | ET 80 (73) | CR 18 | Discontinuation TEAE: 22% | |||||
| Major VTE: 8 | ||||||||
| Transformations: MF (6) AML (1) | ||||||||
| Kiladjian et al15 | Multicenter; 31.4 mo | PEG 90 µg/wk | 40 PV | New diagnosis | 49 | 100 (94.6) | 89.6 | Grade III AE 3% |
| CR 24.1 | Any AE: 94% | |||||||
| Discontinuation TEAE 24.3% No VTE | ||||||||
| Silver20 | Long-term data; 13 y | rIFNα 1 MU/TIW | 55 PV | Phlebotomy and HU | 50 (24-80) | NA | Discontinuation TEAE 15% | |
| No VTE | ||||||||
| Gisslinger et al19 | Multicenter; 80 wk | RoPEG 50-540 µg q 2 wk | 51 PV | New diagnosis and previously treated | 56 (35-82) | 90(47) | PR 47 | All AE: 88% |
| CR 21 | Discontinuation TEAE 20% | |||||||
| Major vascular events: 2 | ||||||||
| Gisslinger et al18 | Multicenter | RoPEG 50-500 µg q 2 wk | 127 PV | Untreated or previously treated (<3 y) | 60 (30-85) | 43.1% | — | — |
| Yacoub et al, current study | Multicenter; 12 mo | PEG 45 µg/wk | 65 ET | Previously treated | 64 (20-85) | ET 69 (43) | 41.3 | Grade III/IV: 39% |
| 50 PV | PV 60 (22) | Discontinuation TEAE 13.9% | ||||||
| Mascarenhas et al21 | Multicenter; 12 mo | PEG 45 µg/wk | 39 ET | New diagnosis <5 y | 60 (19-79) | 78 (35.4) | NR | Grade III/IV: 37% |
| 43 PV | PV 86 (28) | Discontinuation TEAE 12.5% | ||||||
| ET 69 (43) |
IP, investigational product; MU: million units; VTE, venous thromboembolism; TEAE, treatment-emergent adverse event, TIW, 3 times a week.