Chemotherapeutic regimens for newly diagnosed advanced-stage or relapsed/refractory ENKL
| Reference . | Study design . | Treatment . | Disease state . | No. of patients . | ORR, % . | CR, % . | Med. f/u, mo (range) . | OS, % . | PFS, % . | Leukopenia grade 3, %/grade 4, % . | Other adverse events grade 3, %/grade 4, % . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Prospective clinical trials | |||||||||||
| 63 | Phase 2 | AspaMetDex ×3 | Relapsed (n = 11), refractory (n = 8) | 19 | 78 (n = 18) | 61 (n = 18) | 26 (17-49) | 12 mo* | 12 mo* | n = 8†,‡ | Liver, n = 3† Anemia, n = 4† Allergy, n = 1† |
| 52 | Phase 2 | SMILE ×2 | N-d stage IV (n = 20), first relapse (n = 14), first refractory (n = 4) | 38 | 79 (n = 38) 80 (N-d stage IV) | 45 (n = 38) 40 (N-d stage IV) | 24 (13-35) | 55 (1 y) | 53 (1 y) | 24/76 | Infection, 45/16 Anemia, 47/3 Thrombocytopenia, 24/40 |
| Retrospective studies | |||||||||||
| 69 | Multicenter | MEDA Med., 4 (range, 1-6) | Relapsed (n = 7) or refractory (n = 6) with advanced disease | 13 | 77 | 62 | 25 (20-30) | 69 (1 y) | 62 (1 y) | 46†,‡ | Infection, 15† |
| Thrombocytopenia, 31† | |||||||||||
| 70 | Single center | P-GEMOX Med., 5 (range, 2-8) → RT or HD-AHSCT | N-d advanced (n = 19), relapsed or refractory (n = 16) | 35 | 94§ | 26§ | 28 (9-50) | 65 (2 y) | 39 (2 y) | 31/9 | Anemia, 20/6 Thrombocytopenia, 14/17Hypertriglyceridemia, 9/11 |
| 73 | Single center | GDP Med., 6 (range, 2-8) | N-d stage IV (n = 15), relapsed or refractory (n = 26) | 41 | 83 | 42 | 16 (2-96) | 73 (1 y) | 55 (1 y) | 34†,‡ | Anemia, 15†Thrombocytopenia, 20† |
| Reference . | Study design . | Treatment . | Disease state . | No. of patients . | ORR, % . | CR, % . | Med. f/u, mo (range) . | OS, % . | PFS, % . | Leukopenia grade 3, %/grade 4, % . | Other adverse events grade 3, %/grade 4, % . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Prospective clinical trials | |||||||||||
| 63 | Phase 2 | AspaMetDex ×3 | Relapsed (n = 11), refractory (n = 8) | 19 | 78 (n = 18) | 61 (n = 18) | 26 (17-49) | 12 mo* | 12 mo* | n = 8†,‡ | Liver, n = 3† Anemia, n = 4† Allergy, n = 1† |
| 52 | Phase 2 | SMILE ×2 | N-d stage IV (n = 20), first relapse (n = 14), first refractory (n = 4) | 38 | 79 (n = 38) 80 (N-d stage IV) | 45 (n = 38) 40 (N-d stage IV) | 24 (13-35) | 55 (1 y) | 53 (1 y) | 24/76 | Infection, 45/16 Anemia, 47/3 Thrombocytopenia, 24/40 |
| Retrospective studies | |||||||||||
| 69 | Multicenter | MEDA Med., 4 (range, 1-6) | Relapsed (n = 7) or refractory (n = 6) with advanced disease | 13 | 77 | 62 | 25 (20-30) | 69 (1 y) | 62 (1 y) | 46†,‡ | Infection, 15† |
| Thrombocytopenia, 31† | |||||||||||
| 70 | Single center | P-GEMOX Med., 5 (range, 2-8) → RT or HD-AHSCT | N-d advanced (n = 19), relapsed or refractory (n = 16) | 35 | 94§ | 26§ | 28 (9-50) | 65 (2 y) | 39 (2 y) | 31/9 | Anemia, 20/6 Thrombocytopenia, 14/17Hypertriglyceridemia, 9/11 |
| 73 | Single center | GDP Med., 6 (range, 2-8) | N-d stage IV (n = 15), relapsed or refractory (n = 26) | 41 | 83 | 42 | 16 (2-96) | 73 (1 y) | 55 (1 y) | 34†,‡ | Anemia, 15†Thrombocytopenia, 20† |