Selected experiences with approved single-agents and off-label compounds in PTCL patients, including PTCL-NOS
| Treatment . | Reference . | No. of patients . | ORR, % . | CR, % . | Median OS, mo . | Median PFS, mo . | PTCL-NOS, N (%) . | PTCL-NOS ORR, % . | Toxicity* . |
|---|---|---|---|---|---|---|---|---|---|
| Pralatrexate† | 53 | 111 | 29 | 11 | 14.5 | 3.5 | 59 (53) | 32 | Mucositis, thrombocytopenia, nausea, fatigue, anemia, constipation, pyrexia, anemia, edema, cough, epistaxis, vomiting, neutropenia, diarrhea |
| Romidepsin† | 55 | 47 | 38 | 18 | NA‡ | NA‡ | 27 (57) | 41 (19)§ | ECG T-wave changes, nausea, fatigue, thrombocytopenia, leukopenia, hypocalcemia |
| 56 | 130 | 25 | 15 | NA‡ | 4.0 | 69 (53) | 29 (14)§ | Nausea, asthenia/fatigue, thrombocytopenia, vomiting, diarrhea, pyrexia, neutropenia, constipation, anorexia, anemia, dysgeusia | |
| Bendamustine | 66 | 58 | 50 | 28 | 6.3 | 3.6 | 23 (40) | 41 | Neutropenia, thrombocytopenia, infections |
| Lenalidomide | 68 | 10 | 30 | 30 | NA‡ | NA‡ | 10 (100) | 30 (30)§ | Neutropenia |
| 69 | 54 | 22 | 11 | NA‡ | 2.5 | 20 (37) | 20 | Thrombocytopenia | |
| 70 | 39|| | 26 | 8 | 12.0 | 4.0 | 14 (36) | 43 (14)§ | Pain, fatigue, constipation, rash, diarrhea, anorexia, edema, nausea, anemia, dizziness, dyspnea, infection, insomnia, muscle weakness, thrombocytopenia, cough, pruritus | |
| Brentuximab vedotin¶ | 62 | 34 | 42 | 24 | NA‡ | 2.6 | 21 (62) | 33 (14)§ | Peripheral neuropathy, fatigue, leukopenia, neutropenia, thrombocytopenia, anemia, nausea, anorexia |
| Belinostat† | 65 | 129 | 23 | 9 | 7.9 | 1.6 | 77 (64) | 23 | Nausea, fatigue, pyrexia, vomiting, constipation, diarrhea, dyspnea, rash, peripheral edema |
| Alisertib | 73 | 37 | 24 | 5 | 8.0 | 3.0 | 13 (35) | 31 (8)§ | Anemia, thrombocytopenia, fatigue, neutropenia, leucopenia, lymphopenia, alopecia, mucositis |
| Treatment . | Reference . | No. of patients . | ORR, % . | CR, % . | Median OS, mo . | Median PFS, mo . | PTCL-NOS, N (%) . | PTCL-NOS ORR, % . | Toxicity* . |
|---|---|---|---|---|---|---|---|---|---|
| Pralatrexate† | 53 | 111 | 29 | 11 | 14.5 | 3.5 | 59 (53) | 32 | Mucositis, thrombocytopenia, nausea, fatigue, anemia, constipation, pyrexia, anemia, edema, cough, epistaxis, vomiting, neutropenia, diarrhea |
| Romidepsin† | 55 | 47 | 38 | 18 | NA‡ | NA‡ | 27 (57) | 41 (19)§ | ECG T-wave changes, nausea, fatigue, thrombocytopenia, leukopenia, hypocalcemia |
| 56 | 130 | 25 | 15 | NA‡ | 4.0 | 69 (53) | 29 (14)§ | Nausea, asthenia/fatigue, thrombocytopenia, vomiting, diarrhea, pyrexia, neutropenia, constipation, anorexia, anemia, dysgeusia | |
| Bendamustine | 66 | 58 | 50 | 28 | 6.3 | 3.6 | 23 (40) | 41 | Neutropenia, thrombocytopenia, infections |
| Lenalidomide | 68 | 10 | 30 | 30 | NA‡ | NA‡ | 10 (100) | 30 (30)§ | Neutropenia |
| 69 | 54 | 22 | 11 | NA‡ | 2.5 | 20 (37) | 20 | Thrombocytopenia | |
| 70 | 39|| | 26 | 8 | 12.0 | 4.0 | 14 (36) | 43 (14)§ | Pain, fatigue, constipation, rash, diarrhea, anorexia, edema, nausea, anemia, dizziness, dyspnea, infection, insomnia, muscle weakness, thrombocytopenia, cough, pruritus | |
| Brentuximab vedotin¶ | 62 | 34 | 42 | 24 | NA‡ | 2.6 | 21 (62) | 33 (14)§ | Peripheral neuropathy, fatigue, leukopenia, neutropenia, thrombocytopenia, anemia, nausea, anorexia |
| Belinostat† | 65 | 129 | 23 | 9 | 7.9 | 1.6 | 77 (64) | 23 | Nausea, fatigue, pyrexia, vomiting, constipation, diarrhea, dyspnea, rash, peripheral edema |
| Alisertib | 73 | 37 | 24 | 5 | 8.0 | 3.0 | 13 (35) | 31 (8)§ | Anemia, thrombocytopenia, fatigue, neutropenia, leucopenia, lymphopenia, alopecia, mucositis |
ECG, electrocardiogram; NA, not assessed.
Toxic effects demonstrated in at least 20% of patients.
Drug has received a Food and Drug Administration approval in patients with relapsed and refractory peripheral T-cell lymphoma.
OS/PFS evaluation was not an endpoint of the study.
Figures in parentheses indicate the percentage of patients with PTCL-NOS obtaining a CR.
Includes 8 previously untreated patients not eligible for combination chemotherapy and 2 patients with lymphoblastic T-cell lymphoma.
Indicates that the drug has received a Food and Drug Administration approval in patients with CD30+ relapsed or refractory ALCL.