Table 1.
Clinical trials in relapsed or refractory MCL | N | PR | CR | ORRa | Significant AEb |
---|---|---|---|---|---|
Bortezomib21 | 141 | 26% (36/141) | 6% (9/141) | 47% | Fatigue, thrombocytopenia, neuropathy |
Bortezomib22 | 28 | 43% (12/28) | 0 | 46.4% | |
Bortezomib23 | 29 | 21% (6/29) | 21% (6/29) | 41% (12/29) | |
Bortezomib24 | 10 | 40% (4/10) | 0 | 50% (5/10) | |
Lenalidomide30 | 15 | 33% (5/15) | 20% (3/15) | 53% (8/15) | Neutropenia, leucopenia, thrombocytopenia |
Thalidomide29 | 16 | 50% (8/16) | 25% (4/16) | 81% (13/16) | Somnolence, neuropathy, constipation |
Bendamustine + fludarabine25 | 9 | 66% (6/9) | 33% (3/9) | 100% (9/9) | Leukopenia, neutropenic fever, thrombocytopenia, anemia |
Bendamustine + rituximab26 | 16 | 25% (4/16) | 50% (8/16) | 75% (12/16) | |
Bendamustine + rituximab + mitoxantrone28 | 18 | 44% (8/18) | 33% (6/18) | 78% (14/18) | |
Temsirolimus31 | 27 | 37% (10/27) | 4% (1/27) | 41% (11/27) | Thrombocytopenia, fatigue, hyperglycemia, dyspnea |
Temsirolimus32 | 34 | 35% (12/34) | 3% (1/34) | 38% (13/34) |
Notes:
ORR based on PR and CR.
Generally grade 3 or higher.
Abbreviations: N, number of patients with MCL evaluable for efficacy; PR, partial response; CR, complete response; ORR, overall response rate; AE, adverse events.