Table 1.
Major Phase II studies of bortezomib monotherapy in mantle cell lymphoma.
Ref. | Bortezomib dose and schedule | No. of patients | No. of prior therapies | Results |
---|---|---|---|---|
[24,76] | 1.3 mg/m2 on days 1, 4, 8, 11 (every 21 days) | 155 treated, 141 assessable for response | 1 (median) | 33% ORR, 8% CR/CRu, median TTP 6.7 months, median OS 23.5 months, median DOR 9.2 months |
[77] | 1.3 mg/m2 on days 1, 4, 8, 11 (every 21 days) | 29 (13 previously untreated) | 0 in 13, 1 in 11, 2 in 5 | 46.4% ORR, 1 CRu, median DOR 10 months |
[78] | 1.5 mg/m2 on days 1, 4, 8, 11 (every 21 days)* | 40 | 2 | 47% ORR (5 CRs) |
Dose reductions to 1.3 and 1.1 mg/m2 were allowed.
CR: Complete response; CRu: Unconfirmed complete response; DOR: Duration of response; ORR: Overall response rate; OS: Overall survival; TTP: Time to progression.