Table 3.
Major Phase II trials of bortezomib-based regimens in Waldenström’s macroglobulinemia.
| Ref. | Bortezomib combination studied | Bortezomib dose and schedule | No. of patients | Results |
|---|---|---|---|---|
| [93] | BDR | 1.3 mg/m2 on days 1, 4, 8, 11, every 21 days, dexamethasone 40 mg on same days, rituximab 375 mg/m2 on day 11 | 23 (previously untreated) | ORR 96%, 3 CRs, median time to response 1.4 months, 18 of 23 free of progression at median f/u of 22.8 months |
| [95] | Bortezomib and rituximab* | 1.6 mg/m2 on days 1, 8, 15, every 28 days | 26 (previously untreated) | 88% ORR, 1 CR and 1 near CR |
| [94] | Bortezomib and rituximab* | 1.6 mg/m2 on days 1, 8, 15, every 28 days | 37 (relapsed or refractory) | 81% ORR, 2 CR/near CRs, median TTP 16.4 months |
*
Rituximab given at a dose of 375 mg/m2 weekly in cycles 1 and 4.
BDR: Bortezomib, dexamethasone, rituximab; CR: Complete response; f/u: Follow up; ORR: Overall response rate; TTP: Time to progression.