Table 3.
Combinations of bortezomib with other chemotherapeutic agents as first line therapy
Study drugs | Reference | No of patients | Median assessable cycles | Major no of rate (CP+PR) | Response rates response | Follow up | Toxicities | |
---|---|---|---|---|---|---|---|---|
Bortezomib +/− Dexamethasone | Phase II | Jagannath, Durie, et al 2005 | 40 | Up to 6 cycles given | 85% | 28 patients had dex added and 64% showed improved response | 12 patients underwent SCT | Neuropathy Fatigue Constipation Neutropenia |
Bortezomib Dexamethasone | Phase II | Harousseau et al 2004 | 18 | 16 patients received 4 cycles | 83% | CR 17% VGPR 11% PR 55% | Stem cells collected in all cases | Neuropathy |
Bortezomib Doxorubicin Dexamethasone | Phase I/II | Oakervee et al 2005 | 21 | 19 patients received 4 cycles | 95% | CR 24% n-CR 5% VGPR 33% PR 33% | 18 patients underwent SCT with 44% CR and 95% ORR at 3 months | Neuropathy Postural hypotension Shingles Gastrointestinal |
Bortezomib Melphalan Prednisolone | Phase I/II | Mateos et al 2005 | 53 | 3 | 84% | CR 28% n-CR 11% PR 45% MR 2% | 90% alive at 7 months | Gastrointestinal Myelosuppression Infection Neuropathy |
Bortezomib Thalidomide Dexamethasone | Phase I/II | Alexanian et al 2004 | 25 | Up to 2 cycles given | 84% | 76% had >75% reduction in paraprotein +/− >l95% reduction in BJP | Median time to remission 0.6 months (compared with 1.1 months with Thal/Dex)12 patients underwent SCT | Infection Postural DVT Cytopenia |
Bortezomib Thalidomide Dexamethasone | Phase I/II | Wang et al 2005 | 36 | No more than 2 cycles needed for response | 92% | CR 19% PR 73% | 22 patients underwent SCT 89% in remission (31% CR) at 4 months | Neuropathy DVT Infections |
Abbreviations: CR, complete response; DVT, deep vein thrombosis; MR, minor response; n-CR, near complete response; ORR, overall response rate (CR+PR+MR); PR, partial response; SCT, stem cell transplant; VGPR, very good partial remission.