Subcutaneous Administration of Bortezomib in Combination with Thalidomide and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma Patients.

Shenghao Wu,Yuejian Shi,Songyan Chen,Bijing Lin,Cuiping Zheng,Yuemiao Chen,Xiaoping Cai

doi:10.1155/2015/927105

Shenghao Wu, Yuejian Shi + Show 5 more

Open Access

https://doi.org/10.1155/2015/927105

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Journal: BioMed research international	Publication Date: Jan 1, 2015
Citations: 16	License type: CC BY 3.0

Affiliation: Wenzhou Central Hospital

Abstract

Objective. To investigate the efficacy and safety of the treatment of the newly diagnosed multiple myeloma (MM) patients with the therapy of subcutaneous (subQ) administration of bortezomib and dexamethasone plus thalidomide (VTD) regimen. Methods. A total of 60 newly diagnosed MM patients were analyzed. 30 patients received improved VTD regimen (improved VTD group) with the subQ injection of bortezomib and the other 30 patients received conventional VTD regimen (VTD group).The efficacy and safety of two groups were analyzed retrospectively. Results. The overall remission (OR) after eight cycles of treatment was 73.3% in the VTD group and 76.7% in the improved VTD group (P > 0.05). No significant differences in time to 1-year estimate of overall survival (72% versus 75%, P = 0.848) and progression-free survival (median 22 months versus 25 months; P = 0.725) between two groups. The main toxicities related to therapy were leukopenia, neutropenia, thrombocytopenia, asthenia, fatigue, and renal and urinary disorders. Grade 3 and higher adverse events were significantly less common in the improved VTD group (50%) than VTD group (80%, P = 0.015). Conclusions. The improved VTD regimen by changing bortezomib from intravenous administration to subcutaneous injection has noninferior efficacy to standard VTD regimen, with an improved safety profile and reduced adverse events.

Highlights

Bortezomib, the first potent therapeutic proteasome inhibitor, has been suggested as a standard care in patients with newly diagnosed and relapsed multiple myeloma (MM) [1]
Bortezomib is associated with high efficacy response rate when it is used as induction therapy before high-dose therapy (HDT) plus autologous stem cell transplantation (ASCT) [2, 3]
The results demonstrated that subQ administration of bortezomib was possible because there were no differences in overall systemic availability and pharmacodynamic activity, toxicity profiles, and response rates in MM [7]

Summary

Introduction

Bortezomib, the first potent therapeutic proteasome inhibitor, has been suggested as a standard care in patients with newly diagnosed and relapsed multiple myeloma (MM) [1]. A phase I study conducted by French Francophone Myeloma Intergroup compared the pharmacokinetics and pharmacodynamics, safety and efficacy of IV, and subQ administration of bortezomib in patients with relapsed and/or refractory MM. The results demonstrated that subQ administration of bortezomib was possible because there were no differences in overall systemic availability and pharmacodynamic activity, toxicity profiles, and response rates in MM [7]. Multicenter, BioMed Research International and randomized phase III study was performed to confirm the safety and efficacy of this new route; 222 patients were randomly assigned to receive up to eight 21-day cycles of subcutaneous or intravenous bortezomib; the results confirmed that subQ bortezomib was not inferior to standard IV route, with even an improved safety profile and lower incidence of severe adverse events [8]

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Results

Conclusion