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

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.

Efficacy and safety of autologous stem cell transplantation after induction therapy with lenalidomide, bortezomib, and dexamethasone

“…In a meta‐analysis evaluating TVD, Leiba et al found a postinduction VGPR rate (or better) around 60%, compared to 75% in our study. Moreover, the median PFS is higher with the RVD combination (45 months in our work) than with TVD (range: 18.3‐33.1 months) . These results are similar to those found by Rosiñol et al in their integrated analysis of randomized clinical trials evaluating RVD or TVD: Responses were deeper with RVD than TVD (≥ VGPR rate after induction with VRD vs VTD was 66.3% vs 51.2%; P = .00281).…”

“…The incidence of thalidomide‐related neuropathy (all grades) varies between 10% and 83% . With TVD combination, the risk of peripheral neuropathy ≥grade 3 is about 10 to 31%, in comparison with our 5% rate with RVD combination. This rate of peripheral neuropathy ≥grade 3 related to RVD was similar to the rate found by Rosiñol et al comparing RVD and TVD (5% versus 15.4%) .…”

Tolerance, Kinetics, and Depth of Response for Subcutaneous Versus Intravenous Administration of Bortezomib Combination in Chinese Patients With Newly Diagnosed Multiple Myeloma

“…These outcomes were subsequently confirmed in the randomized, prospective MMY-3021 study involving RRMM patients 11–13 which led to the 2012 approval of SC Btz in the United States and European Union. However, despite several other reports supporting the use of SC Btz, 14, 15 , there is very limited data available about the safety and efficacy profile of SC Btz in Chinese and Asian patients with newly-diagnosed multiple myeloma (NDMM) 16–19 . Few studies with small cohorts compared the two administration routes in Asian patients 20, 21 .…”

Once-weekly bortezomib had similar effectiveness and lower thrombocytopenia occurrence compared with twice-weekly bortezomib regimen in treating patients with newly diagnosed multiple myeloma in China

“…The median PFS of subcutaneous injection group and intravenous injection group was 10.2 months and 8 months, respectively ( P > .05), and the 1-year OS rate were 72.6% and 76.7%, respectively ( P > .05). Merz et al, [39] Liu et al, [40] and Wu et al [41] showed better tolerability and similar treatment response of subcutaneous vs intravenous bortezomib. On the other hand, Minarik et al [42] reported similar effectiveness but also similar adverse reactions of subcutaneous and intravenous bortezomib.…”