Efficacy and safety of subcutaneous versus intravenous bortezomib in multiple myeloma: a meta-analysis .

PURPOSE

We performed this meta-analysis to compare the efficacy and safety between two different administration routes of bortezomib, subcutaneous and intravenous.

METHODS

Six retrospective studies and three randomized controlled trials (RCTs) were included in our study. Data from retrospective studies or RCTs were pooled and displayed in their corresponding subgroup, retrospective studies subgroup or RCTs subgroup. We comprehensively compared the overall response rate (ORR) and the incidence of adverse events between subcutaneous and intravenous bortezomib.

RESULTS

We did not find statistical difference in ORR between the two administration routes. The pooled RRs for ORR were 0.99 (95% CI = 0.79 - 1.25, p = 0.95; retrospective studies subgroup) and 1.02 (95% CI = 0.93 - 1.11, p = 0.69; RCTs subgroup). Compared with intravenous bortezomib, the subcutaneous bortezomib reduced the incidence of peripheral neuropathy, both any grade and grade ≥ 3. The pooled RRs for any grade of peripheral neuropathy were 0.33 (95% CI = 0.15 - 0.71, p = 0.004; retrospective studies subgroup) and 0.55 (95% CI = 0.31 - 0.97, p = 0.04; RCTs subgroup), and for peripheral neuropathy grade ≥ 3 were 0.40 (95% CI = 0.16 - 0.95, p = 0.04; retrospective trials subgroup) and 0.39 (95% CI = 0.19 - 0.80, p = 0.01; RCTs subgroup). Only retrospective trials subgroup found that the incidence of thrombocytopenia and renal and urinary disorders were lower in subcutaneous bortezomib than in intravenous, with the pooled RRs 0.46 (95% CI = 0.29 - 0.72, p = 0.0007; retrospective trials subgroup) and 0.23 (95% CI = 0.09 - 0.56, p = 0.001; retrospective trials subgroup), respectively. The RCTs subgroup did not find statistical differences in these two adverse events.

CONCLUSIONS: Subcutaneous bortezomib did not significantly reduce therapeutic efficacy but resulted in a lower incidence of peripheral neuropathy than intravenous bortezomib. Compared with intravenous bortezomib, subcutaneous bortezomib might reduce the incidence of thrombocytopenia and renal and urinary disorders, but this needs more clinical trials to confirm.
.