Subcutaneous Bortezomib Offers Improved Safety Profile for Treating Patients with Relapsed Multiple Myeloma

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Subcutaneous administration of bortezomib (Velcade) was comparably efficacious to intravenous administration in a phase III trial in patients with relapsed multiple myeloma, but the SC route “seemed to have an improved systemic safety profile compared with intravenous delivery,’’ investigators reported in Lancet Oncology. “Subcutaneous administration is a promising alternative to intravenous administration, particularly in patients with poor venous access or at increased risk of side effects,” they concluded.

Trial Data

Patients were enrolled at 53 centers in 10 countries in Europe, Asia, and South America. Eligible patients had secretory multiple myeloma, had received one to three previous lines of therapy (excluding previous bortezomib), and had evidence of disease progression since the last therapy. After a median follow-up of 11.8 months for the 145 evaluable patients in the subcutaneous group and 12.0 months for the 73 patients in the intravenous group, there were no significant differences in time to progression (median, 10.4 months for those receiving subcutaneous administration vs 9.4 months for intravenous administration) and 1-year overall survival (72.6% vs 76.7%). Grade 3 or worse adverse events were reported in 57% of the patients in the subcutaneous group vs 70% in the intravenous group, with 22% of patients in the subcutaneous group vs 27% in the intravenous group discontinuing treatment because of adverse events and 31% in the subcutaneous group and 43% in the intravenous group requiring bortezomib dose reductions due to adverse events.

“Notably, we recorded significantly lower rates of peripheral neuropathy of all grades, grade 2 and higher, and grade 3 and higher with subcutaneous bortezomib than with intravenous bortezomib, despite similar rates of potential risk factors in each group,” the investigators reported. “Subcutaneous administration seems to provide an additional option to reduce bortezomib-related peripheral neuropathy, and in conjunction with dosing or schedule modifications, could further reduce neuropathy side effects to a level such that potential peripheral neuropathy risk factors no longer constitute a limiting factor for selection of bortezomib treatment,” they added.

“The increased convenience of subcutaneous administration might also be relevant for investigation in settings such as maintenance therapy,” the authors commented. This route of administration could facilitate home administration of the drug, “with substantial cost reduction and greatly improved patient convenience,” they concluded. ■

Moreau P, et al: Lancet Oncol 12:431-440, 2011.




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