Subcutaneous Bortezomib
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Subcutaneous Bortezomib In Multiple Myeloma Sheridan M. Hoy
Published online: 22 January 2013 Ó Springer International Publishing Switzerland 2013
Abstract A subcutaneous formulation of bortezomib is now indicated in the EU and the US for the treatment of patients with multiple myeloma. This article reviews pharmacological, therapeutic efficacy and tolerability data relevant to the utilization of subcutaneous bortezomib (VelcadeÒ) in the treatment of patients with multiple myeloma. In a randomized, nonblind, phase III study, subcutaneous bortezomib was noninferior to intravenous bortezomib in the treatment of adults with relapsed multiple myeloma, as determined by the overall response rate after four cycles of therapy (primary endpoint). No significant differences between the subcutaneous and intravenous bortezomib formulations were observed in the median time to first response, median progression-free survival, median time to progression and 1-year overall survival. Compared with intravenous bortezomib, subcutaneous bortezomib confers a significant advantage with respect to the incidence of peripheral neuropathy (all grades, grade C2 and grade C3). As a consequence, it provides a new treatment option for patients with multiple myeloma, particularly those with pre-existing neuropathy or at a high risk of developing peripheral neuropathy.
The manuscript was reviewed by: M. Delforge, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium; M-V. Mateos, Haematology Department, University Hospital of Salamanca, Salamanca, Spain; P. Moreau, University Hospital, Nantes Cedex 1, France; P.G. Richardson, Department of Medical Oncology, DanaFarber Cancer Institute, Harvard Medical School, Boston, MA, USA. S. M. Hoy (&) Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand e-mail: [email protected]
Key features and properties of subcutaneous bortezomib (Velcade) Featured indication Treatment of patients with multiple myeloma (MM) Mechanism of action 26S proteasome inhibitor Dosage and administration Dose
1.3 mg/m2
Frequency of administration in patients (pts) with previously untreated MM
Days 1, 4, 8, 11, 22, 25, 29 and 32 of a 6-week cycle for four cycles and then days 1, 8, 22 and 29 of a 6-week cycle for five cycles
Frequency of administration in pts with progressive or relapsed MM
Days 1, 4, 8 and 11 of a 3-week cycle for up to eight cycles
Route of administration
Subcutaneous
Pharmacokinetic profile of multiple-dose subcutaneous bortezomib 1.3 mg/m2 in pts with relapsed MM Mean maximum plasma concentration (Cmax) Mean area under the plasma concentration-time curve from time zero to the last quantifiable timepoint (72 h)
20.4 ng/mL
Median time to Cmax
30 min
155 ng h/mL
Most frequent grade ‡3 treatment-emergent adverse events (incidence ‡6 %) Neutropenia, thrombocytopenia, anaemia, peripheral neuropathy, leukopenia
1 Introduction Multiple myeloma is a malignant plasma cell disorder that is, for the most part, sensitive to a variety
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