Tuesday, April 19, 2011 (Last Updated: 04/21/2011)
TUESDAY, April 19 (HealthDay News) -- Subcutaneous bortezomib has non-inferior efficacy and better safety than standard intravenous administration for patients with relapsed multiple myeloma, according to a study published online April 19 in The Lancet Oncology.
Philippe Moreau, M.D., from the University Hospital in Nantes, France, and colleagues compared the efficacy and safety of subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma. Patients were randomly assigned to receive up to eight 21-day cycles of 1.3 mg/m² bortezomib by subcutaneous injection (148 patients) or intravenous infusion (74 patients), and were followed up for an average of 11.8 and 12 months, respectively. Non-inferiority of subcutaneous bortezomib, defined as retaining 60 percent of the intravenous treatment effect, was the main objective studied and was measured by overall response rate (ORR) after four cycles of bortezomib in all patients who received one or more doses of drug (response-evaluable population).
The investigators found that the ORR in the response-evaluable population was 42 percent in both groups (61 of 145 patients in the subcutaneous group and 31 of 73 patients in the intravenous group), which demonstrated non-inferiority. There were no significant differences in time to progression and one-year overall survival. Grade 3 or worse adverse events, including thrombocytopenia, neutropenia, and anemia, were reported in 57 and 70 percent of patients in the subcutaneous and intravenous groups, respectively. Significantly less peripheral neuropathy of any grade, grade 2 or worse, and grade 3 or worse was seen in the subcutaneous group. Subcutaneous bortezomib was well tolerated locally.
"Subcutaneous bortezomib offers non-inferior efficacy to standard intravenous administration, with an improved safety profile," the authors write.
Several authors disclosed financial relationships with the pharmaceutical industry, including Johnson & Johnson and Millennium Pharmaceuticals, both of which funded the study.
Hematology & Oncology
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