Study Evaluates Bortezomib Combinations in Frail Myeloma Patients
A 2-drug combination with subcutaneous bortezomib and oral prednisone should be the preferred treatment for frail patients with multiple myeloma.
A 2-drug combination with subcutaneous bortezomib and oral prednisone followed by maintenance therapy should be the preferred treatment for frail patients with multiple myeloma, a study published in the journal Leukemia has shown.1
For the phase 2 trial, researchers in Italy sought to evaluate 3 low-dose intensity subcutaneous bortezomib-based treatments in patients 75 years of age or older with newly diagnosed multiple myeloma.
Investigators enrolled 152 previously untreated patients, half of whom were frail, and assigned them 1:1:1 to receive subcutaneous bortezomib plus oral prednisone (VP), VP plus cyclophosphamide (VCP), or VP plus melphalan (VMP). Participants then received maintenance therapy with bortezomib.
Results showed that response rates were 64% with VP, 67% with VCP, and 86% with VMP. Very good partial responses or better occurred in 26%, 28.5%, and 49% of patients, respectively.
Researchers found that median progression-free survival was 14.0 months in the VP arm, 15.2 months in the VCP arm, and 17.1 months in the VMP arm. The 2-year overall survival rate was 60%, 70%, and 76%, respectively.
The study further demonstrated that bortezomib maintenance was effective and feasible.
In terms of safety, 22%, 27%, and 33% of VP, VCP, and VMP patients, respectively, experienced at least 1 treatment-related grade 3 or higher non-hematologic adverse event. The most common grade 3 or higher adverse events included infections (8% - 20%), constitutional (10% - 14%), and cardiovascular events (4% - 12%). Grade 3 or worse peripheral neuropathy was limited to 4% to 6% of patients.
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Ultimately, there was no substantial difference between the 3 regimens; however, toxicity was higher with VMP, suggesting that a 2-drug combination followed by maintenance therapy should be preferred in this older patient population.
- Larocca A, Brighen S, Petrucci MT, et al. A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma [published online ahead of print March 8, 2016]. Leukemia. doi: 10.1038/leu.2016.36.