The addition of bortezomib to lenalidomide with dexamethasone treatment significantly improves progression-free survival (PFS) and overall survival (OS) for patients with multiple myeloma, according to new clinical trial results.
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Multiple myeloma is the second most common blood cancer in the world. In the past decade, new drugs have changed the standard of care landscape for multiple myeloma and have slowly begun increasing the life expectancy for people diagnosed with the disease. The current standard of care for newly diagnosed, previously untreated patients with multiple myeloma is lenalidomide with dexamethasone. However, researchers have now found the addition of bortezomib to this two-drug regimen not only gives patients another year of remission, but also another year of life.
Researchers led by Brian G M Durie, MD, physician at Cedars-Sinai Outpatient Cancer Center in Los Angeles, CA, analyzed 471 patients between February 2008 and February 2012. A total of 232 patients were randomized to receive lenalidomide with dexamethasone treatment for six 28-day cycles, and 242 patients were randomized to receive lenalidomide with dexamethasone plus bortezomib for eight 21-day cycles. Treatment was stopped after progression, unacceptable toxicity, or withdrawal of consent. The SWOG study was first presented in December 2015 at the 57th Annual Meeting of the American Society of Hematology (Orlando, FL).
Results of the study showed improved PFS and OS for patients on the regimen that included bortezomib. During the first six months of treatment, these patients had a median remission of 43 months, compared with a median remission of 30 months for those on the regimen without bortezomib. Patients who received the lenalidomide with dexamethasone plus bortezomib regimen also lived a median of 6 years after their initial treatment, compared with a median survival of 5 years after initial treatment for those who received the regimen without bortezomib.
Trial results indicated an increased likelihood of sensory neuropathy (tingling, pain, numbness, or weakness in the hands and feet), fatigue, hyperglycemia, and dehydration, among other events for patients who received bortezomib. Nonetheless, researchers concluded the three-drug treatment had an acceptable safety and tolerability profile.
"There's a lot of excitement about these research findings and this treatment option, which helps myeloma patients stay healthier longer and gives them more time to spend with people they love. Because the research was so solid, and the findings so strong, we're looking at a potential new standard of care," said Dr Durie.
