Second-Line Therapy for Myeloma: Adding Low-Dose Decitabine to Bortezomib
Posted: Monday, July 6, 2020
According to findings from a single-center, open-label phase II Chinese study, published in the British Journal of Haematology, second-line treatment consisting of bortezomib, dexamethasone, and low-dose decitabine may prove to be safe and effective in patients with relapse or /refractory multiple myeloma. Baijun Fang, MD, of Zhengzhou University in China, and colleagues sought to determine whether decitabine might be a cost-effective, available-in-country addition to other antimyeloma agents.
The study included 47 patients with relapsed or refractory multiple myeloma who underwent up to eight cycles of bortezomib/dexamethasone/decitabine. Patients received 5 mg/m2 of intravenous decitabine on days 1 to 5; 1.3 mg/m2 of subcutaneous bortezomib on days 1, 4, 8, and 11; and 20 mg of oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12.
At the time of data cutoff on February 12, 2020, and at a median follow-up of 17.2 months, the overall response rate was 87%. A total of 15% of patients achieved a stringent complete response, 15% achieved a complete response, and 37% achieved a very good partial response. Among patients with bortezomib-refractory disease, the overall response rate was 75%, with 25% achieving at least a complete response and 62% reaching at least a very good partial response. The overall 12-month and 18-month progression-free survival rates were 72% and 67%, respectively, versus 50% and 50% for patients with bortezomib-refractory disease. The median progression-free survival for all groups was not reached.
Adverse events, the most common of which were peripheral neuropathy (43.5%), thrombocytopenia (41.3%), and fatigue (34.5%), were consistent with the established safety profile. Overall, three patients discontinued treatment due to grade 3 or 4 adverse events, and one patient did not complete the study due to early death.
Disclosure: The study authors reported no conflicts of interest.