Following its US Food and Drug Administration (FDA) approval in 2008 based on a single-arm phase 2 study (SDX-105-01; ClinicalTrials.gov Identifier: NCT00069758), bendamustine has emerged as the standard chemotherapy portion of the chemoimmunotherapy regimen used to treat non-Hodgkin lymphoma (NHL).1
Yet SDX-105-01 and 2 other studies — SDX-105-02 and SDX-105-03 (ClinicalTrials.gov Identifier: NCT00076349 and NCT00139841, respectively) — provide limited follow up for the long-term safety of bendamustine.1-3
In a retrospective analysis using patient-level data from the 3 studies, an analysis published in the British Journal of Haematology reported that after a median follow up of about 9 years, “no clear new safety signals attributable to bendamustine were identified,” and bendamustine did not appear to adversely affect stem cell collection (required for potential transplantation) or subsequent therapy.4
“With a follow up of nearly 10 years, this analysis confirms that bendamustine is an efficacious anti-lymphoma drug with a safety profile similar to what was observed in earlier studies,” corresponding author Peter Martin, MD, lymphoma service chief at Weill Cornell Medicine and New York-Presbyterian Hospital in New York, told Cancer Therapy Advisor.
Three Studies Provided Patient-level Data
For this analysis, data from 149 of the 245 patients from SDX-105-01, SDX-105-02, and SDX-105-03 were made available. In 2 of the studies (SDX-105-01 and SDX-105-03), bendamustine was provided as a single agent, while in SDX-105-02 bendamustine was provided in combination with rituximab.
Patients included in the analysis had relapsed or refractory follicular, small lymphocytic, marginal zone, mantle cell, transformed, or lymphoplasmacytic lymphoma and had received a median of 3 prior therapies, with a range of 1 to 8.
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Patients treated with single-agent bendamustine (106) or the combination regimen (43) received a median of 6 cycles. Patients receiving bendamustine in combination received a dose of 90 mg/m2, while those receiving the single agent received a dose of 120 mg/m2 — all on days 1 and 2 of each treatment cycle.