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Published on: December 7, 2014
Bendamustine produces durable responses with an acceptable safety profile in patients with rituximab-refractory
Bruce D Cheson1, Jonathan W Friedberg, Brad S Kahl
1Georgetown University Hospital, Lombardi Comprehensive Cancer Center, 3800 Reservoir Road N.W., Washington, DC, USA. bdc4@georgetown.edu
Background:
Although initially responsive to therapy, indolent non-Hodgkin lymphomas (NHLs) are generally incurable. Therefore, active and tolerable treatments for patients with relapsed or refractory disease are needed. Bendamustine, a mechlorethamine alkylator with novel mechanisms of action, is approved in the United States for rituximab-refractory indolent B-cell NHL.
Patients And Methods:
Data from 2 North American multicenter studies with similar design, enrollment, and response criteria were pooled to evaluate safety and durability of response. Bendamustine was administered at 120 mg/m2 days 1 and 2 every 21 days for 6-8 cycles. Endpoints included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and safety.
Results:
The studies enrolled 161 patients with a median of 2 previous chemotherapy regimens. Histologies included follicular (68%), small lymphocytic (20%), marginal zone (11%), and lymphoplasmacytic (1%) lymphoma. Sixty patients (34.1%) were refractory to their last chemotherapy, 53 (30.1%) were alkylating agent refractory. Overall response rate was 76% with 23% complete remissions (CRs) and unconfirmed CR (CRu). The median follow-up was 25.3 months (range, 24-27.8 months) and DOR was 10 months (range, 8.3-14 months). At 1 and 2 years, 45% and 23% of responders continued to respond. Among 127 patients previously treated with alkylators, ORR was 88% (28% CR/CRu) in responsive and 59% (12% CR/CRu) in refractory patients. Fifty opportunistic infections were reported in 48 patients. Second malignancies occurred in 9 patients (5.6%; 5 myelodysplastic syndromes, 2 acute myelogenous leukemia, 1 chronic myelomonocytic leukemia, and 1 squamous cell carcinoma).
Conclusion:
Bendamustine induces durable responses with acceptable long-term safety in rituximab-refractory indolent NHL.
Insights
Bendamustine offers durable responses for patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL). This chemotherapy is a tolerable treatment option, showing acceptable long-term safety in clinical studies.
Area of Science:
- Hematology
- Oncology
- Clinical Pharmacology
Background:
- Indolent non-Hodgkin lymphomas (NHLs) are typically incurable, necessitating effective treatments for relapsed or refractory cases.
- Bendamustine, an alkylator, is approved for rituximab-refractory indolent B-cell NHL, indicating its potential in managing this disease.
Purpose of the Study:
- To evaluate the safety and durability of response to bendamustine in patients with indolent NHL.
- To assess the efficacy of bendamustine in a broader population of indolent NHL patients, including those refractory to prior therapies.
Main Methods:
- Pooled data from two North American multicenter studies.
- Bendamustine administered at 120 mg/m2 on days 1 and 2 every 21 days for 6-8 cycles.
- Key endpoints included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and safety assessment.
Main Results:
- The study enrolled 161 patients with indolent NHL, with a median of 2 prior chemotherapy regimens.
- An overall response rate (ORR) of 76% was observed, with 23% complete remissions (CRs/CRu).
- Fifty opportunistic infections were reported in 48 patients; second malignancies occurred in 9 patients (5.6%).
Conclusions:
- Bendamustine demonstrates efficacy in inducing durable responses in patients with indolent NHL.
- The drug exhibits acceptable long-term safety in the studied patient population, including those refractory to rituximab.
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