Objectives: Bendamustine is a unique cytotoxic agent active against various human malignancies, including chronic lymphocytic leukemia (CLL). In vitro studies suggest that cytotoxic activity of bendamustine on CLL-derived cells is synergized by rituximab. A retrospective chart review was conducted to characterize treatment-naïve outpatients and those with relapsed disease aged 70 years and over with CLL receiving bendamustine (with or without rituximab) and to evaluate real-world patterns of care, safety, and effectiveness. Methods: Using McKesson Specialty Care/US Oncology Network iKnowMed databases, 91 outpatients with at least two recorded visits and at least two cycles of bendamustine monotherapy or bendamustine-rituximab combination therapy were identified and included. Mean age at diagnosis and start of first therapy was 70.3 and 77.4 years respectively, and 63.7% of patients were men. Results: Observed overall response rate was 56.3% in pooled treatment-naïve patients [n = 9; complete response (CR) 18.8%; partial response (PR) 37.5%; nodular partial response (nPR) 0%] and 58.7% in pooled patients with relapsed disease (n = 44; CR 13.3%; PR 44.0%; nPR 1.3%). Median time to progressive disease has not been reached for the 16 treatment-naïve patients (median follow up 15.1 months), and was 18.4 months for those with relapsed disease (n = 73). No unexpected toxicities were observed. Overall rate of blood/bone marrow toxicities (all grades) was 40.7%; grade 3/4 rates were 18.8% in treatment-naïve patients and 25.3% in those with relapsed disease. Most frequent nonhematologic adverse events were fatigue and rash. Conclusion: In this retrospective chart review of 91 outpatients with CLL aged 70 years and over, bendamustine (with or without rituximab) was an effective therapeutic option with manageable toxicity.
BackgroundThe objective of this analysis was to evaluate the cost-effectiveness of using bendamustine versus alemtuzumab or bendamustine versus chlorambucil as a first-line therapy in patients with Binet stage B or C chronic lymphocytic leukemia (CLL) in the US.MethodsA discrete event simulation of the disease course of CLL was developed to evaluate the economic implications of single-agent treatment with bendamustine, alemtuzumab, or chlorambucil, which are indicated for a treatment-naïve patient population with Binet stage B or C CLL. Data from clinical trials were used to create a simulated patient population, risk equations for progression-free survival and survival post disease progression, response rates, and rates of adverse events. Costs from a US health care payer perspective in 2012 US dollars, survival (life years), and quality-adjusted life years (QALYs) were estimated over a patient’s lifetime; all were discounted at 3% per year.ResultsCompared with alemtuzumab, bendamustine was considered to be a dominant treatment providing greater benefit (6.10 versus 5.37 life years and 4.02 versus 3.45 QALYs) at lower cost ($78,776 versus $121,441). Compared with chlorambucil, bendamustine was associated with higher costs ($78,776 versus $42,337) but with improved health outcomes (6.10 versus 5.21 life years and 4.02 versus 3.30 QALYs), resulting in incremental cost-effectiveness ratios of $40,971 per life year gained and $50,619 per QALY gained.ConclusionBendamustine is expected to provide cost savings and greater health benefit than alemtuzumab in treatment-naïve patients with CLL. Furthermore, it can be considered as a cost-effective treatment providing health benefits at an acceptable cost versus chlorambucil in the US.
This retrospective study compared adverse-event rates in patients with chronic lymphocytic leukemia (CLL) or non-Hodgkin lymphoma (NHL), with and without renal impairment, receiving bendamustine alone or with rituximab. Patients (n = 940) were stratified into a renally impaired group (creatinine clearance [CrCL] < 40 mL/min) and two comparator groups (CrCL ≥ 40 mL/min and CrCL ≥ 60 mL/min). Renally impaired patients with NHL had a significantly greater incidence of grade 3-4 thrombocytopenia compared with the CrCL ≥ 60 mL/min group (hazard ratio [HR], 2.57; p = 0.025). For CLL and NHL together, grade 3-4 increased blood urea nitrogen was significantly higher in the renally impaired group than in the CrCL ≥ 40 mL/min (HR, 2.36; p = 0.02) and CrCL ≥ 60 mL/min (HR, 4.46; p = 0.001) groups. Based on these results, monitoring blood counts (including platelets) and renal function would be prudent in the management of patients with renal dysfunction and NHL or CLL who receive bendamustine-based regimens.
6553 Background: To assess the cost-effectiveness of bendamustine plus rituximab (B-R) vs cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP‑R) for treatment-naive patients with MCL or IL from a US healthcare payer perspective. Methods: A discrete event simulation was developed for a mixed population of patients with MCL or IL. Two arms were simulated, each containing 1000 identical MCL or IL patients treated with B-R or CHOP-R. Input data for baseline characteristics, overall response, and risks for treatment-related adverse events (AEs) and infections were obtained from the NHL 1-2003 trial (n=549, primarily stage IV MCL and IL); gaps were filled by consultation with experts. Direct medical costs and utilities were estimated based on US databases and published literature. Costs and benefits were discounted at 3% per annum. Base case model predictions were performed by selecting regression models that had a best fit to progression free survival (PFS). Robustness of these models was evaluated by testing other models with reasonably good fit. Results: In the base case, model predicts longer PFS for B-R than for CHOP-R in MCL (average of 49.8 vs 28.6 months) and IL (67.9 vs 51.0). Quality-adjusted life-years (QALYs) per patient were higher for B-R than CHOP-R for MCL (3.51 vs 2.68) and IL (4.42 vs 3.58). For MCL, total per-patient costs were $115,191 for B-R and $100,261 for CHOP-R; for IL, respective costs were $134,814 and $110,065, resulting in incremental cost-effectiveness ratios (ICERs) for B-R vs CHOP-R of $18,161 per QALY for MCL and $29,549 for IL (ICER<$50,000 to be cost-effective). Higher complete and partial response rates for B-R than for CHOP-R impacted subsequent treatment costs, which were lower for B-R by $21,632 for MCL and $24,961 for IL, as well as AE costs, lower by $10,113 and $10,570, respectively. The model results were robust with respect to the use of alternative regression models for PFS estimation. Conclusions: In patients with MCL or IL, the model demonstrates that B-R is a cost-effective alternative to CHOP-R. Alternative regression models confirmed robustness of results. Support: Teva Pharmaceutical Industries Ltd.
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