Bendamustine with or without rituximab in the treatment of relapsed chronic lymphocytic leukaemia: an Italian retrospective study

Abstract

Summary To retrospectively assess the efficacy of bendamustine alone and with rituximab (R–B), 109 patients with relapsed chronic lymphocytic leukaemia (CLL) were enrolled in 24 Italian centres. The median age was 66 years (range 39–85). Forty‐three percent of patients had relapsed and 57% were resistant (median previous therapies = 3; range 1–8). Twenty‐two patients received bendamustine alone and 87 patients received R–B (median B dosage: 100 mg/m2 per day, range 90–130 mg/m2 per day). The overall response rate was 69·6% (complete response 28·6%; partial response 41%), and was significantly higher in patients treated with R–B (P = 0·014) and in those responsive to the previous treatment (P = 0·04). After a median follow‐up of 7·9 months (range 1–148), the median progression‐free survival was 16 months and the median duration of response was 13 months. Median overall survival (OS) was 16·8 months for the whole cohort; patients not responding to the treatment had a significantly worse outcome than those who attained a response (P = 0·0001). In multivariate analysis, only resistant disease status at start of bendamustine treatment (HR 3·2, 95% CI 1·4–7·3, P = 0·006) had an independent prognostic value for OS. Toxicity was manageable and mostly haematological. In conclusion, in our experience R–B was an effective and well‐tolerated treatment for relapsed/refractory CLL patients, producing a remarkable high CR rate and mild toxicity.

Bendamustine and Rituximab in Relapsed and Refractory Hairy Cell Leukemia

“…Bendamustine with or without rituximab has demonstrated efficacy in a wide variety of hematologic malignancies (11), including both treated and untreated CLL (17–19, 33), indolent B-cell NHL and mantle cell lymphoma (MCL) (11, 20, 21, 34–36), aggressive B-cell NHL (37, 38), T-cell lymphomas (35), acute myeloid and lymphocytic leukemia and myelodysplastic syndrome (39), Hodgkin’s lymphoma (40), and multiple myeloma (41–43). In many of these settings it has demonstrated safety and efficacy in heavily pretreated patients and in older populations without major toxicities.…”

“…Bendamustine and rituximab (BR) are synergistic in vitro, with rituximab increasing malignant cell sensitivity to bendamustine (14–16). BR has been used effectively for untreated or relapsed and refractory CLL (17–19), indolent NHL and mantle cell lymphoma (20, 21), and diffuse large B-cell lymphoma (22). To determine the tolerability of BR in HCL, we performed a pilot trial using 2 different dose levels of bendamustine, 70 and 90 mg/m 2 , given on days 1 and 2 of 6 cycles with rituximab, and studied both toxicity and response.…”

Bendamustine as Monotherapy and in Combination Regimens for the Treatment of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma: A Retrospective Analysis

“…In a recently published phase II study [20], the OR and CR rates in patients with relapsed/refractory CLL treated with BR were 59 and 9%, respectively. In the 2 retrospective studies on the use of bendamustine-based regimens in patients with relapsed/refractory CLL, the OR and CR rates were 69.6 and 28.6%, respectively, in one study [21] and 60 and 15%, respectively, in another [22]. In our study, as well as in the one by Sanchez-Gonzalez et al [22], the response to treatment was not affected by the resistance to fludarabine, suggesting that regimens with bendamustine should be considered among the therapeutic options for patients resistant to fludarabine.…”

Emerging Therapies in Chronic Lymphocytic Leukemia

“…A retrospective Italian study was conducted in 109 relapsed/refractory CLL patients. Results showed that the combination of rituxmab plus bendamustine was an effective and well-tolerated treatment for these patients, producing a remarkable high CR rate and mild toxicity (Iannitto et al 2011). …”