Abstract
Previous studies investigated the efficacy and the safety of bendamustine (B) vs. chlorambucil (Chl) associated with rituximab (R) in fludarabine-ineligible patients with treated and untreated chronic lymphocytic leukemia (CLL). We conducted a retrospective multicenter study in the Lazio region to further evaluate and compare the efficacy and the toxicity of Chl-R and B-R regimen in CLL patients over the age of 65. We enrolled 192 untreated CLL patients: 111 treated with B-R and 81 with Chl-R. The overall response rates (ORR; 93.6% in B-R and 86.5% in Chl-R) were not statistically different between the two groups, such as progression-free survival (PFS), time to retreatment (TTR), and overall survival (OS). The B-R group showed a higher hematological (p = 0.007) and extra-hematological (p = 0.008) toxicity. When comparing the toxicities according to age, we noted that the extra-hematological toxicity was higher in patients over the age of 75 who were treated with B-R than those treated with Chl-R (p = 0.03). This retrospective study confirms the feasibility of B-R and Chl-R in elderly untreated CLL patients. Currently, patients who are over 75 and unfit are usually treated with Chl-R. This scheme allows achieving the same ORR, PFS, TTR, and OS when compared with B-R because of hematological and extra-hematological toxicities due to B, in which a greater dose reduction has been shown in comparison to Chl.
Highlights
Chronic lymphocytic leukemia (CLL) mainly affects elderly people, with a median age at onset of 72
We collected the main clinical and the biological characteristics of these patients and we registered their clinical impact on overall response rates (ORR), CR rate, progression-free survival (PFS), to retreatment (TTR), overall survival (OS), and hematologic or extra-hematologic toxicities
We retrospectively evaluated two R-based regimens, the Chl-R and the bendamustine and rituximab (B-R), in elderly (>65 years of age) untreated chronic lymphocytic leukemia (CLL), aiming to understand whether these regimens differ in the real-life for clinical characteristics, efficacy, and toxicity
Summary
Chronic lymphocytic leukemia (CLL) mainly affects elderly people, with a median age at onset of 72. The standard first-line treatment (fludarabine, cyclophosphamide, and rituximab—FCR) is poorly tolerated in elderly patients or in patients with comorbidities [2,3,4,5]. A suitable option in elderly patients is chlorambucil (Chl) which, as a single agent, is well-tolerated, but the response rates are modest with Chl only (31 to 72%), with only a few patients achieving complete remission (CR, 0 to 7%). To improve the treatment outcomes, combinations of Chl with monoclonal antibodies obtained better results [6, 7]; a phase III CLL11 study demonstrated an improved efficacy with Chl plus rituximab (ChlR) and Chl plus obinutuzumab vs Chl monotherapy, with a superiority of obinutuzumab compared to rituximab in patients with comorbidities [6]. The overall response rates (ORR) of ChlR ranged in different studies from 66 to 84%, with CR between 8 and 26% and progression-free survival (PFS) from 16.3 to 34.7 months [8,9,10]
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