This article is more than 5 years old. Information may no longer be current.
Rituximab, chlorambucil may benefit certain patients with CLL
Click Here to Manage Email Alerts
Patients with chronic lymphocytic leukemia treated with chlorambucil and rituximab experienced better outcomes than those reported in prior studies of chlorambucil monotherapy, according to results of an open-label, phase 2 study.
The findings suggest that the addition of rituximab (Rituxan, Genentech/Biogen Idec) to chlorambucil (Leukeran, Aspen Global) may provide a viable alternative treatment for elderly or comorbid patients with CLL not suitable for fludarabine-based treatment.
The analysis included 100 patients with CLL who received a first-line regimen of rituximab plus chlorambucil for six 28-day cycles. The median patient age was 70 years (range, 43-86 years), and patients had a median seven comorbidities.
The patients underwent treatment with rituximab (375 mg/m2 on day 1 of cycle one, and 500 mg/m2 on day 1 of subsequent cycles) plus chlorambucil (10 mg/m2/day on days 1 through 7 of all cycles). Patients who did not achieve a complete response had the option to receive six additional cycles of chlorambucil monotherapy.
The safety of the regimen served as the primary endpoint.
The majority of grade 3 to grade 4 adverse events were hematologic toxicities, including neutropenia/lymphopenia (41%) and leukopenia (23%).
Researchers reported an 84% overall response rate and a 10% complete response rate. Median PFS was 23.5 months and median OS was not reached.
“These results compare favorably with previously published results for chlorambucil monotherapy, suggesting that the addition of rituximab to chlorambucil may improve efficacy with no unexpected adverse events,” the researchers wrote. “[Rituximab plus chlorambucil] may improve outcomes for patients who are ineligible for fludarabine-based treatments.”
Disclosure: The researchers report no relevant financial disclosures.
Click Here to Manage Email Alerts