Combination of Rituximab and High-Dose Methylprednisolone for High-Risk Patients With CLL
Posted: Thursday, January 9, 2020
Although BTK and BCL2 inhibitors have improved the treatment of high-risk and elderly patients with chronic lymphocytic leukemia (CLL), questions remain regarding their long-term efficacy and toxicity. According to a study published in Medicina, a higher dose of rituximab with a shorter schedule of high-dose methylprednisolone appeared to be safe and effective among elderly patients with relapsed CLL. Laimonas Griskevicius, MD, PhD, of Vilnius University, Lithuania, and colleagues suggested that if other targeted therapies are contraindicated or unavailable, this new combination may be effective as a 5-day regimen for patients with resistant high-risk disease or as a 3-day regimen among elderly or unfit patients with CLL.
The phase II trial included 25 elderly or unfit patients with CLL. The researchers measured the safety and efficacy of a higher dose of rituximab (1,000 mg/m2) after four cycles of high-dose methylprednisolone. To reduce the risk of initial infusion reactions, the investigators administered the first dose of rituximab split into 50 mg on day 1, 150 mg on day 2, and the remaining 800 mg on day 3. During the second through fourth cycles, a full dose of rituximab was given on the first day, and the treatment regimen was repeated every 21 days.
The research team reported a median progression-free survival of 11 months. The overall survival was 68 months. Adverse events were generally found to be well tolerated, and 77% of the patient pool reported grade 1 and grade 2 events. No deaths occurred in the treatment group. The progression-free survival was similar between the 3-day and 5-day studies of high-dose methylprednisolone. The toxicity of the 3-day regimen was lower than the longer 5-day schedule.
“Further studies of high-dose methylprednisolone and rituximab combination [therapy] in CLL refractory to pathway inhibitors are warranted,” the research team concluded.
Disclosure: For full disclosures of the study authors, visit mdpi.com.