1. Most treatment-naïve patients with chronic lymphocytic leukemia (CLL) safely tolerated escalating doses of combined lenalidomide and rituximab.
2. Younger patients showed higher response rates but similar progression free survival compared to older patients.
Evidence rating level: 1 (Excellent)
Study rundown: Some patients with chronic lymphocytic leukemia (CLL), particularly older patients and those with comorbidities, do not tolerate intensive chemotherapy regimens well. Lenalidomide, an immunomodulatory drug, has been shown to be active against CLL, and combinations of Lenalidomide and Rituximab have demonstrated some effectiveness in relapsed CLL. At the conclusion of this Phase II trial, the authors found that intrapatient dose-escalation of combined lenalidomide and rituximab was safe for patients naïve to treatment with chemotherapy. Furthermore, most patients reached the maximum dose and demonstrated some response. Based off these results, the authors suggest that lenalidomide and rituximab together present an immune-based alternative approach to the management of treatment-naïve CLL patients.
In-Depth [phase II prospective clinical trial]: For this phase II clinical trial, the authors enrolled 69 treatment-naïve patients with chronic lymphocytic leukemia into one of two age-specific strata: those less than 65 years old (mean age 56) and those greater than 65 years old (mean age 70). All patients started at 2.5 mg/day lenalidomide and then escalated based on tolerability to a maximum of 10mg/day for a maximum of 7 21 day cycles. Rituximab was started at the end of cycle 1 and continued for 7 cycles. Median follow-up was more than 20 months. The primary outcome was the complete response rate for each age group, and secondary outcomes drug safety, overall response rate, progression free survival and overall survival. These two arms differed in that patients in the older patient stratum more frequently had elevated serum beta-2 microglobulin levels, high-risk Rai stage, and were less likely to complete maximum number of cycles. The response rate also differed: 95% with 20% complete responses and 20% nodular partial responses in the younger age group and 78% response rate with 11% complete responses in the older age strata. Progression-free survival did not differ significantly, with 19 months for the younger cohort and 20 months for the older group.
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