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Lenalidomide, rituximab achieved responses in treatment-naive patients with follicular lymphoma
The combination of lenalidomide and rituximab induced responses with a tolerable safety profile in a majority of treatment-naive patients with follicular lymphoma, according to results of a phase 2 study presented at the ASCO Annual Meeting.
In the CALGB 50803 study, Peter Martin, MD, of Weill Cornell Medical College, and colleagues evaluated data from 65 patients. The median age of patients was 53 years, and 34 were female. Most patients had a Follicular Lymphoma International Prognostic Index (FLIPI) of 2 (n=41) or 0 to 1 (n=20). Two patients had a FLIPI of 3, and two patients had insufficient data to calculate FLIPI. Fourteen patients had bulky disease.
Peter Martin
Patients received 20 mg lenalidomide (Revlimid, Celgene) on days 1 through 21 of twelve 28-day cycles in addition to four weekly doses of 375 mg/m2 rituximab in cycle 1 plus four additional doses on day 1 of cycles 4, 6, 8 and 10. Fifty patients completed all 12 cycles of lenalidomide with relatively low rates of grade 3-4 toxicity.
The most common grade 3 to grade 4 hematologic toxicities were neutropenia (19%), lymphopenia (8%) and thrombocytopenia (2%). One patient experienced febrile neutropenia.
Common grade 3 to grade 4 non-hematologic adverse events included rash (8%), infection (8%), pain (8%), fatigue (6%) and tumor lysis syndrome (3%).
Of 57 evaluable patients, 53 (93%) responded to treatment. The response rate included 72% of patients who achieved a complete response, and the average time to complete response was 10 weeks. Ninety-two percent of PET-negative complete responses had occurred by 24 weeks of treatment.
Researchers noted treatment response occurred regardless of FLIPI risk, histological grade or bulky disease.
After a median follow-up of 2.3 years, 89% of patients achieved 2-year PFS.
“These efficacy data are comparable to cytotoxic chemotherapy regimens… and support evaluation of this regimen in randomized trials,” Martin told HemOnc Today.
For more information:
Martin P. Abstract #8521. Presented at: ASCO Annual Meeting; May 30-June 3, 2014; Chicago.
Disclosure: Researchers report consultant/advisory roles or employment/leadership positions with and research funding from Celgene, Genentech and Roche.