Durable PFS With Fludarabine, Rituximab, and Lenalidomide in CLL
Fludarabine and rituximab plus lenalidomide results in durable prolonged PFS compared with FR or FR plus cyclophosphamide among patients with untreated chronic lymphocytic leukemia.
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Fludarabine and rituximab plus lenalidomide (FR+L) results in durable prolonged progression-free survival (PFS) compared with FR or FR plus cyclophosphamide (FCR) among patients with untreated chronic lymphocytic leukemia (CLL), according to a study that will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
The optimal chemoimmunotherapy regimen for the treatment of CLL has not been defined. This study compared several chemoimmunotherapy regimens in non-del(11q) CLL.
The phase 2 CALGB 10404 trial (ClinicalTrials.gov Identifier: NCT00602459) randomly assigned 342 patients with non-del(11q) CLL to receive FR, FR+L, or FCR. Patient characteristics were similar among groups at baseline.
The median PFS was shortest with FR at 43 months (95% CI, 33-50 months) compared with 66 months (95% CI, 45 months-not reached) with FR+L (P = .03) and 78 months (95% CI, 59 months-not reached) with FCR (P < .01). The 2-year PFS was also shortest with FR (64%; 90% CI, 57-71%) compared with FR+L (71%; 90% CI, 63-78%) and FCR (74%; 90% CI, 66-80%).
The median overall survival (OS) has not been reached for all arms, though the OS at 1, 2, and 3 years was similar between arms. In the FR+L arm, the OS curve plateaus with no events after 41 months. Events occurred after 41 months in the FR and FCR arms.
Cytopenias and infection were the most common adverse events.
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According to the investigators, these data indicate that “future studies comparing FR+L to FCR or incorporating lenalidomide into other novel treatment regimens are justified.”
Read more of Cancer Therapy Advisor's coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.
- Ruppert AS, Byrd JC, Heerema NA, et al. A genetic risk-stratified, randomized phase 2 intergroup study of fludarabine/antibody combinations in symptomatic, untreated chronic lymphocytic leukemia (CLL): results from Cancer and Leukemia Group B (CALGB) 10404 (Alliance). J Clin Oncol. 2017;35(suppl; abstr 7503).