Reduced-dose fludarabine, cyclophosphamide, and rituximab (FCR-Lite) plus lenalidomide, followed by lenalidomide consolidation/maintenance, in previously untreated chronic lymphocytic leukemia

TY - JOUR

T1 - Reduced-dose fludarabine, cyclophosphamide, and rituximab (FCR-Lite) plus lenalidomide, followed by lenalidomide consolidation/maintenance, in previously untreated chronic lymphocytic leukemia

AU - Mato, Anthony R.

AU - Foon, Kenneth A.

AU - Feldman, Tatyana

AU - Schuster, Stephen J.

AU - Svoboda, Jakub

AU - Chow, Kar Fai

AU - Valentinetti, Marisa

AU - Mrkulic, Mary

AU - Azzollini, Kelly

AU - Gadaleta, Gabriella

AU - Bhattacharyya, Pritish K.

AU - Zenreich, Joshua

AU - Pascual, Lauren Nicole

AU - Yannotti, Kara

AU - Kdiry, Sabrina

AU - Howlett, Christina

AU - Strelec, Lauren

AU - Porter, David

AU - Bejot, Coleen

AU - Goy, André

N1 - Publisher Copyright: © 2015 Wiley Periodicals, Inc.

PY - 2015/6/1

Y1 - 2015/6/1

N2 - Fludarabine, cyclophosphamide, and rituximab (FCR) remains the standard of care for fit chronic lymphocytic leukemia (CLL) patients requiring first therapy. However, side effects can be significant, and patients with poor risk features have inferior outcomes. The purpose of this study was to evaluate reduced-dose FCR (FCR-Lite) plus lenalidomide (FCR2) followed by lenalidomide maintenance as a strategy to shorten immunochemotherapy in untreated CLL. Patients received four to six cycles of FCR2. Patients who were minimal residual disease (MRD) negative in peripheral blood (PB) and bone marrow (BM) initiated 12 months of lenalidomide maintenance after either four or six cycles (based on MRD status). The primary study endpoint was the complete response (CR) rate after four cycles of FCR2. Twenty patients were evaluable. After four cycles of FCR2, response rates were: CR, 45.0%; CR with incomplete blood count recovery (CRi), 5.0%; partial response (PR), 45.0%; and stable disease (SD), 5.0%. BM and PB samples from 27.8% and 52.9% of patients, respectively, were MRD negative. After six cycles, response rates were: CR, 58.3%; CRi, 16.7%; and PR, 25.0%. BM and PB samples from 50.0% and 72.7% of patients, respectively, were MRD negative. Overall, 75% of evaluable patients achieved a CR or CRi following FCR2. After 17.4 months of median follow-up, one progression and one death occurred. Our findings suggest that FCR2 combines encouraging clinical activity with acceptable toxicity in previously untreated CLL. Lenalidomide can be safely added to FCR and may reduce chemotherapy exposure without compromising outcomes.

AB - Fludarabine, cyclophosphamide, and rituximab (FCR) remains the standard of care for fit chronic lymphocytic leukemia (CLL) patients requiring first therapy. However, side effects can be significant, and patients with poor risk features have inferior outcomes. The purpose of this study was to evaluate reduced-dose FCR (FCR-Lite) plus lenalidomide (FCR2) followed by lenalidomide maintenance as a strategy to shorten immunochemotherapy in untreated CLL. Patients received four to six cycles of FCR2. Patients who were minimal residual disease (MRD) negative in peripheral blood (PB) and bone marrow (BM) initiated 12 months of lenalidomide maintenance after either four or six cycles (based on MRD status). The primary study endpoint was the complete response (CR) rate after four cycles of FCR2. Twenty patients were evaluable. After four cycles of FCR2, response rates were: CR, 45.0%; CR with incomplete blood count recovery (CRi), 5.0%; partial response (PR), 45.0%; and stable disease (SD), 5.0%. BM and PB samples from 27.8% and 52.9% of patients, respectively, were MRD negative. After six cycles, response rates were: CR, 58.3%; CRi, 16.7%; and PR, 25.0%. BM and PB samples from 50.0% and 72.7% of patients, respectively, were MRD negative. Overall, 75% of evaluable patients achieved a CR or CRi following FCR2. After 17.4 months of median follow-up, one progression and one death occurred. Our findings suggest that FCR2 combines encouraging clinical activity with acceptable toxicity in previously untreated CLL. Lenalidomide can be safely added to FCR and may reduce chemotherapy exposure without compromising outcomes.

UR - https://www.scopus.com/pages/publications/84929463439

U2 - 10.1002/ajh.23983

DO - 10.1002/ajh.23983

M3 - Article

C2 - 25691474

SN - 0361-8609

VL - 90

SP - 487

EP - 492

JO - American Journal of Hematology

JF - American Journal of Hematology

IS - 6

ER -