TY - JOUR
T1 - Lenalidomide consolidation benefits patients with CLL receiving chemoimmunotherapy
T2 - Results for CALGB 10404 (Alliance)
AU - Byrd, John C.
AU - Ruppert, Amy S.
AU - Heerema, Nyla A.
AU - Halvorson, Alese E.
AU - Hoke, Eva
AU - Smith, Mitchell R.
AU - Godwin, John E.
AU - Couban, Stephen
AU - Fehniger, Todd A.
AU - Thirman, Michael J.
AU - Tallman, Martin S.
AU - Appelbaum, Frederick R.
AU - Stone, Richard M.
AU - Robinson, Sue
AU - Chang, Julie E.
AU - Mandrekar, Sumithra J.
AU - Larson, Richard A.
N1 - Publisher Copyright:
© 2018 by The American Society of Hematology.
PY - 2018/7/24
Y1 - 2018/7/24
N2 - Prior to novel targeted agents for chronic lymphocytic leukemia (CLL), the best chemoimmunotherapy regimen in patients with non-del(11q) disease was unclear. The role of lenalidomide was also not defined. This phase 2 study randomized 342 untreated patients with non-del(11q) CLL requiring therapy to fludarabine plus rituximab (FR; n 5 123), FR plus lenalidomide consolidation (FR1L; n 5 109), or FR plus cyclophosphamide (FCR; n 5 110) and compared 2-year progression-free survival (PFS) rates of each to the historical control rate with FC (60%). Patients with del(11q) in at least 20% of pretreatment cells continued with FCR (n 5 27) or were reassigned to FCR1L (n 5 31) and excluded from the primary analysis. Among non-del(11q) patients, 2-year PFS rates were 64% (90% confidence interval [CI], 57-71; FR), 72% (90% CI, 65-79; FR1L), and 74% (90% CI, 66-80; FCR); FR1L and FCR had rates significantly greater than historical control. Median PFS was significantly shorter with FR compared with FR1L (P 5 .04) and FCR (P, .001): 43 (95% CI, 33-50), 61 (95% CI, 45-71), and 97 (95% CI, 61 to not reached) months, respectively. Median follow-up was 73 months and median overall survival (OS) was only reached with FCR (101 months; 95% CI, 96 to not reached). With FR1L, the risk of death decreased over time and was lower than with FR at later time points (P 5 .01), but not significantly different from FCR (P 5 .21). Future studies incorporating short courses of lenalidomide into other novel treatment regimens are justified.
AB - Prior to novel targeted agents for chronic lymphocytic leukemia (CLL), the best chemoimmunotherapy regimen in patients with non-del(11q) disease was unclear. The role of lenalidomide was also not defined. This phase 2 study randomized 342 untreated patients with non-del(11q) CLL requiring therapy to fludarabine plus rituximab (FR; n 5 123), FR plus lenalidomide consolidation (FR1L; n 5 109), or FR plus cyclophosphamide (FCR; n 5 110) and compared 2-year progression-free survival (PFS) rates of each to the historical control rate with FC (60%). Patients with del(11q) in at least 20% of pretreatment cells continued with FCR (n 5 27) or were reassigned to FCR1L (n 5 31) and excluded from the primary analysis. Among non-del(11q) patients, 2-year PFS rates were 64% (90% confidence interval [CI], 57-71; FR), 72% (90% CI, 65-79; FR1L), and 74% (90% CI, 66-80; FCR); FR1L and FCR had rates significantly greater than historical control. Median PFS was significantly shorter with FR compared with FR1L (P 5 .04) and FCR (P, .001): 43 (95% CI, 33-50), 61 (95% CI, 45-71), and 97 (95% CI, 61 to not reached) months, respectively. Median follow-up was 73 months and median overall survival (OS) was only reached with FCR (101 months; 95% CI, 96 to not reached). With FR1L, the risk of death decreased over time and was lower than with FR at later time points (P 5 .01), but not significantly different from FCR (P 5 .21). Future studies incorporating short courses of lenalidomide into other novel treatment regimens are justified.
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U2 - 10.1182/bloodadvances.2017015396
DO - 10.1182/bloodadvances.2017015396
M3 - Article
C2 - 30030269
AN - SCOPUS:85059827893
SN - 2473-9529
VL - 2
SP - 1705
EP - 1718
JO - Blood advances
JF - Blood advances
IS - 14
ER -