Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 1402-1410 |
| Number of pages | 9 |
| Journal | American Journal of Hematology |
| Volume | 93 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - 2018 |
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Single-agent ibrutinib versus chemoimmunotherapy regimens for treatment-naïve patients with chronic lymphocytic leukemia: A cross-trial comparison of phase 3 studies. / Robak, T; Burger, JA; Tedeschi, A; Barr, PM; Owen, C; Bairey, O; Hillmen, P; Simpson, D; Grosicki, S; Devereux, S; McCarthy, H; Coutre, SE; Quach, H; Gaidano, G; Maslyak, Z; Stevens, DA; Moreno, C; Gill, DS; Flinn, IW; Gribben, JG; Mokatrin, A; Cheng, M; Styles, L; James, DF; Kipps, TJ; Ghia, P.
In: American Journal of Hematology, Vol. 93, No. 11, 2018, p. 1402-1410.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Single-agent ibrutinib versus chemoimmunotherapy regimens for treatment-naïve patients with chronic lymphocytic leukemia: A cross-trial comparison of phase 3 studies
AU - Robak, T
AU - Burger, JA
AU - Tedeschi, A
AU - Barr, PM
AU - Owen, C
AU - Bairey, O
AU - Hillmen, P
AU - Simpson, D
AU - Grosicki, S
AU - Devereux, S
AU - McCarthy, H
AU - Coutre, SE
AU - Quach, H
AU - Gaidano, G
AU - Maslyak, Z
AU - Stevens, DA
AU - Moreno, C
AU - Gill, DS
AU - Flinn, IW
AU - Gribben, JG
AU - Mokatrin, A
AU - Cheng, M
AU - Styles, L
AU - James, DF
AU - Kipps, TJ
AU - Ghia, P
PY - 2018
Y1 - 2018
N2 - Chemoimmunotherapy (CIT) and targeted therapy with single-agent ibrutinib are both recommended first-line treatments for chronic lymphocytic leukemia (CLL), although their outcomes have not been directly compared. Using ibrutinib data from the RESONATE-2 (PCYC-1115/1116) study conducted in patients ≥65 years without del(17p), we performed a cross-trial comparison with CIT data from published phase 3 studies in first-line treatment of CLL. Progression-free survival (PFS), overall survival (OS), and safety data for ibrutinib (median follow-up 35.7 months) were evaluated alongside available CIT data. CIT regimens included: fludarabine + cyclophosphamide + rituximab (CLL8, CLL10), bendamustine + rituximab (CLL10), obinutuzumab + chlorambucil and rituximab + chlorambucil (CLL11), and ofatumumab + chlorambucil (COMPLEMENT-1). Median age across studies was 61-74 years, with older populations receiving ibrutinib, obinutuzumab + chlorambucil, or rituximab + chlorambucil. Median follow-up varied across studies/regimens (range 14.5-37.4 months). Among all patients, PFS appeared longer with ibrutinib relative to CIT and OS appeared comparable. Relative to CIT studies that similarly excluded patients with del(17p) (CLL10) or enrolled older/less-fit patients (CLL11), PFS appeared favorable for ibrutinib in high-risk subgroups, including advanced disease, bulky lymph nodes, unmutated IGHV status, and presence of del(11q). Grade ≥ 3 infections ranged from 9% (ofatumumab + chlorambucil) to 40% (fludarabine + cyclophosphamide + rituximab), and was 25% with ibrutinib. Grade ≥ 3 neutropenia was 12% for ibrutinib and 26%-84% for CIT. Although definitive conclusions cannot be made due to inherent limitations of cross-trial comparisons, this report suggests that ibrutinib has a favorable benefit/risk profile and may potentially eliminate the need for chemotherapy in some patients. Randomized, comparative studies are needed to support these findings. © 2018 The Authors. American Journal of Hematology published by Wiley Periodicals, Inc.
AB - Chemoimmunotherapy (CIT) and targeted therapy with single-agent ibrutinib are both recommended first-line treatments for chronic lymphocytic leukemia (CLL), although their outcomes have not been directly compared. Using ibrutinib data from the RESONATE-2 (PCYC-1115/1116) study conducted in patients ≥65 years without del(17p), we performed a cross-trial comparison with CIT data from published phase 3 studies in first-line treatment of CLL. Progression-free survival (PFS), overall survival (OS), and safety data for ibrutinib (median follow-up 35.7 months) were evaluated alongside available CIT data. CIT regimens included: fludarabine + cyclophosphamide + rituximab (CLL8, CLL10), bendamustine + rituximab (CLL10), obinutuzumab + chlorambucil and rituximab + chlorambucil (CLL11), and ofatumumab + chlorambucil (COMPLEMENT-1). Median age across studies was 61-74 years, with older populations receiving ibrutinib, obinutuzumab + chlorambucil, or rituximab + chlorambucil. Median follow-up varied across studies/regimens (range 14.5-37.4 months). Among all patients, PFS appeared longer with ibrutinib relative to CIT and OS appeared comparable. Relative to CIT studies that similarly excluded patients with del(17p) (CLL10) or enrolled older/less-fit patients (CLL11), PFS appeared favorable for ibrutinib in high-risk subgroups, including advanced disease, bulky lymph nodes, unmutated IGHV status, and presence of del(11q). Grade ≥ 3 infections ranged from 9% (ofatumumab + chlorambucil) to 40% (fludarabine + cyclophosphamide + rituximab), and was 25% with ibrutinib. Grade ≥ 3 neutropenia was 12% for ibrutinib and 26%-84% for CIT. Although definitive conclusions cannot be made due to inherent limitations of cross-trial comparisons, this report suggests that ibrutinib has a favorable benefit/risk profile and may potentially eliminate the need for chemotherapy in some patients. Randomized, comparative studies are needed to support these findings. © 2018 The Authors. American Journal of Hematology published by Wiley Periodicals, Inc.
U2 - 10.1002/ajh.25259
DO - 10.1002/ajh.25259
M3 - Article
VL - 93
SP - 1402
EP - 1410
JO - American Journal of Hematology
JF - American Journal of Hematology
SN - 0361-8609
IS - 11
ER -