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Clin Lymphoma Myeloma Leuk. 2019 Jul 15. pii: S2152-2650(19)30398-2. doi: 10.1016/j.clml.2019.07.004. [Epub ahead of print]

Long-Term Studies Assessing Outcomes of Ibrutinib Therapy in Patients With Del(11q) Chronic Lymphocytic Leukemia.

Author information

1
UC San Diego Moores Cancer Center, La Jolla, CA. Electronic address: tkipps@ucsd.edu.
2
Department of Oncology, Juravinski Cancer Centre, McMaster University, Hamilton, Ontario, Canada.
3
Division of Hematology, Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA.
4
Center for Chronic Lymphocytic Leukemia, Dana-Farber Cancer Institute, Boston, MA.
5
CLL Research and Treatment Program, Northwell Health Cancer Institute, Hempstead, NY.
6
University of Rochester, Rochester, NY.
7
Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, OH.
8
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA.
9
Hôpital Haut-Lévêque, Pessac, France.
10
University of Leeds, Leeds, UK.
11
Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.
12
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
13
Department of Internal Medicine and German CLL Study Group, University of Cologne, Cologne, Germany.
14
Department of Internal Medicine III, University of Ulm, Ulm, Germany.
15
Division of Hematology, Mayo Clinic Cancer Center, Jacksonville, FL.
16
Janssen Research and Development, Horsham, PA.
17
Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA.

Abstract

BACKGROUND:

Certain genomic features, such as del(11q), expression of unmutated immunoglobulin heavy-chain variable region (IGHV) gene, or complex karyotype, predict poorer outcomes to chemotherapy in patients with chronic lymphocytic leukemia (CLL).

PATIENTS AND METHODS:

We examined the pooled long-term follow-up data from PCYC-1115 (RESONATE-2), PCYC-1112 (RESONATE), and CLL3001 (HELIOS), comprising a total of 1238 subjects, to determine the prognostic significance of these markers in patients treated with ibrutinib.

RESULTS:

With a median follow-up of 47 months, ibrutinib-treated patients had longer progression-free survival (PFS) than patients treated in the comparator arm, regardless of genomic risk factors. Among patients treated with ibrutinib, we found that high-risk genomic features were not associated with shorter PFS (63-75% across all subgroups at 42 months) or overall survival (79-83% across all subgroups at 42 months). Surprisingly, we observed that ibrutinib-treated patients with del(11q) actually had a significantly longer PFS than ibrutinib-treated patients without del(11q) (42-month PFS rate 70% vs. 65%, P = .02).

CONCLUSION:

These analyses not only demonstrate that genomic risk factors previously associated with poor outcomes lose their adverse prognostic significance but also that del(11q) can be associated with a superior PFS with ibrutinib therapy.

KEYWORDS:

Prognostic factors; Risk factors; Small lymphocytic lymphoma; Survival

PMID:
31447270
DOI:
10.1016/j.clml.2019.07.004
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