Universität zu Köln

Kipps, Thomas J., Fraser, Graeme, Coutre, Steven E., Brown, Jennifer R., Barrientos, Jacqueline C., Barr, Paul M., Byrd, John C., O'Brien, Susan M., Dilhuydy, Marie-Sarah, Hillmen, Peter, Jaeger, Ulrich, Moreno, Carol, Cramer, Paula, Stilgenbauer, Stephan, Chanan-Khan, Asher A., Mahler, Michelle, Salman, Mariya, Eckert, Karl, Solman, Isabelle G., Balasubramanian, Sriram, Cheng, Mei, Londhe, Anil, Ninomoto, Joi, Howes, Angela, James, Danelle F. and Hallek, Michael (2019). Long-Term Studies Assessing Outcomes of Ibrutinib Therapy in Patients With Del(11q) Chronic Lymphocytic Leukemia. Clin. Lymphoma Myeloma Leuk., 19 (11). S. 715 - 729. DALLAS: CIG MEDIA GROUP, LP. ISSN 2152-2669

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Abstract

A pooled analysis of 1238 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma from three phase 3 studies found that genomic risk factors were not associated with shorter progression-free survival (PFS) or overall survival for patients treated with ibrutinib. Ibrutinib-treated patients with del(11q) were found to have a longer PFS than those without del(11q). These results suggest less prognostic relevance for certain genomic risk factors with ibrutinib treatment. 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kipps, Thomas J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fraser, Graeme UNSPECIFIED UNSPECIFIED UNSPECIFIED Coutre, Steven E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brown, Jennifer R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Barrientos, Jacqueline C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Barr, Paul M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Byrd, John C. UNSPECIFIED UNSPECIFIED UNSPECIFIED O'Brien, Susan M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dilhuydy, Marie-Sarah UNSPECIFIED UNSPECIFIED UNSPECIFIED Hillmen, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaeger, Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Moreno, Carol UNSPECIFIED UNSPECIFIED UNSPECIFIED Cramer, Paula UNSPECIFIED UNSPECIFIED UNSPECIFIED Stilgenbauer, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Chanan-Khan, Asher A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mahler, Michelle UNSPECIFIED UNSPECIFIED UNSPECIFIED Salman, Mariya UNSPECIFIED UNSPECIFIED UNSPECIFIED Eckert, Karl UNSPECIFIED UNSPECIFIED UNSPECIFIED Solman, Isabelle G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Balasubramanian, Sriram UNSPECIFIED UNSPECIFIED UNSPECIFIED Cheng, Mei UNSPECIFIED UNSPECIFIED UNSPECIFIED Londhe, Anil UNSPECIFIED UNSPECIFIED UNSPECIFIED Ninomoto, Joi UNSPECIFIED UNSPECIFIED UNSPECIFIED Howes, Angela UNSPECIFIED UNSPECIFIED UNSPECIFIED James, Danelle F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-129058
DOI:	10.1016/j.clml.2019.07.004
Journal or Publication Title:	Clin. Lymphoma Myeloma Leuk.
Volume:	19
Number:	11
Page Range:	S. 715 - 729
Date:	2019
Publisher:	CIG MEDIA GROUP, LP
Place of Publication:	DALLAS
ISSN:	2152-2669
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language IN-SITU HYBRIDIZATION; GENOMIC ABERRATIONS; 1ST-LINE TREATMENT; COMPLEX KARYOTYPE; INITIAL THERAPY; OPEN-LABEL; FOLLOW-UP; RITUXIMAB; CLL; CHEMOIMMUNOTHERAPY Multiple languages Oncology; Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/12905