TY - JOUR
T1 - Outcomes in 370 patients with mantle cell lymphoma treated with ibrutinib
T2 - a pooled analysis from three open-label studies
AU - Rule, Simon
AU - Dreyling, Martin
AU - Goy, Andre
AU - Hess, Georg
AU - Auer, Rebecca
AU - Kahl, Brad
AU - Cavazos, Nora
AU - Liu, Black
AU - Yang, Shiyi
AU - Clow, Fong
AU - Goldberg, Jenna D.
AU - Beaupre, Darrin
AU - Vermeulen, Jessica
AU - Wildgust, Mark
AU - Wang, Michael
N1 - Funding Information:
The authors would like to thank Michelle Olsher, PhD for writing assistance (PAREXEL, Hackensack, NJ, USA), funded by Janssen Global Services, LLC. We also thank the patients who participated in this trial, their families, and the investigators and coordinators at each of the clinical sites. The investigators are listed in the supplemental material.
Funding Information:
SR reports grants and personal fees from Janssen, during the conduct of the study; personal fees from Roche, personal fees from Pharmacyclics, personal fees from Celgene, outside the submitted work. MD reports grants and personal fees from Janssen, outside the submitted work. GH reports grants and personal fees from Roche, grants and personal fees from Pfizer, grants from CTI, personal fees from Janssen, grants and personal fees from Celgene, outside the submitted work. RA reports personal fees from Janssen, other from Janssen, nonfinancial support from Janssen, personal fees from Bristol Myers Squibb, personal fees from Celgene, outside the submitted work. BK reports grants from Pharmacyclics, during the conduct of the study; personal fees from Gilead, personal fees from Infinity, personal fees from Pharmacyclics, outside the submitted work. NC, FC and DB are employees of Phar-macyclics. BL, SY, JG and MW are employees of Janssen Research & Development and hold stock in Johnson & Johnson outside the submitted work. JV is an employee of Jans-sen Biologics and holds stock in Johnson & Johnson outside the submitted work. AG and MW declare no competing interests.
Funding Information:
This study was funded by Janssen Research & Development. Funders were involved in the study design, data collection, data analysis and interpretation, and provided writing support. Lead investigators (SR, MW) had full access to the data and analyses for compilation of this report.
Publisher Copyright:
© 2017 John Wiley & Sons Ltd
PY - 2017/11
Y1 - 2017/11
N2 - Ibrutinib is highly active in treating mantle cell lymphoma (MCL), an aggressive B-cell lymphoma. We pooled data from three ibrutinib studies to explore the impact of baseline patient characteristics on treatment response. Patients with relapsed/refractory MCL (n = 370) treated with ibrutinib had an objective response rate (ORR) of 66% (20% complete response; 46% partial response); median duration of response (DOR), progression-free survival (PFS) and overall survival (OS) were 18·6, 12·8 and 25·0 months, respectively. Univariate analyses showed patients with one versus >one prior line of therapy had longer OS. Multivariate analyses identified that one prior line of therapy affected PFS; Eastern Cooperative Oncology Group (ECOG) performance status, simplified MCL international prognostic index (sMIPI) score, bulky disease, and blastoid histology affected OS and PFS. Patients with blastoid versus non-blastoid histology had similar time to best response, but lower ORR, DOR, PFS and OS. OS and PFS were longer in patients with better sMIPI, patients with ECOG performance status 0–1, non-bulky disease and non-blastoid histology. Additionally, the proportion of patients with poor prognostic factors increased with increasing lines of therapy. Together, results suggest that patient outcomes following treatment failure with ibrutinib are related to the natural biological evolution of the disease.
AB - Ibrutinib is highly active in treating mantle cell lymphoma (MCL), an aggressive B-cell lymphoma. We pooled data from three ibrutinib studies to explore the impact of baseline patient characteristics on treatment response. Patients with relapsed/refractory MCL (n = 370) treated with ibrutinib had an objective response rate (ORR) of 66% (20% complete response; 46% partial response); median duration of response (DOR), progression-free survival (PFS) and overall survival (OS) were 18·6, 12·8 and 25·0 months, respectively. Univariate analyses showed patients with one versus >one prior line of therapy had longer OS. Multivariate analyses identified that one prior line of therapy affected PFS; Eastern Cooperative Oncology Group (ECOG) performance status, simplified MCL international prognostic index (sMIPI) score, bulky disease, and blastoid histology affected OS and PFS. Patients with blastoid versus non-blastoid histology had similar time to best response, but lower ORR, DOR, PFS and OS. OS and PFS were longer in patients with better sMIPI, patients with ECOG performance status 0–1, non-bulky disease and non-blastoid histology. Additionally, the proportion of patients with poor prognostic factors increased with increasing lines of therapy. Together, results suggest that patient outcomes following treatment failure with ibrutinib are related to the natural biological evolution of the disease.
KW - ibrutinib
KW - mantle cell lymphoma
KW - pooled analysis
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U2 - 10.1111/bjh.14870
DO - 10.1111/bjh.14870
M3 - Article
C2 - 28832957
AN - SCOPUS:85032180251
SN - 0007-1048
VL - 179
SP - 430
EP - 438
JO - British Journal of Haematology
JF - British Journal of Haematology
IS - 3
ER -