Universität zu Köln

Gopal, Ajay K., Pro, Barbara, Connors, Joseph M., Younes, Anas, Engert, Andreas, Shustov, Andrei R., Chi, Xuedong, Larsen, Emily K., Kennedy, Dana A. and Sievers, Eric L. (2016). Response assessment in lymphoma: Concordance between independent central review and local evaluation in a clinical trial setting. Clin. Trials, 13 (5). S. 545 - 555. LONDON: SAGE PUBLICATIONS LTD. ISSN 1740-7753

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Abstract

Background: Independent central review of clinical imaging remains the standard for oncology clinical trials with registration potential. A limited independent central review strategy has been proposed for solid tumor trials based on concordance between central and local evaluation of response. Concordance between independent central review and local evaluation of response in hematological malignancies is not known. Methods: We retrospectively evaluated concordance between prospectively performed central and local assessments of response using the Revised Response Criteria for Malignant Lymphoma across two international, open-label, single-arm, registration studies of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma (N=102) or systemic anaplastic large-cell lymphoma (N=58). Results: Overall objective response rates were similar between assessors for both the trial in Hodgkin lymphoma (75% independent central review, 72% local evaluation) and the trial in anaplastic large-cell lymphoma (86% independent central review, 83% local evaluation). Patient-specific objective response concordance was also substantial (Hodgkin lymphoma: kappa=0.68; anaplastic large-cell lymphoma: kappa=0.74). Median progression-free survival was similar between assessors for patients with anaplastic large-cell lymphoma (14.3months by independent central review (95% confidence interval: 6.9, -); 14.5months by local evaluation (95% confidence interval: 9.4, -)), but longer by local evaluation in patients with Hodgkin lymphoma (5.8months by independent central review (95% confidence interval: 5.0, 9.0); 9.0months by local evaluation (95% confidence interval: 7.1, 12.0)). Median duration of response was longer by local evaluation in both malignancies, which was primarily attributable to earlier computed tomography and positron emission tomography-based scoring of progression by independent central review. Conclusion: A limited independent review audit strategy for clinical trials of some lymphomas appears feasible and practical based on substantial concordance in assessments of overall objective response by central and local evaluation in two international, prospective, registration trials in lymphoma. Some variability between assessors in the time-to-event endpoints was observed, which appeared attributable to earlier assignments of progression by independent central review compared with local evaluation.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Gopal, Ajay K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pro, Barbara UNSPECIFIED UNSPECIFIED UNSPECIFIED Connors, Joseph M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Younes, Anas UNSPECIFIED UNSPECIFIED UNSPECIFIED Engert, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Shustov, Andrei R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chi, Xuedong UNSPECIFIED UNSPECIFIED UNSPECIFIED Larsen, Emily K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kennedy, Dana A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sievers, Eric L. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-261018
DOI:	10.1177/1740774516645338
Journal or Publication Title:	Clin. Trials
Volume:	13
Number:	5
Page Range:	S. 545 - 555
Date:	2016
Publisher:	SAGE PUBLICATIONS LTD
Place of Publication:	LONDON
ISSN:	1740-7753
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language BRENTUXIMAB VEDOTIN; PHASE-II; PROGRESSION; METAANALYSIS; CRITERIA Multiple languages Medicine, Research & Experimental Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/26101