Universität zu Köln

Salles, Gilles, Schuster, Stephen J., Fischer, Luca, Kuruvilla, John, Patten, Piers Em, von Tresckow, Bastian, Smith, Sonali M., Ubieto, Ana Isabel Jiminez, Davis, Keith L., Nagar, Saurabh P. ORCID: 0000-0003-4616-0926, Zhang, Jie, Bollu, Vamsi, Jousseaume, Etienne, Ramos, Roberto, Wang, Yucai and Link, Brian K. (2022). A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL). Hemasphere, 6 (7). PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 2572-9241

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Abstract

This study (ReCORD-FL) sought to construct a historical control cohort to augment single-arm trials in relapsed/refractory follicular lymphoma (r/r FL). A retrospective study in 10 centers across North America and Europe was conducted. Adults with grade 1-3A FL were required to be r/r after >= 2 therapy lines including an anti-CD20 and an alkylator. After first becoming r/r, patients were required to initiate >= 1 additional therapy line, which defined the study index date. Endpoints were observed from start of each therapy line (including index line) until death, last follow-up, or December 31, 2020. Endpoints were complete response (CR) rate, overall response rate (ORR), time to next treatment or death (TNT-D), event-free survival (EFS), and overall survival (OS). One hundred eighty-seven patients were identified. Most patients' (80.2%) index therapy occurred in third line (3L) (range, 3L-6L). Median follow-up from FL diagnosis was 9 years (range, 1-21 years). CR and ORR to the index therapy were 39.0% and 70.6%, respectively. Median (95% confidence interval) EFS from index was 14.6 (11.0-18.0) months; median OS from index was 10.6 years. Outcomes worsened across successive treatment lines and for patients who were double refractory (r/r to both an anti-CD20 monoclonal antibody and an alkylator) or POD24 (progressed <= 24 months after front-line anti-CD20) at index. Findings demonstrate the unmet need of FL patients with multiply relapsed, double refractory, or POD24 disease. Based on robustness of the historical data collected and comparability with a previous study (SCHOLAR-5), ReCORD-FL presents a valuable source of control data for comparative studies in r/r FL.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Salles, Gilles UNSPECIFIED UNSPECIFIED UNSPECIFIED Schuster, Stephen J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischer, Luca UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuruvilla, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Patten, Piers Em UNSPECIFIED UNSPECIFIED UNSPECIFIED von Tresckow, Bastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Smith, Sonali M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ubieto, Ana Isabel Jiminez UNSPECIFIED UNSPECIFIED UNSPECIFIED Davis, Keith L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nagar, Saurabh P. UNSPECIFIED orcid.org/0000-0003-4616-0926 UNSPECIFIED Zhang, Jie UNSPECIFIED UNSPECIFIED UNSPECIFIED Bollu, Vamsi UNSPECIFIED UNSPECIFIED UNSPECIFIED Jousseaume, Etienne UNSPECIFIED UNSPECIFIED UNSPECIFIED Ramos, Roberto UNSPECIFIED UNSPECIFIED UNSPECIFIED Wang, Yucai UNSPECIFIED UNSPECIFIED UNSPECIFIED Link, Brian K. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-695656
DOI:	10.1097/HS9.0000000000000745
Journal or Publication Title:	Hemasphere
Volume:	6
Number:	7
Date:	2022
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	2572-9241
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language R-CVP; RITUXIMAB; CYCLOPHOSPHAMIDE; VINCRISTINE; PREDNISONE; CHOP; DOXORUBICIN; THERAPY Multiple languages Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69565