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A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL)
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 thera...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Lippincott Williams & Wilkins
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9263496/ https://www.ncbi.nlm.nih.gov/pubmed/35813099 http://dx.doi.org/10.1097/HS9.0000000000000745 |
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author | Salles, Gilles Schuster, Stephen J. Fischer, Luca Kuruvilla, John Patten, Piers E. M. von Tresckow, Bastian Smith, Sonali Jiménez-Ubieto, Ana Davis, Keith L. Nagar, Saurabh Zhang, Jie Bollu, Vamsi Jousseaume, Etienne Ramos, Roberto Wang, Yucai Link, Brian K. |
author_facet | Salles, Gilles Schuster, Stephen J. Fischer, Luca Kuruvilla, John Patten, Piers E. M. von Tresckow, Bastian Smith, Sonali Jiménez-Ubieto, Ana Davis, Keith L. Nagar, Saurabh Zhang, Jie Bollu, Vamsi Jousseaume, Etienne Ramos, Roberto Wang, Yucai Link, Brian K. |
author_sort | Salles, Gilles |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9263496 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-92634962022-07-08 A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL) Salles, Gilles Schuster, Stephen J. Fischer, Luca Kuruvilla, John Patten, Piers E. M. von Tresckow, Bastian Smith, Sonali Jiménez-Ubieto, Ana Davis, Keith L. Nagar, Saurabh Zhang, Jie Bollu, Vamsi Jousseaume, Etienne Ramos, Roberto Wang, Yucai Link, Brian K. Hemasphere Article 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. Lippincott Williams & Wilkins 2022-06-21 /pmc/articles/PMC9263496/ /pubmed/35813099 http://dx.doi.org/10.1097/HS9.0000000000000745 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Article Salles, Gilles Schuster, Stephen J. Fischer, Luca Kuruvilla, John Patten, Piers E. M. von Tresckow, Bastian Smith, Sonali Jiménez-Ubieto, Ana Davis, Keith L. Nagar, Saurabh Zhang, Jie Bollu, Vamsi Jousseaume, Etienne Ramos, Roberto Wang, Yucai Link, Brian K. A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL) |
title | A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL) |
title_full | A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL) |
title_fullStr | A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL) |
title_full_unstemmed | A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL) |
title_short | A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL) |
title_sort | retrospective cohort study of treatment outcomes of adult patients with relapsed or refractory follicular lymphoma (record-fl) |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9263496/ https://www.ncbi.nlm.nih.gov/pubmed/35813099 http://dx.doi.org/10.1097/HS9.0000000000000745 |
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