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...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2022-07-01
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| Series: | HemaSphere |
| Online Access: | http://journals.lww.com/10.1097/HS9.0000000000000745 |
| _version_ | 1797286647292755968 |
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| author | Gilles Salles Stephen J. Schuster Luca Fischer John Kuruvilla Piers E. M. Patten Bastian von Tresckow Sonali Smith Ana Jiménez Ubieto Keith L. Davis Saurabh Nagar Jie Zhang Vamsi Bollu Etienne Jousseaume Roberto Ramos Yucai Wang Brian K. Link |
| author_facet | Gilles Salles Stephen J. Schuster Luca Fischer John Kuruvilla Piers E. M. Patten Bastian von Tresckow Sonali Smith Ana Jiménez Ubieto Keith L. Davis Saurabh Nagar Jie Zhang Vamsi Bollu Etienne Jousseaume Roberto Ramos Yucai Wang Brian K. Link |
| author_sort | Gilles Salles |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-07T18:21:20Z |
| format | Article |
| id | doaj.art-e780703b57a547aa9be64bc3cbede090 |
| institution | Directory Open Access Journal |
| issn | 2572-9241 |
| language | English |
| last_indexed | 2024-03-07T18:21:20Z |
| publishDate | 2022-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | HemaSphere |
| spelling | doaj.art-e780703b57a547aa9be64bc3cbede0902024-03-02T07:19:15ZengWileyHemaSphere2572-92412022-07-0167e74510.1097/HS9.0000000000000745202207000-00007A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL)Gilles Salles0Stephen J. Schuster1Luca Fischer2John Kuruvilla3Piers E. M. Patten4Bastian von Tresckow5Sonali Smith6Ana Jiménez Ubieto7Keith L. Davis8Saurabh Nagar9Jie Zhang10Vamsi Bollu11Etienne Jousseaume12Roberto Ramos13Yucai Wang14Brian K. Link151 Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA2 Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA3 Department of Internal Medicine III, LMU Hospital, Munich, Germany4 Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada5 Comprehensive Cancer Centre, King’s College London, United Kingdom7 Department I of Internal Medicine, Medical Faculty and University Hospital Cologne, University of Cologne, Germany9 Section of Hematology/Oncology, The University of Chicago, IL, USA10 Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Hospital Universitario 12 de Octubre, Madrid, Spain11 Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA11 Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA12 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA12 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA12 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA12 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA13 Division of Hematology, Mayo Clinic, Rochester, MN, USA14 Department of Medicine, University of Iowa, Iowa City, IA, USAThis 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.http://journals.lww.com/10.1097/HS9.0000000000000745 |
| spellingShingle | Gilles Salles Stephen J. Schuster Luca Fischer John Kuruvilla Piers E. M. Patten Bastian von Tresckow Sonali Smith Ana Jiménez Ubieto Keith L. Davis Saurabh Nagar Jie Zhang Vamsi Bollu Etienne Jousseaume Roberto Ramos Yucai Wang Brian K. Link A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL) HemaSphere |
| 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 |
| url | http://journals.lww.com/10.1097/HS9.0000000000000745 |
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