Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL
© 2017 Macmillan Publishers Limited, part of Springer Nature. All rights reserved. ARCTIC was a multicenter, randomized-controlled, open, phase IIB non-inferiority trial in previously untreated chronic lymphocytic leukemia (CLL). Conventional frontline therapy in fit patients is fludarabine, cycloph...
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ftunivhullir:oai:hull-repository.worktribe.com:746715 2023-05-15T14:59:19+02:00 Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL Howard, D. R. Munir, T. McParland, L. Rawstron, A. C. Milligan, D. Schuh, A. Hockaday, A. Allsup, D. J. Marshall, S. Duncombe, A. S. Smith, A. F. Longo, R. Varghese, A. Hillmen, P. O'Dwyer, J. L. 2017-05-02 https://hull-repository.worktribe.com/file/746715/1/Article https://hull-repository.worktribe.com/output/746715 https://doi.org/10.1038/leu.2017.96 unknown Nature Publishing Group https://hull-repository.worktribe.com/output/746715 Leukemia Volume 31 Issue 11 Pagination 2416-2425 doi:https://doi.org/10.1038/leu.2017.96 https://hull-repository.worktribe.com/file/746715/1/Article 0887-6924 doi:10.1038/leu.2017.96 openAccess Anesthesiology and Pain Medicine Cancer Research Hematology Health and Health Inequalities Journal Article 2017 ftunivhullir https://doi.org/10.1038/leu.2017.96 2023-03-26T20:24:22Z © 2017 Macmillan Publishers Limited, part of Springer Nature. All rights reserved. ARCTIC was a multicenter, randomized-controlled, open, phase IIB non-inferiority trial in previously untreated chronic lymphocytic leukemia (CLL). Conventional frontline therapy in fit patients is fludarabine, cyclophosphamide and rituximab (FCR). The trial hypothesized that including mitoxantrone with low-dose rituximab (FCM-miniR) would be non-inferior to FCR. A total of 200 patients were recruited to assess the primary end point of complete remission (CR) rates according to IWCLL criteria. Secondary end points were progression-free survival (PFS), overall survival (OS), overall response rate, minimal residual disease (MRD) negativity, safety and cost-effectiveness. The trial closed following a pre-planned interim analysis. At final analysis, CR rates were 76 FCR vs 55% FCM-miniR (adjusted odds ratio: 0.37; 95% confidence interval: 0.19-0.73). MRD-negativity rates were 54 FCR vs 44% FCM-miniR. More participants experienced serious adverse reactions with FCM-miniR (49%) compared to FCR (41%). There are no significant differences between the treatment groups for PFS and OS. FCM-miniR is not expected to be cost-effective over a lifetime horizon. In summary, FCM-miniR is less well tolerated than FCR with an inferior response and MRD-negativity rate and increased toxicity, and will not be taken forward into a confirmatory trial. The trial demonstrated that oral FCR yields high response rates compared to historical series with intravenous chemotherapy. Article in Journal/Newspaper Arctic University of Hull: Repository@Hull Arctic Leukemia 31 11 2416 2425 |
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University of Hull: Repository@Hull |
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ftunivhullir |
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topic |
Anesthesiology and Pain Medicine Cancer Research Hematology Health and Health Inequalities |
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Anesthesiology and Pain Medicine Cancer Research Hematology Health and Health Inequalities Howard, D. R. Munir, T. McParland, L. Rawstron, A. C. Milligan, D. Schuh, A. Hockaday, A. Allsup, D. J. Marshall, S. Duncombe, A. S. Smith, A. F. Longo, R. Varghese, A. Hillmen, P. O'Dwyer, J. L. Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL |
topic_facet |
Anesthesiology and Pain Medicine Cancer Research Hematology Health and Health Inequalities |
description |
© 2017 Macmillan Publishers Limited, part of Springer Nature. All rights reserved. ARCTIC was a multicenter, randomized-controlled, open, phase IIB non-inferiority trial in previously untreated chronic lymphocytic leukemia (CLL). Conventional frontline therapy in fit patients is fludarabine, cyclophosphamide and rituximab (FCR). The trial hypothesized that including mitoxantrone with low-dose rituximab (FCM-miniR) would be non-inferior to FCR. A total of 200 patients were recruited to assess the primary end point of complete remission (CR) rates according to IWCLL criteria. Secondary end points were progression-free survival (PFS), overall survival (OS), overall response rate, minimal residual disease (MRD) negativity, safety and cost-effectiveness. The trial closed following a pre-planned interim analysis. At final analysis, CR rates were 76 FCR vs 55% FCM-miniR (adjusted odds ratio: 0.37; 95% confidence interval: 0.19-0.73). MRD-negativity rates were 54 FCR vs 44% FCM-miniR. More participants experienced serious adverse reactions with FCM-miniR (49%) compared to FCR (41%). There are no significant differences between the treatment groups for PFS and OS. FCM-miniR is not expected to be cost-effective over a lifetime horizon. In summary, FCM-miniR is less well tolerated than FCR with an inferior response and MRD-negativity rate and increased toxicity, and will not be taken forward into a confirmatory trial. The trial demonstrated that oral FCR yields high response rates compared to historical series with intravenous chemotherapy. |
format |
Article in Journal/Newspaper |
author |
Howard, D. R. Munir, T. McParland, L. Rawstron, A. C. Milligan, D. Schuh, A. Hockaday, A. Allsup, D. J. Marshall, S. Duncombe, A. S. Smith, A. F. Longo, R. Varghese, A. Hillmen, P. O'Dwyer, J. L. |
author_facet |
Howard, D. R. Munir, T. McParland, L. Rawstron, A. C. Milligan, D. Schuh, A. Hockaday, A. Allsup, D. J. Marshall, S. Duncombe, A. S. Smith, A. F. Longo, R. Varghese, A. Hillmen, P. O'Dwyer, J. L. |
author_sort |
Howard, D. R. |
title |
Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL |
title_short |
Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL |
title_full |
Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL |
title_fullStr |
Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL |
title_full_unstemmed |
Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL |
title_sort |
results of the randomized phase iib arctic trial of low-dose rituximab in previously untreated cll |
publisher |
Nature Publishing Group |
publishDate |
2017 |
url |
https://hull-repository.worktribe.com/file/746715/1/Article https://hull-repository.worktribe.com/output/746715 https://doi.org/10.1038/leu.2017.96 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_relation |
https://hull-repository.worktribe.com/output/746715 Leukemia Volume 31 Issue 11 Pagination 2416-2425 doi:https://doi.org/10.1038/leu.2017.96 https://hull-repository.worktribe.com/file/746715/1/Article 0887-6924 doi:10.1038/leu.2017.96 |
op_rights |
openAccess |
op_doi |
https://doi.org/10.1038/leu.2017.96 |
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Leukemia |
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31 |
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11 |
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2416 |
op_container_end_page |
2425 |
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