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Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial

Alison Jane Birtle Orcid Logo, Robert Jones Orcid Logo, John Chester Orcid Logo, Rebecca Lewis Orcid Logo, Katie Biscombe Orcid Logo, Mark Johnson Orcid Logo, Anthony Blacker, Richard T. Bryan Orcid Logo, James W.F. Catto Orcid Logo, Ananya Choudhury, Prantik Das, Satinder Jagdev, Thomas Powles Orcid Logo, John Wagstaff, Ka Ching Cheung Orcid Logo, Fay Cafferty Orcid Logo, Emma Hall Orcid Logo

Journal of Clinical Oncology, Volume: 42, Issue: 13, Pages: 1466 - 1471

Swansea University Author: John Wagstaff

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DOI (Published version): 10.1200/jco.23.01659

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate...

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Published in: Journal of Clinical Oncology
ISSN: 0732-183X 1527-7755
Published: American Society of Clinical Oncology (ASCO) 2024
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URI: https://cronfa.swan.ac.uk/Record/cronfa66426
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Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.POUT was a phase III, randomized, open-label trial, including 261 patients with muscle-invasive or lymph node–positive, nonmetastatic upper tract urothelial cancer (UTUC) randomly assigned after radical nephroureterectomy to platinum-based chemotherapy (132) or surveillance (129). Primary outcome analysis demonstrated that chemotherapy improved disease-free survival (DFS). At that time, the planned secondary outcome analysis of overall survival (OS) was immature. By February 2022, 50 and 67 DFS events had occurred in the chemotherapy and surveillance groups, respectively, at a median follow-up of 65 months. The 5-year DFS was 62% versus 45%, univariable hazard ratio (HR), 0.55 (95% CI, 0.38 to 0.80, P = .001). The restricted mean survival time (RMST) was 18 months longer (95% CI, 6 to 30) in the chemotherapy arm. There were 46 and 60 deaths in the chemotherapy and control arms, respectively. The 5-year OS was 66% versus 57%, with univariable HR, 0.68 (95% CI, 0.46 to 1.00, P = .049) and RMST difference 11 months (95% CI, 1 to 21). Treatment effects were consistent across chemotherapy regimens (carboplatin or cisplatin) and disease stage. Toxicities were similar to those previously reported, and there were no clinically relevant differences in quality of life between arms. 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spelling v2 66426 2024-05-15 Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial fdab5e9e2fe06c93d3ffa19c816bdcf6 John Wagstaff John Wagstaff true false 2024-05-15 MEDS Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.POUT was a phase III, randomized, open-label trial, including 261 patients with muscle-invasive or lymph node–positive, nonmetastatic upper tract urothelial cancer (UTUC) randomly assigned after radical nephroureterectomy to platinum-based chemotherapy (132) or surveillance (129). Primary outcome analysis demonstrated that chemotherapy improved disease-free survival (DFS). At that time, the planned secondary outcome analysis of overall survival (OS) was immature. By February 2022, 50 and 67 DFS events had occurred in the chemotherapy and surveillance groups, respectively, at a median follow-up of 65 months. The 5-year DFS was 62% versus 45%, univariable hazard ratio (HR), 0.55 (95% CI, 0.38 to 0.80, P = .001). The restricted mean survival time (RMST) was 18 months longer (95% CI, 6 to 30) in the chemotherapy arm. There were 46 and 60 deaths in the chemotherapy and control arms, respectively. The 5-year OS was 66% versus 57%, with univariable HR, 0.68 (95% CI, 0.46 to 1.00, P = .049) and RMST difference 11 months (95% CI, 1 to 21). Treatment effects were consistent across chemotherapy regimens (carboplatin or cisplatin) and disease stage. Toxicities were similar to those previously reported, and there were no clinically relevant differences in quality of life between arms. In summary, although OS was not the primary outcome measure, the updated results add further support for the use of adjuvant chemotherapy in patients with UTUC, suggesting long-term benefits. Journal Article Journal of Clinical Oncology 42 13 1466 1471 American Society of Clinical Oncology (ASCO) 0732-183X 1527-7755 1 5 2024 2024-05-01 10.1200/jco.23.01659 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University 2024-06-17T16:08:35.2596534 2024-05-15T08:51:14.8916778 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Alison Jane Birtle 0000-0002-2621-0909 1 Robert Jones 0000-0002-2904-6980 2 John Chester 0000-0002-7830-3840 3 Rebecca Lewis 0000-0001-9222-5263 4 Katie Biscombe 0009-0002-9298-3093 5 Mark Johnson 0000-0002-2323-6046 6 Anthony Blacker 7 Richard T. Bryan 0000-0003-2853-4293 8 James W.F. Catto 0000-0003-2787-8828 9 Ananya Choudhury 10 Prantik Das 11 Satinder Jagdev 12 Thomas Powles 0000-0001-7760-4724 13 John Wagstaff 14 Ka Ching Cheung 0000-0002-1349-0016 15 Fay Cafferty 0000-0002-0973-660x 16 Emma Hall 0000-0001-5999-5020 17 66426__30374__4ec4bf01151643e3b08284ee2a851d7e.pdf 66426.pdf 2024-05-15T08:55:59.8894012 Output 952495 application/pdf Version of Record true Licensed under the Creative Commons Attribution 4.0 License. true eng https://creativecommons.org/licenses/by/4.0/
title Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial
spellingShingle Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial
John Wagstaff
title_short Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial
title_full Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial
title_fullStr Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial
title_full_unstemmed Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial
title_sort Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial
author_id_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6
author_id_fullname_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6_***_John Wagstaff
author John Wagstaff
author2 Alison Jane Birtle
Robert Jones
John Chester
Rebecca Lewis
Katie Biscombe
Mark Johnson
Anthony Blacker
Richard T. Bryan
James W.F. Catto
Ananya Choudhury
Prantik Das
Satinder Jagdev
Thomas Powles
John Wagstaff
Ka Ching Cheung
Fay Cafferty
Emma Hall
format Journal article
container_title Journal of Clinical Oncology
container_volume 42
container_issue 13
container_start_page 1466
publishDate 2024
institution Swansea University
issn 0732-183X
1527-7755
doi_str_mv 10.1200/jco.23.01659
publisher American Society of Clinical Oncology (ASCO)
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
document_store_str 1
active_str 0
description Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.POUT was a phase III, randomized, open-label trial, including 261 patients with muscle-invasive or lymph node–positive, nonmetastatic upper tract urothelial cancer (UTUC) randomly assigned after radical nephroureterectomy to platinum-based chemotherapy (132) or surveillance (129). Primary outcome analysis demonstrated that chemotherapy improved disease-free survival (DFS). At that time, the planned secondary outcome analysis of overall survival (OS) was immature. By February 2022, 50 and 67 DFS events had occurred in the chemotherapy and surveillance groups, respectively, at a median follow-up of 65 months. The 5-year DFS was 62% versus 45%, univariable hazard ratio (HR), 0.55 (95% CI, 0.38 to 0.80, P = .001). The restricted mean survival time (RMST) was 18 months longer (95% CI, 6 to 30) in the chemotherapy arm. There were 46 and 60 deaths in the chemotherapy and control arms, respectively. The 5-year OS was 66% versus 57%, with univariable HR, 0.68 (95% CI, 0.46 to 1.00, P = .049) and RMST difference 11 months (95% CI, 1 to 21). Treatment effects were consistent across chemotherapy regimens (carboplatin or cisplatin) and disease stage. Toxicities were similar to those previously reported, and there were no clinically relevant differences in quality of life between arms. In summary, although OS was not the primary outcome measure, the updated results add further support for the use of adjuvant chemotherapy in patients with UTUC, suggesting long-term benefits.
published_date 2024-05-01T16:08:34Z
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