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Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European coun...

Camillo Porta, Antonin Levy, Robert Hawkins, Daniel Castellano, Joaquim Bellmunt, Paul Nathan, Ray McDermott, John Wagstaff, Paul Donnellan, John McCaffrey, Francis Vekeman, Maureen P. Neary, Jose Diaz, Faisal Mehmud, Mei Sheng Duh

Cancer Medicine, Volume: 3, Issue: 6, Pages: 1517 - 1526

Swansea University Author: John Wagstaff

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DOI (Published version): 10.1002/cam4.302

Abstract

Angiogenesis inhibitors have become standard of care for advanced and/or metastatic renal cell carcinoma (RCC), but data on the impact of adverse events (AEs) and treatment modifications associated with these agents are limited. Medical records were abstracted at 10 tertiary oncology centers in Euro...

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Published in: Cancer Medicine
ISSN: 2045-7634 2045-7634
Published: Wiley 2014
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URI: https://cronfa.swan.ac.uk/Record/cronfa57727
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spelling 2021-09-20T12:52:32.1341607 v2 57727 2021-08-31 Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries fdab5e9e2fe06c93d3ffa19c816bdcf6 John Wagstaff John Wagstaff true false 2021-08-31 MEDS Angiogenesis inhibitors have become standard of care for advanced and/or metastatic renal cell carcinoma (RCC), but data on the impact of adverse events (AEs) and treatment modifications associated with these agents are limited. Medical records were abstracted at 10 tertiary oncology centers in Europe for 291 patients ≥18 years old treated with sunitinib as first-line treatment for advanced RCC (no prior systemic treatment for advanced disease). Logistic regression models were estimated to compare dose intensity among patients who did and did not experience AEs during the landmark periods (18, 24, and 30 weeks). Cox proportional hazard models were used to explore the possible relationship of low-dose intensity (defined using thresholds of 0.7, 0.8, and 0.9) and treatment modifications during the landmark periods to survival. 64.4% to 67.9% of patients treated with sunitinib reported at least one AE of any grade, and approximately 10% of patients experienced at least one severe (grade 3 or 4) AE. Patients reporting severe AEs were statistically significantly more likely to have dose intensities below either 0.8 or 0.9. Dose intensity below 0.7 and dose discontinuation during all landmark periods were statistically significantly associated with shorter survival time. This study of advanced RCC patients treated with sunitinib in Europe found a significant relationship between AEs and dose intensity. It also found correlations between dose intensity and shorter survival, and between dose discontinuation and shorter survival. These results confirm the importance of tolerable treatment and maintaining dose intensity. Journal Article Cancer Medicine 3 6 1517 1526 Wiley 2045-7634 2045-7634 Angiogenesis, clinical observations, statisticalmethods, urological oncology 1 12 2014 2014-12-01 10.1002/cam4.302 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University 2021-09-20T12:52:32.1341607 2021-08-31T12:46:19.8600902 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Camillo Porta 1 Antonin Levy 2 Robert Hawkins 3 Daniel Castellano 4 Joaquim Bellmunt 5 Paul Nathan 6 Ray McDermott 7 John Wagstaff 8 Paul Donnellan 9 John McCaffrey 10 Francis Vekeman 11 Maureen P. Neary 12 Jose Diaz 13 Faisal Mehmud 14 Mei Sheng Duh 15 57727__20939__e808a6675ecd43f59826666144171fd9.pdf 57727.pdf 2021-09-20T12:48:12.1167064 Output 234482 application/pdf Version of Record true © 2014 The Authors. This is an open access article under the terms of the Creative Commons Attribution License true eng http://creativecommons.org/licenses/by/3.0/
title Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries
spellingShingle Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries
John Wagstaff
title_short Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries
title_full Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries
title_fullStr Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries
title_full_unstemmed Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries
title_sort Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries
author_id_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6
author_id_fullname_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6_***_John Wagstaff
author John Wagstaff
author2 Camillo Porta
Antonin Levy
Robert Hawkins
Daniel Castellano
Joaquim Bellmunt
Paul Nathan
Ray McDermott
John Wagstaff
Paul Donnellan
John McCaffrey
Francis Vekeman
Maureen P. Neary
Jose Diaz
Faisal Mehmud
Mei Sheng Duh
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container_title Cancer Medicine
container_volume 3
container_issue 6
container_start_page 1517
publishDate 2014
institution Swansea University
issn 2045-7634
2045-7634
doi_str_mv 10.1002/cam4.302
publisher Wiley
college_str Faculty of Medicine, Health and Life Sciences
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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 - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
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description Angiogenesis inhibitors have become standard of care for advanced and/or metastatic renal cell carcinoma (RCC), but data on the impact of adverse events (AEs) and treatment modifications associated with these agents are limited. Medical records were abstracted at 10 tertiary oncology centers in Europe for 291 patients ≥18 years old treated with sunitinib as first-line treatment for advanced RCC (no prior systemic treatment for advanced disease). Logistic regression models were estimated to compare dose intensity among patients who did and did not experience AEs during the landmark periods (18, 24, and 30 weeks). Cox proportional hazard models were used to explore the possible relationship of low-dose intensity (defined using thresholds of 0.7, 0.8, and 0.9) and treatment modifications during the landmark periods to survival. 64.4% to 67.9% of patients treated with sunitinib reported at least one AE of any grade, and approximately 10% of patients experienced at least one severe (grade 3 or 4) AE. Patients reporting severe AEs were statistically significantly more likely to have dose intensities below either 0.8 or 0.9. Dose intensity below 0.7 and dose discontinuation during all landmark periods were statistically significantly associated with shorter survival time. This study of advanced RCC patients treated with sunitinib in Europe found a significant relationship between AEs and dose intensity. It also found correlations between dose intensity and shorter survival, and between dose discontinuation and shorter survival. These results confirm the importance of tolerable treatment and maintaining dose intensity.
published_date 2014-12-01T05:08:14Z
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