Cargando…

SYST-09 IMPACT OF END-STAGE RENAL DISEASE AND CONCOMITANT DIALYSIS ON THE EFFICACY OF IMMUNOTHERAPY IN BRAIN METASTASES PATIENTS: A PROPENSITY-MATCHED SURVIVAL ANALYSIS

INTRODUCTION: Mounting evidence demonstrates the therapeutic promise of immunotherapies (ITs) for brain metastases (BM). However, there is concern that stringent eligibility criteria in these clinical studies have selected against patients with comorbid conditions. As a result, it remains unclear if...

Descripción completa

Detalles Bibliográficos
Autores principales: Baroz, Angel, Bhanja, Debarati, Stahl, Caleb, Wilding, Hannah, Mansouri, Alireza
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354167/
http://dx.doi.org/10.1093/noajnl/vdac078.088
_version_ 1784763007200395264
author Baroz, Angel
Bhanja, Debarati
Stahl, Caleb
Wilding, Hannah
Mansouri, Alireza
author_facet Baroz, Angel
Bhanja, Debarati
Stahl, Caleb
Wilding, Hannah
Mansouri, Alireza
author_sort Baroz, Angel
collection PubMed
description INTRODUCTION: Mounting evidence demonstrates the therapeutic promise of immunotherapies (ITs) for brain metastases (BM). However, there is concern that stringent eligibility criteria in these clinical studies have selected against patients with comorbid conditions. As a result, it remains unclear if these results are truly applicable to the general population, particularly in individuals with end-stage renal disease (ESRD) on dialysis. Therefore, we sought to determine the impact of concomitant dialysis treatment and IT on overall survival (OS) of patients with BM. METHODS: Data were collected from TriNetX (TriNetX, Inc., Cambridge, MA), a global research network that aggregates clinical data from 92 healthcare organizations. Independent variables included ‘secondary malignant neoplasm of brain’, ‘ipilimumab’, ‘pembrolizumab’, ‘ESRD’, ‘dependence on renal dialysis’, and ‘dialysis services and procedures’. Patients with BM receiving IT were dichotomized by dialysis use. Cohorts were propensity matched on age, gender, and race. Kaplan-Meier analyses and log rank tests were conducted to assess overall survival (OS) and survival probability over a five-year period. RESULTS: Of the 14,368 confirmed BM patients treated with IT, 95 (0.6%) began dialysis within three months of IT initiation. Propensity matching established 95 patients in each cohort. The dialyzed cohort had a median OS of 277 days with a survival probability of 11.6%, compared to the non-dialyzed group with a median OS of 419 days and survival probability of 40.29% (p=0.109; hazard ratio 1.422, 95% confidence interval, 0.923-2.191, p=0.891). A separate comparison cohort was created to compare ESRD diagnosis with or without dialysis (n=56 and n=106 respectively). The comparison cohorts did not show a difference in median OS and survival probability (p=0.49). CONCLUSION: Despite their health complexities, individuals with ESRD, with or without dependence on dialysis, may nonetheless derive a similar survival benefit from ITs. Therefore, we advocate for greater inclusion of patients with advanced comorbidities in clinical trials to assess for real-world safety and efficacy outcomes.
format Online
Article
Text
id pubmed-9354167
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-93541672022-08-09 SYST-09 IMPACT OF END-STAGE RENAL DISEASE AND CONCOMITANT DIALYSIS ON THE EFFICACY OF IMMUNOTHERAPY IN BRAIN METASTASES PATIENTS: A PROPENSITY-MATCHED SURVIVAL ANALYSIS Baroz, Angel Bhanja, Debarati Stahl, Caleb Wilding, Hannah Mansouri, Alireza Neurooncol Adv Supplement Abstracts INTRODUCTION: Mounting evidence demonstrates the therapeutic promise of immunotherapies (ITs) for brain metastases (BM). However, there is concern that stringent eligibility criteria in these clinical studies have selected against patients with comorbid conditions. As a result, it remains unclear if these results are truly applicable to the general population, particularly in individuals with end-stage renal disease (ESRD) on dialysis. Therefore, we sought to determine the impact of concomitant dialysis treatment and IT on overall survival (OS) of patients with BM. METHODS: Data were collected from TriNetX (TriNetX, Inc., Cambridge, MA), a global research network that aggregates clinical data from 92 healthcare organizations. Independent variables included ‘secondary malignant neoplasm of brain’, ‘ipilimumab’, ‘pembrolizumab’, ‘ESRD’, ‘dependence on renal dialysis’, and ‘dialysis services and procedures’. Patients with BM receiving IT were dichotomized by dialysis use. Cohorts were propensity matched on age, gender, and race. Kaplan-Meier analyses and log rank tests were conducted to assess overall survival (OS) and survival probability over a five-year period. RESULTS: Of the 14,368 confirmed BM patients treated with IT, 95 (0.6%) began dialysis within three months of IT initiation. Propensity matching established 95 patients in each cohort. The dialyzed cohort had a median OS of 277 days with a survival probability of 11.6%, compared to the non-dialyzed group with a median OS of 419 days and survival probability of 40.29% (p=0.109; hazard ratio 1.422, 95% confidence interval, 0.923-2.191, p=0.891). A separate comparison cohort was created to compare ESRD diagnosis with or without dialysis (n=56 and n=106 respectively). The comparison cohorts did not show a difference in median OS and survival probability (p=0.49). CONCLUSION: Despite their health complexities, individuals with ESRD, with or without dependence on dialysis, may nonetheless derive a similar survival benefit from ITs. Therefore, we advocate for greater inclusion of patients with advanced comorbidities in clinical trials to assess for real-world safety and efficacy outcomes. Oxford University Press 2022-08-05 /pmc/articles/PMC9354167/ http://dx.doi.org/10.1093/noajnl/vdac078.088 Text en © The Author(s) 2022. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Supplement Abstracts
Baroz, Angel
Bhanja, Debarati
Stahl, Caleb
Wilding, Hannah
Mansouri, Alireza
SYST-09 IMPACT OF END-STAGE RENAL DISEASE AND CONCOMITANT DIALYSIS ON THE EFFICACY OF IMMUNOTHERAPY IN BRAIN METASTASES PATIENTS: A PROPENSITY-MATCHED SURVIVAL ANALYSIS
title SYST-09 IMPACT OF END-STAGE RENAL DISEASE AND CONCOMITANT DIALYSIS ON THE EFFICACY OF IMMUNOTHERAPY IN BRAIN METASTASES PATIENTS: A PROPENSITY-MATCHED SURVIVAL ANALYSIS
title_full SYST-09 IMPACT OF END-STAGE RENAL DISEASE AND CONCOMITANT DIALYSIS ON THE EFFICACY OF IMMUNOTHERAPY IN BRAIN METASTASES PATIENTS: A PROPENSITY-MATCHED SURVIVAL ANALYSIS
title_fullStr SYST-09 IMPACT OF END-STAGE RENAL DISEASE AND CONCOMITANT DIALYSIS ON THE EFFICACY OF IMMUNOTHERAPY IN BRAIN METASTASES PATIENTS: A PROPENSITY-MATCHED SURVIVAL ANALYSIS
title_full_unstemmed SYST-09 IMPACT OF END-STAGE RENAL DISEASE AND CONCOMITANT DIALYSIS ON THE EFFICACY OF IMMUNOTHERAPY IN BRAIN METASTASES PATIENTS: A PROPENSITY-MATCHED SURVIVAL ANALYSIS
title_short SYST-09 IMPACT OF END-STAGE RENAL DISEASE AND CONCOMITANT DIALYSIS ON THE EFFICACY OF IMMUNOTHERAPY IN BRAIN METASTASES PATIENTS: A PROPENSITY-MATCHED SURVIVAL ANALYSIS
title_sort syst-09 impact of end-stage renal disease and concomitant dialysis on the efficacy of immunotherapy in brain metastases patients: a propensity-matched survival analysis
topic Supplement Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354167/
http://dx.doi.org/10.1093/noajnl/vdac078.088
work_keys_str_mv AT barozangel syst09impactofendstagerenaldiseaseandconcomitantdialysisontheefficacyofimmunotherapyinbrainmetastasespatientsapropensitymatchedsurvivalanalysis
AT bhanjadebarati syst09impactofendstagerenaldiseaseandconcomitantdialysisontheefficacyofimmunotherapyinbrainmetastasespatientsapropensitymatchedsurvivalanalysis
AT stahlcaleb syst09impactofendstagerenaldiseaseandconcomitantdialysisontheefficacyofimmunotherapyinbrainmetastasespatientsapropensitymatchedsurvivalanalysis
AT wildinghannah syst09impactofendstagerenaldiseaseandconcomitantdialysisontheefficacyofimmunotherapyinbrainmetastasespatientsapropensitymatchedsurvivalanalysis
AT mansourialireza syst09impactofendstagerenaldiseaseandconcomitantdialysisontheefficacyofimmunotherapyinbrainmetastasespatientsapropensitymatchedsurvivalanalysis