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Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer

BACKGROUND: The prognostic value of patient-reported outcomes (PROs) has been minimally explored in advanced breast cancer (BC), and their comparative prognostic performance against Eastern Cooperative Oncology Group performance status (ECOG PS) is largely unknown. PATIENTS AND METHODS: This study p...

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Autores principales: Modi, N.D., Danell, N.O., Perry, R.N.A., Abuhelwa, A.Y., Rathod, A., Badaoui, S., McKinnon, R.A., Haseloff, M., Shahnam, A., Swain, S.M., Welslau, M., Sorich, M.J., Hopkins, A.M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9271483/
https://www.ncbi.nlm.nih.gov/pubmed/35490579
http://dx.doi.org/10.1016/j.esmoop.2022.100475
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author Modi, N.D.
Danell, N.O.
Perry, R.N.A.
Abuhelwa, A.Y.
Rathod, A.
Badaoui, S.
McKinnon, R.A.
Haseloff, M.
Shahnam, A.
Swain, S.M.
Welslau, M.
Sorich, M.J.
Hopkins, A.M.
author_facet Modi, N.D.
Danell, N.O.
Perry, R.N.A.
Abuhelwa, A.Y.
Rathod, A.
Badaoui, S.
McKinnon, R.A.
Haseloff, M.
Shahnam, A.
Swain, S.M.
Welslau, M.
Sorich, M.J.
Hopkins, A.M.
author_sort Modi, N.D.
collection PubMed
description BACKGROUND: The prognostic value of patient-reported outcomes (PROs) has been minimally explored in advanced breast cancer (BC), and their comparative prognostic performance against Eastern Cooperative Oncology Group performance status (ECOG PS) is largely unknown. PATIENTS AND METHODS: This study pooled individual participant data from clinical trials CLEOPATRA, EMILIA, and MARIANNE. Pre-treatment PRO associations with overall survival (OS), progression-free survival (PFS), and grade ≥3 adverse events were evaluated via Cox proportional hazards regression. Prognostic performance was assessed with the C-statistic (c). PRO values were collected via the Functional Assessment of Cancer Therapy—Breast (FACT-B) questionnaire. All analyses were stratified by study and treatment arms. Analyses adjusted for known prognostic variables were conducted. Exploratory analysis of the prognostic performance of PROs compared to ECOG PS was undertaken. RESULTS: The study included data from 2894 patients initiated on contemporary therapies including pertuzumab (n = 765), trastuzumab (n = 1173), trastuzumab emtansine (n = 1225), taxanes (n = 1173), lapatinib (n = 496), and capecitabine (n = 496). On univariable and adjusted analysis, patient-reported physical well-being, functional well-being, and BC subscale were all identified to be associated with OS, PFS, and grade ≥3 adverse events (P < 0.05). Patient-reported physical well-being was the most prognostic PRO for all assessed outcomes. The OS prognostic performance of physical well-being (c = 0.58) was superior to ECOG PS (c = 0.56) (P < 0.05), with multivariable analysis indicating that both provide independent information (P < 0.0001). CONCLUSIONS: PROs were identified as independent prognostic factors for OS, PFS, and grade ≥3 adverse events in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced BC initiating contemporary treatment options. Further, patient-reported physical well-being was more prognostic of OS than ECOG PS and contained independent information. PROs have value as prognostic and stratification factors for clinical use and research trials of anticancer treatment in HER2-positive ABC.
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spelling pubmed-92714832022-07-12 Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer Modi, N.D. Danell, N.O. Perry, R.N.A. Abuhelwa, A.Y. Rathod, A. Badaoui, S. McKinnon, R.A. Haseloff, M. Shahnam, A. Swain, S.M. Welslau, M. Sorich, M.J. Hopkins, A.M. ESMO Open Original Research BACKGROUND: The prognostic value of patient-reported outcomes (PROs) has been minimally explored in advanced breast cancer (BC), and their comparative prognostic performance against Eastern Cooperative Oncology Group performance status (ECOG PS) is largely unknown. PATIENTS AND METHODS: This study pooled individual participant data from clinical trials CLEOPATRA, EMILIA, and MARIANNE. Pre-treatment PRO associations with overall survival (OS), progression-free survival (PFS), and grade ≥3 adverse events were evaluated via Cox proportional hazards regression. Prognostic performance was assessed with the C-statistic (c). PRO values were collected via the Functional Assessment of Cancer Therapy—Breast (FACT-B) questionnaire. All analyses were stratified by study and treatment arms. Analyses adjusted for known prognostic variables were conducted. Exploratory analysis of the prognostic performance of PROs compared to ECOG PS was undertaken. RESULTS: The study included data from 2894 patients initiated on contemporary therapies including pertuzumab (n = 765), trastuzumab (n = 1173), trastuzumab emtansine (n = 1225), taxanes (n = 1173), lapatinib (n = 496), and capecitabine (n = 496). On univariable and adjusted analysis, patient-reported physical well-being, functional well-being, and BC subscale were all identified to be associated with OS, PFS, and grade ≥3 adverse events (P < 0.05). Patient-reported physical well-being was the most prognostic PRO for all assessed outcomes. The OS prognostic performance of physical well-being (c = 0.58) was superior to ECOG PS (c = 0.56) (P < 0.05), with multivariable analysis indicating that both provide independent information (P < 0.0001). CONCLUSIONS: PROs were identified as independent prognostic factors for OS, PFS, and grade ≥3 adverse events in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced BC initiating contemporary treatment options. Further, patient-reported physical well-being was more prognostic of OS than ECOG PS and contained independent information. PROs have value as prognostic and stratification factors for clinical use and research trials of anticancer treatment in HER2-positive ABC. Elsevier 2022-04-28 /pmc/articles/PMC9271483/ /pubmed/35490579 http://dx.doi.org/10.1016/j.esmoop.2022.100475 Text en © 2022 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Research
Modi, N.D.
Danell, N.O.
Perry, R.N.A.
Abuhelwa, A.Y.
Rathod, A.
Badaoui, S.
McKinnon, R.A.
Haseloff, M.
Shahnam, A.
Swain, S.M.
Welslau, M.
Sorich, M.J.
Hopkins, A.M.
Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer
title Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer
title_full Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer
title_fullStr Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer
title_full_unstemmed Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer
title_short Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer
title_sort patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced her2-positive breast cancer
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9271483/
https://www.ncbi.nlm.nih.gov/pubmed/35490579
http://dx.doi.org/10.1016/j.esmoop.2022.100475
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