Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population

Abstract The combination of cyclin dependent kinase 4/6 inhibitors with endocrine therapy is the standard therapy in hormone receptor positive HER-2 negative metastatic breast cancer (HR+/HER2− MBC). Several randomized trials have shown the benefits of this combination, however, real world evidence...

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Autores principales:	Chaturbhuj Agrawal, Pankaj Goyal, Amit Agarwal, Rupal Tripathi, Chandragouda Dodagoudar, Saphalta Baghmar, Archana Sharma, Ullas Batra, Vineet Talwar, Sumit Goyal, Rajeev Kumar, Dinesh Chandra Doval
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/0a2eee6afaf34fa489c4e65d644828a3
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spelling	oai:doaj.org-article:0a2eee6afaf34fa489c4e65d644828a32021-12-02T16:27:45ZMulticentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population10.1038/s41598-021-95758-12045-2322https://doaj.org/article/0a2eee6afaf34fa489c4e65d644828a32021-08-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-95758-1https://doaj.org/toc/2045-2322Abstract The combination of cyclin dependent kinase 4/6 inhibitors with endocrine therapy is the standard therapy in hormone receptor positive HER-2 negative metastatic breast cancer (HR+/HER2− MBC). Several randomized trials have shown the benefits of this combination, however, real world evidence in the Indian patients is warranted. The present study reports the largest real world multicentric data from Indian population on the use of Palbociclib in HR+/HER2− MBC. A multicentric study on the HR+/HER2− MBC patients who received palbociclib with hormonal agent (Aromatase inhibitors/Fulvestrant) between February 2017 and May 2020 was conducted. Clinical and demographic information and survival data was retrieved from the Hospital medical records. Among a total of 188 patients, 57% patients were premenopausal and 17% patients had bone only disease. Altogether, 115 (61%) patients received palbociclib with Aromatase inhibitors in the first line whereas 73 (39%) patients received it in the second line with Fulvestrant. The median follow up period with advanced disease was 13 months. The median progression free survival in the first line and second line was 20.2 months and 12 months, respectively (p-value < 0.0001). The objective response rate was 80% and 47.9% in first and second lines, respectively. Dose interruptions/ discontinuation were done in 14.9% and 2.7% patients in the first and second lines, respectively. In terms of toxicity, 10% patients had grade 3–4 adverse events. The present real world data of the use of palbociclib in Indian population suggests similar effectiveness to previously published real world evidences and has been adapted as the standard of care in the first and second line treatment of HR+/HER2− MBC.Chaturbhuj AgrawalPankaj GoyalAmit AgarwalRupal TripathiChandragouda DodagoudarSaphalta BaghmarArchana SharmaUllas BatraVineet TalwarSumit GoyalRajeev KumarDinesh Chandra DovalNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-6 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Chaturbhuj Agrawal Pankaj Goyal Amit Agarwal Rupal Tripathi Chandragouda Dodagoudar Saphalta Baghmar Archana Sharma Ullas Batra Vineet Talwar Sumit Goyal Rajeev Kumar Dinesh Chandra Doval Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population
description	Abstract The combination of cyclin dependent kinase 4/6 inhibitors with endocrine therapy is the standard therapy in hormone receptor positive HER-2 negative metastatic breast cancer (HR+/HER2− MBC). Several randomized trials have shown the benefits of this combination, however, real world evidence in the Indian patients is warranted. The present study reports the largest real world multicentric data from Indian population on the use of Palbociclib in HR+/HER2− MBC. A multicentric study on the HR+/HER2− MBC patients who received palbociclib with hormonal agent (Aromatase inhibitors/Fulvestrant) between February 2017 and May 2020 was conducted. Clinical and demographic information and survival data was retrieved from the Hospital medical records. Among a total of 188 patients, 57% patients were premenopausal and 17% patients had bone only disease. Altogether, 115 (61%) patients received palbociclib with Aromatase inhibitors in the first line whereas 73 (39%) patients received it in the second line with Fulvestrant. The median follow up period with advanced disease was 13 months. The median progression free survival in the first line and second line was 20.2 months and 12 months, respectively (p-value < 0.0001). The objective response rate was 80% and 47.9% in first and second lines, respectively. Dose interruptions/ discontinuation were done in 14.9% and 2.7% patients in the first and second lines, respectively. In terms of toxicity, 10% patients had grade 3–4 adverse events. The present real world data of the use of palbociclib in Indian population suggests similar effectiveness to previously published real world evidences and has been adapted as the standard of care in the first and second line treatment of HR+/HER2− MBC.
format	article
author	Chaturbhuj Agrawal Pankaj Goyal Amit Agarwal Rupal Tripathi Chandragouda Dodagoudar Saphalta Baghmar Archana Sharma Ullas Batra Vineet Talwar Sumit Goyal Rajeev Kumar Dinesh Chandra Doval
author_facet	Chaturbhuj Agrawal Pankaj Goyal Amit Agarwal Rupal Tripathi Chandragouda Dodagoudar Saphalta Baghmar Archana Sharma Ullas Batra Vineet Talwar Sumit Goyal Rajeev Kumar Dinesh Chandra Doval
author_sort	Chaturbhuj Agrawal
title	Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population
title_short	Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population
title_full	Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population
title_fullStr	Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population
title_full_unstemmed	Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population
title_sort	multicentric real world evidence with palbociclib in hormone positive her2 negative metastatic breast cancer in indian population
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/0a2eee6afaf34fa489c4e65d644828a3
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Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population

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