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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Nature Portfolio
2021-08-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-021-95758-1 |
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| 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 |
| collection | DOAJ |
| 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. |
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| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-12-13T17:17:30Z |
| publishDate | 2021-08-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj.art-0a2eee6afaf34fa489c4e65d644828a32022-12-21T23:37:24ZengNature PortfolioScientific Reports2045-23222021-08-011111610.1038/s41598-021-95758-1Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian populationChaturbhuj Agrawal0Pankaj Goyal1Amit Agarwal2Rupal Tripathi3Chandragouda Dodagoudar4Saphalta Baghmar5Archana Sharma6Ullas Batra7Vineet Talwar8Sumit Goyal9Rajeev Kumar10Dinesh Chandra Doval11Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research CentreDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research CentreDepartment of Medical Oncology, Fortis HospitalDepartment of Research, Rajiv Gandhi Cancer Institute and Research CentreDepartment of Medical Oncology, BLK Super Specialty HospitalDepartment of Medical Oncology, Max Super Specialty HospitalDepartment of Research, Rajiv Gandhi Cancer Institute and Research CentreDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research CentreDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research CentreDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research CentreDepartment of Surgical Oncology, Rajiv Gandhi Cancer Institute and Research CentreDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research CentreAbstract 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.https://doi.org/10.1038/s41598-021-95758-1 |
| spellingShingle | 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 Scientific Reports |
| title | 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_short | 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 |
| url | https://doi.org/10.1038/s41598-021-95758-1 |
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