Academic Journal
Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up
| العنوان: | Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up |
|---|---|
| المؤلفون: | Finn, RS, Rugo, HS, Gelmon, KA, Cristofanilli, M, Colleoni, M, Loi, S, Schnell, P, Lu, DR, Theall, KP, Mori, A, Gauthier, E, Bananis, E, Turner, NC, Dieras, V |
| بيانات النشر: | WILEY |
| سنة النشر: | 2021 |
| المجموعة: | The University of Melbourne: Digital Repository |
| الوصف: | BACKGROUND: Previous studies demonstrated the tolerability of palbociclib plus endocrine therapy (ET). This analysis evaluated safety based on more recent cutoff dates and a longer palbociclib treatment exposure. PATIENTS AND METHODS: Data were pooled from three randomized studies of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC), including postmenopausal women who had not received prior systemic treatment for advanced disease (PALOMA-1/-2) and pre- and postmenopausal women who had progressed on prior ET (PALOMA-3). RESULTS: Updated cutoff dates were December 21, 2017 (PALOMA-1), May 31, 2017 (PALOMA-2), and April 13, 2018 (PALOMA-3). Total person-years of treatment exposure were 1,421.6 with palbociclib plus ET (n = 872) and 528.4 with ET (n = 471). Any-grade neutropenia and infections were more frequent with palbociclib plus ET (82.1% and 59.2%, respectively) than with ET (5.1% and 39.5%). The hazard ratios were 1.6 (p = .0995) for grade 3/4 infections, 1.8 (p = .4358) for grade 3/4 viral infections, 1.4 (p = .0001) for infections, and 30.8 (p < .0001) for neutropenia. Febrile neutropenia was reported in 1.4% of patients receiving palbociclib plus ET. Cumulative incidence of all-grade hematologic adverse events in both arms peaked during the first year of treatment and plateaued over the 5 subsequent years. Interstitial lung disease was reported in 13 patients receiving palbociclib plus ET and 3 receiving ET. CONCLUSION: This 5-year, long-term analysis demonstrated that palbociclib plus ET has a consistent and stable safety profile and is a safe treatment for patients with HR+/HER2- ABC. IMPLICATIONS FOR PRACTICE: Several treatments for patients with breast cancer are associated with long-term or latent adverse events. This long-term, 5-year analysis demonstrated that palbociclib plus endocrine therapy has a consistent and stable safety profile without cumulative or delayed toxicities. These results further support ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1083-7159 1549-490X |
| Relation: | Finn, R. S., Rugo, H. S., Gelmon, K. A., Cristofanilli, M., Colleoni, M., Loi, S., Schnell, P., Lu, D. R., Theall, K. P., Mori, A., Gauthier, E., Bananis, E., Turner, N. C. & Dieras, V. (2021). Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. ONCOLOGIST, 26 (5), pp.E749-E755. https://doi.org/10.1002/onco.13684.; http://hdl.handle.net/11343/274179 |
| الاتاحة: | http://hdl.handle.net/11343/274179 |
| Rights: | CC BY-NC-ND ; https://creativecommons.org/licenses/by-nc-nd/4.0 |
| رقم الانضمام: | edsbas.647D085A |
| قاعدة البيانات: | BASE |
Full Text Finder | ResultId |
1 |
|---|---|
| Header |
edsbas BASE edsbas.647D085A 919 3 Academic Journal academicJournal 918.9462890625 |
| PLink |
https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&scope=site&db=edsbas&AN=edsbas.647D085A&custid=s6537998&authtype=sso |
| FullText |
Array
(
[Availability] => 0
)
Array ( [0] => Array ( [Url] => http://hdl.handle.net/11343/274179# [Name] => EDS - BASE [Category] => fullText [Text] => View record in BASE [MouseOverText] => View record in BASE ) [1] => Array ( [Url] => https://resolver.ebscohost.com/openurl?custid=s6537998&groupid=main&authtype=ip,guest&sid=EBSCO:edsbas&genre=article&issn=10837159&ISBN=&volume=&issue=&date=20210101&spage=&pages=&title=Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up&atitle=Long-Term%20Pooled%20Safety%20Analysis%20of%20Palbociclib%20in%20Combination%20with%20Endocrine%20Therapy%20for%20Hormone%20Receptor-Positive%2FHuman%20Epidermal%20Growth%20Factor%20Receptor%202-Negative%20Advanced%20Breast%20Cancer%3A%20Updated%20Analysis%20with%20up%20to%205%20Years%20of%20Follow-Up&id=DOI: [Name] => Full Text Finder (s6537998api) [Category] => fullText [Text] => Full Text Finder [Icon] => https://imageserver.ebscohost.com/branding/images/FTF.gif [MouseOverText] => Full Text Finder ) ) |
| Items |
Array
(
[Name] => Title
[Label] => Title
[Group] => Ti
[Data] => Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up
)
Array ( [Name] => Author [Label] => Authors [Group] => Au [Data] => <searchLink fieldCode="AR" term="%22Finn%2C+RS%22">Finn, RS</searchLink><br /><searchLink fieldCode="AR" term="%22Rugo%2C+HS%22">Rugo, HS</searchLink><br /><searchLink fieldCode="AR" term="%22Gelmon%2C+KA%22">Gelmon, KA</searchLink><br /><searchLink fieldCode="AR" term="%22Cristofanilli%2C+M%22">Cristofanilli, M</searchLink><br /><searchLink fieldCode="AR" term="%22Colleoni%2C+M%22">Colleoni, M</searchLink><br /><searchLink fieldCode="AR" term="%22Loi%2C+S%22">Loi, S</searchLink><br /><searchLink fieldCode="AR" term="%22Schnell%2C+P%22">Schnell, P</searchLink><br /><searchLink fieldCode="AR" term="%22Lu%2C+DR%22">Lu, DR</searchLink><br /><searchLink fieldCode="AR" term="%22Theall%2C+KP%22">Theall, KP</searchLink><br /><searchLink fieldCode="AR" term="%22Mori%2C+A%22">Mori, A</searchLink><br /><searchLink fieldCode="AR" term="%22Gauthier%2C+E%22">Gauthier, E</searchLink><br /><searchLink fieldCode="AR" term="%22Bananis%2C+E%22">Bananis, E</searchLink><br /><searchLink fieldCode="AR" term="%22Turner%2C+NC%22">Turner, NC</searchLink><br /><searchLink fieldCode="AR" term="%22Dieras%2C+V%22">Dieras, V</searchLink> ) Array ( [Name] => Publisher [Label] => Publisher Information [Group] => PubInfo [Data] => WILEY ) Array ( [Name] => DatePubCY [Label] => Publication Year [Group] => Date [Data] => 2021 ) Array ( [Name] => Subset [Label] => Collection [Group] => HoldingsInfo [Data] => The University of Melbourne: Digital Repository ) Array ( [Name] => Abstract [Label] => Description [Group] => Ab [Data] => BACKGROUND: Previous studies demonstrated the tolerability of palbociclib plus endocrine therapy (ET). This analysis evaluated safety based on more recent cutoff dates and a longer palbociclib treatment exposure. PATIENTS AND METHODS: Data were pooled from three randomized studies of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC), including postmenopausal women who had not received prior systemic treatment for advanced disease (PALOMA-1/-2) and pre- and postmenopausal women who had progressed on prior ET (PALOMA-3). RESULTS: Updated cutoff dates were December 21, 2017 (PALOMA-1), May 31, 2017 (PALOMA-2), and April 13, 2018 (PALOMA-3). Total person-years of treatment exposure were 1,421.6 with palbociclib plus ET (n = 872) and 528.4 with ET (n = 471). Any-grade neutropenia and infections were more frequent with palbociclib plus ET (82.1% and 59.2%, respectively) than with ET (5.1% and 39.5%). The hazard ratios were 1.6 (p = .0995) for grade 3/4 infections, 1.8 (p = .4358) for grade 3/4 viral infections, 1.4 (p = .0001) for infections, and 30.8 (p < .0001) for neutropenia. Febrile neutropenia was reported in 1.4% of patients receiving palbociclib plus ET. Cumulative incidence of all-grade hematologic adverse events in both arms peaked during the first year of treatment and plateaued over the 5 subsequent years. Interstitial lung disease was reported in 13 patients receiving palbociclib plus ET and 3 receiving ET. CONCLUSION: This 5-year, long-term analysis demonstrated that palbociclib plus ET has a consistent and stable safety profile and is a safe treatment for patients with HR+/HER2- ABC. IMPLICATIONS FOR PRACTICE: Several treatments for patients with breast cancer are associated with long-term or latent adverse events. This long-term, 5-year analysis demonstrated that palbociclib plus endocrine therapy has a consistent and stable safety profile without cumulative or delayed toxicities. These results further support ... ) Array ( [Name] => TypeDocument [Label] => Document Type [Group] => TypDoc [Data] => article in journal/newspaper ) Array ( [Name] => Language [Label] => Language [Group] => Lang [Data] => English ) Array ( [Name] => ISSN [Label] => ISSN [Group] => ISSN [Data] => 1083-7159<br />1549-490X ) Array ( [Name] => NoteTitleSource [Label] => Relation [Group] => SrcInfo [Data] => Finn, R. S., Rugo, H. S., Gelmon, K. A., Cristofanilli, M., Colleoni, M., Loi, S., Schnell, P., Lu, D. R., Theall, K. P., Mori, A., Gauthier, E., Bananis, E., Turner, N. C. & Dieras, V. (2021). Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. ONCOLOGIST, 26 (5), pp.E749-E755. https://doi.org/10.1002/onco.13684.; http://hdl.handle.net/11343/274179 ) Array ( [Name] => URL [Label] => Availability [Group] => URL [Data] => http://hdl.handle.net/11343/274179 ) Array ( [Name] => Copyright [Label] => Rights [Group] => Cpyrght [Data] => CC BY-NC-ND ; https://creativecommons.org/licenses/by-nc-nd/4.0 ) Array ( [Name] => AN [Label] => Accession Number [Group] => ID [Data] => edsbas.647D085A ) |
| RecordInfo |
Array
(
[BibEntity] => Array
(
[Languages] => Array
(
[0] => Array
(
[Text] => English
)
)
[Titles] => Array
(
[0] => Array
(
[TitleFull] => Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up
[Type] => main
)
)
)
[BibRelationships] => Array
(
[HasContributorRelationships] => Array
(
[0] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Finn, RS
)
)
)
[1] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Rugo, HS
)
)
)
[2] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Gelmon, KA
)
)
)
[3] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Cristofanilli, M
)
)
)
[4] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Colleoni, M
)
)
)
[5] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Loi, S
)
)
)
[6] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Schnell, P
)
)
)
[7] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Lu, DR
)
)
)
[8] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Theall, KP
)
)
)
[9] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Mori, A
)
)
)
[10] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Gauthier, E
)
)
)
[11] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Bananis, E
)
)
)
[12] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Turner, NC
)
)
)
[13] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Dieras, V
)
)
)
)
[IsPartOfRelationships] => Array
(
[0] => Array
(
[BibEntity] => Array
(
[Dates] => Array
(
[0] => Array
(
[D] => 01
[M] => 01
[Type] => published
[Y] => 2021
)
)
[Identifiers] => Array
(
[0] => Array
(
[Type] => issn-print
[Value] => 10837159
)
[1] => Array
(
[Type] => issn-print
[Value] => 1549490X
)
[2] => Array
(
[Type] => issn-locals
[Value] => edsbas
)
[3] => Array
(
[Type] => issn-locals
[Value] => edsbas.oa
)
)
)
)
)
)
)
|
| IllustrationInfo |