Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer

This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metasta...
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Autor*in:	Xuan Ge [verfasserIn] Susan E. Yost [verfasserIn] Jin Sun Lee [verfasserIn] Paul H. Frankel [verfasserIn] Christopher Ruel [verfasserIn] Yujie Cui [verfasserIn] Mireya Murga [verfasserIn] Aileen Tang [verfasserIn] Norma Martinez [verfasserIn] Samuel Chung [verfasserIn] Christina Yeon [verfasserIn] Daphne Stewart [verfasserIn] Daneng Li [verfasserIn] Swapnil Rajurkar [verfasserIn] George Somlo [verfasserIn] Joanne Mortimer [verfasserIn] James Waisman [verfasserIn] Yuan Yuan [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	pembrolizumab aromatase inhibitor metastatic hormone receptor positive breast cancer

Übergeordnetes Werk:	In: Cancers - MDPI AG, 2010, 14(2022), 17, p 4279
Übergeordnetes Werk:	volume:14 ; year:2022 ; number:17, p 4279

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3390/cancers14174279

Katalog-ID:	DOAJ023687983

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allfields	10.3390/cancers14174279 doi (DE-627)DOAJ023687983 (DE-599)DOAJ9b5cccea381444f597de8e8c7e330929 DE-627 ger DE-627 rakwb eng RC254-282 Xuan Ge verfasserin aut Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metastatic breast cancer (MBC) in a phase II study with a safety lead-in (NCT 02648477). Patients received pembrolizumab plus AI up to 2 years or until confirmed progression or unacceptable toxicity. Key eligibility criteria were HR<sup<+</sup< HER2<sup<−</sup< MBC; RECIST v1.1 measurable disease; adequate organ function; and ECOG 0-1. Primary endpoints were safety and overall response rate. A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial responses, three (15%) had stable disease, and 15 (75%) had progression of disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up time was 40.1 months (range 31.3–46.8 months). The combination was well tolerated, but clinical activity was comparable to AI alone. pembrolizumab aromatase inhibitor metastatic hormone receptor positive breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens Susan E. Yost verfasserin aut Jin Sun Lee verfasserin aut Paul H. Frankel verfasserin aut Christopher Ruel verfasserin aut Yujie Cui verfasserin aut Mireya Murga verfasserin aut Aileen Tang verfasserin aut Norma Martinez verfasserin aut Samuel Chung verfasserin aut Christina Yeon verfasserin aut Daphne Stewart verfasserin aut Daneng Li verfasserin aut Swapnil Rajurkar verfasserin aut George Somlo verfasserin aut Joanne Mortimer verfasserin aut James Waisman verfasserin aut Yuan Yuan verfasserin aut In Cancers MDPI AG, 2010 14(2022), 17, p 4279 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:17, p 4279 https://doi.org/10.3390/cancers14174279 kostenfrei https://doaj.org/article/9b5cccea381444f597de8e8c7e330929 kostenfrei https://www.mdpi.com/2072-6694/14/17/4279 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 17, p 4279
spelling	10.3390/cancers14174279 doi (DE-627)DOAJ023687983 (DE-599)DOAJ9b5cccea381444f597de8e8c7e330929 DE-627 ger DE-627 rakwb eng RC254-282 Xuan Ge verfasserin aut Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metastatic breast cancer (MBC) in a phase II study with a safety lead-in (NCT 02648477). Patients received pembrolizumab plus AI up to 2 years or until confirmed progression or unacceptable toxicity. Key eligibility criteria were HR<sup<+</sup< HER2<sup<−</sup< MBC; RECIST v1.1 measurable disease; adequate organ function; and ECOG 0-1. Primary endpoints were safety and overall response rate. A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial responses, three (15%) had stable disease, and 15 (75%) had progression of disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up time was 40.1 months (range 31.3–46.8 months). The combination was well tolerated, but clinical activity was comparable to AI alone. pembrolizumab aromatase inhibitor metastatic hormone receptor positive breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens Susan E. Yost verfasserin aut Jin Sun Lee verfasserin aut Paul H. Frankel verfasserin aut Christopher Ruel verfasserin aut Yujie Cui verfasserin aut Mireya Murga verfasserin aut Aileen Tang verfasserin aut Norma Martinez verfasserin aut Samuel Chung verfasserin aut Christina Yeon verfasserin aut Daphne Stewart verfasserin aut Daneng Li verfasserin aut Swapnil Rajurkar verfasserin aut George Somlo verfasserin aut Joanne Mortimer verfasserin aut James Waisman verfasserin aut Yuan Yuan verfasserin aut In Cancers MDPI AG, 2010 14(2022), 17, p 4279 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:17, p 4279 https://doi.org/10.3390/cancers14174279 kostenfrei https://doaj.org/article/9b5cccea381444f597de8e8c7e330929 kostenfrei https://www.mdpi.com/2072-6694/14/17/4279 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 17, p 4279
allfields_unstemmed	10.3390/cancers14174279 doi (DE-627)DOAJ023687983 (DE-599)DOAJ9b5cccea381444f597de8e8c7e330929 DE-627 ger DE-627 rakwb eng RC254-282 Xuan Ge verfasserin aut Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metastatic breast cancer (MBC) in a phase II study with a safety lead-in (NCT 02648477). Patients received pembrolizumab plus AI up to 2 years or until confirmed progression or unacceptable toxicity. Key eligibility criteria were HR<sup<+</sup< HER2<sup<−</sup< MBC; RECIST v1.1 measurable disease; adequate organ function; and ECOG 0-1. Primary endpoints were safety and overall response rate. A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial responses, three (15%) had stable disease, and 15 (75%) had progression of disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up time was 40.1 months (range 31.3–46.8 months). The combination was well tolerated, but clinical activity was comparable to AI alone. pembrolizumab aromatase inhibitor metastatic hormone receptor positive breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens Susan E. Yost verfasserin aut Jin Sun Lee verfasserin aut Paul H. Frankel verfasserin aut Christopher Ruel verfasserin aut Yujie Cui verfasserin aut Mireya Murga verfasserin aut Aileen Tang verfasserin aut Norma Martinez verfasserin aut Samuel Chung verfasserin aut Christina Yeon verfasserin aut Daphne Stewart verfasserin aut Daneng Li verfasserin aut Swapnil Rajurkar verfasserin aut George Somlo verfasserin aut Joanne Mortimer verfasserin aut James Waisman verfasserin aut Yuan Yuan verfasserin aut In Cancers MDPI AG, 2010 14(2022), 17, p 4279 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:17, p 4279 https://doi.org/10.3390/cancers14174279 kostenfrei https://doaj.org/article/9b5cccea381444f597de8e8c7e330929 kostenfrei https://www.mdpi.com/2072-6694/14/17/4279 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 17, p 4279
allfieldsGer	10.3390/cancers14174279 doi (DE-627)DOAJ023687983 (DE-599)DOAJ9b5cccea381444f597de8e8c7e330929 DE-627 ger DE-627 rakwb eng RC254-282 Xuan Ge verfasserin aut Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metastatic breast cancer (MBC) in a phase II study with a safety lead-in (NCT 02648477). Patients received pembrolizumab plus AI up to 2 years or until confirmed progression or unacceptable toxicity. Key eligibility criteria were HR<sup<+</sup< HER2<sup<−</sup< MBC; RECIST v1.1 measurable disease; adequate organ function; and ECOG 0-1. Primary endpoints were safety and overall response rate. A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial responses, three (15%) had stable disease, and 15 (75%) had progression of disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up time was 40.1 months (range 31.3–46.8 months). The combination was well tolerated, but clinical activity was comparable to AI alone. pembrolizumab aromatase inhibitor metastatic hormone receptor positive breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens Susan E. Yost verfasserin aut Jin Sun Lee verfasserin aut Paul H. Frankel verfasserin aut Christopher Ruel verfasserin aut Yujie Cui verfasserin aut Mireya Murga verfasserin aut Aileen Tang verfasserin aut Norma Martinez verfasserin aut Samuel Chung verfasserin aut Christina Yeon verfasserin aut Daphne Stewart verfasserin aut Daneng Li verfasserin aut Swapnil Rajurkar verfasserin aut George Somlo verfasserin aut Joanne Mortimer verfasserin aut James Waisman verfasserin aut Yuan Yuan verfasserin aut In Cancers MDPI AG, 2010 14(2022), 17, p 4279 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:17, p 4279 https://doi.org/10.3390/cancers14174279 kostenfrei https://doaj.org/article/9b5cccea381444f597de8e8c7e330929 kostenfrei https://www.mdpi.com/2072-6694/14/17/4279 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 17, p 4279
allfieldsSound	10.3390/cancers14174279 doi (DE-627)DOAJ023687983 (DE-599)DOAJ9b5cccea381444f597de8e8c7e330929 DE-627 ger DE-627 rakwb eng RC254-282 Xuan Ge verfasserin aut Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metastatic breast cancer (MBC) in a phase II study with a safety lead-in (NCT 02648477). Patients received pembrolizumab plus AI up to 2 years or until confirmed progression or unacceptable toxicity. Key eligibility criteria were HR<sup<+</sup< HER2<sup<−</sup< MBC; RECIST v1.1 measurable disease; adequate organ function; and ECOG 0-1. Primary endpoints were safety and overall response rate. A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial responses, three (15%) had stable disease, and 15 (75%) had progression of disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up time was 40.1 months (range 31.3–46.8 months). The combination was well tolerated, but clinical activity was comparable to AI alone. pembrolizumab aromatase inhibitor metastatic hormone receptor positive breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens Susan E. Yost verfasserin aut Jin Sun Lee verfasserin aut Paul H. Frankel verfasserin aut Christopher Ruel verfasserin aut Yujie Cui verfasserin aut Mireya Murga verfasserin aut Aileen Tang verfasserin aut Norma Martinez verfasserin aut Samuel Chung verfasserin aut Christina Yeon verfasserin aut Daphne Stewart verfasserin aut Daneng Li verfasserin aut Swapnil Rajurkar verfasserin aut George Somlo verfasserin aut Joanne Mortimer verfasserin aut James Waisman verfasserin aut Yuan Yuan verfasserin aut In Cancers MDPI AG, 2010 14(2022), 17, p 4279 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:17, p 4279 https://doi.org/10.3390/cancers14174279 kostenfrei https://doaj.org/article/9b5cccea381444f597de8e8c7e330929 kostenfrei https://www.mdpi.com/2072-6694/14/17/4279 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 17, p 4279
language	English
source	In Cancers 14(2022), 17, p 4279 volume:14 year:2022 number:17, p 4279
sourceStr	In Cancers 14(2022), 17, p 4279 volume:14 year:2022 number:17, p 4279
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	pembrolizumab aromatase inhibitor metastatic hormone receptor positive breast cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens
isfreeaccess_bool	true
container_title	Cancers
authorswithroles_txt_mv	Xuan Ge @@aut@@ Susan E. Yost @@aut@@ Jin Sun Lee @@aut@@ Paul H. Frankel @@aut@@ Christopher Ruel @@aut@@ Yujie Cui @@aut@@ Mireya Murga @@aut@@ Aileen Tang @@aut@@ Norma Martinez @@aut@@ Samuel Chung @@aut@@ Christina Yeon @@aut@@ Daphne Stewart @@aut@@ Daneng Li @@aut@@ Swapnil Rajurkar @@aut@@ George Somlo @@aut@@ Joanne Mortimer @@aut@@ James Waisman @@aut@@ Yuan Yuan @@aut@@
publishDateDaySort_date	2022-01-01T00:00:00Z
hierarchy_top_id	614095670
id	DOAJ023687983
language_de	englisch
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callnumber-first	R - Medicine
author	Xuan Ge
spellingShingle	Xuan Ge misc RC254-282 misc pembrolizumab misc aromatase inhibitor misc metastatic misc hormone receptor positive misc breast cancer misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer
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topic_title	RC254-282 Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer pembrolizumab aromatase inhibitor metastatic hormone receptor positive breast cancer
topic	misc RC254-282 misc pembrolizumab misc aromatase inhibitor misc metastatic misc hormone receptor positive misc breast cancer misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
topic_unstemmed	misc RC254-282 misc pembrolizumab misc aromatase inhibitor misc metastatic misc hormone receptor positive misc breast cancer misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
topic_browse	misc RC254-282 misc pembrolizumab misc aromatase inhibitor misc metastatic misc hormone receptor positive misc breast cancer misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
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title	Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer
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title_full	Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer
author_sort	Xuan Ge
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author_browse	Xuan Ge Susan E. Yost Jin Sun Lee Paul H. Frankel Christopher Ruel Yujie Cui Mireya Murga Aileen Tang Norma Martinez Samuel Chung Christina Yeon Daphne Stewart Daneng Li Swapnil Rajurkar George Somlo Joanne Mortimer James Waisman Yuan Yuan
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title_sort	phase ii study combining pembrolizumab with aromatase inhibitor in patients with metastatic hormone receptor positive breast cancer
callnumber	RC254-282
title_auth	Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer
abstract	This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metastatic breast cancer (MBC) in a phase II study with a safety lead-in (NCT 02648477). Patients received pembrolizumab plus AI up to 2 years or until confirmed progression or unacceptable toxicity. Key eligibility criteria were HR<sup<+</sup< HER2<sup<−</sup< MBC; RECIST v1.1 measurable disease; adequate organ function; and ECOG 0-1. Primary endpoints were safety and overall response rate. A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial responses, three (15%) had stable disease, and 15 (75%) had progression of disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up time was 40.1 months (range 31.3–46.8 months). The combination was well tolerated, but clinical activity was comparable to AI alone.
abstractGer	This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metastatic breast cancer (MBC) in a phase II study with a safety lead-in (NCT 02648477). Patients received pembrolizumab plus AI up to 2 years or until confirmed progression or unacceptable toxicity. Key eligibility criteria were HR<sup<+</sup< HER2<sup<−</sup< MBC; RECIST v1.1 measurable disease; adequate organ function; and ECOG 0-1. Primary endpoints were safety and overall response rate. A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial responses, three (15%) had stable disease, and 15 (75%) had progression of disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up time was 40.1 months (range 31.3–46.8 months). The combination was well tolerated, but clinical activity was comparable to AI alone.
abstract_unstemmed	This study investigated the safety and antitumor activity of aromatase inhibitors (AI) with immune checkpoint inhibitor (ICI) pembrolizumab in patients with hormone receptor positive (HR<sup<+</sup<) human epidermal growth factor receptor 2-negative (HER2<sup<−</sup<) metastatic breast cancer (MBC) in a phase II study with a safety lead-in (NCT 02648477). Patients received pembrolizumab plus AI up to 2 years or until confirmed progression or unacceptable toxicity. Key eligibility criteria were HR<sup<+</sup< HER2<sup<−</sup< MBC; RECIST v1.1 measurable disease; adequate organ function; and ECOG 0-1. Primary endpoints were safety and overall response rate. A 3-at-risk design was used for the safety lead-in with a targeted accrual of 20 patients. Grade 2 adverse events (AEs) included 35% fatigue, 20% rash, and 10% hot flashes. Grade 3 immune-related AEs (irAEs) related to pembrolizumab included 5% elevated AST/ALT, 5% rash, and 5% lymphopenia. Two (10%) patients had partial responses, three (15%) had stable disease, and 15 (75%) had progression of disease. Median progression-free survival was 1.8 months (95% CI 1.6, 2.6), median overall survival was 17.2 months (95% CI 9.4, NA), and median follow-up time was 40.1 months (range 31.3–46.8 months). The combination was well tolerated, but clinical activity was comparable to AI alone.
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title_short	Phase II Study Combining Pembrolizumab with Aromatase Inhibitor in Patients with Metastatic Hormone Receptor Positive Breast Cancer
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up_date	2024-07-03T18:57:21.346Z
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