Cancer Research and Treatment

Review Article

Recent Developments in the Therapeutic Landscape of Advanced or Metastatic Hormone Receptor–Positive Breast Cancer: Eunice Yoojin Lee, Dae-Won Lee, Kyung-Hun Lee, Seock-Ah Im; Cancer Res Treat. 2023;55(4):1065-1076. Published online October 5, 2023; DOI: https://doi.org/10.4143/crt.2023.846

Hormone receptor–positive (HR+) disease is the most frequently diagnosed subtype of breast cancer. Among tumor subtypes, natural course of HR+ breast cancer is indolent with favorable prognosis compared to other subtypes such as human epidermal growth factor protein 2–positive disease and triple-negative disease. HR+ tumors are dependent on steroid hormone signaling and endocrine therapy is the main treatment option. Recently, the discovery of cyclin-dependent kinase 4/6 inhibitors and their synergistic effects with endocrine therapy has dramatically improved treatment outcome of advanced HR+ breast cancer. The demonstrated efficacy of additional nonhormonal agents, such as targeted therapy against mammalian target of rapamycin and phosphatidylinositol 3-kinase signaling, poly(ADP-ribose) polymerase inhibitors, antibody-drug conjugates, and immunotherapeutic agents have further expanded the available therapeutic options. This article reviews the latest advancements in the treatment of HR+ breast cancer, and in doing so discusses not only the development of currently available treatment regimens but also emerging therapies that invite future research opportunities in the field.

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Therapies for the Treatment of Advanced/Metastatic Estrogen Receptor-Positive Breast Cancer: Current Situation and Future Directions
Rohan Kalyan Rej, Joyeeta Roy, Srinivasa Rao Allu
Cancers.2024; 16(3): 552. CrossRef

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Original Articles

Breast Cancer

Implications of Tamoxifen Resistance in Palbociclib Efficacy for Patients with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: Subgroup Analyses of KCSG-BR15-10 (YoungPEARL): Jiyun Lee, Seock-Ah Im, Gun Min Kim, Kyung Hae Jung, Seok Yun Kang, In Hae Park, Jee Hyun Kim, Hee Kyung Ahn, Yeon Hee Park; Cancer Res Treat. 2021;53(3):695-702. Published online December 17, 2020; DOI: https://doi.org/10.4143/crt.2020.1246

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Purpose
YoungPEARL (KCSG-BR15-10) trial demonstrated a significant progression-free survival (PFS) benefit for premenopausal patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (MBC) for palbociclib plus exemestane with ovarian function suppression compared to capecitabine. However, the number of tamoxifen-sensitive premenopausal patients was small because most recurrences occurred early during adjuvant endocrine therapy (ET), with tamoxifen being the only drug used; hence, the data for these patients were limited. Here we present a subgroup analysis according to tamoxifen sensitivity from the YoungPEARL study. Materials and Methods Patients were randomized 1:1 to receive palbociclib+ET (oral exemestane 25 mg/day for 28 days, palbociclib 125 mg/day for 21 days, plus leuprolide 3.75 mg subcutaneously every 4 weeks) or chemotherapy (oral capecitabine 1,250 mg/m2 twice daily for 14 days every 3 weeks). Tamoxifen resistance was defined as: relapse while on adjuvant tamoxifen, relapse within 12 months of completing adjuvant tamoxifen, or progression while on first-line tamoxifen within 6 months for MBC.
Results
In total, 184 patients were randomized and 178 were included in the modified intention-to-treat population. PFS improvement in the palbociclib+ET group was observed in tamoxifen-sensitive patients (hazard ratio, 0.38; 95% confidence interval, 0.12 to 1.19). Furthermore, palbociclib+ET prolonged median PFS compared with capecitabine in tamoxifen-sensitive (20.5 months vs. 12.6 months) and tamoxifen-resistant (20.1 months vs. 14.5 months) patients. Palbociclib+ET demonstrated a higher rate of objective response, disease control, and clinical benefit in tamoxifen-sensitive patients. Conclusion This post hoc exploratory analysis suggests that palbociclib+ET is a promising therapeutic option for premenopausal HR+/HER2– MBC patients irrespective of tamoxifen sensitivity.

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Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: a multicenter real-world study in the northwest of China
Jiao Yang, Bing Zhao, Xiaoling Ling, Donghui Li, Jiuda Zhao, Yonggang Lv, Guangxi Wang, Xinlan Liu, Nanlin Li, Jin Yang
BMC Cancer.2023;[Epub] CrossRef

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Breast cancer

Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions: Jieun Lee, Hyung Soon Park, Hye Sung Won, Ji Hyun Yang, Hee Yeon Lee, In Sook Woo, Kabsoo Shin, Ji Hyung Hong, Young Joon Yang, Sang Hoon Chun, Jae Ho Byun; Cancer Res Treat. 2021;53(2):409-423. Published online October 28, 2020; DOI: https://doi.org/10.4143/crt.2020.451

Abstract PDF Supplementary Material PubReader ePub

Purpose
Use of cyclin-dependent kinase 4/6 inhibitors improved survival outcome of hormone receptor (HR) positive metastatic breast cancer (MBC) patients, including Asian population. However, Asian real-world data of palbociclib is limited. We analyzed the real-world clinical practice patterns and outcome in HR-positive, MBC Asian patients treated with palbociclib.
Materials and Methods
Between April 2017 to November 2019, 169 HR-positive, human epidermal growth factor-2–negative MBC patients treated with letrozole or fulvestrant plus palbocilib were enrolled from eight institutions. Survival outcome (progression-free survival [PFS]), treatment response and toxicity profiles were analyzed.
Results
Median age of letrozole plus palbociclib (145 patients, 85.8%) and fulvestrant plus palbociclib (24 patients, 14.2%) was 58 and 53.5 years, with median follow-up duration of 14.63 months (range 0.2 to 33.9 months). Median PFS (mPFS) of letrozole plus palbociclib and fulvestrant plus palbociclib was 25.6 (95% confidence interval [CI], 19.1 to not reached) and 6.37 months (95% CI, 5.33 to not reached), comparable to previous phase 3 trials. In letrozole plus palbociclib arm, luminal A (hazard ratio, 2.86; 95% CI, 1.20 to 6.80; p=0.017) and patients with good performance (Eastern Cooperative Oncology Group 0-1 [hazard ratio, 3.68; 95% CI, 1.70 to 7.96]) showed better mPFS. In fulvestrant plus palbociclib group, chemotherapy naïve patients showed better mPFS (hazard ratio, 12.51, 95% CI, 1.59 to 99.17; p=0.017). The most common grade 3 or 4 adverse event was neutropenia (letrozole 86.3%, fulvestrant 88.3%).
Conclusion
To our knowledge, this is the first real-world data of palbociclib reported in Asia. Palbociclib showed comparable benefit to previous phase 3 trials in Asian patients during daily clinical practice.

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Efficacy and Safety of Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Breast Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials and Real-World Studies
Hui-Chen Su, Ho-Wei Lin, Ka-Wai Tam
Targeted Oncology.2025; 20(1): 71. CrossRef
Palbociclib in Older Patients with Advanced/Metastatic Breast Cancer: A Systematic Review
Etienne Brain, Connie Chen, Sofia Simon, Vinay Pasupuleti, Kathleen Vieira Pfitzer, Karen A. Gelmon
Targeted Oncology.2024; 19(3): 303. CrossRef
Real-world progression-free survival and overall survival of palbociclib plus endocrine therapy (ET) in Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in the first-line or second-l
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Breast Cancer.2024; 31(4): 621. CrossRef
The Effect of C-Reactive Protein/Lymphocyte Ratio (CLR) on PFS in Metastatic Breast Cancer Patients Treated with CDK4/6 Inhibitors: A Novel Biomarker
Mehmet Buyukbayram, Zekeriya Hannarici, Yakup Duzkopru, Aykut Turhan, Alperen Caglar, Pınar Coban Esdur, Mehmet Bilici, Salim Tekin, Doğan Yazılıtaş
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Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: a multicenter real-world study in the northwest of China
Jiao Yang, Bing Zhao, Xiaoling Ling, Donghui Li, Jiuda Zhao, Yonggang Lv, Guangxi Wang, Xinlan Liu, Nanlin Li, Jin Yang
BMC Cancer.2023;[Epub] CrossRef
A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance® Patient Program
Carlo Palmieri, Alison Musson, Catherine Harper-Wynne, Duncan Wheatley, Gianfilippo Bertelli, Iain R. Macpherson, Mark Nathan, Ellie McDowall, Ajay Bhojwani, Mark Verrill, Joe Eva, Colm Doody, Ruhe Chowdhury
British Journal of Cancer.2023; 129(5): 852. CrossRef
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Fábio Cardoso Borges, Filipa Alves da Costa, Adriana Ramos, Catarina Ramos, Catarina Bernardo, Cláudia Brito, Alexandra Mayer-da-Silva, Cláudia Furtado, Arlindo R. Ferreira, Diogo Martins-Branco, Ana Miranda, António Lourenço
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Fulbert Fu, Jessica Kano, Julia Ma, Mera Guindy
Current Oncology.2022; 29(3): 1761. CrossRef
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Lesang Shen, Jun Zhou, Yiding Chen, Jinhua Ding, Haiyan Wei, Jian Liu, Wenjie Xia, Bojian Xie, Xiaohong Xie, Xujun Li, Yuechu Dai, Guobing Zhang, Xia Qiu, Chao Li, Shanshan Sun, Wuzhen Chen, Dihe Gong, Hengyu Li, Jian Huang, Xia Jiang, Chao Ni
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Starting dose selection of palbociclib in Chinese patients with breast cancer based on population kinetic–pharmacodynamic model of neutropenia
Weizhe Jian, Junsheng Xue, Qingyu Yao, Rong Chen, Ye Yao, Mopei Wang, Tianyan Zhou
Cancer Chemotherapy and Pharmacology.2022; 90(6): 489. CrossRef
Early Application of Palbociclib Plus Endocrine Therapy in HR+/HER2− Metastatic Breast Cancer: A Better Choice Based on Data From the Chinese Population
Yusi Zhang, Wenlin Chen, Shuanglong Chen, Qingmo Yang, Zhong Ouyang
Technology in Cancer Research & Treatment.2022;[Epub] CrossRef
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Katie Mycock, Kent A. Hanson, Gavin Taylor-Stokes, Gary Milligan, Christian Atkinson, Debanjali Mitra, Salena Preciado, Ernest H. Law
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Frontiers in Oncology.2021;[Epub] CrossRef

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