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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
AbstractAbstract PDFSupplementary MaterialPubReaderePub
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.

Citations

Citations to this article as recorded by  
  • 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
    Tetsuhiro Yoshinami, Shigenori E. Nagai, Masaya Hattori, Takuho Okamura, Kenichi Watanabe, Takahiro Nakayama, Hiroko Masuda, Michiko Tsuneizumi, Daisuke Takabatake, Michiko Harao, Hiroshi Yoshino, Natsuko Mori, Hiroyuki Yasojima, Chiya Oshiro, Madoka Iwas
    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
    Breast Cancer: Targets and Therapy.2024; Volume 16: 329.     CrossRef
  • The treatment pattern of advanced HR-positive and HER2-negative breast cancer in central southern China: a hospital-based cross-sectional study
    Zhe-Yu Hu, Binliang Liu, Ning Xie, Xiaohong Yang, Liping Liu, Huawu Xiao, Jing Li, Hui Wu, Jianxiang Gao, Jun Lu, Xuming Hu, Min Cao, Zhengrong Shui, Can Tian, Quchang Ouyang
    BMC Cancer.2024;[Epub]     CrossRef
  • Palbociclib in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer: A Systematic Scoping Review of Real-World Evidence from Countries Outside of Western Regions that Are Underrepresented in Clinical Trials
    Amit Rauthan, Ankita Jain, Manmohan Singh, Mehmet A. N. Sendur
    Oncology and Therapy.2024; 12(3): 395.     CrossRef
  • 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
  • Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study
    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
    The Breast.2022; 62: 135.     CrossRef
  • The Impact of Real-World Alternative Dosing Strategies of Palbociclib on Progression-Free Survival in Patients with Metastatic Breast Cancer
    Fulbert Fu, Jessica Kano, Julia Ma, Mera Guindy
    Current Oncology.2022; 29(3): 1761.     CrossRef
  • Treatment patterns, effectiveness, and patient‐reported outcomes of palbociclib therapy in Chinese patients with advanced breast cancer: A multicenter ambispective real‐world study
    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
    Cancer Medicine.2022; 11(22): 4157.     CrossRef
  • 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
  • Real-world Treatment Patterns and Clinical Outcomes Associated With Palbociclib Combination Therapy: A Multinational, Pooled Analysis From the Ibrance Real World Insights Study
    Katie Mycock, Kent A. Hanson, Gavin Taylor-Stokes, Gary Milligan, Christian Atkinson, Debanjali Mitra, Salena Preciado, Ernest H. Law
    Clinical Therapeutics.2022; 44(12): 1588.     CrossRef
  • Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population
    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
    Scientific Reports.2021;[Epub]     CrossRef
  • Which Clinicopathologic Parameters Suggest Primary Resistance to Palbociclib in Combination With Letrozole as the First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer?
    Ji-Yeon Kim, Jung Min Oh, Yeon Hee Park, Jin Seok Ahn, Young-Hyuck Im
    Frontiers in Oncology.2021;[Epub]     CrossRef
  • 9,726 View
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  • 16 Web of Science
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Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting
Jin Hyoung Kang, Jung Hye Kwon, Yun-Gyoo Lee, Keon Uk Park, Ho Jung An, Joohyuk Sohn, Young Mi Seol, Hyunwoo Lee, Hwan-Jung Yun, Jin Seok Ahn, Ji Hyun Yang, Hunho Song, Dong-Hoe Koo, Jin Young Kim, Gun Min Kim, Hwa Jung Kim
Cancer Res Treat. 2020;52(3):907-916.   Published online March 18, 2020
DOI: https://doi.org/10.4143/crt.2019.713
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highly-emetogenic chemotherapy (HEC)–induced nausea and vomiting.
Materials and Methods
Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by gender, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6.
Results
A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], −7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, −2.3%; 95% CI, −13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, −7.9 to 15.5), respectively. FLIE total score ≥ 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups.
Conclusion
In all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.

Citations

Citations to this article as recorded by  
  • Impact of body weight-based dosing of palonosetron and ondansetron on postoperative nausea and vomiting following laparoscopic sleeve gastrectomy: a randomized, double-blind study
    Büşra Burcu, Nadir Adnan Hacım, Ozan Caliskan, Serdar Demirgan, Talar Vartanoglu Aktokmakyan, Serhat Meric, Tomris Duymaz, Onder Karabay, Ali Solmaz
    Acta Chirurgica Belgica.2024; 124(1): 41.     CrossRef
  • 2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agents
    Jørn Herrstedt, L Celio, PJ Hesketh, L Zhang, R Navari, A Chan, M Saito, R Chow, M Aapro
    Supportive Care in Cancer.2024;[Epub]     CrossRef
  • 2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting
    J. Herrstedt, R. Clark-Snow, C.H. Ruhlmann, A. Molassiotis, I. Olver, B.L. Rapoport, M. Aapro, K. Dennis, P.J. Hesketh, R.M. Navari, L. Schwartzberg, M.L. Affronti, M.A. Garcia-Del-Barrio, A. Chan, L. Celio, R. Chow, M. Fleury, R.J. Gralla, R. Giusti, F.
    ESMO Open.2024; 9(2): 102195.     CrossRef
  • Ramosetron 3.0 μg/mL Combining with Dexamethasone (0.05, 0.1, 0.2 mg/mL) in Infusion Solutions: A Physicochemical Stability Study
    Baoxia Fang, Lijun Zhao, Shirong Yu, Fuchao Chen
    Dose-Response.2024;[Epub]     CrossRef
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    Marco Filetti, Pasquale Lombardi, Raffaele Giusti, Rosa Falcone, Florian Scotte, Diana Giannarelli, Antonella Carcagnì, Valeria Altamura, Giovanni Scambia, Gennaro Daniele
    Cancer Treatment Reviews.2023; : 102512.     CrossRef
  • Effect of Acupuncture on Delayed Emesis for the Patients Who Received High-Emetogenic Chemotherapy with Standard Antiemetic Prophylaxis (KHMC-HO-01): An Open-Label, Randomized Study
    Chi Hoon Maeng, Seunghoon Lee, Jae Joon Han, Hong Jun Kim, Dongwoo Nam, Junhee Lee, Sun Kyung Baek, Maria Grazia Ferraro
    Evidence-Based Complementary and Alternative Medicine.2022; 2022: 1.     CrossRef
  • Cardioprotective action of aprepitant in a rat model of ischemia-reperfusioninduced myocardial injury: role of PI3K-AkT-GSK-3β-HIF-1α signaling pathway
    Mei Qian, Yang Liu
    Acta Cirúrgica Brasileira.2022;[Epub]     CrossRef
  • Comparison of the Effectiveness of Palonosetron and Ramosetron in Preventing Postoperative Nausea and Vomiting: Updated Systematic Review and Meta-Analysis with Trial Sequential Analysis
    Hyo Jin Kim, EunJin Ahn, Geun Joo Choi, Hyun Kang
    Journal of Personalized Medicine.2022; 13(1): 82.     CrossRef
  • Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials
    Timothy L. Beard, Cathy Michalsky, Keith A. Candiotti, Paul Rider, Linda Wase, Ashraf S. Habib, Mark A. Demitrack, Michael J. Fossler, Eugene R. Viscusi
    Pain and Therapy.2021; 10(1): 401.     CrossRef
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    Bioscience, Biotechnology, and Biochemistry.2021; 85(9): 2054.     CrossRef
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    Vanessa Piechotta, Anne Adams, Madhuri Haque, Benjamin Scheckel, Nina Kreuzberger, Ina Monsef, Karin Jordan, Kathrin Kuhr, Nicole Skoetz
    Cochrane Database of Systematic Reviews.2021;[Epub]     CrossRef
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    Ajay Raghunath, Sahan D. Chandrasekara, Shane N. Anthony, Ben Markman
    Critical Reviews in Oncology/Hematology.2020; 152: 103012.     CrossRef
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  • 198 Download
  • 10 Web of Science
  • 12 Crossref
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Clinical Significance of Discordance between Carcinoembryonic Antigen Levels and RECIST in Metastatic Colorectal Cancer
In-Ho Kim, Ji Eun Lee, Ji Hyun Yang, Joon Won Jeong, Sangmi Ro, Seong Taek Oh, Jun-Gi Kim, Moon Hyung Choi, Myung Ah Lee
Cancer Res Treat. 2018;50(1):283-292.   Published online May 8, 2017
DOI: https://doi.org/10.4143/crt.2016.537
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The purpose of this study was to investigate the prognostic implications of carcinoembryonic antigen (CEA) levels that are inconsistent with Response Evaluation Criteria in Solid Tumor (RECIST) responses in metastatic colorectal cancer patients.
Materials and Methods
We retrospectively evaluated 360 patients with at least one measurable lesion who received first-line palliative chemotherapy. CEA-response was defined as CEA-complete response (CR; CEA normalization), CEA-partial response (PR; ≥ 50% decrease in CEA levels), CEA-progressive disease (PD; ≥ 50% increase in CEA levels), and CEA-stable disease (SD; non-CR/PR/PD). Overall survival (OS) and progression-free survival (PFS) were evaluated according to CEA-response.
Results
In RECIST-PR patients, poorer CEA-response was associated with disease progression at the subsequent evaluation. In RECIST-SD patients, CEA-CR and -PR were associated with lower disease progression rates than CEA-PD at the subsequent evaluation. Correlations between survival outcome and CEA-response in same-category RECIST patients were assessed. In RECIST-PR patients, discordant CEA-response (CEA-PD/SD) was associated with poorer survival than CEA-CR/PR (median OS and PFS, 44.0 and 15.4 [CEA-CR], 28.9 and 12.5 [CEA-PR], 21.0 and 9.8 [CEA-SD], and 13.0 and 7.0 [CEA-PD] months, respectively; all p < 0.001). In RECIST-SD patients, favorable CEA-response produced better survival (median OS and PFS, 26.8 and 21.0 [CEA-CR], 21.0 and 11.0 [CEA-PR], 16.1 and 8.2 [CEA-SD], and 12.2 and 6.0 [CEA-PD] months, respectively; all p < 0.001). RECIST-PD patients with CEA-CR showed longer OS than those with CEA-PD. Multivariate analysis demonstrated that discordant CEA-response is a powerful prognostic factor for RECIST-PR and RECIST-SD patients.
Conclusion
Among patients of the same RECIST-response categories, CEA-response patterns are significantly prognostic and strongly predictive of subsequent evaluation outcomes.

Citations

Citations to this article as recorded by  
  • Presence of CD44v9-Expressing Cancer Stem Cells in Circulating Tumor Cells and Effects of Carcinoembryonic Antigen Levels on the Prognosis of Colorectal Cancer
    Katsuji Sawai, Takanori Goi, Youhei Kimura, Kenji Koneri
    Cancers.2024; 16(8): 1556.     CrossRef
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    Cancer Research and Treatment.2019; 51(1): 252.     CrossRef
  • 10,557 View
  • 189 Download
  • 6 Web of Science
  • 4 Crossref
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Case Report
Orbital Infiltration as the First Site of Relapse of Primary Testicular T-cell Lymphoma
Hyun Jung Jun, Won Seog Kim, Ji Hyun Yang, Seong Yoon Yi, Young H. Ko, Jeeyun Lee, Chul Won Jung, Se Woong Kang, Keunchil Park
Cancer Res Treat. 2007;39(1):40-43.   Published online March 31, 2007
DOI: https://doi.org/10.4143/crt.2007.39.1.40
AbstractAbstract PDFPubReaderePub

A 43-year-old male presented with a painless left testicular mass. The pathologic diagnosis of the radical orchiectomy specimen was peripheral T-cell lymphoma, unspecified (PTCL-u). According to the Ann Arbor staging system, his initial stage was III because of the right nasopharyngeal involvement. After first-line chemotherapy with four courses of the CHOP regimen and this was followed by involved-field radiotherapy, he achieved complete remission. Two months later, disease recurred to the left ciliary body of the left eye without evidence of involvement at other sites. Although the patient received intensive chemotherapy with autologous hematopoietic stem cell transplantation, he ultimately died of leptomeningeal seeding. Because both the central nervous system (CNS) and the orbit are sanctuary sites for chemotherapy, orbital infiltration of lymphoma should prompt physicians to evaluate involvement of the CNS and to consider performing prophylactic intrathecal chemotherapy as a treatment option.

Citations

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  • 7 Crossref
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