Literature DB >> 31662535

Efficacy and Safety of Palbociclib and Fulvestrant in Japanese Patients With ER+/HER2- Advanced/Metastatic Breast Cancer.

Hirohito Seki1, Takashi Sakurai2, Yuka Maeda2, Naohiko Oki2, Mina Aoyama2, Ryou Yamaguchi2, Toshiki Tokuda2, Takuji Kaburagi2, Takehiro Okumura2, Tsuyoshi Karahashi2, Kenichiro Nakajima2, Kaori Higeta3, Ken Shimizu4.   

Abstract

BACKGROUND/AIM: Published data have shown that palbociclib-fulvestrant can significantly improve the progression-free survival (PFS) of estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer patients, but not of Japanese patients. We conducted this retrospective study to verify the efficacy and safety of palbociclib-fulvestrant in Japanese patients. PATIENTS AND METHODS: ER+/HER2- metastatic breast cancer patients treated with fulvestrant (n=39) or palbociclib-fulvestrant (n=31) at the Saitama Medical Center from July 2012 to November 2018 were evaluated.
RESULTS: Overall response rates (ORRs) were 2.6% (fulvestrant) and 41.9% (palbociclib-fulvestrant) (p<0.001), and clinical benefit rates (CBRs) were 23.1% and 61.3% (p=0.002), respectively. The palbociclib-fulvestrant group had significantly higher CBR and PFS (hazard ratio(HR):0.272, 95% confidence interval(95CI):0.128-0.574 for PFS). Grade 3/4 neutropenia occurred in 80.6% of the palbociclib-fulvestrant group, while febrile neutropenia was not detected.
CONCLUSION: Japanese ER+/HER2- metastatic breast cancer patients tolerated palbociclib-fulvestrant, with significantly improved clinical outcomes. Copyright
© 2019, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Entities:  

Keywords:  CDK4/6 inhibitor; ER positive; Fulvestrant; Metastatic breast cancer; palbociclib

Mesh:

Substances:

Year:  2019        PMID: 31662535      PMCID: PMC6899113          DOI: 10.21873/invivo.11701

Source DB:  PubMed          Journal:  In Vivo        ISSN: 0258-851X            Impact factor:   2.155


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7.  Palbociclib in Combination With Fulvestrant in Women With Hormone Receptor-Positive/HER2-Negative Advanced Metastatic Breast Cancer: Detailed Safety Analysis From a Multicenter, Randomized, Placebo-Controlled, Phase III Study (PALOMA-3).

Authors:  Sunil Verma; Cynthia Huang Bartlett; Patrick Schnell; Angela M DeMichele; Sherene Loi; Jungsil Ro; Marco Colleoni; Hiroji Iwata; Nadia Harbeck; Massimo Cristofanilli; Ke Zhang; Alexandra Thiele; Nicholas C Turner; Hope S Rugo
Journal:  Oncologist       Date:  2016-07-01

8.  Pharmacokinetics/genotype associations for major cytochrome P450 enzymes in native and first- and third-generation Japanese populations: comparison with Korean, Chinese, and Caucasian populations.

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9.  Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer.

Authors:  Nicholas C Turner; Dennis J Slamon; Jungsil Ro; Igor Bondarenko; Seock-Ah Im; Norikazu Masuda; Marco Colleoni; Angela DeMichele; Sherene Loi; Sunil Verma; Hiroji Iwata; Nadia Harbeck; Sibylle Loibl; Fabrice André; Kathy Puyana Theall; Xin Huang; Carla Giorgetti; Cynthia Huang Bartlett; Massimo Cristofanilli
Journal:  N Engl J Med       Date:  2018-10-20       Impact factor: 91.245

10.  Palbociclib in combination with fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-3 subgroup analysis of Japanese patients.

Authors:  Norikazu Masuda; Kenichi Inoue; Rikiya Nakamura; Yoshiaki Rai; Hirofumi Mukai; Shinji Ohno; Fumikata Hara; Yuko Mori; Satoshi Hashigaki; Yasuaki Muramatsu; Takashi Nagasawa; Yoshiko Umeyama; Xin Huang; Hiroji Iwata
Journal:  Int J Clin Oncol       Date:  2018-11-03       Impact factor: 3.402

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  1 in total

Review 1.  Palbociclib as an early-line treatment for Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: a review of clinical trial and real-world data.

Authors:  Norikazu Masuda; Nobuyoshi Kosaka; Hiroji Iwata; Masakazu Toi
Journal:  Int J Clin Oncol       Date:  2021-10-26       Impact factor: 3.402

  1 in total

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