Cardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, André F, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020;31:1623–49.

Article  CAS  PubMed  Google Scholar 

Dai X, Xiang L, Li T, Bai Z. Cancer hallmarks, biomarkers and breast cancer molecular subtypes. J Cancer. 2016;7:1281–94.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kümler I, Knoop AS, Jessing CAR, Ejlertsen B, Nielsen DL. Review of hormone-based treatments in postmenopausal patients with advanced breast cancer focusing on aromatase inhibitors and fulvestrant. ESMO Open. 2016;1:1–16.

Article  Google Scholar 

Agnese D, Burns J, Giordano SH, Kumar R. NCCN clinical practice guidelines in oncology. Breast cancer. 2020.

Hayashi N, Kumamaru H, Isozumi U, Aogi K, Asaga S, Iijima K, et al. Annual report of the Japanese Breast Cancer Registry for 2017. Breast Cancer. 2020;27:803–9.

Article  PubMed  Google Scholar 

Tada K, Kumamaru H, Miyata H, Asaga S, Iijima K, Ogo E, et al. Characteristics of female breast cancer in Japan: annual report of the National Clinical Database in 2018. Breast Cancer. 2023;30:157–66.

Article  PubMed  Google Scholar 

Shimoi T, Nagai SE, Yoshinami T, Takahashi M, Arioka H, Ishihara M, et al. The Japanese breast cancer Society clinical practice guidelines for systemic treatment of breast cancer, 2018 edition. Breast Cancer. 2020;27:322–31.

Article  PubMed  Google Scholar 

Finn RS, Martin M, Rugo HS, Jones S, Im S-A, Gelmon K, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375:1925–36.

Article  CAS  PubMed  Google Scholar 

Cristofanilli M, DeMichele A, Giorgetti C, Turner NC, Slamon DJ, Im SA, et al. Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer in PALOMA-3. Eur J Cancer. 2018;104:21–31.

Article  CAS  PubMed  Google Scholar 

Rugo HS, Finn RS, Diéras V, Ettl J, Lipatov O, Joy AA, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174:719–29.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Cristofanilli M, Rugo HS, Im SA, Slamon DJ, Harbeck N, Bondarenko I, et al. Overall survival with palbociclib and fulvestrant in women with HR+/HER2- ABC: updated exploratory analyses of PALOMA-3, a double-blind, phase III randomized study. Clin Cancer Res. 2022;28:3433–42.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Slamon DJ, Diéras V, Rugo HS, Harbeck N, Im S-A, Gelmon KA, et al. Overall survival with palbociclib plus letrozole in advanced breast cancer. J Clin Oncol. 2024;42:994-–1000.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Takahashi M, Masuda N, Nishimura R, Inoue K, Ohno S, Iwata H, et al. Palbociclib-letrozole as first-line treatment for advanced breast cancer: updated results from a Japanese phase 2 study. Cancer Med. 2020;9:4929–40.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Takahashi M, Osako T, Yasojima H, Inoue K, Kawashima M, Maeda H, et al. Overall survival in Japanese patients with ER+/HER2− advanced breast cancer treated with first-line palbociclib plus letrozole. Breast Cancer. 2024;31:53–62.

Article  PubMed  Google Scholar 

Rugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, et al. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2− metastatic breast cancer. NPJ Breast Cancer. 2022;8:114.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Papanicolas I, Woskie LR, Jha AK. Health care spending in the United States and other high-income countries. J Am Med Assoc. 2018;319:1024–39.

Article  Google Scholar 

Seki H, Sakurai T, Maeda Y, Oki N, Aoyama M, Yamaguchi R, et al. Efficacy and safety of palbociclib and fulvestrant in Japanese patients with ER+/HER2− advanced/metastatic breast cancer. In Vivo (Brooklyn). 2019;33:2037–44.

Article  CAS  Google Scholar 

Yang J, Zhao B, Ling X, Li D, Zhao J, Lv Y, et al. Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: a multicenter real-world study in the northwest of China. BMC Cancer. 2023;23:1–13.

Google Scholar 

Alves-da-Costa F, Cardoso Borges F, Ramos A, Mayer A, Brito C, Ramos C, et al. Effectiveness of palbociclib with aromatase inhibitors for the treatment of advanced breast cancer in an exposure retrospective cohort study: implications for clinical practice. Breast Cancer Res. 2023;25:1–11.

Article  Google Scholar 

Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16:25–35.

Article  CAS  PubMed  Google Scholar 

Terada M, Ito A, Kikawa Y, Koizumi K, Naito Y, Shimoi T, et al. The Japanese Breast Cancer Society Clinical Practice Guidelines for systemic treatment of breast cancer, 2022 edition. Breast Cancer. 2023;30:872–84.

Article  PubMed  Google Scholar 

Sawaki M, Muramatsu Y, Togo K, Laurent T, Iwata H. Real-world treatment patterns of palbociclib and blood count monitoring in patients with advanced breast cancer in Japan. Futur Oncol. 2022;18:2101–11.

Article  CAS  Google Scholar 

Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17:425–39.

Article  CAS  PubMed  Google Scholar 

Turner NC, Ro J, André F, Loi S, Verma S, Iwata H, et al. Palbociclib in hormone-receptor–positive advanced breast cancer. N Engl J Med. 2015;373:209–19.

Article  CAS  PubMed  Google Scholar 

Neven P, Johnston SRD, Toi M, Sohn J, Inoue K, Pivot X, et al. MONARCH 2: Subgroup analysis of patients receiving abemaciclib plus fulvestrant as first-line and second-line therapy for HRþ, HER2–advanced breast cancer. Clin Cancer Res. 2021;27:5801–9.

Article  CAS  PubMed  Google Scholar 

Sledge GW, Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2-advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35:2875–84.

Article  CAS  PubMed  Google Scholar 

Sledge GW, Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. The Effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy—MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6:116–24.

Article  PubMed  Google Scholar 

Patt D, Liu X, Li B, McRoy L, Layman R, Brufsky A. Real-world treatment patterns and outcomes of palbociclib plus an aromatase inhibitor for metastatic breast cancer: Flatiron database analysis. Clin Breast Cancer. 2022;22:601–10.

Article  CAS  PubMed  Google Scholar 

Lee J, Park HS, Won HS, Yang JH, Lee HY, Woo IS, et al. Real-world clinical data of palbociclib in Asian metastatic breast cancer patients: experiences from eight institutions. Cancer Res Treat. 2021;53:409–23.

Article  CAS  PubMed  Google Scholar 

Zhong B, Zhang J, Wu J, Sun L, Li S, Zeng X, et al. Efficacy and safety of palbociclib plus endocrine therapy for patients with HR+/HER2− advanced breast cancer in real-world clinical practice. Ann Transl Med. 2022;10:362–362.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mukai H, Shimizu C, Masuda N, Ohtani S, Ohno S, Takahashi M, et al. Palbociclib in combination with letrozole in patients with estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients. Int J Clin Oncol. 2019;24:274–87.

Article  CAS  PubMed  Google Scholar 

Masuda N, Mukai H, Inoue K, Rai Y, Ohno S, Mori Y, et al. Neutropenia management with palbociclib in Japanese patients with advanced breast cancer. Breast Cancer. 2019;26:637–50.

Article  PubMed  Google Scholar 

Mycock K, Hanson KA, Taylor-Stokes G, Milligan G, Atkinson C, Mitra D, et al. Real-world treatment patterns and clinical outcomes associated with palbociclib combination therapy: a multinational, pooled analysis from the Ibrance real world insights study. Clin Ther. 2022;44:1588–601.

Article  CAS  PubMed  Google Scholar 

Masuda N, Inoue K, Nakamura R, Rai Y, Mukai H, Ohno S, et al. 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. Int J Clin Oncol. 2019;24:262–73.

Article  CAS  PubMed  Google Scholar 

Sawaki M, Muramatsu Y, Togo K, Iwata H. Real-world treatment patterns of subsequent therapy after palbociclib in patients with advanced breast cancer in Japan. The Breast. 2023;70:1–7.

Article  PubMed  PubMed Central  Google Scholar