Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer: Primary results from PALOMA-4

Lin, 2019, Contrasting epidemiology and clinicopathology of female breast cancer in Asians vs the US population, J Natl Cancer Inst, 111, 1298, 10.1093/jnci/djz090 Sung, 2021, Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, CA Cancer J Clin, 71, 209, 10.3322/caac.21660 2021 2019 Finn, 2015, 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, 16, 25, 10.1016/S1470-2045(14)71159-3 Finn, 2016, Palbociclib and letrozole in advanced breast cancer, N Engl J Med, 375, 1925, 10.1056/NEJMoa1607303 Turner, 2015, Palbociclib in hormone-receptor-positive advanced breast cancer, N Engl J Med, 373, 209, 10.1056/NEJMoa1505270 Cristofanilli, 2018, 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, 104, 21, 10.1016/j.ejca.2018.08.011 Rugo, 2019, 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, 174, 719, 10.1007/s10549-018-05125-4 Im, 2019, Palbociclib plus letrozole as first-line therapy in postmenopausal Asian women with metastatic breast cancer: results from the phase III, randomized PALOMA-2 study, J Glob Oncol, 5, 1 Xu, 2021, Pharmacokinetics, safety, activity, and biomarker analysis of palbociclib plus letrozole as first-line treatment for ER+/HER2- advanced breast cancer in Chinese women, Cancer Chemother Pharmacol, 88, 131, 10.1007/s00280-021-04263-9 Iwata, 2017, J Glob Oncol, 3, 289, 10.1200/JGO.2016.008318 Masuda, 2019, 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, 24, 262, 10.1007/s10147-018-1359-3 Mukai, 2019, 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, 24, 274, 10.1007/s10147-018-1353-9 Kim, 2021, Palbociclib plus fulvestrant in Korean patients from PALOMA-3 with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer, J Breast Cancer, 24, 97, 10.4048/jbc.2021.24.e13 Zhang, 2020, MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study, Ther Adv Med Oncol, 12, 10.1177/1758835920963925 Xu, 2021, Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial, Nat Med, 27, 1904, 10.1038/s41591-021-01562-9 Dieras, 2019, Palbociclib with letrozole in postmenopausal women with ER+/HER2- advanced breast cancer: hematologic safety analysis of the randomized PALOMA-2 trial, Oncologist, 24, 1514, 10.1634/theoncologist.2019-0019 Dieras, 2019, Long-term pooled safety analysis of palbociclib in combination with endocrine therapy for HR+/HER2- advanced breast cancer, J Natl Cancer Inst, 111, 419, 10.1093/jnci/djy109 Finn, 2021, Long-term pooled safety analysis of palbociclib in combination with endocrine therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: updated analysis with up to 5 years of follow-up, Oncologist, 26, e749, 10.1002/onco.13684 Verma, 2016, 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), Oncologist, 21, 1165, 10.1634/theoncologist.2016-0097 Ettl, 2020, Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies, Breast Cancer Res, 22, 27, 10.1186/s13058-020-01263-0 Zheng, 2021, Impact of dose reduction on efficacy: implications of exposure-response analysis of palbociclib, Target Oncol, 16, 69, 10.1007/s11523-020-00771-5 Sacaan, 2017, CDK4/6 inhibition on glucose and pancreatic beta cell homeostasis in young and aged rats, Mol Cancer Res, 15, 1531, 10.1158/1541-7786.MCR-17-0172