PMID- 37686645 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230911 IS - 2072-6694 (Print) IS - 2072-6694 (Electronic) IS - 2072-6694 (Linking) VI - 15 IP - 17 DP - 2023 Sep 1 TI - Effectiveness and Safety of Palbociclib Plus Endocrine Therapy in Patients with Advanced Breast Cancer: A Multi-Center Study in China. LID - 10.3390/cancers15174360 [doi] LID - 4360 AB - BACKGROUND: Palbociclib has been approved for marketing in China. However, its effectiveness, safety, and latent variables in the Chinese population require further investigation. METHODS: Information was retrieved from 397 patients with metastatic breast cancer (mBC) who received at least two cycles of palbociclib plus endocrine therapy (PAL plus ET) at eight clinical sites in China. The patients' demographic characteristics, treatment patterns, and adverse events (AEs) were analyzed. RESULTS: The objective response rate (ORR) and clinical benefit rate (CBR) for PAL plus ET were 28.97% and 66.25%, respectively. The median PFS was 14.2 months in the whole population. In addition to protein Ki-67 status and sensitivity to ETs, no liver metastases, fewer metastatic sites, an earlier line of therapy, and treatment combined with AI instead of FUL were also considered as independent prognostic factors for PAL treatment. Administration of PAL was generally well tolerated in patients with hormone-receptor-positive and human-epidermal-growth-factor-receptor-2-negative (HR+/HER2-) advanced breast cancer (ABC). The therapy was safe in the elderly population, which is consistent with the outcomes of the whole population and previous reports. CONCLUSIONS: In this most widely distributed study in China to date, palbociclib combined with ET proved its effectiveness for HR+/HER2- ABC treatment, and adverse events were manageable. Here, we identified some independent prognosis factors, but the mechanism by which these factors influence effectiveness requires further verification. FAU - Wu, Xinyu AU - Wu X AUID- ORCID: 0009-0006-5459-298X AD - Department of Medicine, Nanjing Medical University, Nanjing 210029, China. AD - Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China. FAU - Jin, Nan AU - Jin N AD - Department of Medicine, Nanjing Medical University, Nanjing 210029, China. AD - Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China. FAU - Gao, Hongfei AU - Gao H AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Southern Medical University, Guangzhou 510515, China. FAU - Yan, Min AU - Yan M AD - Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China. FAU - Chen, Qianjun AU - Chen Q AD - Department of Breast Disease, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China. FAU - Sun, Tao AU - Sun T AD - Department of Medical Oncology, Liaoning Cancer Hospital & Institute, Shenyang 110042, China. FAU - Hao, Chunfang AU - Hao C AD - Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China. FAU - Zhao, Yanxia AU - Zhao Y AD - Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430074, China. FAU - Han, Xinhua AU - Han X AD - Division of Life Science and Medicine, Department of Oncology, The First Affiliated Hospital of University of Science and Technology of China (USTC), University of Science and Technology of China, Hefei 230026, China. FAU - Pan, Yueyin AU - Pan Y AD - Division of Life Science and Medicine, Department of Oncology, The First Affiliated Hospital of University of Science and Technology of China (USTC), University of Science and Technology of China, Hefei 230026, China. FAU - Huang, Xiang AU - Huang X AUID- ORCID: 0000-0002-7448-1711 AD - Department of Medicine, Nanjing Medical University, Nanjing 210029, China. AD - Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China. FAU - Li, Wei AU - Li W AD - Department of Medicine, Nanjing Medical University, Nanjing 210029, China. AD - Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China. FAU - Wang, Kun AU - Wang K AD - Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Southern Medical University, Guangzhou 510515, China. FAU - Yin, Yongmei AU - Yin Y AUID- ORCID: 0000-0003-3335-369X AD - Department of Medicine, Nanjing Medical University, Nanjing 210029, China. AD - Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China. LA - eng GR - YXJL-2020-0941-0761/Beijing Medical Award Foundation/ PT - Journal Article DEP - 20230901 PL - Switzerland TA - Cancers (Basel) JT - Cancers JID - 101526829 PMC - PMC10487219 OTO - NOTNLM OT - metastatic breast cancer OT - palbociclib OT - real-world study COIS- The authors declare no conflict of interest. EDAT- 2023/09/09 11:45 MHDA- 2023/09/09 11:46 PMCR- 2023/09/01 CRDT- 2023/09/09 01:15 PHST- 2023/07/15 00:00 [received] PHST- 2023/08/23 00:00 [revised] PHST- 2023/08/29 00:00 [accepted] PHST- 2023/09/09 11:46 [medline] PHST- 2023/09/09 11:45 [pubmed] PHST- 2023/09/09 01:15 [entrez] PHST- 2023/09/01 00:00 [pmc-release] AID - cancers15174360 [pii] AID - cancers-15-04360 [pii] AID - 10.3390/cancers15174360 [doi] PST - epublish SO - Cancers (Basel). 2023 Sep 1;15(17):4360. doi: 10.3390/cancers15174360.