1. Palbociclib use with grade 3 neutropenia in hormone receptor-positive metastatic breast cancer
- Author
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Jee Ye Kim, Joohyuk Sohn, Young Up Cho, Hyung Seok Park, Ahrong Ham, Min Hwan Kim, Byeong Woo Park, Seung Il Kim, Gun Min Kim, Seho Park, and Jee Hung Kim
- Subjects
0301 basic medicine ,Cancer Research ,Pyridines ,medicine.medical_treatment ,Gastroenterology ,Piperazines ,0302 clinical medicine ,Antineoplastic Combined Chemotherapy Protocols ,Multicenter Studies as Topic ,Fulvestrant ,Fatigue ,Randomized Controlled Trials as Topic ,Middle Aged ,Metastatic breast cancer ,Neoplasm Proteins ,Receptors, Estrogen ,Oncology ,030220 oncology & carcinogenesis ,Letrozole ,Female ,Chemical and Drug Induced Liver Injury ,Mucositis ,medicine.medical_specialty ,Neoplasms, Hormone-Dependent ,Breast Neoplasms ,Neutropenia ,Palbociclib ,Drug Administration Schedule ,03 medical and health sciences ,Breast cancer ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,Adverse effect ,Protein Kinase Inhibitors ,Aged ,Febrile Neutropenia ,Dose Modification ,Chemotherapy ,business.industry ,Cyclin-Dependent Kinase 4 ,Estrogens ,Cyclin-Dependent Kinase 6 ,medicine.disease ,Thrombocytopenia ,030104 developmental biology ,Clinical Trials, Phase III as Topic ,business ,Febrile neutropenia - Abstract
Neutropenia is the most common toxicity of CDK4/6 inhibitors, causing frequent dose interruptions. However, CDK4/6 inhibitor-induced neutropenia shows a benign clinical course in contrast to that caused by chemotherapy. Here, we investigated the safety of a new dose scheme for palbociclib, which avoids dose delays or reductions due to afebrile grade 3 neutropenia. A consecutive cohort of ER( +)/HER2( −) advanced breast cancer patients who received palbociclib between 2017 and 2018 was analyzed. The patients were classified into Group 1 (patients who maintained palbociclib dose with afebrile grade 3 neutropenia), Group 2 (patients who experienced any dose modification with afebrile grade 3 neutropenia), and Group 3 (patients without afebrile grade 3 neutropenia). The primary endpoint was febrile neutropenia incidence; other toxicities were compared with those of the PALOMA-2 trial. Among the 107 patients, 54.2%, 22.4%, and 23.4% were classified into Groups 1, 2, and 3, respectively. There was no febrile neutropenia in Groups 1 and 2 during palbociclib treatment. Group 1 showed higher incidence of thrombocytopenia (all-grade, 32.8%; grade 3–4, 8.6%) than Group 2 and the PALOMA-2 data, but there was no bleeding related to thrombocytopenia. Group 1 showed higher incidence of all-grade non-hematologic adverse events than Group 2; only one grade 3 non-hematologic toxicity was observed in Group 1. There were no treatment-related hospitalizations or deaths in Group 1. Thus, omitting palbociclib dose modification with afebrile grade 3 neutropenia is safe and tolerable without febrile neutropenia events. This scheme could be useful to avoid unnecessary reductions in palbociclib doses in future practice.
- Published
- 2020
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