التفاصيل البيبلوغرافية
| العنوان: |
An open label, randomized phase 2 trial assessing the impact of food on the tolerability of abemaciclib in patients with advanced breast cancer |
| المؤلفون: |
Lim, Elgene, Boyle, Frances, Okera, Meena, Loi, Sherene, Goksu, Sema Sezgin, van Hal, Gertjan, Chapman, Sonya C., Gable, Jonathon Colby, Chen, Yanyun, Price, Gregory L., Hossain, Anwar M., Gainford, M. Corona, Ezquerra, Meritxell Bellet |
| المساهمون: |
Eli Lilly and Company, University of New South Wales |
| المصدر: |
Breast Cancer Research and Treatment ; volume 195, issue 3, page 275-287 ; ISSN 0167-6806 1573-7217 |
| بيانات النشر: |
Springer Science and Business Media LLC |
| سنة النشر: |
2022 |
| مصطلحات موضوعية: |
Cancer Research, Oncology |
| الوصف: |
Purpose Abemaciclib, a CDK4 & 6 inhibitor, is indicated for advanced breast cancer treatment. Diarrhea is a frequently associated adverse event of abemaciclib. The study objective was to investigate if food intake impacts local gastrointestinal toxicity. Methods This Phase 2 study (I3Y-MC-JPCP, NCT03703466) randomized 72 patients 1:1:1 to receive abemaciclib 200 mg monotherapy twice daily (1) with a meal, (2) in a modified fasting state or (3) without regard to food. Primary endpoints included: incidence of investigator assessed severe (≥ Grade 3), prolonged (> 7 days) Grade 2 diarrhea, treatment discontinuation, dose modifications, and loperamide utilization during the first 3 cycles of treatment. Patient outcomes were captured via a daily electronic diary. Pharmacokinetics (PK) are reported. Results Incidence of investigator assessed severe diarrhea (Grade ≥ 3) was 1.4% (1 patient in Arm 1). Median duration of Grade 3 diarrhea was 1 day by both investigator assessment (1 patient in Arm 1) and patient-reported assessment (1 patient each in Arms 1 and 3). Median duration of investigator-assessed Grade 2 diarrhea was 2 days overall. No patient discontinued treatment due to diarrhea. Nine patients (12.7%) had a dose reduction, and 7 patients (9.9%) had a dose omission due to diarrhea. Ninety-four percent of patients used loperamide at least once. Abemaciclib PK was comparable across the 3 arms. Conclusion The results suggest that diarrhea incidence associated with abemaciclib was unrelated to timing of food intake, was predominantly low grade, of short duration and well managed with loperamide and dose modifications. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.1007/s10549-022-06690-5 |
| DOI: |
10.1007/s10549-022-06690-5.pdf |
| DOI: |
10.1007/s10549-022-06690-5/fulltext.html |
| الإتاحة: |
https://doi.org/10.1007/s10549-022-06690-5Test |
| حقوق: |
https://creativecommons.org/licenses/by/4.0Test ; https://creativecommons.org/licenses/by/4.0Test |
| رقم الانضمام: |
edsbas.32B84700 |
| قاعدة البيانات: |
BASE |
