1. Abstract P4-09-01: Incidence of patient-reported fatigue developing in patients receiving palbociclib and endocrine therapy for advanced HR+ HER2- breast cancer
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Shadab A Rahman, Erica L Mayer, Hanneke Poort, Deborah Schrag, Stephanie C Tung, Eric S Zhou, Aleta Wiley, Lauren Finkelstein, Elkhansaa Elguenaoui, Moira Nolan, and Hadine Joffe
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Cancer Research ,Oncology - Abstract
Background: Clinician-rated adverse event data from pivotal trials of the CDK4/6 inhibitor palbociclib (palbo) in patients (pts) with HR+ HER2- metastatic breast cancer (MBC) describe fatigue as a common non-hematologic toxicity. While palbo and endocrine therapy (ET) significantly improve outcomes compared to ET alone, in a pooled analysis of the PALOMA trials, rates of incident Common Terminology Criteria for Adverse Events (CTCAE) all-grade fatigue over 4.2 years of treatment approached 39.2%, with grade 3/4 at 2.5%. As these studies included only provider-rated CTCAE toxicity, it is important to quantify pts’ ratings of fatigue severity, which may differ from clinician assessments. Methods: Eligible pts with HR+ HER2- MBC, initiating standard-dose palbo with ET (aromatase inhibitor or fulvestrant), and without clinically meaningful fatigue prior to initiation of palbo, were followed for the 6 initial treatment cycles. The absence of baseline fatigue was established using the patient-reported Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F), a 13-item scale (range 0-52, lower score = more fatigue) validated against anemia to indicate clinically meaningful fatigue if FACIT-F score =34; PRO-CTCAE fatigue severity grade 3/4 vs. Citation Format: Shadab A Rahman, Erica L Mayer, Hanneke Poort, Deborah Schrag, Stephanie C Tung, Eric S Zhou, Aleta Wiley, Lauren Finkelstein, Elkhansaa Elguenaoui, Moira Nolan, Hadine Joffe. Incidence of patient-reported fatigue developing in patients receiving palbociclib and endocrine therapy for advanced HR+ HER2- breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-09-01.
- Published
- 2022
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