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Holistic Treatment of Patients with HRpos HER2neg MBC and Comorbidities

CME

Treating the Whole Patient: Understanding Needs of Patients With HR-Positive/HER2-Negative MBC and Comorbidities

Physicians: Maximum of 0.50 AMA PRA Category 1 Credit™

Released: March 07, 2025

Expiration: September 06, 2025

Sara A. Hurvitz
Sara A. Hurvitz, MD, FACP
CME/CE Information

Activity

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Course Completed

Real-world Study: Analysis of Risk Factors of QTc Prolongation in HR+/HER2- MBC

A retrospective, real-world, cross-sectional cohort study was performed using the Truven Health MarketScan and Optum Clinformatics administrative claims databases.17 The study included 24,340 women aged 18 years or older at initial diagnosis of HR-positive/HER2-negative MBC. The study investigated the overall risk of QTc prolongation in patients who either had congenital long QT syndrome, cardiovascular disease, or electrolyte abnormalities, or patients who received a concomitant medication that had the potential to increase the risk of developing QTc prolongation.

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Women With HR+/HER2- MBC With Risk Factors for QTc Prolongation at Baseline

This retrospective analysis demonstrated that approximately 16% of patients with HR-positive, HER2-negative metastatic breast cancer will have a congenital long QT syndrome, cardiovascular disease, or an electrolyte abnormality. Overall, approximately 30% of patients with HR-positive/HER2-negative MBC have a risk of developing QTc prolongation. It is interesting to note that as the patient's age increases, the risk for QTc prolongation increases. Women younger than age 65 have approximately a 24.4% risk of developing QTc prolongation, whereas for those aged 75 years or older, the risk for developing QTc prolongation is approximately 41%. Similarly, the risk of developing electrolyte abnormalities and cardiovascular diseases increases with age.

These results underscore the need to be mindful of this risk when prescribing drugs like ribociclib, which can cause QTc prolongation. For this reason, patients starting ribociclib should have an electrocardiogram (ECG) at baseline and every 2 weeks for the first 2 months of treatment.11 These data also call attention to the importance of monitoring electrolytes in patients starting ribociclib as alterations could increase the risk of QTc prolongation. Finally, it is important to evaluate patients for potential drug–drug interactions before prescribing CDK4/6 inhibitors. This approach may be taken in concert with our pharmacy colleagues.

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BC Medications Associated With Increased Risk of QTc Prolongation in Women With HR+/HER2- MBC

Medications that may increase the risk of QTc prolongation include antibiotics, antiemetics, antidepressants, analgesics, antipsychotics, diuretics, and proton pump inhibitors. These real-world data collected from over 24,000 women with HR-positive/HER2-negative MBC indicated that a large proportion of women have risk factors associated with QTc prolongation, especially with increasing age. Real-world data like these provide a reminder that the patients we are treating outside of a clinical trial may be at a higher risk of drug toxicity than observed in a trial setting. These data remind us to be cognizant of a patient's comorbid conditions, concomitant medications, and laboratory and ECG results before prescribing therapies that carry their own risks of toxicity.

Real-world Study: Analysis of Clinical Complexity and HRQoL in Patients With HR+/HER2- ABC Who Received a CDK4/6i

A prospective, observational, real-world study was conducted in pre- and postmenopausal women with HR-positive, HER2-negative ABC who planned to initiate therapy with a CDK4/6 inhibitor in combination with ET.18 In total, 54 patients were enrolled, and data collection began at the time of the first administration of the CDK4/6 inhibitor. The data collected included demographics, Eastern Cooperative Oncology Group performance status, comorbid conditions, disease characteristics, details of previous and current treatments, and quality of life changes. The endpoints included multimorbidity burden assessed using the cumulative illness rating scale, polypharmacy, and patient-reported outcomes at baseline, after 3 months of therapy, and at time of disease progression using standardized questionnaires.

Real-world Study in Patients With HR+/HER2- ABC Who Received a CDK4/6i: Baseline Characteristics

The median age of patients on the study was 66 years, with the vast majority being postmenopausal (87%). Over half of the patients (53.8%) had endocrine-sensitive disease. Approximately 76% of patients had received first-line therapy. Of the 54 patients enrolled, 74% received palbociclib, 16.7% received ribociclib, and 9.3% received abemaciclib. It is important to note that 79.3% of the patients had at least 1 other comorbid condition, and close to half were receiving at least 2 other drugs.

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HR+/HER2- ABC With CDK4/6i Therapy: Proportion With a Change in PROs Perceived as Important by Patients

Of the 53 patients who received questionnaires, 20 experienced disease progression and filled out the questionnaire at the end of treatment. Between baseline and intermediate time, the most frequently reported improved symptom was fatigue, followed by emotional functioning and global health status. The highest proportion of patients who experienced a decline in their condition attributed this to physical functioning, followed by fatigue and emotional functioning.

This prospective real-world study indicates that multimorbidity and polypharmacy increase the clinical complexity of patients with ABC. These factors may affect patient-reported outcomes at baseline and at the end of treatment. Larger patient studies are needed to evaluate the clinical complexity in patients with ABC since many of these patients have preexisting comorbid conditions and use multiple drugs.

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