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Biomedical subjects

Kathryn J Ruddy

Publications and source records attributed to Kathryn J Ruddy.

2 recordsLinked to original sources

Cardiovascular Health Across the Life Course for Individuals With Breast Cancer: A Review.

IMPORTANCE: Breast cancer is the most common cancer diagnosed in women. Therapies for breast cancer are evolving rapidly, and several are associated with cardiovascular adverse effects, can exacerbate cardiovascular risk factors, or can increase the risk of cardiovascular disease. OBSERVATIONS: Advances in screening and treatment have led to earlier diagnosis and improved disease-free survival. For long-term survivors of breast cancer, cardiovascular adverse effects can pose a greater threat to overall long-term health than the cancer itself. Additionally, the increasing incidence of breast cancer in younger, premenopausal women has created a distinct demographic with unique medical needs. CONCLUSIONS AND RELEVANCE: Cardiology practitioners need to remain updated on rapidly evolving breast cancer therapies to care for this growing, unique patient population. The field of cardio-oncology has evolved to address the cardiovascular needs of patients and survivors.

Humans

Patient-reported outcomes from the TBCRC 022 study of neratinib and ado-trastuzumab emtansine for HER2-positive breast cancer brain metastases.

PURPOSE: In TBCRC 022 (NCT01494662), neratinib and ado-trastuzumab emtansine (T-DM1) demonstrated intracranial activity among patients with HER2-positive breast cancer brain metastases. However, gastrointestinal (GI) toxicities-particularly diarrhea-were common, potentially impacting quality of life. Clinician-reported adverse event (CTCAE) grading may underestimate the patient experience. We report GI toxicities using patient-reported outcomes (PROs) in TBCRC's neratinib-T-DM1 cohort. METHODS: Patients received neratinib (160&#x202f;mg daily) and T-DM1 (3.6&#x202f;mg/kg IV every 21 days). A pre-planned analysis assessed patient-reported GI toxicities during Cycles 1-4 using the Patient-reported Outcomes Measurement Information System (PROMIS) GI Diarrhea scale, Systemic Therapy-Induced Diarrhea Assessment Tool (STIDAT), and PRO-CTCAE. Descriptive statistics and linear mixed effects models evaluated symptom trajectories over time. We evaluated agreement for PRO and clinician-reported data. RESULTS: Forty-four patients enrolled; all completed &#x2265;1 PRO. GI symptom burden increased over Cycles 1-3. PROMIS scores worsened significantly by Cycle 2, with a peak mean increase of 6.62 (95% confidence interval (CI): 2.67-10.59; p&#x202f;=&#x202f;0.002) at Cycle 3. STIDAT scores also worsened by Cycle 3 (mean change 0.50; 95%CI: 0.11-0.90; p&#x202f;=&#x202f;0.015). Based on maximum PRO-CTCAE scores, moderate-to-severe symptoms were reported by 20.5% (diarrhea), 24.4% (appetite loss), and 41.0% (constipation). Agreement between PRO-CTCAE and clinician-reported CTCAE was low (kappa <0.2) with clinicians reporting less toxicity. PROMIS and STIDAT scores were significantly correlated. CONCLUSION: This GI-focused PRO analysis highlights the value of PROs in capturing patient-experienced toxicities that impact quality of life yet are underestimated by clinicians. Incorporating PROs into clinical trials can inform supportive care and prophylactic strategies.

Humans