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•नेपालमा पिसाब नलीको संक्रमण र एन्टिबायोटिक प्रतिरोधको बढ्दो संकट•Frontline Perspectives on Nursing Leadership in Nepal•Protecting the Smallest Lungs from the Hidden Grip of RSV in Kathmandu•The Heavy Burden of Bullying on Student Wellbeing in Nepal•The Emerging Landscape of Thyroid Health in Central Nepal•How a Recent Western Nepal Study is Redefining Anemia Diagnosis•How H. Pylori is Impacting the Health of Karnali’s High-Altitude Communities•Sweet Poison, Bitter Reality: The Unseen Diabetes Epidemic Among Nepal’s Youth•How Missing Checklists and Protocols are Costing Lives in Nepal’s ERs•Why Your Lungs May Hold the Secret to Your Stress Levels•नेपालमा पिसाब नलीको संक्रमण र एन्टिबायोटिक प्रतिरोधको बढ्दो संकट•Frontline Perspectives on Nursing Leadership in Nepal•Protecting the Smallest Lungs from the Hidden Grip of RSV in Kathmandu•The Heavy Burden of Bullying on Student Wellbeing in Nepal•The Emerging Landscape of Thyroid Health in Central Nepal•How a Recent Western Nepal Study is Redefining Anemia Diagnosis•How H. Pylori is Impacting the Health of Karnali’s High-Altitude Communities•Sweet Poison, Bitter Reality: The Unseen Diabetes Epidemic Among Nepal’s Youth•How Missing Checklists and Protocols are Costing Lives in Nepal’s ERs•Why Your Lungs May Hold the Secret to Your Stress Levels

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

Researchers

Thomas Grinda, Hillary M Heiling, Nabihah Tayob, Karen L Smith, Raechel Davis, Christine Cotter, Michelle K DeMeo, Cesar A Santa-Maria, Catherine Van Poznak, Beverly Moy, Adam M Brufsky, Michelle E Melisko, Ciara C O'Sullivan, Claudine Isaacs, Yasmeen Rauf, Julie R Nangia, Robyn T Burns, Jennifer Savoie, Antonio C Wolff, Eric P Winer, Erica L Mayer, Sara M Tolaney, Mothaffar F Rimawi, Kathryn J Ruddy, Gabrielle Rocque, Ian E Krop, Nancy U Lin, Rachel A Freedman

Abstract

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. Patients received neratinib (160 mg daily) and T-DM1 (3.6 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. Forty-four patients enrolled; all completed ≥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 = 0.002) at Cycle 3. STIDAT scores also worsened by Cycle 3 (mean change 0.50; 95%CI: 0.11-0.90; p = 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. 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.
Source: PubMed (PMID: 42501479)View Original on PubMed