Multi-Site Real World Data from Patient Reported Outcomes of Patients with Breast Cancer on Immunotherapy or Antibody Drug Conjugates using the Carevive PROmpt Web-Based Platform

Authors: Kim RM Blenman^1,2,3, Kaicheng Wang⁴, Mariya Rozenblit^1,2, Adriana Kahn^1,2, Mateo Montalvo Campana², Danielle S. Lee¹, Yiran Liu¹, Alice Wnuk², Jessica Robitaille², Cassidy Lockwood², Kelley Messina², Mya Davis¹, Renelle Gee¹, Suzanne Johnson⁵, Emelly Rusli⁵, Julie Scott⁵, Aaron Galaznik⁵, and Maryam Lustberg^1,2

¹Department of Internal Medicine, Section of Medical Oncology, Yale School of Medicine, USA, ²Yale Cancer Center and Yale New Haven Health System (Smilow Hospital), USA, ³Department of Computer Science, Yale School of Engineering and Applied Science, USA, ⁴Department of Biostatistics, Yale School of Public Health, USA, ⁵Carevive of Health Catalyst, USA

Introduction

Immunotherapy and antibody drug conjugates are quickly becoming the backbone of treatment regimens for breast cancer. However, these therapies do present with appreciable treatment emergent adverse events that are variable and difficult to predict in individual patients. Patient reported outcomes (PROs) are critical for understanding the patient experience and kinetics of treatment emergent adverse event. Therefore, providing tools for patients to capture these events outside of a clinical visit is critical.

Methods

• 97 patients, from the Carevive database, with breast cancer treated with IO (atezolizumab, pembrolizumab, avelumab) and/or an ADC (T-DM1, T-Dxd, Sacituzumab) were included.
• PRO mobile web-based platform, Carevive PROmpt was used to collect symptom and wellness data once per week for at least 12 weeks using validated psychometric tools (PRO-CTCAE (symptoms), FACT-GP5 (treatment bother), PROMIS 4a (physical function), ECORTC QLQ C30 (quality of life)).
• 16 symptoms measured: anxiety, constipation, cough, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth/throat sores, muscle pain, nausea, numbness/tingling, rash, sadness, shortness of breath, and vomiting.
• Prevalence of each symptom over a 12-week period and median percentage and interquartile range (IQR) of each symptom over a 32-week period is reported.

Summary

• Onset and duration of treatment emergent adverse events can be assessed for individual patients. This information will facilitate earlier interventions for symptom management of individual patients.
• The highest reported symptoms over time were anxiety, fatigue, muscle pain, and numbness/tingling.
• The highest reported symptoms were reported starting within the first week of reporting and were often reported in at least 50% of the timepoints for each patient that reported the symptom.
• There were no appreciable differences between reported symptoms from patients with metastatic versus early-stage disease.
• A major limitation is that although the questionnaires were sufficient to alert clinical care teams of potential toxicity in general, they were not specific to toxicities associated with immunotherapies or antibody drug conjugates.
• An opportunity area for the field is to create more specific or tailored PROs for immune toxicities associated with immunotherapies, antibody drug conjugates, and cell-based therapies.

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