P11.03 Importance of Capturing the Patient Experience of Overall Symptoms and HRQoL Impact in Patients With ALK+ NSCLC

Abstract

Non–small cell lung cancer (NSCLC) with the anaplastic lymphoma kinase-positive (ALK+) mutation is a rare subtype of NSCLC. Available treatments include several ALK inhibitor therapies (eg, crizotinib, alectinib, ceritinib, and brigatinib) with some showing health-related quality of life (HRQoL) benefits. HRQoL, including disease- and treatment-related symptoms and impacts, is a significant factor when making treatment decisions. However, qualitative research on HRQoL among ALK+ patients is limited. The aim of this study was to better understand the overall symptom experience and HRQoL impact from the perspective of ALK+ NSCLC patients. Interviews with expert oncologists were conducted to provide the clinical perspective and guide patient interviews. Following approval by an independent review board, semi-structured qualitative interviews were conducted with NSCLC patients with epidermal growth factor receptor or ALK mutations who had been symptomatic in the past month. During interviews, patients described their symptoms and the related HRQoL impact. Six oncologists were interviewed, identifying NSCLC symptoms, particularly: shortness of breath (100%), fatigue (100%), cough (83%), pain (67%), and hemoptysis (67%). The most common impacts were anxiety (50%), depression (50%), and confusion/bewilderment surrounding the diagnosis (50%), as most patients were never smokers and younger. A total of 36 NSCLC patients were interviewed, including 8 ALK+ patients (median age 48.5 years [28–53]; 50% female, median disease duration 2.8 years [0–7]). All ALK+ patients had received radiation, 87.5% had received chemotherapy, and 62.5% had received targeted therapy. The most commonly reported symptoms from ALK+ patients were shortness of breath (100%), phlegm/congestion (100%), pain (87.5%), feeling tired/fatigue (87.5%), weight loss (75%), cough, coughing blood, appetite loss, constipation, and diarrhea (all 62.5%). Patients described experiencing negative impacts on daily activities (87.5%), including household chores and the ability to do hobbies. Additionally, impacts on social, emotional (both 62.5%), and physical functioning (50%) were also commonly reported. The patient experience with the core symptoms of lung cancer (dyspnea, cough, and pain) among ALK+ NSCLC patients was similar across our sample, irrespective of mutation. This qualitative research also confirmed the selection of patient-reported outcome instruments to assess core concepts that best capture the patient experience of ALK+ patients in a clinical trial setting, including a recent clinical trial of brigatinib versus crizotinib in ALK+ NSCLC. In this clinical trial, patients on brigatinib showed significant HRQoL benefits compared with crizotinib in the most common symptoms or impacts reported in the current qualitative study, including fatigue, nausea and vomiting, appetite loss, constipation, as well as emotional, social functioning, and global health status/QoL. Incorporation of the patient voice through direct patient engagement provided valuable in-depth insight about patient experience in ALK+ NSCLC. This qualitative research provided insights into the unmet needs and patient goals for treatment, which may then be measured in a clinical trial to demonstrate treatment benefit from the patient perspective. It is important to measure what matters most to patients to improve treatment decision-making.