Abstract 73P
Background
Exon 19 deletion (19Del) and exon 21 point mutation (L858R) account for 85–90% of EGFR mutations in NSCLC and confer sensitivity to EGFR tyrosine kinase inhibitors. To evaluate the content validity and relevance of 4 PROs (NSCLC-SAQ, EORTC QLQ-C30, PROMIS-PF-8, TASQ) for use in clinical trials of this specific NSCLC population and understand perceptions of biomarker testing (BT), qualitative interviews were conducted.
Methods
ICAN, International Cancer Advocacy Network, helped identify study participants. Participants completed one Zoom interview containing concept elicitation and cognitive debriefing questions, guided by an interview guide, developed for this study. Interviews were recorded, transcribed, and analyzed using qualitative software. Symptoms/impacts were mapped to the PROs, and gap analysis was conducted. IRB approval was obtained.
Results
A total of 36 NSCLC adult patients with a confirmed diagnosis of advanced or metastatic 19Del or L858R NSCLC in the US, UK, Canada, Spain, and India were enrolled (mean age = 56, 81% female, 64% receiving 1st-line treatment, 92% with metastatic disease). Pain in areas other than the chest (69%), cough (67%), fatigue (64%), shortness of breath (58%), difficulty remembering/focusing (58%), and chest pain (33%) were the most common symptoms. Physical (35%), social (40%), and emotional (82%) impacts, and difficulty with daily activities (77%) were common. In general, patients found the PROs to be clear, comprehensive, and relevant. Gap analysis revealed the only concept missing was weight loss. All patients had undergone BT. 68% underwent BT at the time of diagnosis, biopsy, or surgery. 42% were unaware that BT was being done until after it had occurred. 79% reported BT was done to inform the targeted treatment decision, 96% felt results affected the type of treatment received, and 60% reported that they understood at least a little about the results. 78% would consider a timeframe of < 1 week to receive results as acceptable.
Conclusions
Findings provide evidence to support the content validity, clarity, and relevance of the four PROs in a population with EGFR-mutated NSCLC. Patients understand the value of BT.
Legal entity responsible for the study
Health Outcomes Solutions.
Funding
Janssen Global Services LLC.
Disclosure
S.D. Mathias: Financial Interests, Institutional, Research Grant: Health Outcomes Solutions. H. Colwell: Financial Interests, Institutional, Research Grant: Health Outcomes Solutions. A.C. Heerdegen: Financial Interests, Personal, Stocks/Shares: Janssen. K. Bevans: Financial Interests, Personal, Stocks/Shares: Janssen. T. Li: Financial Interests, Personal, Stocks/Shares: Janssen. A. Stevens: Financial Interests, Personal, Stocks/Shares: Janssen. J. Sermon: Financial Interests, Personal, Stocks/Shares: Janssen. J. Fastenau: Financial Interests, Personal, Stocks/Shares: Janssen. R. Pierson: Financial Interests, Personal, Stocks/Shares: Janssen. All other authors have declared no conflicts of interest.