Changes in Patient Reported Outcomes Relative to the Time of Disease Progression in Non-Small Cell Lung Cancer
Author(s)
Julia Schuchard, PhD1, Susan C. Bolge, PhD2, Mariah Ennis, MD3, Sandeep Kumar, MD3, Seema Sethi, MD4, Sujay Shah, MD4, Monica Withelder, MD5, Molly J. Gardner, PhD6, Andrea Savord, PhD6, James S. McGinley, PhD6;
1Janssen Global Services, LLC, Associate Director, PROs, Horsham, PA, USA, 2Janssen Global Services, LLC, Raritan, NJ, USA, 3Janssen Research and Development, LLC, Titusville, NJ, USA, 4Janssen Research and Development, LLC, Spring House, PA, USA, 5Janssen Research and Development, LLC, Raritan, NJ, USA, 6Vector Psychometric Group, LLC, Chapel Hill, NC, USA
1Janssen Global Services, LLC, Associate Director, PROs, Horsham, PA, USA, 2Janssen Global Services, LLC, Raritan, NJ, USA, 3Janssen Research and Development, LLC, Titusville, NJ, USA, 4Janssen Research and Development, LLC, Spring House, PA, USA, 5Janssen Research and Development, LLC, Raritan, NJ, USA, 6Vector Psychometric Group, LLC, Chapel Hill, NC, USA
Presentation Documents
OBJECTIVES: Although progression free survival is a common primary endpoint in cancer clinical trials, it is not universally accepted as being patient relevant. This study is the first to use pre- and post-progression patient-reported outcome (PRO) data to assess how symptoms and functioning change in relation to the time of radiographic disease progression in non-small cell lung cancer (NSCLC).
METHODS: Data were derived from the Phase 3 MARIPOSA (NCT04487080) and MARIPOSA 2 (NCT04988295) trials evaluating amivantamab-based treatment regimens in adult patients with EGFR-mutant advanced NSCLC. The study included patient-reported lung cancer symptoms (measured by NSCLC-SAQ) and global health, physical function, and role function (measured by EORTC QLQ-C30). Analyses included 590 participants in the MARIPOSA study that experienced disease progression and 240 participants across the MARIPOSA and MARIPOSA 2 studies that experienced intracranial disease progression. Longitudinal change in PRO scores was evaluated with piecewise mixed effects modeling using the time of progression as the transition point.
RESULTS: Across all four PRO measures and all treatment groups, PRO score trajectories showed increased worsening in the months leading up to progression, worsening at the time of progression, and trends in a worsening direction after progression. In the MARIPOSA study, all fixed effect time estimates were significant (p<.01), and the extent of worsening was particularly pronounced for the subgroup of patients who experienced intracranial progression. Results from MARIPOSA 2 were consistent with the findings from MARIPOSA showing associations between intracranial progression and worsening in PROs.
CONCLUSIONS: This study provides evidence that radiographic disease progression, including intracranial progression, is associated with worsening of patients’ NSCLC symptoms and health-related quality of life. The findings support prolonging time to disease progression and development or progression of brain metastases as patient relevant endpoints in NSCLC.
METHODS: Data were derived from the Phase 3 MARIPOSA (NCT04487080) and MARIPOSA 2 (NCT04988295) trials evaluating amivantamab-based treatment regimens in adult patients with EGFR-mutant advanced NSCLC. The study included patient-reported lung cancer symptoms (measured by NSCLC-SAQ) and global health, physical function, and role function (measured by EORTC QLQ-C30). Analyses included 590 participants in the MARIPOSA study that experienced disease progression and 240 participants across the MARIPOSA and MARIPOSA 2 studies that experienced intracranial disease progression. Longitudinal change in PRO scores was evaluated with piecewise mixed effects modeling using the time of progression as the transition point.
RESULTS: Across all four PRO measures and all treatment groups, PRO score trajectories showed increased worsening in the months leading up to progression, worsening at the time of progression, and trends in a worsening direction after progression. In the MARIPOSA study, all fixed effect time estimates were significant (p<.01), and the extent of worsening was particularly pronounced for the subgroup of patients who experienced intracranial progression. Results from MARIPOSA 2 were consistent with the findings from MARIPOSA showing associations between intracranial progression and worsening in PROs.
CONCLUSIONS: This study provides evidence that radiographic disease progression, including intracranial progression, is associated with worsening of patients’ NSCLC symptoms and health-related quality of life. The findings support prolonging time to disease progression and development or progression of brain metastases as patient relevant endpoints in NSCLC.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
P10
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Oncology