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Relationships Between Clinician-Confirmed Symptomatic Progression and Change in Patient-Reported Outcomes in
James S McGinley1, Andrea Savord1, R J Wirth1
1Vector Psychometric Group, LLC, USA.
Summary
Patient-reported outcomes (PROs) worsen significantly before and after symptomatic progression events in non-small cell lung cancer (NSCLC). This finding supports the patient relevance of time to symptomatic progression (TTSP) as a clinical trial endpoint.
Area of Science:
- Oncology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Time to symptomatic progression (TTSP) is a novel endpoint in cancer clinical trials.
- Understanding the relationship between clinician-confirmed symptomatic progression and patient experiences is crucial.
Purpose of the Study:
- To evaluate how changes in patient-reported outcome (PRO) measures relate to the timing of symptomatic progression events.
- To assess the patient relevance of TTSP as a clinical endpoint in NSCLC.
Main Methods:
- Utilized data from the phase 3 MARIPOSA study of patients with previously untreated EGFR-mutated NSCLC.
- Examined relationships between symptomatic progression and 4 PRO measures (EORTC QLQ-C30 and NSCLC-SAQ).
- Modeled longitudinal changes in PROs pre- and post-symptomatic progression using piecewise mixed effect models.
Main Results:
- 362 out of 1074 patients experienced symptomatic progression.
- PRO scores significantly worsened starting 9 months prior to progression (p<0.01).
- Worsening accelerated closer to progression and continued post-progression (p<0.0001).
Conclusions:
- Consistent associations between symptomatic progression and worsening PROs support the patient relevance of TTSP.
- This highlights the importance of PROs in evaluating treatment efficacy and patient experience in NSCLC.
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