The use of investigator-assigned subjective or judgmental efficacy and toxicity reporting in early phase clinical trials of lung cancer treatments.

Abstract

Introduction: Investigator-assigned Subjective or Judgmental Efficacy and Toxicity (ISJET) reporting represents language used to contextualize efficacy or toxicity data in clinical trials that may be inappropriate or misleading. In addition, pooling of grade 1 and 2 adverse events (AEs) may reflect a practice based on acute chemotherapy treatments rather than the expansion of chronic treatments that are now commonplace for many lung cancer patients. In this study, we set out to evaluate the use of ISJETs and combined grade 1 and 2 reporting in early phase clinical trials of lung treatments at the 2024 ASCO Annual Meeting.

Methods: Phase I and II clinical trials of systemic treatments in adults with at least 1 lung cancer patient presented at the 2024 ASCO Annual Meeting were reviewed. Baseline information and toxicity/efficacy reporting were collected. ISJETs were captured based on pre-defined phrases such as "tolerable", "manageable", "acceptable", or "favorable".

Results: 100 eligible studies were identified. The median sample size was 43 (IQR 29-73), 61 (61%) were phase I trials. Most studies reported any grade (99%) and grade 3 (96%) AEs. Only 12% of studies distinguished between grade 1/2 AEs. ISJETs were used to report toxicity in 88% and efficacy in 41% of studies, respectively.

Conclusion: The majority of early phase lung cancer clinical trials presented at the 2024 ASCO Annual Meeting included ISJETs and did not distinguish between grade 1 and 2 AEs. Initiatives to increase objective efficacy and toxicity reporting language and more fit-for-purpose toxicity reporting are warranted.