Toxicity reporting consistency and subjective minimizing language use in colorectal cancer (CRC) and pancreatic cancer (PaC) clinical trials: A systematic review of phase III randomized controlled trials (RCTs) presented at ASCO between 2012-2022.

Abstract

1567 Background: Objective and complete toxicity reporting in clinical trials is critical for patient-centered shared decision-making. Conference abstracts inform initial impressions of practice-changing treatments. Methods: We performed a systematic review of all abstracts of CRC and PaC phase 3 RCTs presented at ASCO annual meetings between 2012 – 2022; long-term follow-up, supportive care, and solely non-pharmacological studies were excluded. Objective minimization of adverse event (AE) reporting was defined as absent and/or incomplete reporting of cumulative grade 3-5 CTCAE (common terminology criteria for AE). We also assessed the use of subjective minimizing language (Chin-Yee et al ASH 2022), defined as use of “acceptable,” “tolerable”, “manageable”, “favorable” (primary minimization terms), or “feasible”, “safe”, “patients did well”, “limited” (secondary minimization terms), terms that falsely imply patients deemed the therapy as such. Presence/absence of PRO or QOL data was also assessed. Results: 63 RCTs met entry criteria (42 CRC, 21 PaC), detailed in Table. Most trials studied chemotherapy +/- other drugs (52; 83%). 17% of all abstracts did not provide any information on AE. Quantitative data on AEs were reported by 38 (60%) of abstracts. However, serious AE reporting was frequently absent (Table), with some trials reporting only specific toxicities (e.g. cytopenias) instead of cumulative CTCAE. Only 7 (11%) of abstracts noted the occurrence or absence of fatal AE. Any subjective-minimizing language was used in 15 (24%) abstracts. Notably, none of the abstracts using subjective-minimizing language provided information on fatal AE rates, nor reported on the patient perspective via QOL or PRO. Average grade ≥ 3 AE in the experimental arm were similar in abstracts with vs without minimizing language (44% vs 45%). Conclusions: Our systematic review of ph 3 RCTs in GI oncology presented at ASCO annual meetings reveals that subjective minimizing language is often used to describe serious toxicities, and without formally assessing the patient voice. Serious AE reporting is frequently absent or incomplete.[Table: see text]