H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
James Yu , Turab J Mohammed , Benjamin Chin-Yee , Clarissa Skorupski , Bishal Gyawali , Gary H. Lyman , Lauren Adkins , Lisa K. Hicks , Nicole M. Kuderer
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.
No. of abstracts | 63 (Total) | 42 (CRC) | 21 (PaC) |
---|---|---|---|
No. of Pts, Mean (Range) | 621 (40 - 6088) | 719 (108-6088) | 425 (40-1062) |
Absent AE Reporting, No. (%) | 11 (17%) | 7 (17%) | 4 (19%) |
Absent Fatal AE reporting | 56 (89%) | 37 (88%) | 19 (90%) |
Absent Grade ≥ 3 CTCAE reporting | 48 (76%) | 30 (71%) | 18 (86%) |
Use of any subjective minimizing language | 15 (24%) | 8 (19%) | 7 (33%) |
Primary terms use | 13 (21%) | 8 (19%) | 5 (24%) |
Secondary term use | 4 (6%) | 2 (5%) | 2 (10%) |
Multiple minimization terms use | 4 (6%) | 3 (7%) | 1 (5%) |
Combined Subjective or Objective Toxicity minimization | 60 (95%) | 41 (98%) | 19 (90%) |
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2024 ASCO Annual Meeting
First Author: Yoanna S. Pumpalova
2023 ASCO Annual Meeting
First Author: Laure-Anne Marie Nicole Teuwen
2023 ASCO Gastrointestinal Cancers Symposium
First Author: Ahsan Ayaz
2023 ASCO Annual Meeting
First Author: Chi Mai Nguyen