Abstract 1065P
Background
Major changes in daily administrations of cancer treatments have been based on the published results of prospective randomized clinical trials of immune checkpoint inhibitors (ICIs). Harms reporting is a key issue to assess the risk-benefit profile of immunotherapy. To assess the quality of adverse events (AEs) reporting in randomized cancer phase III trials of ICIs.
Methods
PubMed, EMBASE, and Cochrane Library databases were searched for phase III randomized cancer clinical trials of ICIs published on or before September 2019 to assess how they abide by the TRIO and 2004 CONSORT harms extension recommendations on toxicity reporting. The two reviewers who screened the studies independently performed toxicity data extraction.
Results
A total of 46 trials with 30615 patients were included. 74% of studies presented the incidence of grade 3 and 4 AEs collectively. Timing of onset, duration, and resolution were reported in 30%, 28% and 26% of the studies, respectively. AEs occurring in <10% of patients were reported in only 35% of reports. Grade 2 toxicity was never presented separately. Co-occurrence of distinct toxicities was never described. Patient-related outcomes were analyzed in only 17% of reports. Eight studies defined the toxicity profile as “manageable”, “tolerable”, “well tolerated” or “favorable” despite the grade 3-4 AEs rate of > 33%.
Conclusions
Toxicity is underreported in immune checkpoint inhibitors trials. Improvement in reporting and incorporation of new tools are warranted.
Clinical trial identification
Editorial acknowledgement
Magdalena Benetkiewicz (PhD) for her assistance help in the literature search and manuscript editing.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
C. Tournigand: Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Research grant/Funding (institution): Bayer; Honoraria (self), Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Research grant/Funding (institution): Amgen. All other authors have declared no conflicts of interest.