Abstract 1626P
Background
In our previous systematic review (Marandino et al, Ann Oncol 2018) of phase III trials in solid tumors published between 2012 and 2016, we showed that QoL was not included among endpoints and QoL results were underreported in a relevant proportion of trials. To assess time trends in QoL inclusion among endpoints and reporting of QoL results in publications, we reviewed phase III oncology trials published in major journals in 2017-2021, compared to the previous 5 years.
Methods
All issues published between 2017 and 2021 by 11 major journals were hand-searched for primary publications of phase III trials in adult patients with solid tumors. Information about endpoints was derived from paper, study protocol and ClinicalTrials.gov, when available. Secondary QoL publications were searched in PubMed. Results were compared with trials published in 2012-2016 included in the previous analysis.
Results
388 publications between 2017 and 2021 were eligible and compared with 446 publications between 2012 and 2016. QoL was included among endpoints in 68.0% of the trials published in 2017-2021 vs 52.9% in 2012-2016 (p<0.001). Considering the advanced/metastatic setting, QoL was included in 75.8% of trials in 2017-2021 vs. 59.9% in 2012-2016 (p<0.001). Out of 264 primary publications of trials published in 2017-2021 with QoL among endpoints, QoL results were available in 51.9%, vs 62.3% in 2012-2016 (p=0.02). Overall, QoL was included among endpoints and presented in primary publications in 35.3% of trials in 2017-2021 vs 33.0% in 2012-2016 (p=0.83). In the advanced/metastatic setting, QoL was included and presented in 39.4% of publications in 2017-2021 vs. 37.9% in 2012-2016 (p=0.77). For trials without QoL results in the primary publication, probability of secondary publication was 10.8%, 29.0% and 42.4% at 1, 2 and 3 years respectively.
Conclusions
While the proportion of oncology trials including QoL among endpoints significantly increased in the last 5 years compared to 2012-2016, a significantly lower proportion of trials reported QoL results in primary publications. QoL is still subject to remarkable underreporting and delay in publication.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
L. Marandino: Personal, Funding: AstraZeneca. F. Perrone: Financial Interests, Personal, Advisory Board: Bayer, Pierre Fabre, AstraZeneca, Incyte, Ipsen, Clovis, Astellas, Sanofi; Financial Interests, Institutional, Research Grant, Financial support for clinical trials promoted by the NCI Naples: Roche, Bayer, AstraZeneca, Pfizer, Merck; Financial Interests, Institutional, Research Grant, Financial support for phase 1 trials at the NCI Naples: Incyte, Tesaro/GSK; Non-Financial Interests, Leadership Role, I've been elected President and will be active from 2023 to 2025: AIOM Associazione Italiana di Oncologia Medica. M. Di Maio: Financial Interests, Personal, Advisory Board, Consultancy about clinical trial methodology and clinical trial results interpretation: Novartis; Financial Interests, Personal, Advisory Board, Consultancy about immunotherapy in SCLC: Roche; Financial Interests, Personal, Advisory Board, Consultancy about role and interpretation of patient-reported outcomes and quality of life in clinical trials: Takeda; Financial Interests, Personal, Advisory Board, Advisory board about the role of chemotherapy and hormonal treatment in hormone-sensitive prostate cancer: Janssen; Financial Interests, Personal, Advisory Board, Consultancy about the results obtained with lorlatinib and dacomitinib in advanced non-small cell lung cancer: Pfizer; Financial Interests, Personal, Advisory Board, Consultancy about role of osimertinib as adjuvant treatment of NSCLC: AstraZeneca; Financial Interests, Personal, Invited Speaker, Compensation for a talk and a document about role of patient-reported outcomes in clinical trials and in clinical practice, with a specific focus on lung cancer: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board, Participation in advisory boards about olaparib in pancreatic cancer, about olaparib in prostate cancer, and about immunotherapy in lung cancer: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant, Financial support and drug supply for the Meet-URO12 trial (niraparib as maintenance treatment of urothelial carcinoma after first-line treatment with platinum-based chemotherapy): Tesaro - GlaxoSmithKline; Financial Interests, Institutional, Invited Speaker, Local PI of trial with tislelizumab in hepatocellular carcinoma: Beigene; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with cabozantinib and atezolizumab in advanced HCC: Exelixis; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with atezolizumab and bevacizumab in advanced HCC: Roche; Financial Interests, Institutional, Invited Speaker, Local PI of trials with pembrolizumab in hepatocellular carcinoma: Merck Sharp & Dohme; Financial Interests, Institutional, Invited Speaker, Local PI of a trial with sasanlimab in NMI bladder cancer: Pfizer. All other authors have declared no conflicts of interest.