PMID- 32886422 OWN - NLM STAT- MEDLINE DCOM- 20210719 LR - 20210719 IS - 2045-7634 (Electronic) IS - 2045-7634 (Linking) VI - 9 IP - 21 DP - 2020 Nov TI - Associations between safety, tolerability, and toxicity and the reporting of health-related quality of life in phase III randomized trials in common solid tumors. PG - 7888-7895 LID - 10.1002/cam4.3390 [doi] AB - BACKGROUND: Anti-cancer drugs are approved typically on the basis of efficacy and safety as evaluated in phase III randomized trials (RCTs). Health-related quality of life (HRQoL) is a direct measure of patient benefit, but is under-reported. Here we explore associations with reporting of HRQoL data in phase III RCTs in common solid tumors. METHODS: We searched ClinicalTrials.gov to identify phase III RCTs evaluating new drugs in adults with advanced cancers that completed accrual between January 2005 and October 2016. Data on HRQoL, safety, and tolerability comprising treatment-related death, treatment discontinuation and commonly reported grade 3 or 4 adverse events (AEs) were extracted. Associations between these measures and reporting of HRQoL data were explored using logistic regression. RESULTS: Of 377 phase III RCTs identified initially, 143 studies were analysed and comprised 55% positive trials and 90% industry sponsored trials. HRQoL was listed as an endpoint in 59% trials; and of these, only 65% reported HRQoL data. There were higher odds of reporting HRQoL data for positive trials (OR 2.05, P = .04) and trials published in journals with higher impact factor (OR 1.35, P = .01). Reporting of HRQoL was not associated with treatment-related death (OR 1.25, P = .40) or treatment discontinuation (OR 1.12, P = .61), but was positively associated with dyspnea and dermatological adverse events. CONCLUSIONS: HRQoL is reported in only two-thirds of RCTs that describe collecting such data. Reporting of HRQoL is associated with positive trial outcome and higher journal impact factor, but not associated with overall safety and tolerability of anti-cancer drugs. CI - (c) 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. FAU - Saleh, Ramy R AU - Saleh RR AD - Division of Medical Oncology & Hematology, Department of Medicine, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada. FAU - Meti, Nicholas AU - Meti N AD - Division of Medical Oncology & Hematology, Department of Medicine, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada. FAU - Ribnikar, Domen AU - Ribnikar D AD - Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia. FAU - Goldvaser, Hadar AU - Goldvaser H AD - Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel. AD - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. FAU - Ocana, Alberto AU - Ocana A AD - Experimental Therapeutics Unit, Medical Oncology Department, Hospital Clinico San Carlos, and IdISSC, Madrid, Spain. AD - Centro de Investigacion Biomedica en Red Cancer (CIBERONC), Madrid, Spain. AD - Centro Regional de Investigaciones Biomedicas, Castilla-La Mancha University, Ciudad Real, Spain. FAU - Templeton, Arnoud J AU - Templeton AJ AD - Department of Oncology, St. Claraspital, Basel, Switzerland. AD - Faculty of Medicine, University of Basel, Basel, Switzerland. FAU - Seruga, Bostjan AU - Seruga B AD - Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia. FAU - Amir, Eitan AU - Amir E AUID- ORCID: 0000-0002-3706-525X AD - Division of Medical Oncology & Hematology, Department of Medicine, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada. LA - eng PT - Journal Article DEP - 20200904 PL - United States TA - Cancer Med JT - Cancer medicine JID - 101595310 RN - 0 (Antineoplastic Agents) SB - IM MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Clinical Trials, Phase III as Topic MH - Humans MH - Neoplasms/diagnosis/*drug therapy/mortality MH - *Patient Reported Outcome Measures MH - *Quality of Life MH - Randomized Controlled Trials as Topic MH - Research Design MH - Risk Assessment MH - Risk Factors MH - Treatment Outcome PMC - PMC7643655 OTO - NOTNLM OT - oncology OT - quality of life OT - randomized controlled trials OT - treatment toxicity COIS- Dr Eitan Amir reports personal fees from Genentech/Roche, personal fees from Apobiologix, personal fees from Myriad Genetics, personal fees from Agendia, outside the submitted work. Dr Ramy Saleh reports personal fees from Roche, outside the submitted work. Dr Nicholas Meti reports personal fees from Novartis, outside the submitted work. Dr Domen Ribnikar reports personal fees from Novartis, outside the submitted work. Dr Hadar Goldvaser reports personal honorarium fees from Roche, Novartis, Pfizer and Oncotest, personal advisory consultation fees from Novartis, all outside the submitted work. Dr Alberto Ocana reports travel support from Merck, advisory consultation fees from Daichii-Sankyo and Entrechem. Dr Arnoud J. Templeton reports personal fees from Astellas, MSD, and Sanofi. Consultancy fees were paid to his institution by BMS, Janssen, Sanofi, and Roche. Conference/travel support was received from Sanofi, Janssen, Ipsen, and Roche. Dr Bostjan Seruga reports personal honorarium fees from Astellas, Jansse, Novartis and Roche. EDAT- 2020/09/05 06:00 MHDA- 2021/07/20 06:00 PMCR- 2020/09/04 CRDT- 2020/09/05 06:00 PHST- 2020/06/22 00:00 [received] PHST- 2020/07/13 00:00 [revised] PHST- 2020/07/22 00:00 [accepted] PHST- 2020/09/05 06:00 [pubmed] PHST- 2021/07/20 06:00 [medline] PHST- 2020/09/05 06:00 [entrez] PHST- 2020/09/04 00:00 [pmc-release] AID - CAM43390 [pii] AID - 10.1002/cam4.3390 [doi] PST - ppublish SO - Cancer Med. 2020 Nov;9(21):7888-7895. doi: 10.1002/cam4.3390. Epub 2020 Sep 4.