The reporting of adverse events in oncology phase III trials: a comparison of the current status versus the expectations of the EORTC members

Maillet, Denis; Blay, Jean‐Yves; You, Benoît; Rachdi, A.; Gan, Hui; Péron, Julien

doi:10.1093/annonc/mdv485

Cited by 23 publications

(13 citation statements)

References 14 publications

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“…A substantial heterogeneity in AEs data collection, analysis, and reporting has been identified in several studies. 24,25 This may affect the number and severity of reported AEs. 26 This review was performed to assess the rate of key AEs (namely grade 5 AEs, AEs leading to study withdrawal, and serious AEs) and several AEs of special interest such as immune related AEs associated with the use of CPI alone or in a combination setting.…”

Section: Introductionmentioning

confidence: 99%

A systematic review of adverse events in randomized trials assessing immune checkpoint inhibitors

Arnaud-Coffin

Maillet

Gan

et al. 2019

Intl Journal of Cancer

186

163

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The advent of immune checkpoint‐inhibitors (CPI) has transformed treatment for several cancer types. This review was performed to assess the rate of adverse events (AEs) associated with the use of CPI, alone or in combinations. A review of AEs reporting quality was also performed. All publications of Randomized Clinical Trials (RCTs) assessing CPI published before December 2017 were included. To investigate the quality of AEs reporting, a set of items was defined based on the 2004 CONSORT harms extension statement. Rates of Grade 5, serious, and study‐withdrawal related AEs were collected in each treatment category. Specific immune related AEs (irAEs) were also collected when available. Pooled estimates of adverse event rates were calculated by using generalized linear mixed model. A total of 35 RCTs including 16,485 patients were included. The overall quality of AEs reporting was satisfactory, but items pertaining to methods of data collection and analysis were infrequently reported. Grade ≥ 3 AEs were reported for 14% (95% CI 12–16) of patients treated with PD(L)‐1 inhibitors, 34% (95% CI 27–42) of patients treated with CTLA‐4 inhibitors, 55% (95% CI 51–59) of patients on CPI combinations and 46% (95% CI 40–53) of patients on immunotherapy‐chemotherapy combination. The profile of irAEs was different among the treatment categories. The use of CPI, especially in combination, is associated with significant rates of Grade ≥ 3 AEs. Healthcare planning should anticipate the expected high number of patients presenting with irAEs in the future.

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Section: Introductionmentioning

confidence: 99%

A systematic review of adverse events in randomized trials assessing immune checkpoint inhibitors

Arnaud-Coffin

Maillet

Gan

et al. 2019

Intl Journal of Cancer

186

163

View full text Add to dashboard Cite

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“…Despite the critical importance of knowing the safety profiles of cancer treatments, there is evidence that toxicity reporting is suboptimal in clinical trials [ 30 – 33 ], including IO trials [ 34 ]. Accurate and timely toxicity reporting in IO trials would provide critical details about the occurrence and management of IO toxicities.…”

Section: Efficacy Reporting Standards For Io Trialsmentioning

confidence: 99%

Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement

Tsimberidou¹,

Levit²,

Schilsky³

et al. 2018

j. immunotherapy cancer

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PurposeTo develop recommendations for clinical trial reporting that address the unique efficacy, toxicity, and combination and sequencing aspects of immuno-oncology (IO) treatments.MethodsASCO and the Society for Immunotherapy of Cancer (SITC) convened a working group that consisted of practicing medical oncologists, immunologists, clinical researchers, biostatisticians, and representatives from industry and government to develop Trial Reporting in Immuno-Oncology (TRIO) recommendations. These recommendations are based on expert consensus, given that existing data to support evidence-based recommendations are limited.ConclusionThe TRIO recommendations are intended to improve the reporting of IO clinical trials and thus provide more complete evidence on the relative benefits and risks of an IO therapeutic approach. Given the rapid expansion of the number of IO clinical trials and ongoing improvements to the evidence base supporting the use of IO treatments in clinical care, these recommendations will likely need regular revision as the IO field develops.

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“…Health research reporting problems have been well-documented in recent years, and oncology research is no exception ( Papathanasiou and Zintzaras, 2010 ; Peron et al , 2012 , 2013 ; Jankova et al , 2015 ; Maillet et al , 2016 ; Sivendran and Galsky, 2016 ). Despite these continuing reporting issues, two specific guidelines for haematology research have been very well cited.…”

Section: Future Work Of Equator Oncologymentioning

confidence: 99%

Reporting guidelines for oncology research: helping to maximise the impact of your research

et al. 2018

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Many reports of health research omit important information needed to assess their methodological robustness and clinical relevance. Without clear and complete reporting, it is not possible to identify flaws or biases, reproduce successful interventions, or use the findings in systematic reviews or meta-analyses. The EQUATOR Network (http://www.equator-network.org/) promotes responsible reporting and the use of reporting guidelines to improve the accuracy, completeness, and transparency of health research. EQUATOR supports researchers by providing online resources and training. EQUATOR Oncology, a project funded by Cancer Research UK, aims to support cancer researchers reporting their research through the provision of online resources. In this article, our objective is to highlight reporting issues related to oncology research publications and to introduce reporting guidelines that are designed to aid high-quality reporting. We describe generic reporting guidelines for the main study types, and explain how these guidelines should and should not be used. We also describe 37 oncology-specific reporting guidelines, covering different clinical areas (e.g., haematology or urology) and sections of the report (e.g., methods or study characteristics); most of these are little-used. We also provide some background information on EQUATOR Oncology, which focuses on addressing the reporting needs of the oncology research community.

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The reporting of adverse events in oncology phase III trials: a comparison of the current status versus the expectations of the EORTC members

Abstract: A phase I/II study with a CNS-penetrant, selective ALK inhibitor alectinib in ALK-rearranged non-small cell lung cancer (ALK+NSCLC) patients (pts): updates on progression free survival (PFS) and safety results from AF-001JP.

Cited by 23 publications

References 14 publications

A systematic review of adverse events in randomized trials assessing immune checkpoint inhibitors

A systematic review of adverse events in randomized trials assessing immune checkpoint inhibitors

Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement

Reporting guidelines for oncology research: helping to maximise the impact of your research

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