Characteristics of clinical trials for haematological malignancies from 2015 to 2020: A systematic review

Wesson, William; Galate, Vincent L.; Sborov, Douglas W.; McClune, Brian; Goodman, Aaron M.; Gyawali, Bishal; Prasad, Vinay; Abbasi, Saqib; Mohyuddin, Ghulam Rehman

doi:10.1016/j.ejca.2021.12.037

Cited by 10 publications

(9 citation statements)

References 33 publications

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“…It is useful to consider our results in light of the recent analysis by Wesson et al [ 12 ] which evaluated all trials registered on clinicaltrials.gov. The use of clinically relevant endpoints (OS and QoL) was similar in both of these studies (15%).…”

Section: Discussionmentioning

confidence: 99%

“…The use of OS as the primary endpoint has decreased over time and is now replaced by progression-free survival (PFS) as the most common endpoint in oncology [ 11 ]. Recent work by Wesson et al [ 12 ] identified some worrisome trends among active clinical trials in haematological cancer. Using information from ClinicalTrials.gov, Wesson et al [ 12 ] identified 2,609 trials registered during 2015–2020.…”

Section: Introductionmentioning

confidence: 99%

“…Recent work by Wesson et al [ 12 ] identified some worrisome trends among active clinical trials in haematological cancer. Using information from ClinicalTrials.gov, Wesson et al [ 12 ] identified 2,609 trials registered during 2015–2020. Among the 2,609 trials included in this cohort, only 21% (538/2,609) were randomised.…”

Section: Introductionmentioning

confidence: 99%

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Randomised controlled trials evaluating anticancer therapies in haematological cancers: an overview of global research activity

Sengar¹,

Hopman²,

Mohyuddin³

et al. 2023

ecancer

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Background: Design, results, and interpretation of oncology randomised controlled trials (RCTs) have changed substantially over the past decade. In this study, we describe all RCTs evaluating anticancer therapies in haematological cancers published globally during 2014-2017 with comparisons with solid tumours RCTs. Methods:A PubMed literature search identified all phase 3 RCTs of anticancer therapy for haematological cancers and solid tumours published globally during 2014-2017. Descriptive statistics, chi-square tests and the Kruskal-Wallis test were used to compare RCT design results, and output between haematological cancers and solid tumours as well as for different haematological cancer subtypes.Results: 694 RCTs were identified; 124 in haematological cancers and 570 in solid tumours. Overall survival (OS) was the primary endpoint in only 12% (15/124) of haematological cancer trials compared to 35% (200/570) in solid tumours (p < 0.001). Haematological cancer RCTs evaluated the systemic novel therapy more often than the solid tumour RCT (98% versus 84%, p = 0.002). Use of surrogate endpoints like progression-free survival (PFS) and time to treatment failure (TTF) were more common in haematological cancers than solid tumours (47% versus 31%, p < 0.001). Within haematological cancers, the use of PFS and TTF was more prevalent in chronic lymphocytic leukaemia and multiple myeloma as compared to others (80%-81% versus 0%-41%, p < 0.001). Seventy-eight percent of haematologic trials were funded by industry as compared to 70% of solid tumour trials. Only 4% (5/124) of haematologicalcancer trials were led by investigators in upper-middle and lower-middle-income countries as compared to the 9% of solid tumour trials. Conclusion:The fact that only 12% of haematological cancer RCTs are designed to show improvements in OS is of grave concern for the field and the care of future patients. This is further compounded by the highly prevalent use of alternative primary endpoints that are rarely valid surrogates for OS in haematological cancers.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Randomised controlled trials evaluating anticancer therapies in haematological cancers: an overview of global research activity

Sengar¹,

Hopman²,

Mohyuddin³

et al. 2023

ecancer

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“…Abemaciclib and palbociclib cannot be considered ETA in HER2-negative, high risk and luminal EBC, although abemaciclib demonstrated efficacy as adjuvant treatment in these patients. Background and Importance Previous work has described changes in the trends in onco-haematological clinical trials in recent years, describing an increase in the use of surrogate endpoints, changes in their funding or a greater number of non-randomised trials (1,2). Aim and Objectives To describe and compare the characteristics of onco-haematological clinical trials opened in a tertiary hospital in 2016 and 2021.…”

Section: Conclusion and Relevancementioning

confidence: 99%

6ER-009 Comparative efficacy of abemaciclib and palbociclib as adjuvant treatment in patients with early breast cancer

Andrades

Olid²,

Del-Rey³

et al. 2023

Section 6: Education and Research

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Information sources: electronic prescription and computerised medical record. Statistical analysis with R ® software. Results 66 patients were included (50% women), median age 48 (IQR 38-56). Median BMI 26.3 (IQR 26-39.1). Most frequent diseases: rheumatoid arthritis (18), Crohn's disease (10), ankylosing spondylitis (8) and multiple sclerosis (7). 42% of patients had no previous comorbidity, 28% had arterial hypertension, 13.6% hypercholesterolemia and 6% depression. The median diagnosis year of the disease was 2012 (IQR 2002-2016). 37.8% of patients have had two lines of treatment, 24.2% three lines, 4.5% four lines. The most frequent drugs were anti-TNF therapy (19 adalimumab, 4 certolizumab, 4 etanercept), tocilizumab (5) secukinumab (4) and tofacitinib (4). Median scale VAS was 4 (IQR 1-6), CIS 83 (IQR 76-91) and FACIT-F 16 (11-24). Median of the PREDIMED questionnaire was 7 (low dietary adherence). No statistically significant differences were found between adherence to the Mediterranean diet and scores on quality of life questionnaires. Statistically significant differences were found with calprotectin levels and glomerular sedimentation volume. 78.7% of patients are not aware of foods with potential anti-inflammatory properties and 87.8% would like to receive dietary recommendations from healthcare professionals. Conclusion and Relevance Although more studies are needed to link diet to autoimmune diseases, it is true that an appropriate diet reduces the risk of multiple pathologies. Patients demand information and as health professionals we must give it to them and reinforce adherence to good dietary patterns such as the Mediterranean diet.

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“…In this report we aim to describe the implementation of MRD in clinical trials of MM between 2015 and 2020 by characterizing trials that utilize MRD. A previously used dataset and search strategy, as reported by Wesson et al was utilized [ 8 ]. The query was performed on February 20, 2021, and data was collected between February 20, 2021, and May 31, 2022.…”

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confidence: 99%

Characteristics of measurable residual disease assessment in myeloma: a review of clinical trials from 2015–2020

et al. 2022

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Characteristics of clinical trials for haematological malignancies from 2015 to 2020: A systematic review

Cited by 10 publications

References 33 publications

Randomised controlled trials evaluating anticancer therapies in haematological cancers: an overview of global research activity

Randomised controlled trials evaluating anticancer therapies in haematological cancers: an overview of global research activity

6ER-009 Comparative efficacy of abemaciclib and palbociclib as adjuvant treatment in patients with early breast cancer

Characteristics of measurable residual disease assessment in myeloma: a review of clinical trials from 2015–2020

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