Generalisability of Common Oncology Clinical Trial Eligibility Criteria in the Real World

Karim, Safiya; Xu, Yuan; Kong, Shiying; Abdel‐Rahman, Omar; Quan, May Lynn; Cheung, Winson Y.

doi:10.1016/j.clon.2019.05.003

Cited by 41 publications

(43 citation statements)

References 22 publications

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“…However, we hypothesized that others may have been denied treatment because of perceived concerns that their cardiovascular comorbidity may place them at heightened risk of toxicities or because of the absence of data from clinical trials regarding the safety of chemotherapy administration in patients with heart disease (30). (31). It has been reported that heart disease represents the second most common cause of ineligibility for clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Impact of Pre-Existing Cardiovascular Disease on Treatment Patterns and Survival Outcomes in Patients With Lung Cancer

Batra¹,

Sheka

Kong

et al. 2020

Preprint

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Background: Baseline cardiovascular disease can impact the patterns of treatment and hence the outcomes of patients with lung cancer. This study aimed to characterize treatment trends and survival outcomes of patients with pre-existing cardiovascular disease prior to their diagnosis of lung cancer.Methods: We conducted a retrospective, population-based cohort study of patients with lung cancer diagnosed from 2004 to 2015in a large Canadian province. Multivariable logistic regression and Cox regression models were constructed to determine the associations between cardiovascular disease and treatment patterns, and its impact on overall and cancer-specific survival, respectively.Results: A total of 20,689 patients with lung cancer were eligible for the current analysis. Men comprised 55%, and the median age at diagnosis was 70 years. One-third had at least one cardiovascular disease, with the most common being congestive heart failure in 15% of patients. Pre-existing cardiovascular disease was associated with a lower likelihood of receiving chemotherapy (odds ratio [OR],0.53;95% confidence interval [CI],0.48-0.58;P < .0001), radiotherapy (OR,0.76;95% CI,0.7-0.82;P < .0001), and surgery (OR, 056; 95% CI,0.44-0.7;P < .0001). Adjusting for measured confounders, the presence of pre-existing cardiovascular disease predicted for inferior OS (hazard ratio [HR], 1.1; 95% CI, 1.1-1.2; P < .0001) and CSS (HR,1.1; 95% CI, 1.1-1.1; P < .0001). Conclusions: Patients with lung cancer and pre-existing cardiovascular disease are less likely to receive any modality of cancer treatment and have poor OS and CSS. As effective therapies such as immuno-oncology drugs are introduced, early cardio-oncology consultation may optimize management and outcomes of lung cancer.

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Section: Discussionmentioning

confidence: 99%

Impact of Pre-Existing Cardiovascular Disease on Treatment Patterns and Survival Outcomes in Patients With Lung Cancer

Batra¹,

Sheka

Kong

et al. 2020

Preprint

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“…However, the inclusion and exclusion criteria employed to enrol patients in clinical trials have increasingly been criticized for being overly strict. This practice leads to poor generalizability of results to the real-world cancer population [ [4] , [5] , [6] ] [ [4] , [5] , [6] ] [ [4] , [5] , [6] ].…”

Section: Introductionmentioning

confidence: 99%

“…Previous studies using different study approaches have demonstrated that as many as 80% of real-world patients may be ineligible to participate in clinical trials [ [6] , [7] , [8] , [9] , [10] ] [ [6] , [7] , [8] , [9] , [10] ] [ [6] , [7] , [8] , [9] , [10] ]. The common reasons cited for ineligibility include advanced age and the presence of specific comorbid conditions such as cardiovascular disease, hepatic dysfunction, and chronic kidney failure [ 6 , 8 ]. This contrasts the demographics of real-world patients with cancer who tend to be older and who are more likely to have comorbid conditions than their younger counterparts [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

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Eligibility of real-world patients with metastatic breast cancer for clinical trials

2020

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Introduction The results of clinical trials in metastatic breast cancer (MBC) are generalized to real-world patients. This study determines the proportion of real-world patients who would be eligible for clinical trials and compares outcomes in eligible versus ineligible patients. Methods Patients diagnosed with MBC from 2004 to 2015 in a large Canadian province were included. Patients with one of the following criteria were considered ineligible: the presence of comorbid conditions (anemia, uncontrolled diabetes, heart disease, liver disease, and kidney disease) or a history of immunosuppression or prior malignancy. The likelihood of receiving cancer therapy was analysed using logistic regression models and factors affecting overall survival (OS) were assessed by Cox proportional hazards models. Results A total of 1585 patients with MBC were identified. The median age at diagnosis was 63 years. Of these, 512 (32.3%) patients were deemed ineligible in whom the two most common reasons for ineligibility were renal dysfunction (17.2%), and previous immunosuppression (7.8%). In the real world, ineligible patients were less likely to receive chemotherapy (29.5% vs 45.8%; P < 0.001) but not radiation treatment (7.6% vs 9.6%; P = 0.196) or hormonal therapy (57.6% vs 60.6%; P = 0.261). The 5-year OS of ineligible patients who received systemic therapy in the real-world was significantly better than those who did not. Conclusions Despite being ineligible for clinical trials based on common eligibility criteria, many real-world patients receive systemic treatment and derive possible benefit. Broadening of inclusion criteria in clinical trials will enhance the representation of real-world patients and increase the generalizability of results.

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“…Evaluation of patient screening in the Alberta Cancer Registry between 2004 and 2015 showed that 38% of 125,316 patients with 11 common malignancies were trial ineligible. The most common reasons for ineligibility were advanced age and heart disease 4 . An additional evaluation of early stage trials with 231 dose‐escalation phase I protocols over 25 years (1991–2016) performed at the Institute for Drug Development, Cancer Therapy and Research Center showed a median number of 23 exclusion criteria for a protocol with narrowly defined population vs. 14 exclusion criteria for a less restrictive protocol.…”

mentioning

confidence: 99%

Broadening Eligibility Criteria for Oncology Clinical Trials: Current Advances and Future Directions

Rahman

Ison

Beaver

2020

Clin Pharma and Therapeutics

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Generalisability of Common Oncology Clinical Trial Eligibility Criteria in the Real World

Cited by 41 publications

References 22 publications

Impact of Pre-Existing Cardiovascular Disease on Treatment Patterns and Survival Outcomes in Patients With Lung Cancer

Impact of Pre-Existing Cardiovascular Disease on Treatment Patterns and Survival Outcomes in Patients With Lung Cancer

Eligibility of real-world patients with metastatic breast cancer for clinical trials

Broadening Eligibility Criteria for Oncology Clinical Trials: Current Advances and Future Directions

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