Dataset Information

Eligibility Criteria and Endpoints in Metastatic Renal Cell Carcinoma Trials.

ABSTRACT:

Objectives

Treatments for metastatic renal cell carcinoma (mRCC) are often compared across trials, but trial eligibility criteria and endpoints differ. In an effort to better align trials, the Definition for the Assessment of Time to event Endpoints in CANcer trials (DATECAN) project published recommendations in 2015 to be used in mRCC clinical trial design. We analyzed mRCC trial criteria to determine if DATECAN's recommendations were followed.

Materials and methods

We compared eligibility criteria across 29 phase 3 mRCC trials conducted between 2003 and 2019. We then evaluated endpoints used in 10 phase 3 trials activated between 2015 and 2019 to determine their compliance with DATECAN's recommendations.

Results

Among the 29 trials, performance status, renal function, and disease characteristics differed in terms of requirements and measures used. In terms of endpoints, the 10 trials did not entirely follow DATECAN's recommendations. In total, 7/10 trials' primary endpoint was progression-free survival (PFS) as recommended; 4/9 trials used PFS as an endpoint but did not publish their definition of PFS, and the 5 that did, included "death from any cause" instead of DATECAN's recommendation of "death from kidney cancer."

Conclusions

Key eligibility criteria were somewhat inconsistent across the phase 3 mRCC trials studied. Endpoints in the newer trials did not align with DATECAN's recommendations. Not only is greater standardization needed to facilitate meta-analyses and cross-trial comparisons, but as evident from lack of adherence to DATECAN's recommendations, greater promotion and adoption of recommendations are needed to better harmonize trial design.

SUBMITTER: Wong SE

PROVIDER: S-EPMC7515769 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

Eligibility Criteria and Endpoints in Metastatic Renal Cell Carcinoma Trials.

Wong Sarah E SE Quinn David I DI Bjarnason Georg A GA North Scott A SA Sridhar Srikala S SS

American journal of clinical oncology 20200801 8

<h4>Objectives</h4>Treatments for metastatic renal cell carcinoma (mRCC) are often compared across trials, but trial eligibility criteria and endpoints differ. In an effort to better align trials, the Definition for the Assessment of Time to event Endpoints in CANcer trials (DATECAN) project published recommendations in 2015 to be used in mRCC clinical trial design. We analyzed mRCC trial criteria to determine if DATECAN's recommendations were followed.<h4>Materials and methods</h4>We compared e ...[more]

PMID: 32398404

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Project description:OBJECTIVE:To use the patient outcome endpoints overall survival and progression-free survival to evaluate functional parameters derived from dynamic contrast-enhanced CT. METHODS:69 patients with metastatic renal cell carcinoma had dynamic contrast-enhanced CT scans at baseline and after 5 and 10 weeks of treatment. Blood volume, blood flow and standardized perfusion values were calculated using deconvolution (BVdeconv, BFdeconv and SPVdeconv), blood flow and standardized perfusion values using maximum slope (BFmax and SPVmax) and blood volume and permeability surface area product using the Patlak model (BVpatlak and PS). Histogram data for each were extracted and associated to patient outcomes. Correlations and agreements were also assessed. RESULTS:The strongest associations were observed between patient outcome and medians and modes for BVdeconv, BVpatlak and BFdeconv at baseline and during the early ontreatment period (p < 0.05 for all). For the relative changes in median and mode between baseline and weeks 5 and 10, PS seemed to have opposite associations dependent on treatment. Interobserver correlations were excellent (r ≥ 0.9, p < 0.001) with good agreement for BFdeconv, BFmax, SPVdeconv and SPVmax and moderate to good (0.5 < r < 0.7, p < 0.001) for BVdeconv and BVpatlak. Medians had a better reproducibility than modes. CONCLUSION:Patient outcome was used to identify the best functional imaging parameters in patients with metastatic renal cell carcinoma. Taking patient outcome and reproducibility into account, BVdeconv, BVpatlak and BFdeconv provide the most clinically meaningful information, whereas PS seems to be treatment dependent. Standardization of acquisition protocols and post-processing software is necessary for future clinical utilization. Advances in knowledge: Taking patient outcome and reproducibility into account, BVdeconv, BVpatlak and BFdeconv provide the most clinically meaningful information. PS seems to be treatment dependent.

Project description:BackgroundBreast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status.MethodsData on clinical trials in BC were extracted from ClinicalTrials.gov. Co-primary outcomes were proportions of trials with different types of the eligibility criteria. Associations between trial characteristics and the presence of certain types of these criteria (binary variable) were determined with univariate and multivariate logistic regression.ResultsOur analysis included 522 trials of systemic anticancer treatments started between 2020 and 2022. Upper age limits, strict exclusion criteria pertaining to comorbidities, and those referring to inadequate performance status of the patient were used in 204 (39%), 404 (77%), and 360 (69%) trials, respectively. Overall, 493 trials (94%) had at least one of these criteria. The odds of the presence of each type of the exclusion criteria were significantly associated with investigational site location and trial phase. We also showed that the odds of the upper age limits and the exclusion criteria involving the performance status were significantly higher in the cohort of recent trials compared with cohort of 309 trials started between 2010 and 2012 (39% vs 19% and 69% vs 46%, respectively; p < 0.001 for univariate and multivariate analysis in both comparisons). The proportion of trials with strict exclusion criteria was comparable between the two cohorts (p > 0.05). Only three of recent trials (1%) enrolled solely patients aged 65 or 70 and older.ConclusionsMany recent clinical trials in BC exclude large groups of patients, especially older adults, individuals with different comorbidities, and those with poor performance status. Careful modification of some of the eligibility criteria in these trials should be considered to allow investigators to assess the benefits and harms of investigational treatments in participants with characteristics typically encountered in clinical practice.

Dataset Information

Eligibility Criteria and Endpoints in Metastatic Renal Cell Carcinoma Trials.

Objectives

Materials and methods

Results

Conclusions

Publications

Eligibility Criteria and Endpoints in Metastatic Renal Cell Carcinoma Trials.

Similar Datasets

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