ArticleJournal of the National Comprehensive Cancer Network : JNCCN2022
Potential Impact of Revised NCI Eligibility Criteria Guidance: Prior Malignancy Exclusion in Breast Cancer Clinical Trials.
Article in Journal of the National Comprehensive Cancer Network : JNCCN, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Prior Cancer among Men Diagnosed with Breast Cancer is Associated with Worse Overall Survival but Equivalent Breast Cancer-Specific Survival.Journal of Cancer · 2026Article
- AI Survival Prediction Modeling: The Importance of Considering Treatments and Changes in Health Status over Time.Cancers · 2024Article
- Temporal Association Rule Mining: Race-Based Patterns of Treatment-Adverse Events in Breast Cancer Patients Using SEER-Medicare Dataset.Biomedicines · 2024Article
- Racial Disparities in Breast Cancer Treatments and Adverse Events in the SEER-Medicare Data.Cancers · 2023Article
- A Historical Misconception in Clinical Trials of Drugs for Cancer-Age Grouping.Journal of personalized medicine · 2022Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundMany individuals with cancer have survived a prior cancer and for this reason may have been excluded from clinical trials. Recent NCI guidance recommends including these individuals, especially when the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low. Using breast cancer as an example, we determined the potential effect this policy change may have on clinical trial accrual. PATIENTS AND
methodsWe reviewed protocols of NCI-sponsored breast cancer clinical trials activated in 1991 through 2016. We quantified prevalence of prior cancer-related exclusion criteria and assessed the association with trial characteristics using Fisher's exact tests. Using SEER data, we estimated the prevalence and timing of prior primary (nonbreast) cancer diagnoses among patients with breast cancer.
resultsAmong 87 clinical trials (total target enrollment, 137,253 patients), 77% excluded individuals with prior cancer, most commonly (79%) within the preceding 5 years. Among trials with radiographic response or toxicity endpoints, 69% excluded prior cancer. In SEER data, the prevalence of a prior (nonbreast) cancer diagnosis ranged from 5.7% to 7.7%, depending on breast cancer stage, of which 39% occurred within 5 years of the incident breast cancer. For trials excluding prior cancer, the estimated proportion of patients excluded for this reason ranged from 1.3% to 5.8%, with the estimated number of excluded patients ranging from 1 to 288.
conclusionsMore than three-fourths of NCI-sponsored breast cancer clinical trials exclude patients with prior cancer, including almost 70% of trials with response or toxicity endpoints. Given that >5% of patients with breast cancer have a history of prior cancer, in large phase III trials this practice may exclude hundreds of patients. Following recent NCI eligibility guidance, the inclusion of patients with prior cancer on breast cancer trials may have a meaningful impact on accrual.
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