Background: Many 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 Methods: We 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. Results: Among 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. Conclusions: More 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.
Matthew Perez, Caitlin C. Murphy, Sandi L. Pruitt, Sawsan Rashdan, Asal Rahimi, and David E. Gerber
Melissa Magrath, Edward Yang, Chul Ahn, Christian A. Mayorga, Purva Gopal, Caitlin C. Murphy, Samir Gupta, Deepak Agrawal, Ethan A. Halm, Eric K. Borton, Celette Sugg Skinner, and Amit G. Singal
Background: Surveillance colonoscopy is required in patients with polyps due to an elevated colorectal cancer (CRC) risk; however, studies suggest substantial overuse and underuse of surveillance colonoscopy. The goal of this study was to characterize guideline adherence of surveillance recommendations after implementation of an electronic medical record (EMR)–based Colonoscopy Pathology Reporting and Clinical Decision Support System (CoRS). Methods: We performed a retrospective cohort study of patients who underwent colonoscopy with polypectomy at a safety-net healthcare system before (n=1,822) and after (n=1,320) implementation of CoRS in December 2013. Recommendations were classified as guideline-adherent or nonadherent according to the US Multi-Society Task Force on CRC. We defined surveillance recommendations shorter and longer than guideline recommendations as potential overuse and underuse, respectively. We used multivariable generalized linear mixed models to identify correlates of guideline-adherent recommendations. Results: The proportion of guideline-adherent surveillance recommendations was significantly higher post-CoRS than pre-CoRS (84.6% vs 77.4%; P<.001), with fewer recommendations for potential overuse and underuse. In the post-CoRS period, CoRS was used for 89.8% of cases and, compared with cases for which it was not used, was associated with a higher proportion of guideline-adherent recommendations (87.0% vs 63.4%; RR, 1.34; 95% CI, 1.23–1.42). In multivariable analysis, surveillance recommendations were also more likely to be guideline-adherent in patients with adenomas but less likely among those with fair bowel preparation and those with family history of CRC. Of 203 nonadherent recommendations, 70.4% were considered potential overuse, 20.2% potential underuse, and 9.4% were not provided surveillance recommendations. Conclusions: An EMR-based CoRS was widely used and significantly improved guideline adherence of surveillance recommendations.