OBJECTIVES:

A large proportion of ontology clinical trials have excluded patients with brain metastases (BM). The Food and Drug Administration recommends including them to construct the efficacy and safety profile. We aimed to assess the impact of relaxing brain metastases exclusion criteria on the colon cancer trials population by (1) identifying the proportion of colon cancer patients with BM, and (2) examining whether BM patients have poorer survival.

METHODS:

We conducted a retrospective study using electronic health records (EHRs) data from the OneFlorida clinical research network. We identified patients who were diagnosed with colon cancer as the study cohort. Among them, we compared the demographic characteristics of the patients with and without BM. We built a multivariate cox proportional hazard model to estimate the hazards of BM on colon cancer survival risk.

RESULTS:

We identified 51,736 colon cancer patients from OneFlorida EHRs data. Among them, 656 (1.3%) patients had BM. The mean age at colon cancer diagnosis is significantly different between patients with and without BM, 58 years verse 64 years. There is no significant difference in the distributions of gender (51% female) or race/ethnicity (48% non-Hispanic White, 16% non-Hispanic Black, 19% Hispanic) between the patients with and without BM. After controlling for the age at colon cancer diagnosis, gender, and race/ethnicity, the hazard ratio of BM for colon cancer survival is 1.07 (p = 0.379). Age at colon cancer diagnosis is the dominant predictor, the hazard ratio is 1.41 (p < 0.001). Males had higher hazards than females, with a hazard ratio of 1.14 (p < 0.001).

CONCLUSIONS:

Although only a small portion of colon cancer patients have BM, the patients with BM were younger when they were diagnosed with colon cancer. Moreover, having BM is not the key predictor for survival. They should not be excluded for the concern of poor outcomes.