Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program.

INTRODUCTION: Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. METHODS: We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare pre-enrollment financial barriers. RESULTS: After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per month greater than expected; p < .001). A greater proportion of CCEP participants were younger, female, in phase I trials, lived farther away, had lower incomes, and had metastatic disease. Of 87 participants who completed the financial barriers survey, 49 CCEP and 38 matched, non-CCEP participants responded (63% response rate). CCEP participants were more likely to report concerns regarding finances (56% vs. 11%), medical costs (47% vs. 14%), travel (69% vs. 11%), lodging (60% vs. 9%), and insurance coverage (43% vs. 14%) related to trial participation (all p < .01). CONCLUSION: CT participation increased following implementation of the CCEP and the program enrolled patients experiencing greater financial burden. These findings highlight the need to address the financial burden associated with CT participation. IMPLICATIONS FOR PRACTICE: Financial barriers likely discourage patients from participating in clinical trials. Implementation of a cancer care equity program (CCEP) seeking to reduce financial barriers by assisting with travel and lodging costs was associated with increased trial accrual. The CCEP provided assistance to patients particularly in need, including those living farther away, those with lower incomes, and those reporting financial barriers related to trial participation. These findings suggest that financial concerns represent a major barrier to patient participation in clinical trials and underscore the importance of efforts to address these concerns.

Prevalence and predictors of androgen receptor and programmed death-ligand 1 in BRCA1-associated and sporadic triple-negative breast cancer.

BACKGROUND: Triple-negative breast cancers comprise 15% of breast cancers and are more common in women with BRCA1 mutations. Although most have basal gene expression signatures, others resemble luminal tumors with expression of androgen receptor-related genes and some express the immunoinhibitory protein programmed death-ligand 1 (PD-L1). Given the availability of androgen receptor-targeted and immune therapies for triple-negative breast cancers, determining predictors of these biomarkers is important. AIMS: To determine the prevalence and predictors of androgen receptor and PD-L1 expression in BRCA1-associated and sporadic triple-negative breast cancer. METHODS: We studied 197 triple-negative breast cancers: 78 (39.6%) from BRCA1 mutation carriers and 119 (60.4%) from noncarriers. Tumor pathology was reviewed and tissue microarray sections were immunostained for androgen receptor and PD-L1. RESULTS: Androgen receptor expression was seen in 18% of tumors and was significantly less common in tumors from BRCA1 mutation carriers than noncarriers (9.2 vs. 23.7%; P=0.01). Twenty-six percent of cancers expressed PD-L1 with no significant difference in frequency between carriers and noncarriers. Factors predicting androgen receptor expression were lower histologic grade (odds ratio (OR) 4.6; 95% confidence interval (CI) 1.1-19.7), older age at diagnosis (OR 1.3; 95% CI 1.03-1.7) and PD-L1 expression (OR 2.6; 95% CI 1.1-6.1). PD-L1 expression was significantly more common in cancers with lymphocytic infiltrates (OR, 3.3; 95% CI 1.1-10.4) and androgen receptor expression (OR, 3.2; 95% CI 1.4-7.5), and less common in tumors with lymphovascular invasion (OR 0.41; 95% CI 0.18-0.92). CONCLUSIONS: These results identify predictors for androgen receptor and PD-L1 expression among triple-negative breast cancers that may lead to better treatment selection and participation in clinical trials.

Outcome of triple negative breast cancer: comparison of sporadic and BRCA1-associated cancers.

The majority of breast cancers developing in BRCA1 mutation carriers are triple negative breast cancers (TNBC), an aggressive subtype that accounts for 15-20 % of sporadic breast cancer. We compare the clinical outcome and sites of relapse of TNBC in BRCA1 mutation carriers and non-carriers who received adjuvant chemotherapy. Women with stage I-III TNBC who had BRCA1 testing within 36 months of diagnosis and received adjuvant chemotherapy were identified from clinical databases at two academic institutions. Sites of relapse, freedom from distant metastasis (FFDM), and breast cancer-specific survival (BCSS) were determined. RCA1 carriers (n = 89) were significantly younger at diagnosis (P < 0.0001) than non-carriers (n = 175). FFDM at 5 years was 80.5 % for carriers and 76.9 % for non-carriers; with median follow-up of 55 months, hazard ratio (HR) was 0.90, P = 0.71. Sites of recurrence, including brain, did not differ significantly. BCSS at 5 years was 88.1 % for carriers and 81.4 % for non-carriers; HR 0.60; P = 0.15 at 55 months follow-up. BRCA1 carriers who underwent oophorectomy had a significantly lower rate of death from TNBC, with an adjusted HR of 0.30 (95 % CI 0.10-0.94). Adjusting for age, oophorectomy, and prophylactic mastectomy, BRCA1 mutation status was not an independent predictor of survival (HR 2.1; P = 0.13). BRCA1 mutation carriers with TNBC had similar survival rates and sites of recurrence to non-carriers after treatment with conventional chemotherapy. Carriers who underwent oophorectomy had a significantly lower rate of breast cancer-related death; this finding should be studied further in all women with TNBC.