Clinical Trials Can Reduce Disparities in Advanced Ovarian Cancer, but Funding Is Needed, Researchers Say

Survival rates in ovarian cancer may differ between racial groups, or among patients who must travel different distances to an oncologist. Taking part in a clinical trial can erase those disparities, according to research presented Saturday at the Society of Gynecologic Oncology’s 2018 Annual Meeting on Women’s Cancer, taking place in New Orleans, Louisiana.

The study was among a group of abstracts presented in the opening scientific plenary session, which featured data on the effect of the Affordable Care Act (ACA) on access to gynecological care, as well as the crisis of a rapid drop in research dollars to study gynecology cancers, despite their deadly toll.

Khilen Patel, MD, of the Medical College of Georgia (MCG), lead author of the retrospective study, presented results from 236 patients who had been treated at the Georgia Cancer Center at Augusta University between 2004 and 2017 for epithelial ovarian, fallopian tube, and peritoneal cancer, at stage III or stage IV. White patients were more likely to live closer to the treatment center and have their cancer caught early. In addition, when 2 otherwise similar patients did not take part in a trial, the white patient lived longer. But being in trial could all but close that gap, Patel said.

Patel said the study demonstrates much more than the need to enroll more minorities in clinical trials—it shows that a project called The Lydia House, which was started by the cancer center’s own gynecologists, has saved lives by putting clinical trials within reach. During his presentation, Patel showed a photo of the building, which allows each patient being treated to stay with a family member for free and have access to a kitchen to prepare meals.

“Our family members love it,” he said in an interview with The American Journal of Managed Care^®. Giving patients a place to stay not only alleviates financial pressure, but has also created a culture that supports and empowers patients. “They often feel they are a burden to their family, and this relieves that burden,” Patel said.

Study Data

Of the 236 patients in the MCG study, 145 had taken part in a clinical trial, while 91 had not. Researchers compared patients’ overall survival (OS) by race and by distance to institution. They found that white patients were more likely to be diagnosed at stage III (82.6% vs 74.1%), and they were more likely to live near MCG; 60.7% of whites lived less than 25 miles from the treatment center compared with 50% of minority patients. Minority patients were more likely to live more than 50 miles away (19.1% for white patients vs 29.3% for minority patients).

When researchers controlled for age and distance from the institution among patients who did not take part in a trial, they found a “near significant trend,” in which being white made a difference in OS (hazard ratio [HR]= 0.398, 95% CI 0.216-0.732, P = 0.0591). White patients’ OS was an average of 71.4 months, while minority patients’ OS was 24.5 months. But the gap closed among patients taking part in trials, (HR = 0.841, 95% CI 0.505—1.401, P = 0.6269). For those in trials, white patients’ average OS was 53.5 months, while minorities’ average OS was 50.9.

Patel said that in contrast with the 6% national average participation rate for minorities, the minority participation rate in clinical trials at Georgia Cancer Center is 25%.

Clinical Trial Crisis

Patel’s hopeful tone was offset by the dire data from Ryan Spencer, MD, of the University of Wisconsin School of Medicine and Public Health, who described a “crisis” in clinical trials for gynecological cancers—a 90% reduction in enrollment and a 68% reduction in available trials, which can both be traced to being low on the priority list at the National Cancer Institute (NCI). At the same time, mortality for uterine cancer is increasing, Spencer said, and “Things may be worse for certain of our patients.”

Spencer led a group that developed a scoring mechanism to show how NCI’s funding for gynecological cancers makes no sense, given how lethal these cancers are. The group studied funding across 13 cancers over an 8-year period ending in 2014. Using NCI’s Surveillance, Epidemiology and End Results (SEER), Cancer Trends Progress Report and Funding Statistics, the researchers developed a score of funding per years of life lost from 100 cases of uterine, ovarian, and cervical cancer, and compared the results with 10 common cancers or those that uniquely affect men.

“Of the 13 cancers studied, uterine cancer ranks next to last in annual NCI funding,” they wrote, and all 3 gynecological cancers were among the lowest in NCI funding. From 2007 to 2014, the final year brought decreases in funding, “from peak levels of 18.5% for ovarian cancer and 18.8% for uterine cancer compared to only a 9.9% decrease for breast, 7.1% for testicular, 6.3% for leukemias, and 5.7% for kidney/renal pelvis, and a 67% increase for pancreatic cancer.” Funding to lethality scores, with ranks in parentheses, include:

• Prostate, 1.81 (first)
• Breast, 1.80 (second)
• Ovarian 0.097 (ninth)
• Cervix 0.087 (10th)
• Uterine 0.057 (12th)

Lack of funding translates into fewer advances, Spencer said. Gynecological cancers risk lagging others in basic research that focuses on genetics and molecular targets, as well as prevention, survival, and targeted therapies that advance to clinical trials.

Effects of the Affordable Care Act

Friday marked 8 years since passage of the ACA, and 2 abstracts took stock of how it has affected insurance availability, especially for the poorest patients. Edward J. Pavlik, PhD, presented research from the University of Kentucky that examined premium pricing for Qualified Health Plans in various markets in Kentucky—a state considered a poster child for expansion of coverage—over time. While the results found significant increases in premium over time, especially for the bronze plans in rural markets (70%) between 2014 and 2017, the study also found large drops in the uninsured rate. Despite this, Qualified Health Plan enrollment is up 42.6%.

A presentation by Haley Moss, MD, MBA, of Duke University, used SEER data from 2011 to 2014 to show how the implementation of the ACA has reduced racial and socioeconomic disparities among women diagnosed with a gynecologic malignancy. Not having insurance, she said, means a patient is less like to have treatment based on clinical guidelines and more likely to experience financial toxicity, reducing mortality. However, the decision of some state to not expand Medicaid amounts to missed opportunities for many blacks, who live disproportionately in states that did not expand Medicaid.

According to the abstract, among cervical cancer patients, “there was a reduction in uninsured rates among those living in high poverty ZIP codes in [expansion states]. There was significant reduction in uninsured rates among black patients with ovarian cancer (9.2% to 0.5%).” Significant differences in lack of insurance among uterine cancer patients were not seen.