Column: Cancer trials can benefit minorities, rural areas

7/29/2019, By Sharad Ghamande, M.D. Guest Columnist, Augusta Chronicle

The word “cancer” brings a range of emotions with it. It can be scary, creating a sense of sadness in cancer patients, as well as their families. A diagnosis will test a person’s will to fight through the treatment for a life worth living. While new discoveries are being made daily in cancer research, it does take time to make significant breakthroughs that lead to new treatment options for patient care that could offer a patient more time with their family and friends, while maintaining a good quality of life.

While discoveries start in a basic science lab, clinical trials involving human patients are where the differences are made. Clinical trials offer patients not only the standard of care chemotherapy, but also the possibility of being on a treatment that could be more beneficial in the future. This, in turn, can help improve a patient’s overall survival and provide new treatment opportunities for patients in the future.

Oncologists examine all factors before placing a patient on a clinical trial, allowing the person the opportunity to be part of the research that could have a profound impact on future cancer patients. Over the past two decades, there has been a major push to ensure that as we affect “quantity of life” that we also maintain quality of life.

The discussion a doctor must have with a patient when deciding to be part of a clinical trial must clearly lay out all options, including what the future will hold if the patient decides not to join the trial. Because of these concerns and oversights, the informed consent forms a patient must sign contain a long list of checks and balances - more so than we’ve seen at any time in the history of medical research.

Research shows only one of 20 cancer patients enroll in clinical trials. Of those patients, fewer than 5% are minorities. There are research studies that show enrollments in clinical trials can produce treatment advances at a faster rate and improvements in cancer population outcomes. This is one of the reasons that promoting clinical trials is important.

Specifically, ovarian cancer accounted for 22,440 cases in 2017 and for 14,080 deaths in the U.S. Most patients present at stage three or greater and have a five-year survival of 35%. While there have been significant advances in the surgical and chemo-based treatments for ovarian cancer, the survival rates have improved only slightly. Therefore, there is a pressing need for innovative treatments that can help the grave outlook for patients with advanced or recurrent ovarian cancer.

In a study performed at the Georgia Cancer Center and the Medical College of Georgia at Augusta University, Dr. Khilen Patel and colleagues analyzed the effect of clinical trial participation on overcoming health disparities - such as race and distance to a cancer center with a gynecological oncologist.

Current research shows that Caucasians who received standard of care treatment for advanced epithelial ovarian cancer have a greater overall survival than minorities, specifically African-Americans. Dr. Patel’s study found that being part of a clinical trial could improve the survival rates of minority cancer patients with advanced epithelial ovarian fallopian tube and peritoneal cancer.

In fact, Dr. Patel’s findings showed the survival rates were comparable to Caucasian patients who also were placed on clinical trials. These survival rates differ significantly from that of Caucasian and minority patients not participating in clinical trials. For those enrolled in clinical trials, Caucasian patients had an average survival of 53 months compared to 50 months for minority patients.

Patel’s research also looked at how far patients had to travel to a cancer center. The findings showed white patients who lived closer to the institution had a higher survival rate than those living in rural communities in Georgia.

Another clinical trial at the Georgia Cancer Center brought a basic science bench research to a patient’s bedside by combining two immunotherapy treatments. One enables a person’s T-cells to better find and attack a tumor. The second produces another immune response that augments it and allows more patients to benefit from this synergy. By giving them to a patient at the same time, researchers hope to see better responses in patients with certain solid tumors.

The trial started in Dr. Esteban Celis’ lab with his finding that poly-IC, which behaves like the genetic material of viruses to also get the attention of the immune system, can improve the effectiveness of therapeutic cancer vaccines synergistically.

The first phase of the trial involved studying the safety of combining the two drugs in a dozen patients with solid tumors, such as lung or liver cancer, who did not respond to standard therapy. Now, the study is in the second phase of recruiting patients with nonresponsive, metastatic colon cancer who normally would not respond to conventional immunotherapy with checkpoint inhibitors.

Today, clinical trials are threatened not only by lack of access, which is getting worse as they are getting expensive for institutions to run and subsidize in today’s economy, but also are affected by funding cuts at the National Cancer Institute.

When doctors discuss clinical trials with patients, it’s important to explain the difference in the types. For example, a phase three trial comparing a new therapy or drug already went through two previous phases and showed promise to offer benefits to patients. This same benefit may not happen for patients enrolling in a phase one trial.

Finally, a new concept in cancer care: Even if we do not cure all cancer patients, we can get them to live much longer, often with a decent quality of life. In essence, cancer can become a chronic disease requiring long-term therapy similar to patients with bad kidney disease who get dialysis three to four times a week.

However, without clinical trials, we may not have the opportunity to find new treatments that could extend a person’s life and give them more quality time with their family and friends.

The writer is associate director for clinical research at the Georgia Cancer Center, at Augusta University.

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