South Florida cancer patients and the Sylvester Comprehensive Cancer Center participated in a clinical trial that could have wide-ranging implications for how doctors treat ovarian cancer.
The results of the study, published Saturday in the New England Journal of Medicine, concluded that an anti-cancer drug called veliparib — which works as a “parp inhibitor,” targeting the way DNA repairs itself — could help more patients than initially understood. The trial confirmed that the benefits of the drug could extend to up to 30 percent more of ovarian cancer patients.
Brian Slomovitz, the chief of gynecologic oncology at Sylvester, was the principal investigator in the two trials in Miami. He said it’s important to have cancer patients involved in clinical trials to better understand treatment.
“Once we have these clinical trials available, it’s nice to be able to demonstrate that this is ... going to affect all women with ovarian cancer,” Slomovitz said.
Patients receive the drug as “maintenance therapy” after completing chemotherapy. When successful, it can extend the period of “progression-free survival,” or time where the cancer is not progressing, for patients with newly diagnosed but already fast-growing ovarian cancer.
Patients with a “BRCA” gene mutation, which indicates an increased risk for breast cancer, account for about 20 percent of ovarian cancer tumors. Those with the mutation and who received the drug had a median time of progression-free survival of 34.7 months, compared to 22 months for those who didn’t receive the medication.
In addition to patients with the BRCA mutation, another 30 percent of the people studied had a different type of ovarian cancer tumor called a homologous recombination deficiency.
They, too, showed positive signs from taking the drug, with a progression-free survival of about 31.9 months.
Gail Silver, of West Palm Beach, was diagnosed with Stage 4 ovarian cancer in May 2017 at age 50. She underwent surgery at the Jupiter Medical Center and contacted Sloan Kettering in New York for a consult halfway through her treatment.
Silver said she received a call back from a doctor there who said that, based on her medical records, she was eligible for a clinical trial, and she wouldn’t have to leave South Florida.
Silver said she takes the anti-cancer drug every day and has not had a recurrence. She believes — based on an adverse reaction to the first doses — that she is getting the drug and not the placebo.
“On the whole, I can’t complain at all,” she said. “I have some fatigue by the end of the day, but not dramatic side effects.”
Silver said she was nervous when she first considered the trial. People asked her, she said, “What if you’re going through this and not even getting the drug?”
But Silver said she would be happy either way.
“Even if I wasn’t getting the drug, I was providing data and information to further science and health,” she said.
The trial, a Phase III randomized study, was led by researchers at the University of Texas MD Anderson Cancer Center and was conducted at 202 sites in 10 countries. The results were presented Saturday at the European Society for Medical Oncology Congress in Barcelona.