Jacqueline Holzbaur, 60, had already been through a lot by the end of 2016, when she switched her care to NYU Langone Health. In May of that year, she had been diagnosed with stage 4 ovarian cancer, necessitating a total hysterectomy along with the removal of her spleen and the tip of her pancreas, where the disease had spread.
Following that difficult surgery at another institution, she had endured six chemotherapy treatments during which she lost her hair and dealt with nausea, achiness, and fatigue. So when doctors told her there was no evidence of cancer remaining and that she didn’t require further treatment, Holzbaur should have been relieved. Instead, she was worried, and with good reason.
She had done research and knew the odds weren’t in her favor: there was an 85 percent probability that the cancer would return, either in the abdomen, the pelvis, or possibly another part of the body, explaining why the 5-year survival rate for late-stage disease is just 17 percent.
The tax accountant from Lawrence Township, New Jersey, wanted to be around to see her three children finish college and to travel the world with her husband, David. Yet there were no maintenance therapies for ovarian cancer available to substantially reduce the risk of recurrence.
Then, Holzbaur learned of a phase 3 clinical trial at Perlmutter Cancer Center, the final stage in evaluating the safety and effectiveness of an investigational treatment known as a PARP inhibitor. The medication, niraparib, blocks an enzyme that cancer cells use to repair damaged DNA, thereby preventing or delaying a recurrence in patients whose metastatic ovarian cancer has, like Holzbaur’s, responded to chemotherapy. Genetic testing at Perlmutter Cancer Center revealed that Holzbaur’s tumor tested positive for a biomarker called HRD, making her a strong candidate to benefit from the therapy.
After meeting with Bhavana Pothuri, MD, director of Perlmutter Cancer Center’s gynecologic oncology clinical trials, she enrolled in March 2017 and has been on the treatment ever since. The trial’s encouraging results, published in The New England Journal of Medicine, showed that niraparib reduced the risk of ovarian cancer progressing by 38 percent compared with patients on placebo, leading to its approval last year by the U.S. Food and Drug Administration.
Holzbaur will complete the therapy in March 2022, when she reaches the five-year mark. “Having access to the trial gave me hope of remaining disease-free and provided a chance to help other women with my condition,” says Holzbaur, who has vacationed in Ireland and Italy and taken up a new sport, pickleball, during her treatment.
“We get first dibs on trials, and that enables us to pick those likely to have the biggest impact. Many of these medications can extend life, and some may even cure a subset of patients, which is our ultimate goal. We are deeply invested in moving the needle in cancer care.”
—Bhavana Pothuri, MD, Director of Perlmutter Cancer Center’s Gynecologic Oncology Clinical Trials
Holzbaur’s case perfectly illustrates the objectives of Perlmutter Cancer Center’s clinical trials program for gynecologic oncology: to provide patients with access to novel therapeutics that stem deadly cancers for months or even years following surgery and chemotherapy, and to advance the most successful of these much-needed maintenance treatments toward approval.
More than 110,000 new cases of gynecologic cancer are diagnosed each year in the United States, and the diseases claim some 32,000 lives annually, according to the American Cancer Society. “Patients with cancer treated in clinical trials live longer,” says Leslie R. Boyd, MD, who was appointed director of gynecologic oncology at Perlmutter Cancer Center in early 2021 and is director of the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology at NYU Grossman School of Medicine. “The more quality trials we can open, the more women we can help.”
That philosophy has helped Perlmutter Cancer Center rise from No. 34 to No. 10 nationally for the recruitment of patients with gynecologic cancers into government and industry clinical trials during the past two years, as ranked by the GOG Foundation, a nonprofit organization dedicated to transforming the standard of care in gynecologic oncology. Three key factors have helped earn the program its No. 1 ranking among New York centers.
1. Shrewd Trial Design and Selection
Dr. Pothuri, professor in the Departments of Medicine and of Obstetrics and Gynecology at NYU Grossman School of Medicine, serves as the GOG Foundation’s associate clinical trial adviser for ovarian and endometrial cancer. In that role, she helps shape trials to ensure that they identify the patients most likely to benefit from targeted therapies, which block cancer cells from growing; immunotherapies, which stimulate the body’s immune response; and combination therapies, which involve two or more therapies working in tandem. Her collaboration not only improves the quality of trials but also provides Perlmutter Cancer Center with access to the most promising of these therapies.
“We get first dibs on trials, and that enables us to pick those likely to have the biggest impact,” says Dr. Pothuri. “Many of these medications can extend life, and some may even cure a subset of patients, which is our ultimate goal. We are deeply invested in moving the needle in cancer care.”
2. Efficient Recruitment and Implementation
Perlmutter Cancer Center has become a preferred site for clinical trials by establishing a strong track record for recruiting patients quickly and running studies efficiently. While Dr. Pothuri and Dr. Boyd, an associate professor in the Department of Obstetrics and Gynecology at NYU Grossman School of Medicine, do the lion’s share of recruiting, they rely on clinicians across the enterprise to recommend appropriate candidates.
To that end, the department holds weekly research meetings with Perlmutter Cancer Center clinicians from NYU Langone’s hospitals in Manhattan, Brooklyn, and Long Island to discuss investigational therapies. It’s a concerted effort to spread the word. “When it comes to clinical trials, a lot of patients think ‘guinea pig,’ not ‘groundbreaking research,’” says Dr. Boyd. “It’s our job to explain why the trials we open are beneficial to them.”
Those efforts have paid off. Trial enrollment has grown in recent years, as has the diversity of volunteers, with Black and Hispanic patients currently comprising about one-third of participants—more than three times the national average. “Having underrepresented minorities in these trials is important to give them access to exciting therapies and to make sure they work on all segments of the patient population,”says Dr. Pothuri.
3. Putting Patients First
Before she decided to switch her care to Perlmutter Cancer Center, Holzbaur visited another institution offering clinical trials for cancer in Manhattan. She was unimpressed. “I felt like a number there, not a patient,” she says. By contrast, she says her team at Perlmutter Cancer Center, including Dr. Pothuri, nurse practitioner Kathleen Lutz, and senior clinical research coordinator Priyanka Patel, has provided personalized care from day one. “They truly care about each of us, not just the trial,” says Holzbaur. “I’ve always felt like I’m in good hands.”
Holzbaur recalls that in the early days of the pandemic, when she was unable to schedule in-person visits, the team devised a workaround. Dr. Pothuri and Lutz, who was recently highlighted as an “Oncology Nursing Champion” by Oncology Nursing News, conducted monthly video visits. Patel arranged for the medication to be delivered to her home and to have her bloodwork done locally until she was fully vaccinated. “They made sure I didn’t miss a single dose,” says Holzbaur.
The high satisfaction rate among enrolled patients in clinical trials for gynecologic cancers has led to further expansion, both by word of mouth and among women who ultimately qualify for a second or even a third trial at Perlmutter Cancer Center. “Having a close relationship with our patients and maintaining their health means we get to take care of them for a long time,” says Dr. Boyd, “and that they can benefit from clinical trials multiple times during their treatment.”