Lynparza, a drug known as a PARP inhibitor, benefits women with BRCA gene mutations who have responded to platinum-based chemotherapy but whose disease has recurred, according to the data. Ovarian cancer is diagnosed in more than 22,000 U.S. women each year and causes about 14,000 deaths annually. Because its symptoms, such as abdominal pain and bloating, are vague it is often diagnosed in later stages and survival is low. The disease accounts for 2.5 percent of all female cancer cases, but 5 percent of cancer deaths because of the low survival rates. BRCA1 and BRAC2 gene mutations increase the risk of several types of cancer, including breast and ovarian cancer. Almost 20 percent of ovarian cancer cases are linked to genetic mutations, with the majority due to BRCA1 and BRCA2 mutations, according to the American Cancer Society. The success of Lynparza in the trial represents a rare advance in the treatment of a disease with a dismal prognosis when the cancer is advanced, said the lead author of the new study, Andres Poveda, MD, of Initia Oncology at Hospital Quironsalud in Valencia, Spain.
Lynparza: Long Term Data Shows It’s a Game Changer
The new study, a multicenter, double-blind trial dubbed SOLO2, enrolled almost 300 patients with relapsed BRCA-related ovarian cancer who responded to platinum-based chemotherapy. Researchers assigned 196 patients to receive Lynparza tablets and 99 to receive a placebo. All of the patients had previously received at least two rounds of chemotherapy. After five years of follow-up, the study showed 42.1 percent of patients who received Lynparza were alive compared with 33.2 percent of the patients who received a placebo. Median overall survival was 51.7 months in the patients taking Lynparza compared with 38.8 months in patients receiving placebo. The study is the first to provide long-term follow-up and overall survival data for Lynparza in patients with ovarian cancer, Dr. Poveda said, calling the results “unprecedented in the setting of relapsed ovarian cancer.” “With the addition of overall survival data, this study helps usher in a new era of personalized medicine for women with this difficult-to-treat cancer,” he said.
PARP Inhibitors Increasingly Important to Ovarian Cancer Treatment
PARP inhibitors are playing a growing role in the treatment of ovarian cancer. On May 8, the U.S. Food and Drug Administration (FDA) announced approval of Lynparza in combination with the drug Avastin (bevacizumab) as first-line maintenance treatment for patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD). HRD includes BRCA gene mutations as well as other genetic alterations. About one-half of all women with advanced ovarian cancer have an HRD-positive tumor. The approval followed the release of data from the PAOLA-1 trial, published in the December 19, 2019, issue of The New England Journal of Medicine, which showed the combination reduced the risk of the disease progressing or death by 67 percent. PARP inhibitors may also emerge as possible therapies for other types of cancers caused by BRCA mutations, including breast cancer, said Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president. Dr. Schilsky was not involved in the study. “I think we’re going to see fairly broad-based utility for this class of drugs certainly in patients with BRCA 1 and 2 mutations.” RELATED: Is It Ovarian Cancer or IBS?
Other News From ASCO’s Annual Meeting
Videoconferencing Helps Distant Cancer Caregivers Cope
A new study shows that telehealth visits are of enormous benefit for caregivers who live some distance from their loved ones. The study examined the impact of medical videoconferencing on 441 cancer caregivers who lived more than one hour from the patient with cancer, called “distance caregivers.” About 20 percent of cancer caregivers in the United States live more than one hour away from the patient, and almost one-third of those caregivers are the sole caregiver for their loved ones, said the lead author of the study, Sara L. Douglas, PhD, RN, the Gertrude Perkins Oliva Professor in Oncology Nursing and assistant dean for research at the Case Western Reserve University School of Nursing in Cleveland. There are scant resources to assist these distance caregivers in helping their loved ones and managing their own stress, she says. Dr. Douglas and her colleagues developed a three-part intervention aimed at supporting distant caregivers. The intervention included monthly videoconferencing coaching sessions with a nurse-practitioners or social worker, videoconference participation in the patient-physician visits, and access to a website with resources designed for distance caregivers. The study, funded by the National Institutes of Health, found reduced anxiety and distress in the group that received the intervention. The caregivers in the study were mostly female with an average age of 47. Two-thirds were the adult children of the cancer patients. “Distance caregivers experience a tremendous amount of anxiety and distress — often greater than people with cancer themselves,” Douglas said. “With COVID-19, the challenges that distance caregivers face are now the same challenges facing many local caregivers who can’t attend their loved ones’ appointments. Our video conferencing intervention shows that it’s possible to meaningfully reduce anxiety and distress for distance caregivers through fairly simple technology.” The authors note that not all hospitals or cancer centers can offer everything in the study intervention, but they said that even the addition of caregivers to the doctor-patient videoconferencing appointments can help alleviate caregiver anxiety. Oncologists value the addition of the caregivers to the patient videoconference too, Douglas said. “They were able to meet the caregiver face to face,” she said. “They were able to pick up verbal cues, and they felt it enhanced communication.” RELATED: The Telemedicine Tipping Point Is Here, and Laws Have Changed to Make It Easier to Access
Fewer Cancer Deaths in States That Participated in Medicaid Expansion
A nationwide study shows that better access to cancer care through expansion of the federal Medicaid health insurance program saves lives. The study compared cancer deaths in states that adopted Medicaid expansion following passage of the Affordable Care Act (ACA) with those that did not participate in expansion. Medicaid is the federal government’s program to provide healthcare coverage for people with disabilities or very low incomes. The program, however, is administered by individual states, who were free to choose to expand or decline expansion under the ACA. Researchers from Memorial Sloan Kettering Cancer Center in New York City analyzed data from patients under age 65 from the National Center for Health Statistics from 1999 through 1997. The ACA was passed in 2010 and many states adopted Medicaid expansion in 2014, according to the study authors. The study showed that states that expanded Medicaid saw a 29 percent decline in cancer death rates — 65.1 deaths per 100,000 people down to 46.3 deaths per 100,000 — over the 18-year period. In comparison, death rates in states that did not expand Medicaid fell by 25 percent (from 69.5 to 52.3 per 100,000). During the time of the study analysis, 27 states and the District of Columbia had adopted Medicaid expansion while 23 states had not. “This is the first study to show the benefit of Medicaid expansion on cancer death rates on a national scale,” said Anna Lee, MD, the study’s lead author and a radiation oncology fellow at Memorial Sloan Kettering Cancer Center. The study showed that some disparities in cancer deaths persist, with black patients seeing no reduction in death rates in states with Medicaid expansion. However, that could be due to rising cancer survival rates among blacks that were occurring prior to Medicaid expansion, Dr. Lee said. Cancer mortality was still significantly worse for black patients in states without Medicaid expansion. The study showed that Hispanic patients in Medicaid expansion states experienced the largest survival gains. Those gains could be due to a high number of uninsured Hispanics in those states prior to Medicaid expansion. “They had the most to gain,” Lee said.