The treatment represents the first new approach in 20 years for this subtype of breast cancer, said the lead author of the study, Stephen Johnston, PhD, a professor with the Royal Marsden Hospital NHS Foundation Trust in London. Hormone receptor positive (HR-positive) breast cancer is the most common type of breast cancer. Many patients with early-stage disease are cured using a range of treatments, including surgery, radiation, chemotherapy, and hormone treatment. But about 20 percent of patients have high-risk disease and suffer a recurrence in the same breast or somewhere else in the body within 10 years of the initial treatment, Dr. Johnston said. Verzenio is a drug known as a CDK4/6 inhibitor. It has shown success in treating metastatic breast cancer in recent years. The new study, a phase 3 trial (the most advanced phase before FDA approval) known as monarchE, tested whether adding the drug to hormone therapy in patients with high-risk early breast cancer lowered the risk of disease recurrence. The trial included 5,637 patients determined to be high risk for recurrence on the basis of the pathology of their tumor or other clinical factors, such as the size of the tumor and the degree of lymph node involvement. The patients were randomized to receive either Verzenio plus hormone therapy or hormone therapy alone. The study found a 25 percent reduced risk of cancer recurrence in the first two years when Verzenio was added to hormone therapy. Overall, 7.8 percent in the Verzenio plus hormone therapy group relapsed compared with 11.3 percent of patients on hormone therapy alone. “This is a really important trial with practice-changing implications,” said Giuseppe Curigliano, MD, PhD, an associate professor of medical oncology at the University of Milan, Italy, and the chair of the ESMO Guidelines Committee. Dr. Curigliano was not involved in the study. Patients should be followed beyond the two years characterized in the study to fully understand the impact of the treatment on long-term survival. “Beyond two years the data are immature at this point,” Johnston said. “Obviously, further follow-up will be important.” RELATED: Supreme Court Justice Ruth Bader Ginsberg Dead at 87
In Other News From ESMO…
Immunotherapy Plus Chemotherapy Boosts Survival in Hard-to-Treat Upper GI Cancers
A combination of chemotherapy plus immunotherapy appears to offer a greater survival benefit for patients with advanced gastroesophageal cancers compared with single treatment, aka mono-therapy, according to several highly anticipated studies released September 21 at ESMO. Chemotherapy alone results in poor overall survival, typically less than one year, said an author of the study, Markus Moehler, MD, PhD, a senior physician of gastroenterology and endosonography at the Mainz University Clinic in Mainz, Germany. The new research shows that a category of immunotherapy drugs known as PD-1 inhibitors, or checkpoint inhibitors, which have been used widely to treat other cancers, are an option for the treatment of upper gastrointestinal tract cancers, such as esophageal cancer, gastric cancer, and cancers that arise at the junction of the esophagus and stomach. One study, dubbed CheckMate649, found significantly improved overall survival using the immunotherapy drug Opdivo (nivolumab) plus chemotherapy for newly diagnosed patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma compared with chemotherapy alone. The study, of 1,581 patients, featured three treatment arms, Opdivo plus chemotherapy, Opdivo plus another checkpoint inhibitor, Yervoy (ipilimumab), or chemotherapy alone. After a minimum of 12 months of follow-up, the study showed a 32 percent reduction in the risk of disease progression or death with Opdivo plus chemotherapy compared with chemotherapy alone in patients whose tumors expressed high levels of a biomarker called PD-L1. High levels of the PD-L1 biomarker can indicate a better response to PD-1 immunotherapy drugs. The study is the largest randomized phase 3 study of a PD-1 immunotherapy in upper GI cancer patients and the first release of data from CheckMate-649. A similar study, released September 21 at ESMO, showed that the combination of the immunotherapy drug Keytruda (pembrolizumab) plus chemotherapy benefited patients with advanced esophageal cancer compared with chemotherapy alone. The phase 3 study, known as Keynote590, focused on patients who had not received previous treatment. The study randomized 749 patients to Keytruda plus chemotherapy or placebo plus chemotherapy. After a median follow-up period of 10.8 months, the combination resulted in higher rates of overall survival for patients in the combination group. The study is important because of the grim prognosis for advanced esophageal cancer, said study author Peter Enzinger, MD, the director of the Center for Esophageal and Gastric Cancer at Dana-Farber Cancer Institute in TKWHERE. “Unfortunately, for esophageal cancer, the standard of care has remained largely unchanged for a long period of time,” he said. “Pembrolizumab plus chemotherapy should be a new standard of care as a first-line therapy in patients with locally advanced unresectable [inoperable] or metastatic esophageal cancer,” said Dr. Enzinger.
