Expert Point of View: Rita Nanda, MD
“I expect the NATALEE trial results will change clinical practice,” stated ASCO expert Rita Nanda, MD, Director of the Breast Oncology Program at University of Chicago Medicine.
“Three different CDK4/6 inhibitors have all been shown to improve progression-free survival in the first- and second-line advanced cancer setting. Ribociclib and abemaciclib improved overall survival in metastatic breast cancer. All three of these agents have been studied in hormone receptor–positive, HER2-negative early breast cancer. The phase III PALLAS and PENELOPE-B trials of adjuvant palbociclib were negative, and the monarchE trial was positive, but that trial included only node-positive patients,” she explained. “The monarchE trial led to the approval of adjuvant abemaciclib in node-positive patients.”
Rita Nanda, MD
Dr. Nanda continued: “The NATALEE trial showed an early significant reduction in invasive disease–free survival for patients with high-risk, node-positive and node-negative, hormone receptor–positive, HER2-negative early breast cancer. We know that a substantial proportion of these patients can go on to recur, some of them with a delayed recurrence. Up to this point, no CDK4/6 agent has improved outcomes in node-negative early breast cancer.”
In the context of the NATALEE trial, ribociclib was effective and well tolerated, commented Dr. Nanda. “Ribociclib is another option for high-risk, node-positive and node-negative disease, and this will be an important contribution,” she said.
DISCLOSURE: Dr. Nanda has served as a consultant or advisor to Merck, OncoSec, Cardinal Health, Seattle Genetics, Fujifilm, ITeos Therapeutics, AstraZeneca, Gilead Sciences, Infinity Pharmaceuticals, OBI Pharma, GE Healthcare, Beyond Spring Pharmaceuticals, and Sanofi; and has received research support from Concept Therapeutics, Celgene, Merck, Seattle Genetics, Genentech/Roche, Odonate Therapeutics, Pfizer, AstraZeneca, Immunomedica, OncoSec, Arvinas, Taiho Oncology, OBI Pharma, Sun Pharma, and Relay Therapeutics.
Adjuvant Treatment With Ribociclib Reduces Risk of Recurrence in Hormone Receptor–Positive, HER2-Negative, Early-Stage Breast Cancer
The addition of the CDK4/6 inhibitor ribociclib to endocrine therapy significantly improved invasive disease–free survival in women with hormone receptor–positive, HER2-negative, early-stage breast cancer. These results of the phase III NATALEE trial were reported by lead author Dennis J. Slamon,...