![]() Overall, 74.7% of participants remained on treatment at the data cutoff, with 1984 patients on ribociclib and 1826 patients on hormonal therapy alone.This therapeutic option would support patients whose cancer has not spread to the lymph nodes.The addition of ribociclib created survival improvement for a broad population of people with HR+/HER2- EBC.Adding ribociclib reduced the risk for recurrence by 25%. 3-year iDFS rates were 90.4% in the ribociclib group compared with 87.1% in the hormonal therapy alone group.Pairing ribociclib with hormonal therapy created significant improvement in survival. Data being presented at ASCO show 189 people in the ribociclib group (7.4% of patients) had a cancer recurrence, compared with 237 people in the hormonal therapy alone group (9.2% of patients). The prespecified analysis evaluated data once there were 426 iDFS events. After a median follow-up of 34 months, 20.2% of those in the ribociclib group completed 3 years of therapy and 56.8% completed 2 years of treatment. Patients received either adjuvant ribociclib with hormonal therapy (2549 patients) or hormonal therapy alone (2552 patients). The trial randomized 5101 men and premenopausal and postmenopausal women with breast cancer who were at risk of recurrence. The study treated patients for 3 years instead of 2 years.In an effort to improve safety, the dose was reduced from the usual 600 mg to 400 mg, based on findings from other trials with metastatic breast cancer patients that showed when doses were reduced due to tolerability, efficacy was not lost.The trial included patients with earlier stage disease, who Slamon said are “normally considered lower risk than the high-risk population.”.In a press briefing, Slamon listed the ways the trial broke new ground: Slamon, MD, PhD, medical oncologist at UCLA Health. “NATALEE is different from some other early breast cancer studies with CKD4/6 in 3 important ways,” said lead investigator Dennis J. The primary end point, invasive disease-free survival (iDFS), measures whether a patient’s cancer has returned. NATALEE enrolled patients with stage II and stage III HR+/HER2- early breast cancer (EBC), regardless of nodal involvement. Interim findings from the NATALEE trial (NCT03701334) could have widespread impact, as HR+/HER- breast cancer accounts for 70% of all new breast cancer cases, according to National Institutes of Health data. Adding the CDK4/6 inhibitor ribociclib (Kisqali, Novartis) to hormonal therapy made cancer 25% less likely to return for those patients with hormone receptor (HR) positive, HER2-negative early-stage breast cancer (EBC), according to results to be presented today at the 2023 Annual Meeting of the American Society of Clinical Oncology.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |