Nagi S. El-Saghir, MD, FACP, FASCO is Professor of Clinical Medicine, Head of the Division of Hematology Oncology, Department of Internal Medicine and Director of the Breast Center of Excellence, Naef K Basile Cancer Institute, American University of Beirut Medical Center, Beirut, Lebanon.

Dr El-Saghir on the Investigation of Ribociclib Plus ET in HR+, HER2– Advanced Breast Cancer 

“The RIGHT Choice trial was a study for the management of patients with hormone receptor–positive, HER2-negative advanced breast cancer with clinically aggressive disease, which we defined as rapidly progressive and severely symptomatic visceral disease.”

Nagi S. El-Saghir, MD, FACP, FASCO, a professor of clinical medicine, head of the Division of Hematology Oncology in the Department of Internal Medicine, and director of the Breast Center of Excellence at the American, Naef K Basile Cancer Institute, University of Beirut Medical Center, discussed the inception of the phase 2 RIGHT Choice trial (NCT03839823) of ribociclib (Kisqali) plus endocrine therapy vs combination chemotherapy.

RIGHT Choice enrolled patients with hormone receptor–positive, HER2-negative advanced breast cancer, El-Sahir began. Patients had clinically aggressive disease, which was defined as the presence of rapid disease progression and symptomatic visceral disease, he added. The study also included premenopausal patients, he noted.

Prior data from the final analysis of RIGHT Choice, which were published in the 

, revealed that patients who received the combination (n = 112) achieved a median progression-free survival (PFS) of 21.8 months (95% CI, 17.4-26.7) compared with 12.8 months (95% CI, 10.1-18.4) in the chemotherapy arm (n = 110; HR, 0.61; 95% CI, 0.43-0.87; 

 = .003), El-Sahir explained. Beyond PFS benefit, patients in the ribociclib arm also experienced better quality of life compared with those who received standard chemotherapy, he concluded.

Findings from a subgroup analysis of RIGHT Choice presented during the 

 revealed that patients with liver metastases in the investigational arm (n = 54) achieved a median PFS of 18.3 months (95% CI, 10.3-24.0) compared with 12.7 months (95% CI, 7.5-21.0) in the control arm (n = 53; HR, 0.68; 95% CI, 0.42-1.11). Patients without liver metastases in the investigational and control arms achieved a median PFS of 25.2 months (95% CI, 18.6-not evaluable) and 15.4 months (95% CI, 8.8-20.0), respectively (HR, 0.57; 95% CI, 0.34-0.93).

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Nagi S. El-Saghir, MD, FACP, FASCO, discusses the inception of the phase 2 RIGHT Choice trial of ribociclib plus ET.


Dr El-Saghir on the Implications of the RIGHT Choice Trial of Ribociclib Plus ET in HR+, HER2– Advanced Breast Cancer

“[Data from] this study lay to rest the idea that patients with visceral metastases [who are] endocrine responsive with ER-positive, HER2-negative disease need chemotherapy. We can give those patients endocrine therapy plus a CDK4/6 inhibitor, and in our study we used ribociclib.”

Nagi S. El-Saghir, MD, FACP, FASCO, a professor of clinical medicine, head of the Division of Hematology Oncology, Department of Internal Medicine, and director of the Breast Center of Excellence at the American, Naef K Basile Cancer Institute, University of Beirut Medical Center, discussed the clinical implications of the phase 2 RIGHT Choice trial (NCT03839823).

RIGHT Choice examined frontline treatment with ribociclib (Kisqali) in combination with endocrine therapy (ET) vs combination chemotherapy in patients with clinically aggressive hormone receptor (HR)–positive, HER2-negative advanced breast cancer. During 

, El-Saghir presented findings from a subgroup analysis which evaluated the regimen’s activity in patients with or without liver metastases.

Data from the subgroup analysis showed that patients with liver metastases in the ribociclib arm (n = 54) experienced a median progression-free survival (PFS) of 18.3 months (95% CI, 10.3-24.0) compared with 12.7 months (95% CI, 7.5-21.0) in the chemotherapy arm (n = 53; HR, 0.68; 95% CI, 0.42-1.11). Among patients without liver metastases, the median PFS in the investigational and control arms was 25.2 months (95% CI, 18.6-not evaluable) and 15.4 months (95% CI, 8.8-20.0), respectively (HR, 0.57; 95% CI, 0.34-0.93).

These data show that the approach used in RIGHT Choice is superior to combination chemotherapy in terms of efficacy, without many of the toxicities of chemotherapy, El-Saghir said. Notably, the safety profile of ET plus ribociclib, including liver-related safety signals, was similar between patients with and without liver metastases. Patient quality of life benefits vs chemotherapy were also reported in both subgroups.

These data should close the door on the notion that combination chemotherapy should be used in most patients in this population, El-Saghir added. Patients with HR-positive, HER2-negative advanced endocrine-sensitive breast cancer should be treated with ET in combination with a CDK4/6 inhibitor such as ribociclib, he concluded.

Nagi  S. El-Saghir, MD, FACP, FASCO, discusses the clinical implications of the phase 2 RIGHT Choice trial.

Saghir

“We conclude that patients with visceral disease, [including] symptomatic liver metastases, do better with the combination of ribociclib plus endocrine therapy and ovarian function suppression vs combination chemotherapy, and ribociclib plus endocrine therapy is a [treatment] option for those patients."

Nagi S. El-Saghir, MD, FACP, FASCO, a professor of clinical medicine and director of the Breast Center of Excellence at the American University of Beirut Medical Center, discussed subgroup findings from the phase 2 RIGHT Choice trial (NCT03839823), which evaluated ribociclib in combination with endocrine therapy vs combination chemotherapy in premenopausal patients with hormone receptor–positive, HER2-negative advanced breast cancer.

This subgroup analysis, which was presented at the 

, focused on patients with and without liver metastases. Among those with liver metastases, ribociclib plus endocrine therapy (n = 54) produced a median progression-free survival (PFS) of 18.3 months (95% CI, 10.3-24.0) compared with 12.7 months (95% CI, 7.5-21.0) for chemotherapy (n = 53; HR, 0.68; 95% CI, 0.42-1.11). In patients without liver metastases, those given ribociclib plus endocrine therapy (n = 58) achieved a median PFS of 25.2 months (95% CI, 18.6-not evaluable) compared with 15.4 months (95% CI, 8,8-20.0) for chemotherapy (n = 57; HR, 0.57; 95% CI, 0.34-0.93).

El-Saghir noted that these data provide important insights for the treatment of patients with aggressive disease characteristics, particularly those with symptomatic visceral metastases, who have historically been underrepresented in pivotal CDK4/6 inhibitor trials. He noted that patients receiving ribociclib plus endocrine therapy in RIGHT Choice derived not only greater clinical efficacy but also improved quality-of-life outcomes.

According to El-Saghir, these findings support the use of ribociclib plus endocrine therapy as a frontline treatment option in hormone receptor–positive, HER2-negative advanced breast cancer, including for patients with liver metastases, offering a clinically effective, less toxic alternative to chemotherapy that may enhance disease control and patient-reported outcomes in this high-risk subgroup.

Nagi S. El-Saghir, MD, FACP, FASCO, discusses ribociclib plus endocrine therapy in premenopausal HR-positive breast cancer by liver metastases status.

Nagi S. El-Saghir, MD, FACP, FASCO

Articles

Dr El-Saghir on the Investigation of Ribociclib Plus ET in HR+, HER2– Advanced Breast Cancer

Dr El-Saghir on the Implications of the RIGHT Choice Trial of Ribociclib Plus ET in HR+, HER2– Advanced Breast Cancer

Dr Saghir on Ribociclib Plus Endocrine Therapy in Premenopausal HR+/HER2-Negative Advanced Breast Cancer