Final Results of RIGHT Choice: Ribociclib+Endocrine Tx vs Combination Chemotherapy in Premenopausal Women With Aggressive HR+/HER2鈥� Breast Cancer

鈥� An ASCO Reading Room selection

October 8, 2024

Yen-Shen Lu, MD, PhD, Eznal Izwadi Bin Mohd Mahidin, MD, Hamdy Azim, MD, Yesim Eralp, MD, Yoon Sim Yap, MD, PhD, Seock-Ah Im, MD, PhD, Julie Rihani, Erhan Gokmen, MD, PhD, Ahmed El Bastawisy, MD, Nuri Karadurmus, MD, Yueh Ni Lim, MD, Chun Sen Lim, MD, Le Thanh Duc, MD, Wei-Pang Chung, MD, K. Govind Babu, MD, Konstantin Penkov, MD, James Bowles, BMedSci, Teresa Delgar Alfaro, PharmD, MSc, Jiwen Wu, PhD, Melissa Gao, MD, PhD, Khemaies Slimane, MD, and Nagi S. El Saghir, MD

Journal of Clinical Oncology

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Purpose

A head-to-head comparison of efficacy between a cyclin-dependent kinase 4/6 inhibitor plus endocrine therapy (ET) versus combination chemotherapy (CT) has never been reported in patients with clinically aggressive hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer (ABC).

Methods

In this open-label, multicenter, randomized phase II trial, pre/perimenopausal women with clinically aggressive HR+/HER2– ABC were randomly assigned 1:1 to first-line ribociclib (600 mg once daily; 3 weeks on, 1 week off) plus letrozole/anastrozole and goserelin or investigator's choice of combination CT (docetaxel plus capecitabine, paclitaxel plus gemcitabine, or capecitabine plus vinorelbine). The primary end point was progression-free survival (PFS).

Results

Among 222 patients randomly assigned to ribociclib plus ET (n = 112) or combination CT (n = 110), 150 (67.6%) had symptomatic visceral metastases, 41 (18.5%) had rapid disease progression per investigator's judgment, and 31 (14.0%) had symptomatic nonvisceral disease. Overall, 106 patients (47.7%) had investigator-assessed visceral crisis. The median follow-up time was 37.0 months. At data cutoff, 31.3% (ribociclib arm) and 15.5% (CT arm) of patients had completed study treatment and transitioned to post-trial access. The median PFS was 21.8 months (ribociclib plus ET; [95% CI 17.4-26.7]) and 12.8 months (combination CT; [95% CI 10.1-18.4); hazard ratio 0.61 [95% CI 0.43-0.87]; P=0.003. The overall response rates and the median time to response in the ribociclib versus CT arms, respectively, were 66.1% and 61.8% and 4.9 months and 3.2 months (hazard ratio 0.76 [95% CI 0.55-1.06]). Lower rates of symptomatic adverse events were observed in the ribociclib versus CT arm.

Conclusion

First-line ribociclib plus ET showed a significant PFS benefit, similar response rates, and better tolerability over combination CT in patients with clinically aggressive HR+/HER2– ABC.

Read an interview about the study here.

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Final Results of RIGHT Choice: Ribociclib+Endocrine Tx vs Combination Chemotherapy in Premenopausal Women With Aggressive HR+/HER2鈥� Breast Cancer

Primary Source

Journal of Clinical Oncology

Source Reference:

番茄社区