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

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Below is the abstract of the article. or on the link below.

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.

Read the full article

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

Primary Source

Journal of Clinical Oncology

Source Reference:

ASCO Publications Corner

ASCO Publications Corner