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Final Results of RIGHT Choice: Ribociclib Plus Endocrine Therapy Versus Combination Chemotherapy in Premenopausal Women With Clinically Aggressive Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer

Lu YS 1 , Mahidin EIBM 2 , Azim H 3 , Eralp Y 4 , Yap YS 5 , Im SA 6 Show all authors , Rihani J 7 , Gokmen E 8 , El Bastawisy A 9 , Karadurmus N 10 , Lim YN 11 , Lim CS 12 , Duc LT 13 , Chung WP 14 , Babu KG 15 , Penkov K 16 , Bowles J 17 , Alfaro TD 17 , Wu J 18 , Gao M 17 , Slimane K 17 , El Saghir NS 19

Affiliations 

  • 1 National Taiwan University Hospital, Taipei, Taiwan
  • 2 Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
  • 3 School of Medicine, Cairo University, Cairo, Egypt
  • 4 Acıbadem Research Institute of Senology, Acıbadem University, Istanbul, Turkey
  • 5 National Cancer Centre Singapore, Singapore
  • 6 Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea
  • 7 Independent Patient Advocate, Amman, Jordan
  • 8 Ege University Faculty of Medicine, Izmir, Turkey
  • 9 National Cancer Institute, Cairo University, Giza, Egypt
  • 10 Gülhane Education and Research Hospital, University of Health Sciences, Ankara, Turkey
  • 11 Sarawak General Hospital, Kuching, Sarawak, Malaysia
  • 12 Hospital Sultan Ismail, Johor Bharu, Johor Darul Ta'zim, Malaysia
  • 13 National Cancer Hospital, Hanoi, Vietnam
  • 14 National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
  • 15 HCG Curie Centre of Oncology and Kidwai Memorial Institute of Oncology, Bangalore, India
  • 16 Private Medical Institution Euromedservice, St Petersburg, Russian Federation
  • 17 Novartis Pharma AG, Basel, Switzerland
  • 18 Novartis Pharmaceuticals Corporation, East Hanover, NJ
  • 19 American University of Beirut Medical Center, Beirut, Lebanon
J Clin Oncol, 2024 Aug 10;42(23):2812-2821.
PMID: 38771995 DOI: 10.1200/JCO.24.00144

Abstract

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 (47.7%) patients 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 to 26.7]) and 12.8 months (combination CT; [95% CI, 10.1 to 18.4); hazard ratio, 0.61 [95% CI, 0.43 to 0.87]; P = .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 to 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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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