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Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: MAINTAIN Trial.
Kalinsky, Kevin; Accordino, Melissa K; Chiuzan, Codruta; Mundi, Prabhjot S; Sakach, Elizabeth; Sathe, Claire; Ahn, Heejoon; Trivedi, Meghna S; Novik, Yelena; Tiersten, Amy; Raptis, George; Baer, Lea N; Oh, Sun Y; Zelnak, Amelia B; Wisinski, Kari B; Andreopoulou, Eleni; Gradishar, William J; Stringer-Reasor, Erica; Reid, Sonya A; O'Dea, Anne; O'Regan, Ruth; Crew, Katherine D; Hershman, Dawn L.
Afiliação
  • Kalinsky K; Winship Cancer Institute, Emory University, Atlanta, GA.
  • Accordino MK; Columbia University Irving Medical Center, New York, NY.
  • Chiuzan C; Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health, New York, NY.
  • Mundi PS; Columbia University Irving Medical Center, New York, NY.
  • Sakach E; Winship Cancer Institute, Emory University, Atlanta, GA.
  • Sathe C; Columbia University Irving Medical Center, New York, NY.
  • Ahn H; Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health, New York, NY.
  • Trivedi MS; Columbia University Irving Medical Center, New York, NY.
  • Novik Y; New York University Perlmutter Cancer Center, NYU Langone Health, New York, NY.
  • Tiersten A; Icahn School of Medicine at Mount Sinai, New York, NY.
  • Raptis G; Zucker School of Medicine-Northwell Cancer Institute, Lake Success NY.
  • Baer LN; State University of New York at Stony Brook, Stony Brook, NY.
  • Oh SY; Montefiore Medical Center, Bronx, NY.
  • Zelnak AB; Northside Hospital, Atlanta, GA.
  • Wisinski KB; University of Wisconsin Carbone Cancer Center, Madison, WI.
  • Andreopoulou E; Weill Cornell Medicine, New York, NY.
  • Gradishar WJ; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL.
  • Stringer-Reasor E; University of Alabama, Birmingham, Birmingham, AL.
  • Reid SA; Vanderbilt University Medical Center, Nashville, TN.
  • O'Dea A; University of Kansas Medical Center, Westwood, KS.
  • O'Regan R; University of Rochester Medical Center, Rochester, NY.
  • Crew KD; Columbia University Irving Medical Center, New York, NY.
  • Hershman DL; Columbia University Irving Medical Center, New York, NY.
J Clin Oncol ; 41(24): 4004-4013, 2023 08 20.
Article em En | MEDLINE | ID: mdl-37207300
PURPOSE: Cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with endocrine therapy (ET) improves progression-free survival (PFS) and overall survival (OS) in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Although preclinical and clinical data demonstrate a benefit in changing ET and continuing a CDK4/6i at progression, no randomized prospective trials have evaluated this approach. METHODS: In this investigator-initiated, phase II, double-blind placebo-controlled trial in patients with HR+/HER2- MBC whose cancer progressed during ET and CDK4/6i, participants switched ET (fulvestrant or exemestane) from ET used pre-random assignment and randomly assigned 1:1 to the CDK4/6i ribociclib versus placebo. PFS was the primary end point, defined as time from random assignment to disease progression or death. Assuming a median PFS of 3.8 months with placebo, we had 80% power to detect a hazard ratio (HR) of 0.58 (corresponding to a median PFS of at least 6.5 months with ribociclib) with 120 patients randomly assigned using a one-sided log-rank test and significance level set at 2.5%. RESULTS: Of the 119 randomly assigned participants, 103 (86.5%) previously received palbociclib and 14 participants received ribociclib (11.7%). There was a statistically significant PFS improvement for patients randomly assigned to switched ET plus ribociclib (median, 5.29 months; 95% CI, 3.02 to 8.12 months) versus switched ET plus placebo (median, 2.76 months; 95% CI, 2.66 to 3.25 months) HR, 0.57 (95% CI, 0.39 to 0.85); P = .006. At 6 and 12 months, the PFS rate was 41.2% and 24.6% with ribociclib, respectively, compared with 23.9% and 7.4% with placebo. CONCLUSION: In this randomized trial, there was a significant PFS benefit for patients with HR+/HER2- MBC who switched ET and received ribociclib compared with placebo after previous CDK4/6i and different ET.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Limite: Female / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Limite: Female / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article