Breast (Dec 2022)

Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2– advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial

  • Javier Salvador Bofill,
  • Fernando Moreno Anton,
  • Cesar Augusto Rodriguez Sanchez,
  • Elena Galve Calvo,
  • Cristina Hernando Melia,
  • Eva Maria Ciruelos Gil,
  • Maria Vidal,
  • Begoña Jiménez-Rodriguez,
  • Luis De la Cruz Merino,
  • Noelia Martínez Jañez,
  • Rafael Villanueva Vazquez,
  • Ruben de Toro Salas,
  • Antonio Anton Torres,
  • Isabel Manuela Alvarez Lopez,
  • Joaquin Gavila Gregori,
  • Vanesa Quiroga Garcia,
  • Elena Vicente Rubio,
  • Juan De la Haba-Rodriguez,
  • Santiago Gonzalez-Santiago,
  • Nieves Diaz Fernandez,
  • Agusti Barnadas Molins,
  • Blanca Cantos Sanchez de Ibargüen,
  • Juan Ignacio Delgado Mingorance,
  • Meritxell Bellet Ezquerra,
  • Sonia de Casa,
  • Asuncion Gimeno,
  • Miguel Martin

Journal volume & issue
Vol. 66
pp. 77 – 84

Abstract

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Background: Breast cancer is the most common malignancy and the second leading cause of cancer-related mortality in Spanish women. Ribociclib in combination with endocrine therapy (ET) has shown superiority in prolonging survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC) vs. ET alone. Methods: CompLEEment-1 is a single-arm, open-label phase 3b trial evaluating ribociclib plus letrozole in a broad population of patients with HR+, HER2– ABC. The primary endpoints were safety and tolerability. Here we report data for Spanish patients enrolled in CompLEEment-1. Results: A total of 526 patients were evaluated (median follow-up: 26.97 months). Baseline characteristics showed a diverse population with a median age of 54 years. At study entry, 56.5% of patients had visceral metastases and 8.7% had received prior chemotherapy for advanced disease. Rates of all-grade and Grade ≥3 adverse events (AEs) were 99.0% and 76.2%, respectively; 21.3% of patients experienced a serious AE, and 15.8% of AEs led to treatment discontinuation. AEs of special interest of neutropenia, increased alanine aminotransferase, increased aspartate aminotransferase and QTcF prolongation occurred in 77.8%, 14.8%, 11.4% and 4.0% of patients, respectively. Patients aged >70 years experienced increased rates of all-grade and Grade ≥3 neutropenia and anemia. Efficacy results were consistent with the global study. Conclusions: Results from Spanish patients enrolled in CompLEEment-1 are consistent with global data showing efficacy and a manageable safety profile for ribociclib plus letrozole treatment in patients with HR+, HER2− ABC, including populations of interest (NCT02941926). Trial registration: ClinicalTrials.gov NCT02941926

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