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  3. Second-Line Endocrine Therapy With or Without Palbociclib Rechallenge in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: PALMIRA Trial.

Second-Line Endocrine Therapy With or Without Palbociclib Rechallenge in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: PALMIRA Trial.

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Autores de FISABIO

Autores ajenos a FISABIO

  • Harper-Wynne C
  • Perelló A
  • Hennequin A
  • Fernández-Ortega A
  • Colleoni M
  • Quiroga V
  • Medioni J
  • Iranzo V
  • Wheatley D
  • Del Barco Berrón S
  • Antón A
  • Dobi E
  • Ruiz-Borrego M
  • Alcalá-López D
  • Pérez-Escuredo J
  • Antonarelli G
  • Sampayo-Cordero M
  • Pérez-García JM
  • Cortés J

Grupos de Investigación

Abstract

PURPOSE: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors plus endocrine therapy (ET) represents the standard first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HER2-negative) advanced breast cancer (ABC). However, there is no definitive consensus on the preferred second-line treatment option. The PALMIRA trial investigated whether palbociclib rechallenge with an alternative ET would improve the antitumor activity in patients progressing after a first-line palbociclib-containing regimen. METHODS: This international, randomized, open-label, phase II study enrolled 198 patients with hormone receptor-positive/HER2-negative ABC with disease progression after first-line palbociclib plus ET (aromatase inhibitor or fulvestrant). Patients were eligible if they showed clinical benefit to the previous regimen (response or stable disease =24 weeks) or had progressed on a palbociclib-based therapy in the adjuvant setting. Patients were randomly assigned (2:1 ratio) to either palbociclib rechallenge plus second-line ET (fulvestrant or letrozole) or second-line ET alone. Stratification factors were previous ET and visceral involvement. The primary end point was investigator-assessed progression-free survival (PFS). RESULTS: Between April 2019 and October 2022, 136 and 62 patients were randomly assigned to palbociclib plus ET or ET alone, respectively. Median investigator-assessed PFS was 4.9 months (95% CI, 3.6 to 6.1) with palbociclib plus ET versus 3.6 months (95% CI, 2.5 to 4.2) with ET alone (hazard ratio, 0.84 [95% CI, 0.66 to 1.07]; P = .149). Grade =3 treatment-emergent adverse events were higher with palbociclib plus ET (47.4% v 10.0%), without new safety signals. CONCLUSION: Palbociclib rechallenge plus an alternative ET did not significantly improve PFS compared with ET alone in patients with hormone receptor-positive/HER2-negative ABC progressing on a first-line palbociclib-based ET regimen.

Datos de la publicación

ISSN/ISSNe:
0732-183X, 1527-7755

JOURNAL OF CLINICAL ONCOLOGY  AMER SOC CLINICAL ONCOLOGY

Tipo:
Article
Páginas:
2084-2093
PubMed:
40294349

Citas Recibidas en Web of Science: 2

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