CDK 4/6 Inhibitors in Metastatic Breast Cancer

  • Hormone receptor–positive, HER2 negative:
    • Is the most common breast cancer subtype
  • Endocrine therapy (used alone or in combination):
    • Has been a longstanding standard of care for hormone receptor–positive breast cancer:
      • In both the early and advanced stages
  • In more recent years, endocrine therapy combined with a CDK4/6 inhibitor:
    • Has become the first-line standard of care for most women with hormone receptor–positive, HER2 negative metastatic breast cancer (MBC)
  • Use of first-line endocrine therapy plus a CDK4/6 inhibitor is based on positive results from several clinical trials:
    • The hazard ratios for progression-free survival (PFS) were very similar in these trials
  • Recently, statistically significant improvements in overall survival were reported in multiple phase 3 studies of ribociclib plus endocrine therapy:
    • For example, the secondary end point of overall survival (OS) was met in the MONALEESA-2 study of ribociclib plus an aromatase inhibitor
    • Of note, at the second interim analysis of data from the phase 3 MONARCH-3 clinical trial of abemaciclib plus endocrine therapy, OS data remained immature (HR, 0.754; 95% CI, 0.584-0.974; P = 0.03)
    • The addition of palbociclib to letrozole in the PALOMA-2 study of did not yield a statistically significant benefit in terms of OS (HR, 0.956; 95% CI, 0.777–1.177):
      • PALOMA-2 study investigators noted that final OS data were missing for 13% in the experimental arm vs 21% in the control arm
#Arrangoiz #BreastSurgeon #CancerSurgeon #SurgicalOncologist #MountSinaiMedicalCenter #MSCM #Miami #Mexico #BreastCancer

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