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January 10, 2019Breast Cancer Research and Treatment451 citationsOpen Access

Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up

HRHope S. RugoUniversity College DublinRFRichard S. FinnAstraZeneca (United Kingdom)VDVéronique DièrasCentre Eugène Marquis

Key Points

  • Assess the extended efficacy, safety, and quality-of-life outcomes of first-line palbociclib plus letrozole versus placebo plus letrozole in ER+/HER2- advanced breast cancer.
  • Randomized clinical trial comparing palbociclib plus letrozole against placebo plus letrozole as first-line therapy (ClinicalTrials.gov: NCT01740427).
  • Evaluated outcomes across the overall population and subgroups following approximately 15 months of extended follow-up.
  • Palbociclib plus letrozole sustained superior progression-free survival over placebo plus letrozole across the entire cohort and across all clinical subgroups, including patients with low disease burden or long disease-free intervals.
  • The combination maintained a favorable safety profile and preserved patient quality of life over the extended observation period.

Abstract

With approximately 15 months of additional follow-up, palbociclib plus letrozole continued to demonstrate improved PFS compared with placebo plus letrozole in the overall population and across all patient subgroups, while the safety profile remained favorable and quality of life was maintained. These data confirm that palbociclib-letrozole should be considered the standard of care for first-line therapy in patients with ER+/HER2- ABC, including those with low disease burden or long disease-free interval. Sponsored by Pfizer; ClinicalTrials.gov: NCT01740427.

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Cite This Study

Rugo et al. (2019) studied this question.

synapsesocial.com/papers/69d8d9b0d2f7327e70ae46b3https://doi.org/10.1007/s10549-018-05125-4
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