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Poster Display session 2

3536 - Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Breast Cancer

Presenters

Mylin Torres

Citation

Annals of Oncology (2019) 30 (suppl_5): v104-v142. 10.1093/annonc/mdz242

Authors

M. Torres1, X. Liu2, J. Mardekian3, L. McRoy4

Author affiliations

  • 1 Department Of Radiation Oncology, Winship Cancer Institute, Emory University School of Medicine, 30322 - Atlanta/US
  • 2 Us Medical Affairs, Pfizer Inc, 07977 - Peapack/US
  • 3 Statistics, Pfizer Inc, 10017 - New York/US
  • 4 Global Medical Affairs, Pfizer Inc, 10017 - New York/US

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Abstract 3536

Background

CDK4/6 inhibitor in combination with an aromatase inhibitor (AI) as initial endocrine therapy has become standard of care for patients with HR+/HER2– advanced/metastatic breast cancer (mBC). Large representative studies are needed to understand effectiveness of CDK4/6 inhibitor + AI in the real-world clinical setting. This study describes patient characteristics and real-world progression-free survival (rwPFS) in mBC patients treated with Palbociclib + AI in the first line setting.

Methods

The Flatiron longitudinal database contains information from 2 million cancer patients treated in the US from 275 cancer clinics. From this database, 878 HR+/HER2– mBC women treated with Palbociclib + AI as first-line therapy between February 2015 and August 2018 with at least 3 months of follow-up available were identified. Patients were followed from start of Palbociclib + AI therapy to November 2018, death, or last visit, whichever came first. rwPFS was defined as months from start of Palbociclib + AI to death or disease progression based on clinical assessment or radiographic progression with or without biopsy confirmation. Kaplan-Meier methods were used to estimate survival proportions in rwPFS.

Results

In our cohort of 878 eligible patients with a median follow-up of 19.4 months, 66.9% were white, mean age was 65.2 years, 50.8% had visceral disease (liver and/or lung involvement). Among these patients, 92.7% received Letrozole along with Palbociclib. Median rwPFS was 21.9 months (95%CI = 20.1 – 28.2). Table presents median rwPFS by subgroups.Table:

327P Real-world progression-free survival (rwPFS) by subgroups

NMedian rwPFS (months)95%CI
All patients87821.920.1 – 28.2
Age, year
 18-6440721.818.8—26.4
 65-7429421.416.1—29.9
 ≥ 7517728.620.1—NE
Ethnicity
 White58722.620.3—28.6
 Black62NE11.3—NE
 Asian1813.87.8—NE
 Hispanic28NE5.9—NE
 Other/unknown18319.916.1—NE
Menopausal status
 Premenopausal (Age≤50)6719.514.3—25.9
 Postmenopausal (Age>50)81122.420.2—28.7
Disease stage at initial diagnosis
 1 or 231121.917.6—33.1
 311921.013.1—28.6
 4 (De novo)35922.219.5—32.7
 Unknown8926.515.5—NE
ECOG Score
 032222.418.9—NE
 1+22521.016.5—28.3
No bone-only disease62317.314.6—20.2
Bone-only disease255NENE
Visceral disease44614.812.7—18.3
Nonvisceral disease43233.128.3—NE
No# of metastic sites
 1352NENE
 226620.217.1—33.0
 3+25611.39.8—13.7

NE = not estimable

Conclusions

These findings from a large cohort of patients in US routine clinical practices support first-line Palbociclib + AI therapy as standard of care for HR+/HER2- advanced/metastatic breast cancer.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Pfizer Inc.

Funding

Pfizer Inc.

Disclosure

M. Torres: Full / Part-time employment: Emory University; Research grant / Funding (self): Pfizer Inc. X. Liu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. J. Mardekian: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. L. McRoy: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc.

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