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Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.

Real-world effectiveness of palbociclib in combination with an aromatase inhibitor as first-line therapy in metastatic breast cancer.

Sub-category:
Hormone Receptor-Positive

Category:
Breast Cancer—Metastatic

Meeting:
2019 ASCO Annual Meeting

Abstract No:
e12541

Citation:
J Clin Oncol 37, 2019 (suppl; abstr e12541)

Author(s): Xianchen Liu, Jack Mardekian, Lynn McRoy; Pfizer Inc, New York, NY

Abstract Disclosures

Abstract:

Background: Palbociclib in combination with an aromatase inhibitor (AI) was approved as initial endocrine therapy for patients with HR+/HER2– metastatic/advanced breast cancer (mBC) in February 2015. Evidence of real world outcomes for the combination to date has been limited by small sample size and short follow-up. This study describes patient characteristics and effectiveness of palbociclib + AI as first-line therapy in a large cohort of mBC patients in US clinical practice. Methods: Utilizing Flatiron Health’s longitudinal database, a retrospective cohort study was conducted to evaluate patients with HR+/HER2– mBC who started palbociclib + AI as first-line therapy between February 3, 2015 and August, 31, 2018. Patients were evaluated retrospectively from start of palbociclib + AI therapy on or after February 3, 2015 to November 30, 2018, death, or last visit in the database, whichever came first. Real-world progression free survival (rwPFS) was defined as months from start of palbociclib + AI therapy to death or disease progression based on clinical assessment or evidence by radiographic scan/tissue biopsy. Kaplan-Meier methods were used to estimate survival proportions in overall survival (OS) and rwPFS. Results: Of 878 who met the criteria, 66.9% were white, mean age was 65.2 years, 50.8% had visceral disease (liver and/or lung involvement), and 94% were treated in community practice. Patients were followed up to 46 months. Median rwPFS was 21.9 months (95% CI = 20.1 – 28.2). At 3 years of follow-up, OS rate was 91.9%. For additional outcomes, see Table. Conclusions: These findings from the largest cohort yet evaluated for real world effectiveness confirm the effectiveness of palbociclib + AI in routine clinical practice as a standard of care for first line treatment of HR+/HER2- mBC.

Variable%
Number of metastatic sites ≥ 329.2
Bone only29.0
rwPFS rate at 6 months82.5
rwPFS rate at 12 months69.1
rwPFS rate at 18 months57.7
rwPFS rate at 24 months48.2
OS rate at 12 months95.4
OS rate at 24 months91.9
OS rate at 36 months91.9

 
Other Abstracts in this Sub-Category:

 

1. Randomized phase II study of eribulin mesylate (E) with or without pembrolizumab (P) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 1004 First Author: Sara M. Tolaney
Category: Breast Cancer—Metastatic - Hormone Receptor-Positive

 

2. Capivasertib (AZD5363) plus fulvestrant versus placebo plus fulvestrant after relapse or progression on an aromatase inhibitor in metastatic ER-positive breast cancer (FAKTION): A randomized, double-blind, placebo-controlled, phase II trial.

Meeting: 2019 ASCO Annual Meeting Abstract No: 1005 First Author: Robert Hugh Jones
Category: Breast Cancer—Metastatic - Hormone Receptor-Positive

 

3. A randomized phase II study of palbociclib plus exemestane with GNRH agonist versus capecitabine in premenopausal women with hormone receptor-positive metastatic breast cancer (KCSG-BR 15-10, NCT02592746).

Meeting: 2019 ASCO Annual Meeting Abstract No: 1007 First Author: Yeon Hee Park
Category: Breast Cancer—Metastatic - Hormone Receptor-Positive

 

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