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
N | Median rwPFS (months) | 95%CI | |
---|---|---|---|
All patients | 878 | 21.9 | 20.1 – 28.2 |
Age, year | |||
18-64 | 407 | 21.8 | 18.8—26.4 |
65-74 | 294 | 21.4 | 16.1—29.9 |
≥ 75 | 177 | 28.6 | 20.1—NE |
Ethnicity | |||
White | 587 | 22.6 | 20.3—28.6 |
Black | 62 | NE | 11.3—NE |
Asian | 18 | 13.8 | 7.8—NE |
Hispanic | 28 | NE | 5.9—NE |
Other/unknown | 183 | 19.9 | 16.1—NE |
Menopausal status | |||
Premenopausal (Age≤50) | 67 | 19.5 | 14.3—25.9 |
Postmenopausal (Age>50) | 811 | 22.4 | 20.2—28.7 |
Disease stage at initial diagnosis | |||
1 or 2 | 311 | 21.9 | 17.6—33.1 |
3 | 119 | 21.0 | 13.1—28.6 |
4 (De novo) | 359 | 22.2 | 19.5—32.7 |
Unknown | 89 | 26.5 | 15.5—NE |
ECOG Score | |||
0 | 322 | 22.4 | 18.9—NE |
1+ | 225 | 21.0 | 16.5—28.3 |
No bone-only disease | 623 | 17.3 | 14.6—20.2 |
Bone-only disease | 255 | NE | NE |
Visceral disease | 446 | 14.8 | 12.7—18.3 |
Nonvisceral disease | 432 | 33.1 | 28.3—NE |
No# of metastic sites | |||
1 | 352 | NE | NE |
2 | 266 | 20.2 | 17.1—33.0 |
3+ | 256 | 11.3 | 9.8—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.
Resources from the same session
3879 - Efficacy of derazantinib (DZB) in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) expressing FGFR2-fusion or FGFR2 mutations/amplifications
Presenter: Michele Droz Dit Busset
Session: Poster Display session 2
Resources:
Abstract
4679 - It’s Not Only About Weight Loss: Tackling Pancreatic Cancer-Associated Cachexia
Presenter: Ana Leonor Matos
Session: Poster Display session 2
Resources:
Abstract
2276 - Frequency and clinicopathological characteristics of biliary tract carcinomas harboring the FGFR2-fusion gene: a prospective observational study (PRELUDE study)
Presenter: Masafumi Ikeda
Session: Poster Display session 2
Resources:
Abstract
2773 - Post-hoc analyses of a subgroup of patients with advanced biliary tract cancer (BTC) who crossed over to treatment with etoposide toniribate (EDO-S7.1) in a randomized Phase II study
Presenter: Ulrich-Frank Pape
Session: Poster Display session 2
Resources:
Abstract
4479 - Capecitabine +Best supportive care (BSC) or Erlotinib +BSC has Overall survival (OS) benefit over BSC alone in unresectable/metastatic Gall bladder cancer(GBC) patients with ECOG PS-III. Results from a phase II Randomised controlled trial (RCT)
Presenter: Babita Kataria
Session: Poster Display session 2
Resources:
Abstract
4843 - FGFR2 fusions and its effect of patient (pt) outcomes in intrahepatic cholangiocarcinoma (iCCA)
Presenter: Daniel Almquist
Session: Poster Display session 2
Resources:
Abstract
2324 - The Clinical Outcomes of Systemic Chemotherapy in Patients with Unresectable or Metastatic Combined Hepatocellular-cholangiocarcinoma (HCC-CCA): Retrospective Study of 120 Patients
Presenter: Eojin Kim
Session: Poster Display session 2
Resources:
Abstract
3678 - High PD-L1 expression is associated with treatment response to pembrolizumab in patients with advanced biliary tract cancer.
Presenter: Gilhyang Kim
Session: Poster Display session 2
Resources:
Abstract
3901 - Genomic profiling in Chinese biliary tract cancer patients with PI3K/AKT/mTOR pathway and RAS gene mutations
Presenter: Jingyu Cao
Session: Poster Display session 2
Resources:
Abstract
4390 - Phase II trial of trifluridine/tipiracil (TAS-102) in patients with advanced refractory biliary tract cancer (BTC)
Presenter: Sakti Chakrabarti
Session: Poster Display session 2
Resources:
Abstract