This study describes real-world use and population characteristics in HR+/HER2- advanced breast cancer (ABC) patients receiving palbociclib (PAL) in routine practice.
This prospective, noninterventional study has a targeted enrollment of 1500 men and women from ∼110 sites. Site and patient data, monitored remotely for clarity/completeness, are collected from medical charts, physician surveys, and patient-reported outcomes; optional blood samples are collected during standard-of-care lab draws.
This is an interim report of the first 312 patients with completed baseline case report forms as of 9Mar18 from 66 US sites (data snapshot: 9Apr18). Most sites were community sites (79%) with 1-10 treating physicians (61%). Of 33 sites that use clinical pathways, 45% were based on NCCN and 42% on US Oncology guidelines. Selected patient characteristics are shown (Table). Before starting PAL at enrollment, 18% of patients received chemotherapy, 21% hormonal therapy, 11% radiotherapy, 4% surgical resection, and 66% had no prior ABC therapy. Overall, 72% of patients received PAL combination first-line, of whom 56% received PAL+letrozole or anastrozole, 41% PAL+fulvestrant, and 4% PAL+exemestane. Of patients receiving ≥second-line PAL, 46% received prior hormonal monotherapy, 43% prior chemotherapy alone, and 6% both.Table: 344P
Selected patient demographic and clinical characteristics
|All Patients (N = 312)|
|Age at study enrollment, y|
|Median (range)||63 (29-92)|
|Distribution, n (%)|
|Sex, n (%)|
|Race, n (%)|
|Black or African American||46 (14.7)|
|Not reported||3 (1.0)|
|Hispanic/Latino ethnicity, n (%)||31 (9.9)|
|Insurance provider, n (%)|
|Private insurance||152 (48.7)|
|Pre/perimenopausal, n (%)||40 (12.8)|
|Distribution of disease-free interval, mo,* n (%)|
|Number of present comorbidities by system organ class, median (minimum-maximum)||4 (0-27)|
|Musculoskeletal and connective tissue disorders, n (%)||245 (78.5)|
|Gastrointestinal disorders, n (%)||225 (72.1)|
|Metabolism and nutrition disorders, n (%)||190 (60.9)|
|Cardiac disorders, n (%)||49 (15.7)|
Disease-free interval was defined as the time from first diagnosis of breast cancer to onset of advanced/metastatic disease among patients with available initial breast cancer diagnosis dates and available date of first ABC diagnosis.
This is the first large, prospective multicenter study assessing real-world use of a CDK4/6 inhibitor. In the first 312-patient cohort, most were treated at community sites. A heterogeneous real-world population received PAL, including elderly, premenopausal, African-American, Latino/Hispanic, and male patients not commonly represented in clinical trials. Hormone partners received with PAL included steroidal and nonsteroidal aromatase inhibitors or fulvestrant, predominantly first-line.
Clinical trial identification
Legal entity responsible for the study
Editorial support was provided by Anny Wu, PharmD, of Complete Healthcare Communications, LLC (West Chester, PA), a CHC Group company, and funded by Pfizer Inc.
J.L. Blum: Steering committee: Pfizer Inc. M.A. Salkeni: Contracted research funding as study PI via author’s institution: West Virginia University. J.J. Migas, J. Wang: Contracted research: Pfizer Inc. A. Bardia: Advisory board: Novartis, Pfizer Inc, Spectrum Pharma. G. Rocque: Steering committee: Pfizer Inc; Contracted research: Genentech, Carevive, Pack Health, Medscape. J.C. Cappelleri, G. Comstock, Y. Wang: Employee and stockholder: Pfizer Inc. D. Tripathy: Steering committee: Novartis, Pfizer Inc; Contracted research: Novartis, Pfizer Inc. All other authors have declared no conflicts of interest.