Abstract 5825
Background
This study describes real-world use and population characteristics in HR+/HER2- advanced breast cancer (ABC) patients receiving palbociclib (PAL) in routine practice.
Methods
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.
Results
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 (%) | |
| <40 | 12 (3.8) |
| 40-50 | 40 (12.8) |
| 51-69 | 156 (50.0) |
| 70-74 | 41 (13.1) |
| 75-84 | 51 (16.3) |
| ≥85 | 12 (3.8) |
| Sex, n (%) | |
| Women | 308 (98.7) |
| Men | 4 (1.3) |
| Race, n (%) | |
| White | 256 (82.1) |
| Black or African American | 46 (14.7) |
| Other | 7 (2.2) |
| Not reported | 3 (1.0) |
| Hispanic/Latino ethnicity, n (%) | 31 (9.9) |
| Insurance provider, n (%) | |
| Private insurance | 152 (48.7) |
| Medicare | 133 (42.6) |
| Medicaid | 14 (4.5) |
| Uninsured | 5 (1.6) |
| Pre/perimenopausal, n (%) | 40 (12.8) |
| Distribution of disease-free interval, mo,* n (%) | |
| <12 | 97 (31.6) |
| 12-<24 | 11 (3.6) |
| 24-<36 | 25 (8.1) |
| ≥36 | 174 (56.7) |
| 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.
Conclusions
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
NCT03280303.
Legal entity responsible for the study
Pfizer Inc.
Funding
Pfizer Inc.
Editorial Acknowledgement
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.
Disclosure
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.