Found 2 Presentations For Request "327P"
327P - Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis (ID 3536)
- Mylin Torres (Atlanta, United States of America)
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.
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.
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. 327P Real-world progression-free survival (rwPFS) by subgroups NE = not estimable
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
327P Real-world progression-free survival (rwPFS) by subgroups
NE = not estimable
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.
Legal entity responsible for the study
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.
1327P - Clinical factors and overall survival (OS) associated with patterns of metastases (mets) in melanoma patients (pts) (ID 4278)
- Ines Pires da Silva (Wollstonecraft, Australia)
Specific anatomical locations of melanoma mets (MM) influence OS in pts treated with anti-PD-1 based immunotherapy (IT), but little is known about anatomical distribution of mets within a patient (patterns of MM). We investigated the clinical factors and OS associated with the patterns of MM.
Demographics, disease characteristics and patient outcomes were examined from MM pts. Univariate and multivariable (MVA) logistic regression was used to identify factors associated with patterns of MM. Cox proportional hazards method for OS analysis.
6031 MM pts were studied; median age of 61yo, 66% male, 32% elevated LDH, 74% stage IV M1c/d. 17% had systemic treatment; IT (61%), targeted therapy (32%) and chemotherapy (7%) 1st line. Median FU was 57.5 months (mos) and the median OS (mOS) was 9.4 mos (untreated: 7.5 mos; treated: 39.4 mos). In MVA performed on untreated pts, elevated LDH (HR 1.5) and presence of brain (HR 1.5), liver (HR 1.8) and bone (HR 1.5) mets were associated with shorter OS; while gastrointestinal (GI) mets (HR 0.8) were associated with longer OS. Similar results were found for treated pts; but male pts had shorter OS (HR 1.3) and GI mets did not affect OS. Within all pts, mOS for pts with vs without brain mets was 8 vs 10 mos (p < 0.01), respectively; and mOS for pts with vs without liver mets was 7 vs 11 mos (p < 0.01), respectively. In untreated pts, brain mets were associated with adrenal mets, but not liver, GI, bone or subcutaneous (subcut); while in treated pts brain mets were associated with adrenal and subcut mets. Liver mets occurred frequently with bone, adrenal and spleen mets, and less frequently with brain, GI and subcut mets in untreated pts; while they were associated with bone and spleen mets in treated pts. Untreated pts with brain, liver or bone mets had longer mOS in the presence of GI mets (7 vs 11; 6 vs 8; 7 vs 11mos, respectively), while GI mets did not affect OS in treated pts. Treated pts with liver mets have shorter OS (22 mos) if bone (18 mos), adrenal (14 mos) or spleen (18 mos) mets are present, but this was not seen in untreated pts.
Both treated and untreated pts have distinct patterns of MM and survival. These data may help defining prognosis and provides insight to further studies on the biology of mets.
Legal entity responsible for the study
Melanoma Institute Australia.
Has not received any funding.
M.S. Carlino: Advisory / Consultancy: MSD; Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: Amgen; Advisory / Consultancy: Pierre Fabre. A.M. Menzies: Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: Roche; Advisory / Consultancy: Pierre Fabre. G.V. Long: Advisory / Consultancy: Amgen; Advisory / Consultancy: Mass-Array; Advisory / Consultancy: BMS; Advisory / Consultancy: Merck MSD; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Roche; Advisory / Consultancy: Aduro. All other authors have declared no conflicts of interest.