Evidence map›Paper›PMID 37903899›Full record

ArticleBreast cancer research and treatment2024

Outcomes of male patients with HR+/HER2- advanced breast cancer receiving palbociclib in the real-world POLARIS study.

Joanne L Blum, Caroline DiCristo, David Gordon, Meghan S Karuturi, David Oubre, Erin Jepsen, Juan Cuevas, Shailendra Lakhanpal, Monica Z Montelongo, Zhe Zhang and 3 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03280303 (POLARIS), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03280303 completednot on this map

Polaris: palbociclib in hormone receptor positive advanced breast cancer: a prospective multicenter non-interventional study

TypeobservationalSponsorPfizerRan2017 to 2022Enrolled1,285ConditionsAdvanced Breast Cancer, Metastatic Breast CancerArmsnon-interventional
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 12 citations in OpenAlex.

  1. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Joanne L BlumBaylor-Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, TX, USA. jlblum@att.net.ORCID http://orcid.org/0000-0002-7951-6645
Caroline DiCristoPfizer Inc, New York, NY, USA.
David GordonMunson Medical Center, Traverse City, MI, USA.
Meghan S KaruturiThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
David OubrePonchartrain Cancer Center, Hammond, LA, USA.
Erin JepsenNovant Health Cancer Institute, Winston-Salem, NC, USA.
Juan CuevasSt. Louis Cancer Care, St. Louis, MO, USA.
Shailendra LakhanpalSaint Vincent's Birmingham, Birmingham, AL, USA.
Monica Z MontelongoICON plc, Blue Bell, PA, USA.
Zhe ZhangPfizer Inc, La Jolla, CA, USA.
Joseph C CappelleriPfizer Inc, Groton, CT, USA.
Yao WangPfizer Inc, New York, NY, USA.
Debu TripathyThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Pfizer (United States) · USThe University of Texas MD Anderson Cancer Center · USMunson Medical Center · USNovant Health · USSt. Vincent's Birmingham · USTexas Oncology · USVA St. Louis Health Care System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeData on treatments for male breast cancer patients are limited owing to rarity and underrepresentation in clinical trials. The real-world POLARIS study gathers data on palbociclib use for the treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) in female and male patients. This sub-analysis describes real-world palbociclib treatment patterns, clinical outcomes, and quality of life (QoL) in male patients.

methodsPOLARIS is a prospective, noninterventional, multicenter, real-world study of patients with HR+/HER2- ABC receiving palbociclib. Assessments included medical record reviews, patient QoL questionnaires (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30), site characteristics questionnaires, and physician treatment selection surveys. Variables included demographics, disease history, global health status/QoL, clinical assessments and adverse events. Analyses were descriptive in nature. For clinical outcomes, real-world tumor responses and progression were determined by physician assessment in routine clinical practice. Real-world progression-free survival (rwPFS) was described using the Kaplan-Meier method.

resultsAt data cutoff, 15 male patients were enrolled (median age, 66 years). Nine patients received palbociclib as a first-line treatment and 6 as a second-line or later treatment. Patients received a median of 20 cycles of palbociclib. Neutropenia was experienced by 2 patients and grade ≥ 3 adverse events were reported in 11 patients. Global health status/QoL scores remained generally consistent during the study. One patient (6.7%) achieved a complete tumor response, 4 (26.7%) a partial response, and 8 (53.3%) stable disease. Median rwPFS was 19.8 months (95% CI, 7.4-38.0). Median follow-up duration was 24.7 months (95% CI, 20.0-35.7).

conclusionThis real-world analysis showed that palbociclib was well tolerated and provides preliminary data on treatment patterns and outcomes with palbociclib in male patients with HR+/HER2- ABC, helping inform the use of palbociclib in this patient subgroup. TRIAL IDENTIFIER: NCT03280303.

Indexed as

Breast NeoplasmsPiperazinesPyridinesAgedAntineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesHumansMaleProspective StudiesQuality of LifeErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesPyridinesAdvanced breast cancerCDK4/6 inhibitorHormone receptor–positive/human epidermal growth factor receptor 2–negativeMalePalbociclibReal-world

Identifiers

PMID37903899
PMCPMC10805882
OpenAlexW4388033794

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.