Evidence map›Paper›PMID 42017805›Full record

Observational studyCancer medicine2026

Impact of Comorbidities on Clinical Outcomes and Quality of Life of Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer Treated With Palbociclib in the POLARIS Study.

Debu Tripathy, Joanne L Blum, Meghan S Karuturi, Steven McCune, Sobha Kurian, Mehdi M Moezi, Daniel M Anderson, Yan Ji, Timothy J Pluard, John Migas and 8 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cancer medicine, 2026. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

18 authors.

Debu TripathyDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-5711-2404
Joanne L BlumDepartment of Oncology, Baylor-Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, Texas, USA.
Meghan S KaruturiDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-8795-3901
Steven McCuneWilliam S. Gibbons Cancer Research Institute, Northwest Georgia Oncology Centers Wellstar, Marietta, Georgia, USA.
Sobha KurianHematology/Oncology, West Virginia University Cancer Institute, Morgantown, West Virginia, USA.
Mehdi M MoeziMedical Oncology, Cancer Specialists of North Florida, Fleming Island, Florida, USA.
Daniel M AndersonOncology & Hematology, Health Partners Institute, Saint Paul, Minnesota, USA.
Yan JiHealth Partners Institute, St. Paul, Minnesota, USA.
Timothy J PluardSaint Luke's Cancer Institute, Kansas City, Missouri, USA.
John MigasMid-Illinois Hematology & Oncology Associates Ltd, Normal, Illinois, USA.
Shailendra LakhanpalSaint Vincent's Birmingham, Birmingham, Alabama, USA.
Erin JepsenNovant Health, Winston-Salem, North Carolina, USA.
Yao WangOncology Medical Group, Pfizer Inc, New York, New York, USA.
Monica Z MontelongoBiostatistics and Medical Writing, ICON Commercialisation and Outcomes, ICON Plc., Blue Bell, Pennsylvania, USA.
Zhe ZhangOncology Clinical Statistics, Pfizer Inc, San Diego, California, USA.
Joseph C CappelleriStatistical Research and Data Science Center, Pfizer Inc, Groton, Connecticut, USA.
Eric GauthierGlobal Medical Affairs, Pfizer Inc, San Francisco, California, USA.
Gabrielle B RocqueDivision of Hematology/Oncology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0003-4188-9785

Funding

Pfizer Inc
6 · The paper itself

Abstract

backgroundComorbidities, common in patients with advanced breast cancer (ABC), may impact survival outcomes and health-related quality of life (HRQoL). Here, we report subgroup analyses on the basis of comorbidities of patients from POLARIS (NCT03280303), a prospective, observational study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) ABC who were treated with palbociclib plus endocrine therapy in routine clinical practice in North America.

methodsReal-world progression-free survival (rwPFS) and overall survival (OS) were evaluated by line of therapy (1 LOT, ≥ 2 LOT), Charlson Comorbidity Index (CCI) score (0, 1-2, and 3+), and common comorbid disorder categories (cardiovascular, psychiatric, metabolic and nutritional, and blood and lymphatic disorders). HRQoL was assessed using the global health status (GHS)/QoL subscale of the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.

resultsFrom January 2017 to October 2019, 1250 patients (median age, 64 years) initiated palbociclib-based therapy. Median rwPFS (95% CI) for patients with CCI scores of 0, 1-2, and 3+ were 20.3 (17.1-24.8), 24.2 (19.4-29.5), and 16.8 (11.2-20.8) months in 1 LOT and 13.7 (6.2-19.7), 13.2 (9.4-17.5), and 14.9 (8.0-21.9) months in ≥ 2 LOT, respectively. Median OS durations (95% CI) were 48.8 (37.3-not estimable [NE]), not reached (43.0-NE), and 34.8 (29.1-44.1) months in 1 LOT and 39.0 (30.6-50.5), 37.9 (26.5-42.6), and 31.6 (20.9-45.2) months in ≥ 2 LOT, respectively. Patients with blood and lymphatic disorders had shorter rwPFS and OS than those with other common comorbidities. GHS/QoL was maintained irrespective of CCI score. Patients with a CCI score of 0 had clinically meaningful and statistically significantly higher mean GHS/QoL scores than patients with a CCI score of 3+ at each assessment.

conclusionsPatients with HR+/HER2- ABC receiving palbociclib with higher comorbidity burden, especially blood and lymphatic system disorders, had poorer clinical outcomes. GHS/QoL was preserved regardless of comorbidity burden.

trial registrationClinical trial number: NCT03280303.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsPiperazinesPyridinesQuality of LifeAdultAgedComorbidityErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedProgression-Free SurvivalProspective StudiesProtein Kinase InhibitorsReceptors, EstrogenERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesProtein Kinase InhibitorsPyridinesReceptors, EstrogenReceptors, Progesteroneclinical outcomescomorbiditiespalbociclibquality‐of‐lifereal‐worldtreatment patterns

Identifiers

PMID42017805
PMCPMC13101646

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.