Evidence map›Paper›PMID 30632023›Full record

Trial reportBreast cancer research and treatment2019

Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up.

H S Rugo, R S Finn, V Diéras, J Ettl, O Lipatov, A A Joy, N Harbeck, A Castrellon, S Iyer, D R Lu and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01740427 (A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991), which is not on this map. Cited by 252 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
252citing papers in PubMed, 15 pooled it
35.1field-weighted citation impact, top 1% 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.

NCT01740427 phase3completednot on this map

A randomized, multicenter, double-blind phase 3 study of pd-0332991 (oral cdk 4/6 inhibitor) plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with er (+), her2 (-) breast cancer who have not received any prior systemic anti cancer treatment for advanced disease

TypeinterventionalSponsorPfizerRan2013 to 2023Enrolled666ConditionsBreast NeoplasmsArmsPD-0332991, Letrozole, Placebo
3 · Its place in the literature

Who cites it

252 citing papers in PubMed, 15 syntheses or guidelines pooled it, 426 citations in OpenAlex.

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192 more citing papers are in PubMed but not listed here.

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

15 authors at 10 institutions in 6 countries.

H S RugoDepartment of Medicine (Hematology/Oncology), University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, 1600 Divisadero St, 2nd Floor, San Francisco, CA, 94115, USA. hope.rugo@ucsf.edu.
R S FinnDivision of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, CA, USA.
V DiérasDepartment of Medical Oncology, Institut Curie, Paris, France.
J EttlFrauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
O LipatovRepublican Clinical Oncology Dispensary, State Budget Medical Institution, Ufa, Russia.
A A JoyDepartment of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada.
N HarbeckDepartment of Obstetrics and Gynecology, Brustzentrum der Universität München (LMU), Munich, Germany.
A CastrellonBreast Cancer Center, Memorial Cancer Institute, Hollywood, FL, USA.
S IyerPatient and Health Impact, Pfizer Inc, New York, NY, USA.
D R LuClinical Statistics, Pfizer Inc, La Jolla, CA, USA.
A MoriGlobal Product Development, Clinical, Pfizer S.r.l, Milan, Italy.
E R GauthierGlobal Product Development, Clinical, Pfizer Inc, San Francisco, CA, USA.
C Huang BartlettGlobal Product Development, Clinical, Pfizer Inc, Collegeville, PA, USA.
K A GelmonDepartment of Medical Oncology, British Columbia Cancer Agency, Vancouver, BC, Canada.
D J SlamonDivision of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, CA, USA.
Pfizer (United States) · USUniversity of California, Los Angeles · USBC Cancer Agency · CACentre Eugène Marquis · FRLudwig-Maximilians-Universität München · DEPfizer (Italy) · ITRepublican Oncological Clinical Dispensary · RUTechnical University of Munich · DEUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn the initial PALOMA-2 (NCT01740427) analysis with median follow-up of 23 months, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) in women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) [hazard ratio (HR) 0.58; P < 0.001]. Herein, we report results overall and by subgroups with extended follow-up.

methodsIn this double-blind, phase 3 study, post-menopausal women with ER+/HER2- ABC who had not received prior systemic therapy for their advanced disease were randomized 2:1 to palbociclib-letrozole or placebo-letrozole. Endpoints include investigator-assessed PFS (primary), safety, and patient-reported outcomes (PROs).

resultsAfter a median follow-up of approximately 38 months, median PFS was 27.6 months for palbociclib-letrozole (n = 444) and 14.5 months for placebo-letrozole (n = 222) (HR 0.563; 1-sided P < 0.0001). All subgroups benefited from palbociclib treatment. The improvement of PFS with palbociclib-letrozole was maintained in the next 2 subsequent lines of therapy and delayed the use of chemotherapy (40.4 vs. 29.9 months for palbociclib-letrozole vs. placebo-letrozole). Safety data were consistent with the known profile. Patients' quality of life was maintained.

conclusionsWith approximately 15 months of additional follow-up, palbociclib plus letrozole continued to demonstrate improved PFS compared with placebo plus letrozole in the overall population and across all patient subgroups, while the safety profile remained favorable and quality of life was maintained. These data confirm that palbociclib-letrozole should be considered the standard of care for first-line therapy in patients with ER+/HER2- ABC, including those with low disease burden or long disease-free interval. Sponsored by Pfizer; ClinicalTrials.gov: NCT01740427.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDouble-Blind MethodErb-b2 Receptor Tyrosine KinasesFemaleHumansLetrozolePiperazinesPostmenopausePyridinesQuality of LifeReceptors, EstrogenTreatment OutcomeERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLetrozolepalbociclibPiperazinesPyridinesReceptors, EstrogenBreast cancerCyclin-dependent kinase inhibitorER+HER2−LetrozolePalbociclib

Identifiers

PMID30632023
PMCPMC6438948
OpenAlexW2908699784

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.