Evidence map›Paper›PMID 32683565›Full record

Trial reportBreast cancer research and treatment2020

Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1, TRIO-18).

Richard S Finn, Katalin Boer, Igor Bondarenko, Ravindranath Patel, Tamas Pinter, Marcus Schmidt, Yaroslav V Shparyk, Anu Thummala, Nataliia Voitko, Eustratios Bananis and 6 more

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

Trial report in Breast cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00721409 (PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991), which is not on this map. Cited by 111 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 15 pooled it
9.4field-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.

NCT00721409 phase2completednot on this map

Phase 1/2, open-label, randomized study of the safety, efficacy, and pharmacokinetics of letrozole plus pd 0332991 (oral cdk 4/6 inhibitor) and letrozole single agent for the first-line treatment of er positive, her2 negative advanced breast cancer in postmenopausal women

TypeinterventionalSponsorPfizerRan2008 to 2017Enrolled177ConditionsBreast CancerArmsPD 0332991, letrozole
3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 15 syntheses or guidelines pooled it, 169 citations in OpenAlex.

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  16. Trial
  17. Overall Survival With Palbociclib Plus Letrozole in Advanced Breast Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
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51 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

16 authors at 12 institutions in 4 countries.

Richard S FinnDavid Geffen School of Medicine, University of California Los Angeles, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA. RFinn@mednet.ucla.edu.ORCID http://orcid.org/0000-0003-2494-2126
Katalin BoerOnkologia, Szent Margit Korhaz, Budapest, Hungary.
Igor BondarenkoDnipropetrovsk State Medical Academy, Dnipropetrovsk, Ukraine.
Ravindranath PatelComprehensive Blood and Cancer Center, Bakersfield, CA, USA.
Tamas PinterPetz Aladar Megyei Oktato Korhaz, Gyor, Hungary.
Marcus SchmidtDepartment of Obstetrics and Gynecology, University Medical Center Mainz, Mainz, Germany.
Yaroslav V ShparykLviv State Oncologic Regional Treatment and Diagnostic Center, Lviv, Ukraine.
Anu ThummalaComprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.
Nataliia VoitkoKyiv City Clinical Oncology Center, Kyiv, Ukraine.
Eustratios BananisPfizer Inc, New York, NY, USA.
Lynn McRoyPfizer Inc, New York, NY, USA.
Keith WilnerPfizer Inc, San Diego, CA, USA.
Xin HuangPfizer Inc, San Diego, CA, USA.
Sindy KimPfizer Inc, San Diego, CA, USA.
Dennis J SlamonDavid Geffen School of Medicine, University of California Los Angeles, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, USA.
Johannes EttlDepartment of Obstetrics and Gynecology, Klinikum Rechts Der Isar, Technische Universität München, München, Germany.
Pfizer (United States) · USComprehensive Blood & Cancer Center · USComprehensive Cancer Centers of Nevada · USDnipro State Medical University · UAJohannes Gutenberg University Mainz · DEKyiv City Clinical Oncology Center · UALviv National Musical Academy named after Mykola Lysenko · UAPetz Aladár Megyei Oktató Kórház · HUSanta Monica College · USSzent János Kórház · HUTUM Klinikum · DEUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePalbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2- ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.319‒0.748; P = 0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor-positive (ER+)/HER2- ABC. Here, we present the final overall survival (OS) and updated safety results.

methodsPostmenopausal women with ER+/HER2- ABC were randomized 1:1 to receive either palbociclib (125 mg/day, 3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was investigator-assessed PFS; secondary endpoints included OS and safety.

resultsA total of 165 patients were randomized. At the data cutoff date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratified hazard ratio for OS was 0.897 (95% CI 0.623-1.294; P = 0.281); median OS in the palbociclib plus letrozole and letrozole alone arms was 37.5 and 34.5 months, respectively. The median time from randomization to first subsequent chemotherapy use was longer with palbociclib plus letrozole than letrozole alone (26.7 and 17.7 months, respectively). The most frequently reported adverse event in the palbociclib plus letrozole arm was neutropenia (any grade, 75%; grade 3 or 4, 59%).

conclusionsPalbociclib plus letrozole treatment led to a numerical but not statistically significant improvement in median OS. Pfizer Inc (NCT00721409).

Indexed as

PostmenopauseAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaFemaleHumansLetrozoleMiddle AgedPiperazinesPyridinesSurvival RateTreatment OutcomeERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesESR1 protein, humanEstrogen Receptor alphaLetrozolepalbociclibPiperazinesPyridinesAdvanced breast cancerER+/HER2−LetrozoleOverall survivalPalbociclib

Identifiers

PMID32683565
PMCPMC7383036
OpenAlexW3043082495

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.