Evidence map›Paper›PMID 27029704›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016

Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial.

N Harbeck, S Iyer, N Turner, M Cristofanilli, J Ro, F André, S Loi, S Verma, H Iwata, H Bhattacharyya and 3 more

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

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01942135 (MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT), which is not on this map. Cited by 90 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 12 pooled it
19.5field-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.

NCT01942135 phase3completednot on this map

Multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of fulvestrant (faslodex (registered)). with or without pd-0332991 (palbociclib) +/- goserelin in women with hormone receptor-positive, her2-negative metastatic breast cancer whose disease progressed after prior endocrine therapy

TypeinterventionalSponsorPfizerRan2013 to 2022Enrolled521ConditionsMetastatic Breast CancerArmsPalbociclib, Fulvestrant, Placebo
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 12 syntheses or guidelines pooled it, 174 citations in OpenAlex.

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  8. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5).Annals of oncology : official journal of the European Society for Medical Oncology · 2020
    Guideline
  9. Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2020
    Pooled it
  10. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)†.Annals of oncology : official journal of the European Society for Medical Oncology · 2018
    Guideline
  11. Pooled it
  12. 3rd ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3).Annals of oncology : official journal of the European Society for Medical Oncology · 2017
    Guideline
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30 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

13 authors at 10 institutions in 8 countries.

N HarbeckDepartment of Obstetrics and Gynecology, Brustzentrum der Universität München, München (LMU), Germany. Electronic address: nadia.harbeck@med.uni-muenchen.de.
S IyerPfizer Inc, New York, USA.
N TurnerDepartment of Molecular Oncology, Royal Marsden Hospital and Institute of Cancer Research, London, UK.
M CristofanilliDepartment of Medical Oncology, Thomas Jefferson University, Philadelphia, USA.
J RoDepartment of Medicine, National Cancer Center, Goyang-si, Korea.
F AndréDepartment of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
S LoiDepartment of Oncology, Peter MacCallum Cancer Centre, East Melbourne, Australia.
S VermaDepartment of Medicine, Sunnybrook Odette Cancer Centre, Toronto, Canada.
H IwataDepartment of Transfusion, Aichi Cancer Center Hospital, Nagoya, Japan.
H BhattacharyyaPfizer Inc, New York, USA.
K Puyana TheallPfizer Inc, Cambridge, USA.
C H BartlettPfizer Inc, New York, USA.
S LoiblDepartment of Oncology, German Breast Group Forschungs GmbH, Neu-Isenburg, Germany.
Pfizer (United States) · USAichi Cancer Center · JPGerman Breast group · DEInstitut Gustave Roussy · FRLudwig-Maximilians-Universität München · DENational Cancer Center · KRPeter MacCallum Cancer Centre · AURoyal Marsden Hospital · GBSunnybrook Health Science Centre · CAThomas Jefferson University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, HER2- endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient-reported outcomes (PROs) between the two treatment groups. PATIENTS AND

methodsPatients were randomized 2 : 1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n = 347) plus fulvestrant (500 mg i.m. per standard of care) or placebo plus fulvestrant (n = 174). PROs were assessed on day 1 of cycles 1-4 and of every other subsequent cycle starting with cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0-100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated-measures mixed-effect analyses were carried out to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model.

resultsQuestionnaire completion rates were high at baseline and during treatment (from baseline to cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group [66.1, 95% confidence interval (CI) 64.5-67.7 versus 63.0, 95% CI 60.6-65.3; P = 0.0313]. Significantly greater improvement from baseline in pain was also observed in this group (-3.3, 95% CI -5.1 to -1.5 versus 2.0, 95% CI -0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 functioning domains, breast or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone.

conclusionPalbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression. CLINICAL

trial registrationNCT01942135.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsErb-b2 Receptor Tyrosine KinasesEstradiolFemaleFulvestrantHumansMiddle AgedPatient Reported Outcome MeasuresPiperazinesPyridinesQuality of LifeErb-b2 Receptor Tyrosine KinasesEstradiolFulvestrantpalbociclibPiperazinesPyridinesReceptors, Estrogenbreast cancerendocrine resistancepalbociclibpatient-reported outcomesquality of life

Identifiers

PMID27029704
PMCPMC4880065
OpenAlexW2313479654

What OpenQuestion holds

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LicenceCC BY-NC
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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.