Evidence map›Paper›PMID 24504445›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2014

A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer: results of the OMEGA study of the Dutch Breast Cancer Research Group BOOG.

C H Smorenburg, S M de Groot, A E van Leeuwen-Stok, M E Hamaker, A N Wymenga, H de Graaf, F E de Jongh, J J Braun, M Los, E Maartense and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 8 pooled it
4.0field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 8 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
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  9. Pegylated liposomal doxorubicin (DuomeisuBreast cancer research and treatment · 2023
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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 13 institutions in 2 countries.

C H SmorenburgDepartment of Internal Medicine, Medical Center Alkmaar, Alkmaar. Electronic address: c.smorenburg@nki.nl.
S M de GrootComprehensive Cancer Center the Netherlands, Amsterdam.
A E van Leeuwen-StokBOOG Study Center, Dutch Breast Cancer Research Group BOOG, Amsterdam.
M E HamakerDepartment of Geriatric Medicine, Diakonessenhuis, Utrecht.
A N WymengaDepartment of Internal Medicine, Medisch Spectrum Twente, Enschede.
H de GraafDepartment of Internal Medicine, Medical Center Leeuwarden, Leeuwarden.
F E de JonghDepartment of Internal Medicine, Ikazia Hospital, Rotterdam.
J J BraunDepartment of Internal Medicine, Vlietland Hospital, Schiedam.
M LosDepartment of Internal Medicine, St. Antonius Hospital, Nieuwegein.
E MaartenseDepartment of Internal Medicine, Reinier de Graaf Hospital, Delft.
H van TinterenBiometrics Department, Netherlands Cancer Institute, Amsterdam.
J W R NortierDepartment of Medical Oncology, Leiden University Medical Center, Leiden.
C SeynaeveDepartment of Medical Oncology, Erasmus Medical Center-Daniel den Hoed Cancer Center, Rotterdam, The Netherlands.
Breast Cancer Research Foundation · USDiakonessenhuis hospital · NLDutch Cancer Society · NLErasmus MC Cancer Institute · NLFranciscus Vlietland · NLIkazia Ziekenhuis · NLLeiden University Medical Center · NLMedisch Centrum Alkmaar · NLMedisch Centrum Leeuwarden · NLMedisch Spectrum Twente · NLNetherlands Comprehensive Cancer Organisation · NLReinier de Graaf Hospital · NLSt. Antonius Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProspective data on chemotherapy for elderly patients with metastatic breast cancer (MBC) remain scarce. We compared the efficacy and safety of first-line chemotherapy with pegylated liposomal doxorubicin (PLD) versus capecitabine in MBC patients aged ≥65 years in a multicentre, phase III trial. PATIENTS AND

methodsPatients were randomized to six cycles of PLD (45 mg/m(2) every 4 weeks) or eight cycles of capecitabine (1000 mg/m(2) twice daily, day 1-14 every 3 weeks).

resultsThe study enrolled 78 of the planned 154 patients and was closed prematurely due to slow accrual and supply problems of PLD. Many included patients were aged ≥75 years (54%) and vulnerable (≥1 geriatric condition: 71%). The median dose intensity was 85% for PLD and 84% for capecitabine, respectively. In both arms, the majority of patients completed at least 12 weeks of treatment (PLD 73%; capecitabine 74%). After a median follow-up of 39 months, 77 patients had progressed and 62 patients had died of MBC. Median progression-free survival was 5.6 versus 7.7 months (P = 0.11) for PLD and capecitabine, respectively. Median overall survival was 13.8 months for PLD and 16.8 months for capecitabine (P = 0.59). Both treatments were feasible, grade 3 toxicities consisting of fatigue (both arms: 13%), hand-foot syndrome (PLD: 10%; capecitabine: 16%), stomatitis (PLD: 10%; capecitabine: 3%), exanthema (PLD: 5%) and diarrhoea (PLD: 3%; capecitabine: 5%). Only 1 of 10 patients aged ≥80 years completed chemotherapy, while 3 and 6 patients discontinued treatment due to toxicity or progressive disease, respectively.

conclusionBoth PLD and capecitabine demonstrated comparable efficacy and acceptable tolerance as first-line single-agent chemotherapy in elderly patients with MBC, even in vulnerable patients or patients aged ≥75 years. However, patients aged ≥80 years were unlikely to complete chemotherapy successfully. CLINICAL TRIAL NUMBERS: EudraCT 2006-002046-10; ISRCTN 11114726; CKTO 2006-09; BOOG 2006-02.

Indexed as

AgedAged, 80 and overAntibiotics, AntineoplasticAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineDeoxycytidineDisease-Free SurvivalDoxorubicinFemaleFluorouracilHumansNeoplasm MetastasisNetherlandsPolyethylene GlycolsAntibiotics, AntineoplasticAntimetabolites, AntineoplasticCapecitabineDeoxycytidineDoxorubicinFluorouracilliposomal doxorubicinPolyethylene Glycolscapecitabineelderlygeriatricmetastatic breast cancerpegylated liposomal doxorubicinphase III

Identifiers

PMID24504445
PMCPMC4433520
OpenAlexW2130976864

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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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.