Evidence map›Paper›PMID 27391598›Full record

Trial reportBreast cancer research : BCR2015

"New" metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy.

Christopher Twelves, Javier Cortes, Peter A Kaufman, Louise Yelle, Ahmad Awada, Terri A Binder, Martin Olivo, James Song, Joyce A O'Shaughnessy, Maria Jove and 1 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research : BCR, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
–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.

NCT00337103 phase3completednot on this map

A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

TypeinterventionalSponsorEisai Inc.Ran2006 to 2017Enrolled1,276ConditionsMetastatic Breast CancerArmsEribulin Mesylate, Capecitabine
NCT00388726 phase3completednot on this map

The "EMBRACE" Trial: Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus "Treatment of Physician's Choice" in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

TypeinterventionalSponsorEisai Inc.Ran2006 to 2013Enrolled762ConditionsBreast CancerArmsE7389, Physician's Choice
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Impact of progression type on overall survival in patients with advanced gastric cancer based on randomized phase III study of S-1 plus oxaliplatin versus S-1 plus cisplatin.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017
    Trial
  7. Article
  8. Article
  9. Article
  10. EMT and cancer: what clinicians should know.Nature reviews. Clinical oncology · 2025
    Review
  11. Review
  12. Review
  13. Observational
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Observational
  20. Review
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

11 authors.

Christopher TwelvesSection of Oncology and Clinical Research, Leeds Institute of Cancer and Pathology, University of Leeds and Leeds Teaching Hospitals Trust, Leeds, UK. C.J.Twelves@leeds.ac.uk.
Javier CortesDepartment of Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Peter A KaufmanSection of Hematology/Oncology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Louise YelleDepartment of Medicine, University of Montreal, Montreal, QC, Canada.
Ahmad AwadaMedical Oncology Clinic, Medicine Department, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium.
Terri A BinderOncology Imaging, Eisai Inc., Woodcliff Lake, NJ, USA.
Martin OlivoOncology PCU, Clinical Development, Eisai Inc., Woodcliff Lake, NJ, USA.
James SongDepartment of Medical Affairs, Eisai Inc., Woodcliff Lake, NJ, USA.
Joyce A O'ShaughnessyDepartment of Medical Oncology, US Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA.
Maria JoveSection of Oncology and Clinical Research, Leeds Institute of Cancer and Pathology, University of Leeds and Leeds Teaching Hospitals Trust, Leeds, UK.
Edith A PerezDivision of Hematology/Oncology, Department of Cancer Biology, Mayo Clinic, Jacksonville, FL, USA.

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
NCI NIH HHS P30 CA023108
6 · The paper itself

Abstract

introductionProgression-free survival (PFS) and overall survival (OS) endpoints often only weakly correlate. This analysis investigates how different progression events impact on OS, using data from two phase 3 studies with eribulin in women with advanced/metastatic breast cancer (MBC).

methodsIn Study 301, 1102 women with ≤2 prior chemotherapies for advanced/MBC were randomized to eribulin mesylate (1.4 mg/m(2) on days 1 and 8 every 21 days) or capecitabine (1.25 g/m(2) twice daily on days 1-14 every 21 days). Study 305/EMBRACE enrolled 762 patients following two to five prior chemotherapies for advanced/MBC, randomized to eribulin (as above) or treatment of physician's choice. We analyzed OS and PFS post hoc for patients whose disease progressed due to development of "new" metastases, growth of pre-existing lesions, and patients with no reported disease progression.

resultsIn both clinical studies, development of new metastases was associated with an increased risk of death (p < 0.0001). The time to development of new metastasis or death was significantly longer with eribulin than the comparator in Study 305 (p = 0.0017), but not in Study 301 (p = 0.46). Significantly longer OS was observed in the eribulin compared with the comparator arm for the new metastases subgroup in Study 301 (p = 0.008), but not in Study 305 (p = 0.16), compared with other progression subgroups.

conclusionsPatients with MBC progressing with new metastases have a worse prognosis than those whose disease progresses due to growth of existing lesions or patients with no reported disease progression. These findings have potentially important implications for the interpretation of clinical study data and clinical practice.

trial registrationClinicalTrials.gov registration IDs: Study 301: NCT00337103 ; Study 305: NCT00388726 .

Indexed as

Antineoplastic AgentsBreast NeoplasmsCapecitabineDisease-Free SurvivalFemaleFuransHumansKetonesPolyether PolyketidesPrognosisAntineoplastic AgentsCapecitabineeribulinFuransKetonesPolyether Polyketides

Identifiers

PMID27391598
PMCPMC4674925

What OpenQuestion 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 OpenQuestion graph.