Evidence map›Paper›PMID 21821545›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2012

A phase II pilot trial incorporating bevacizumab into dose-dense doxorubicin and cyclophosphamide followed by paclitaxel in patients with lymph node positive breast cancer: a trial coordinated by the Eastern Cooperative Oncology Group.

K D Miller, A O'Neill, E A Perez, A D Seidman, G W Sledge

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.3field-weighted citation impact, top 11% 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

22 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Cardiac effects of anticancer therapy in the elderly.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014
    Review
  9. Review
  10. Review
  11. Chemotherapy-resistant metastatic breast cancer.Current treatment options in oncology · 2012
    Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Antiangiogenic therapy for breast cancer.Breast cancer research : BCR · 2010
    Review
  17. Review
  18. Review
  19. Dose-dense adjuvant Doxorubicin and cyclophosphamide is not associated with frequent short-term changes in left ventricular ejection fraction.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009
    Article
  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

5 authors at 4 institutions in 1 country.

K D MillerDepartment of Medicine, Division of Hematology and Oncology, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, USA. kathmill@iupui.edu
A O'Neill
E A Perez
A D Seidman
G W Sledge
Cornell University · USEastern Cooperative Oncology Group · USIndiana University Health · USIndiana University – Purdue University Indianapolis · US

Funding

ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
ONCOLOGYU10CA049883 · NCI · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI MILLER, KATHY D. · 1989 to 2013
$4.0M
MEMORIAL HOSPITAL AND CANCER AND ACUTE LEUKEMIA GROUP BU10CA077651 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI HUDIS, CLIFFORD A · 1998 to 2013
$3.2M
NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA25224NCI NIH HHS CA49883NCI NIH HHS CA66636NCI NIH HHS CA77651
6 · The paper itself

Abstract

backgroundE2104 was designed to evaluate the safety of two different strategies incorporating bevacizumab into anthracycline-containing adjuvant therapy as a precursor to a definitive randomized phase III trial. PATIENTS AND

methodsPatients were sequentially assigned to one of two treatment arms. In addition to dose-dense doxorubicin and cyclophosphamide followed by paclitaxel (Taxol) (ddAC→T), all patients received bevacizumab (10 mg/kg every 2 weeks × 26) initiated either concurrently with AC (Arm A: ddBAC→BT→B) or with paclitaxel (Arm B: ddAC→BT→B). The primary end point was incidence of clinically apparent cardiac dysfunction (CHF).

resultsPatients enrolled were 226 in number (Arm A 104, Arm B 122). Grade 3 hypertension, thrombosis, proteinuria and hemorrhage were reported for 12, 2, 2 and <1% of patients, respectively. Two patients developed grade 3 or more cerebrovascular ischemia. Three patients in each arm developed CHF. There was no significant difference between arms in the proportion of patients with an absolute decrease in left ventricular ejection fraction of >15% or >10% to below the lower limit of normal post AC or post bevacizumab.

conclusionsIncorporation of bevacizumab into anthracycline-containing adjuvant therapy does not result in prohibitive cardiac toxicity. The definitive phase III trial (E5103) was activated with systematic and extensive cardiac monitoring to define the true impact of bevacizumab on cardiac function.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsCyclophosphamideDoxorubicinFemaleHeart DiseasesHumansMiddle AgedPaclitaxelPilot ProjectsAntibodies, Monoclonal, HumanizedBevacizumabCyclophosphamideDoxorubicinPaclitaxel

Identifiers

PMID21821545
PMCPMC3265545
OpenAlexW2166832443

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.