Evidence map›Paper›PMID 21220618›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2011

Phase III comparison of standard doxorubicin and cyclophosphamide versus weekly doxorubicin and daily oral cyclophosphamide plus granulocyte colony-stimulating factor as neoadjuvant therapy for inflammatory and locally advanced breast cancer: SWOG 0012.

Georgiana K Ellis, William E Barlow, Julie R Gralow, Gabriel N Hortobagyi, Christy A Russell, Melanie E Royce, Edith A Perez, Danika Lew, Robert B Livingston

3 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 42 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 6 pooled it
2.4field-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.

NCT00016406 phase3completednot on this map

A Comparative Randomized Study of Standard Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory and Locally Advanced Breast Cancer

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2001 to 2012Enrolled399ConditionsBreast CancerArmsfilgrastim, cyclophosphamide, doxorubicin, paclitaxel, surgery
NCT00542191 phase2terminatednot on this map

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

TypeinterventionalSponsorLeo W. Jenkins Cancer CenterRan2007 to 2016Enrolled30ConditionsBreast CancerArmsDoxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin, Definitive Surgery, Radiotherapy
NCT04829890 completednot on this map

Adjuvant Dose-dense Sequential Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer: A Hellenic Cooperative Oncology Group (HeCOG) Study

TypeobservationalSponsorHellenic Cooperative Oncology GroupRan2004 to 2014Enrolled89ConditionsBreast Cancer, Adenocarcinoma of Breast
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 6 syntheses or guidelines pooled it, 78 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Systematic review of growth factors and cytokines for the management of oral mucositis in cancer patients and clinical practice guidelines.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Trial
  12. Tumor histological subtyping determined by hormone receptors and HER2 status defines different pathological complete response and outcome to dose-dense neoadjuvant chemotherapy in breast cancer patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2014
    Trial
  13. Trial
  14. Review
  15. Article
  16. Pregnancy and Gastric Cancer: A Narrative Review.Diagnostics (Basel, Switzerland) · 2023
    Review
  17. Article
  18. Article
  19. Article
  20. Inflammatory Breast Cancer at the Extremes of Age.Annals of surgical oncology · 2021
    Article
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

9 authors at 5 institutions in 1 country.

Georgiana K EllisSeattle Cancer Care Alliance, 825 Eastlake Ave East, Seattle, WA 98109-1023, USA. gellis@u.washington.edu
William E Barlow
Julie R Gralow
Gabriel N Hortobagyi
Christy A Russell
Melanie E Royce
Edith A Perez
Danika Lew
Robert B Livingston
Seattle Cancer Care Alliance · USUniversity of Southern California · USArizona Oncology · USUniversity of New Mexico · USUSC Norris Comprehensive Cancer Center · US

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
Beaumont Community Clinical Oncology ProgramU10CA095860 · NCI · WILLIAM BEAUMONT HOSPITAL RESEARCH INST · PI ROBERTSON, JOHN M · 2002 to 2014
$11.3M
WESTERN ONCOLOGY RESEARCH CONSORTIUMU10CA045377 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI CONLIN, ALISON K · 1987 to 2013
$9.9M
NORTHWEST COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035281 · NCI · TACOMA GENERAL HOSPITAL · PI KEECH, JOHN A · 1985 to 2013
$9.2M
Hawaii Minority-Based Clinical Community Oncology ProgramU10CA063844 · NCI · UNIVERSITY OF HAWAII AT MANOA · PI BERENBERG, JEFFREY LEE · 1994 to 2014
$9.0M
NM MINORITY-BASED COMMUNITY CLINICAL ONC. PROGRAMU10CA086780 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI ROYCE, MELANIE E · 2000 to 2014
$8.8M
NCI NIH HHS CA11083NCI NIH HHS CA12644NCI NIH HHS CA14028NCI NIH HHS CA20319NCI NIH HHS CA22433NCI NIH HHS CA35090NCI NIH HHS CA35128NCI NIH HHS CA35192NCI NIH HHS CA35281NCI NIH HHS CA379891NCI NIH HHS CA45377NCI NIH HHS CA45808NCI NIH HHS CA46136NCI NIH HHS CA46282NCI NIH HHS CA52654NCI NIH HHS CA58861NCI NIH HHS CA58882NCI NIH HHS CA63845NCI NIH HHS CA74647NCI NIH HHS CA74811NCI NIH HHS CA76447NCI NIH HHS CA76448NCI NIH HHS CA76462NCI NIH HHS CA86780NCI NIH HHS CA95860NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035176NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA063844NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035128NCI NIH HHS U10 CA035176NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035192NCI NIH HHS U10 CA035281NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA052654NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA063844NCI NIH HHS U10 CA063845NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA074647NCI NIH HHS U10 CA074811NCI NIH HHS U10 CA076447NCI NIH HHS U10 CA086780NCI NIH HHS U10 CA095860
6 · The paper itself

Abstract

purposePatients with inflammatory breast cancer (IBC) or locally advanced breast cancer (LABC) were randomly assigned to 21-day doxorubicin and cyclophosphamide administered for five cycles (standard arm) versus weekly doxorubicin and daily oral cyclophosphamide administered with granulocyte colony-stimulating factor support for 15 weeks (continuous arm). All patients had subsequent weekly paclitaxel for 12 weeks before surgery. PATIENTS AND

methodsPatients (n = 372) were randomly assigned to the standard arm (n = 186) or the continuous arm (n = 186) stratified by disease type (LABC, n = 256; IBC, n = 116). The primary outcome was microscopic pathologic complete response (pCR) at surgery. Secondary outcomes included disease-free survival, overall survival, and toxicity.

resultsMore patients in the standard arm had grade 3 to 4 leukopenia and neutropenia, but there were more instances of stomatitis/pharyngitis and hand-foot skin reaction in the continuous arm. Assessed among 356 eligible patients, pCR was not different between the treatment groups stratified by disease type (P = .42). In subset analysis, higher pCR rates were observed in the continuous arm versus the standard arm only for stage IIIB disease (P = .0057) and in IBC (P = .06). Comparison of overall survival and disease-free survival showed no difference between treatment groups (P = .37 and P = .87, respectively).

conclusionNo significant clinical benefit was seen for the investigational arm in this trial overall.

Indexed as

Administration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantChi-Square DistributionCyclophosphamideDisease-Free SurvivalDoxorubicinDrug Administration ScheduleFemaleGranulocyte Colony-Stimulating FactorHumansKaplan-Meier EstimateBiomarkers, TumorCyclophosphamideDoxorubicinGranulocyte Colony-Stimulating FactorPaclitaxel

Identifiers

PMID21220618
PMCPMC3068051
OpenAlexW2127276782

What OpenQuestion holds

Textmetadata
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.