Evidence map›Paper›PMID 34158245›Full record

Trial reportClinical breast cancer2022

A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Malate in Combination With Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer.

Lynn Symonds, Isaac Jenkins, Hannah M Linden, Brenda Kurland, Julie R Gralow, Vijayakrishna V K Gadi, Georgiana K Ellis, Qian Wu, Eve Rodler, Pavani Chalasani and 6 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical breast cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.8field-weighted citation impact, top 25% 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

10 citing papers in PubMed, 12 citations in OpenAlex.

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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

16 authors at 10 institutions in 1 country.

Lynn SymondsMedical Oncology, University of Washington, Seattle, WA.
Isaac JenkinsClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
Hannah M LindenMedical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
Brenda KurlandeResearch Technologies, Inc., Pittsburgh, PA.
Julie R GralowMedical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
Vijayakrishna V K GadiMedical Oncology, University of Illinois Cancer Center, Chicago, IL.
Georgiana K EllisMedical Oncology, University of Washington, Seattle, WA.
Qian WuClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
Eve RodlerHematology and Oncology, University of California Davis, Sacramento, CA.
Pavani ChalasaniHematology and Oncology, University of Arizona Cancer Center, Tucson, AZ.
Xiaoyu ChaiMicrosoft, Redmond, WA.
Jinny RiedelClinical Cancer Genetics, Duke Cancer Institute, Durham, NC.
Scca Network InvestigatorsSeattle Cancer Care Alliance Network, Seattle, WA.
Alison StopeckHematology and Oncology, Stony Brook University, Stony Brook, NY.
Ursa Brown-GlabermanHematology and Oncology, University of New Mexico, Albuquerque, NM.
Jennifer M SpechtMedical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA. Electronic address: jspecht@uw.edu.
Fred Hutch Cancer Center · USUniversity of Washington Medical Center · USDuke Cancer InstituteMicrosoft (United States) · USSeattle Cancer Care Alliance · USStony Brook University · USUniversity of Arizona · USUniversity of California, Davis · USUniversity of Chicago Medical Center · USUniversity of New Mexico · US

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Eric Collisson · 1985 to 2026
$296.4M
INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
TRAINING IN CANCER BIOLOGY &TRANSPLANTATIONT32CA009515 · NCI · UNIVERSITY OF WASHINGTON · PI NANCY ELLEN DAVIDSON, Effie W Petersdorf · 1985 to 2026
$16.2M
NCI NIH HHS P30 CA015704NCI NIH HHS T32 CA009515NCRR NIH HHS UL1 RR025014
6 · The paper itself

Abstract

introductionNeoadjuvant chemotherapy is standard treatment for locally advanced breast cancer (LABC) or inflammatory breast cancer (IBC). We hypothesized that adding sunitinib, a tyrosine kinase inhibitor with antitumor and antiangiogenic activity, to an anthracycline and taxane regimen would improve pathologic complete response (pCR) rates to a prespecified endpoint of 45% in patients with HER2-negative LABC or IBC.

methodsWe conducted a multicenter, phase II trial of neoadjuvant sunitinib with paclitaxel (S+T) followed by doxorubicin and cyclophosphamide plus G-CSF for patients with HER2-negative LABC or IBC. Patients received sunitinib 25 mg PO daily with paclitaxel 80 mg/m

resultsSeventy patients enrolled, and 66 were evaluable for efficacy. Eighteen patients (27%) had pCR in the breast (10 had ER

conclusionsNeoadjuvant S+T followed by AC+G-CSF was safe and tolerable in LABC and IBC. The study did not meet the prespecified endpoint for pCR; however, 47% were responders using pCR and/or CPS + EG score ≤2. ER positive patients had the highest response rate (64%). The addition of sunitinib to neoadjuvant chemotherapy may provide promising incremental benefit for patients with ER positive LABC.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsDoxorubicinFemaleFollow-Up StudiesGranulocyte Colony-Stimulating FactorHumansInflammatory Breast NeoplasmsMiddle AgedNeoadjuvant TherapySunitinibTreatment OutcomeDoxorubicinGranulocyte Colony-Stimulating FactorSunitinibCyclophosphamideDoxorubicinHER2-negativeInflammatory breast cancerLocally advanced breast cancer (LABC)NeoadjuvantPaclitaxelSunitinib

Identifiers

PMID34158245
PMCPMC8611115
OpenAlexW3165017929

What OpenQuestion holds

Textmetadata
LicenceTDM
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.