Evidence map›Paper›PMID 21569994›Full record

Trial reportClinical breast cancer2011

Sunitinib plus paclitaxel versus bevacizumab plus paclitaxel for first-line treatment of patients with advanced breast cancer: a phase III, randomized, open-label trial.

Nicholas J Robert, Mansoor N Saleh, Devchand Paul, Daniele Generali, Laurent Gressot, Mehmet S Copur, Adam M Brufsky, Susan E Minton, Jeffrey K Giguere, John W Smith and 6 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical breast cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
8.0field-weighted citation impact, top 1% 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

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 117 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
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  9. Review
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  17. Vessel co-option in cancer.Nature reviews. Clinical oncology · 2019
    Review
  18. Article
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

16 authors at 11 institutions in 1 country.

Nicholas J RobertVirginia Cancer Specialists, US Oncology, Fairfax, VA, USA. Nicholas.Robert@USONCOLOGY.COM
Mansoor N Saleh
Devchand Paul
Daniele Generali
Laurent Gressot
Mehmet S Copur
Adam M Brufsky
Susan E Minton
Jeffrey K Giguere
John W Smith
Paul D Richards
Diana Gernhardt
Xin Huang
Katherine F Liau
Kenneth A Kern
John Davis
Pfizer (United States) · USGeorgia Cancer Specialists · USMagee-Womens Hospital · USMoffitt Cancer Center · USMountain Blue Cancer Care Center · USNebraska Cancer Specialists · USNeurology Centers of the Carolinas · USNorthwest Cancer Clinic · USRocky Mountain Cancer Centers · USSaint Francis University · USVirginia Cancer Specialists · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

introductionA multicenter, open-label phase III study was conducted to test whether sunitinib plus paclitaxel prolongs progression-free survival (PFS) compared with bevacizumab plus paclitaxel as first-line treatment for patients with HER2(-) advanced breast cancer. PATIENTS AND

methodsPatients with HER2(-) advanced breast cancer who were disease free for ≥ 12 months after adjuvant taxane treatment were randomized (1:1; planned enrollment 740 patients) to receive intravenous (I.V.) paclitaxel 90 mg/m(2) every week for 3 weeks in 4-week cycles plus either sunitinib 25 to 37.5 mg every day or bevacizumab 10 mg/kg I.V. every 2 weeks. [corrected]

resultsThe trial was terminated early because of futility in reaching the primary endpoint as determined by the independent data monitoring committee during an interim futility analysis. At data cutoff, 242 patients had been randomized to sunitinib-paclitaxel and 243 patients to bevacizumab-paclitaxel. Median PFS was shorter with sunitinib-paclitaxel (7.4 vs. 9.2 months; hazard ratio [HR] 1.63 [95% confidence interval (CI), 1.18-2.25]; 1-sided P = .999). At a median follow-up of 8.1 months, with 79% of sunitinib-paclitaxel and 87% of bevacizumab-paclitaxel patients alive, overall survival analysis favored bevacizumab-paclitaxel (HR 1.82 [95% CI, 1.16-2.86]; 1-sided P = .996). The objective response rate was 32% in both arms, but median duration of response was shorter with sunitinib-paclitaxel (6.3 vs. 14.8 months). Bevacizumab-paclitaxel was better tolerated than sunitinib-paclitaxel. This was primarily due to a high frequency of grade 3/4, treatment-related neutropenia with sunitinib-paclitaxel (52%) precluding delivery of the prescribed doses of both drugs.

conclusionThe sunitinib-paclitaxel regimen evaluated in this study was clinically inferior to the bevacizumab-paclitaxel regimen and is not a recommended treatment option for patients with advanced breast cancer.

Indexed as

AdultAgedAged, 80 and overAlgorithmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsCarcinomaDisease ProgressionFemaleHumansIndolesMiddle AgedNeoadjuvant TherapyAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabIndolesPaclitaxelPyrrolesSunitinib

Identifiers

PMID21569994
PMCPMC4617186
OpenAlexW2085946496

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.