Evidence map›Paper›PMID 27714541›Full record

Trial reportBreast cancer research and treatment2016

Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study.

Sara M Tolaney, Hovav Nechushtan, Ilan-Gil Ron, Patrick Schöffski, Ahmad Awada, Chris A Yasenchak, A Douglas Laird, Bridget O'Keeffe, Geoffrey I Shapiro, Eric P Winer

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.0field-weighted citation impact, top 7% 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

21 citing papers in PubMed, 45 citations in OpenAlex.

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  17. Cooperative Effect of OncogenicMolecular cancer therapeutics · 2019
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  19. Anti-Folate Receptor Alpha-Directed Antibody Therapies Restrict the Growth of Triple-negative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
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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

10 authors at 8 institutions in 3 countries.

Sara M TolaneyDepartment of Medical Oncology, Breast Oncology Center, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA. stolaney@partners.org.
Hovav NechushtanOncology Department, Hadassah Hebrew University Medical Center, Jerusalem, Israel.
Ilan-Gil RonDepartment of Oncology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Patrick SchöffskiDepartment of General Medical Oncology, Leuven Cancer Institute, KU Leuven, Louvain, Belgium.
Ahmad AwadaMedical Oncology, Institut Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium.
Chris A YasenchakWillamette Valley Cancer Institute, RiverBend Pavilion, Springfield, OR, USA.
A Douglas LairdExelixis, South San Francisco, CA, USA.
Bridget O'KeeffeExelixis, South San Francisco, CA, USA.
Geoffrey I ShapiroDepartment of Medical Oncology, Breast Oncology Center, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Eric P WinerDepartment of Medical Oncology, Breast Oncology Center, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Dana-Farber Cancer Institute · USExelixis (United States) · USBrigham and Women's Hospital · USHadassah Medical Center · ILInstitut Jules Bordet · BEKU Leuven · BETel Aviv Sourasky Medical Center · ILWillamette University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCabozantinib (XL184), a multi-targeted oral tyrosine kinase inhibitor with activity against MET, VEGFR2, AXL, and other tyrosine kinases, was assessed in a cohort of metastatic breast cancer (MBC) patients in a phase II randomized discontinuation trial (RDT).

methodsPatients received 100 mg cabozantinib daily during a 12-week lead-in stage. Those with stable disease per modified Response Evaluation Criteria in Solid Tumors version 1.0 at 12 weeks were randomized to either continue cabozantinib or receive placebo. Primary endpoints were objective response rate (ORR) during the 12-week lead-in stage and progression-free survival (PFS) after randomization. Patients were also followed for overall survival (OS).

resultsForty-five patients with MBC and a median of three prior lines of chemotherapy for metastatic disease were enrolled. The ORR during the lead-in stage was 13.6 % (95 % confidence interval [CI] 6-25.7 %), and the disease control rate at week 12 was 46.7 % (95 % CI 31.7-61.6 %). Per the initial RDT study design, patients with stable disease at week 12 were randomized to cabozantinib or placebo. Following a Study Oversight Committee recommendation, randomization was suspended. Patients in the lead-in stage continued on open-label cabozantinib. Patients in the randomization stage were subsequently unblinded. The overall median PFS for all MBC patients was 4.3 months. Median OS was 11.4 months (95 % CI 10.5-16.5 months). The most common grade 3/4 adverse events in the lead-in stage were palmar-plantar erythrodysesthesia (13 %) and fatigue (11 %). One death from respiratory failure was reported as drug-related during the lead-in stage.

conclusionsIn heavily pretreated MBC patients, cabozantinib monotherapy demonstrated clinical activity including objective response and disease control.

Indexed as

AdultAgedAnilidesAntineoplastic AgentsBiopsyBreast NeoplasmsFemaleHumansMagnetic Resonance ImagingMiddle AgedProtein Kinase InhibitorsPyridinesSurvival AnalysisTomography, X-Ray ComputedTreatment OutcomeAnilidesAntineoplastic AgentscabozantinibProtein Kinase InhibitorsPyridinesCabozantinibMetastatic breast cancerOverall survivalProgression-free survivalTumor responseVascular endothelial growth factor receptor

Identifiers

PMID27714541
PMCPMC5065609
OpenAlexW2528809664

What OpenQuestion holds

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LicenceCC BY
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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.