Evidence map›Paper›PMID 23169517›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Cabozantinib in patients with advanced prostate cancer: results of a phase II randomized discontinuation trial.

David C Smith, Matthew R Smith, Christopher Sweeney, Aymen A Elfiky, Christopher Logothetis, Paul G Corn, Nicholas J Vogelzang, Eric J Small, Andrea L Harzstark, Michael S Gordon and 11 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 205 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
205citing papers in PubMed, 2 pooled it
58.8field-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

205 citing papers in PubMed, 2 syntheses or guidelines pooled it, 443 citations in OpenAlex.

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  11. Cabozantinib in hepatocellular carcinoma: results of a phase 2 placebo-controlled randomized discontinuation study.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
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  20. Cabozantinib in chemotherapy-pretreated metastatic castration-resistant prostate cancer: results of a phase II nonrandomized expansion study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014
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145 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 1 institution in 1 country.

David C SmithUniversity of Michigan, Ann Arbor, MI, USA. dcsmith@umich.edu
Matthew R Smith
Christopher Sweeney
Aymen A Elfiky
Christopher Logothetis
Paul G Corn
Nicholas J Vogelzang
Eric J Small
Andrea L Harzstark
Michael S Gordon
Ulka N Vaishampayan
Naomi B Haas
Alexander I Spira
Primo N Lara
Chia-Chi Lin
Sandy Srinivas
Avishay Sella
Patrick Schöffski
Christian Scheffold
Aaron L Weitzman
Maha Hussain
Dana-Farber/Harvard Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCabozantinib (XL184) is an orally bioavailable tyrosine kinase inhibitor with activity against MET and vascular endothelial growth factor receptor 2. We evaluated the activity of cabozantinib in patients with castration-resistant prostate cancer (CRPC) in a phase II randomized discontinuation trial with an expansion cohort. PATIENTS AND

methodsPatients received 100 mg of cabozantinib daily. Those with stable disease per RECIST at 12 weeks were randomly assigned to cabozantinib or placebo. Primary end points were objective response rate at 12 weeks and progression-free survival (PFS) after random assignment.

resultsOne hundred seventy-one men with CRPC were enrolled. Random assignment was halted early based on the observed activity of cabozantinib. Seventy-two percent of patients had regression in soft tissue lesions, whereas 68% of evaluable patients had improvement on bone scan, including complete resolution in 12%. The objective response rate at 12 weeks was 5%, with stable disease in 75% of patients. Thirty-one patients with stable disease at week 12 were randomly assigned. Median PFS was 23.9 weeks (95% CI, 10.7 to 62.4 weeks) with cabozantinib and 5.9 weeks (95% CI, 5.4 to 6.6 weeks) with placebo (hazard ratio, 0.12; P < .001). Serum total alkaline phosphatase and plasma cross-linked C-terminal telopeptide of type I collagen were reduced by ≥ 50% in 57% of evaluable patients. On retrospective review, bone pain improved in 67% of evaluable patients, with a decrease in narcotic use in 56%. The most common grade 3 adverse events were fatigue (16%), hypertension (12%), and hand-foot syndrome (8%).

conclusionCabozantinib has clinical activity in men with CRPC, including reduction of soft tissue lesions, improvement in PFS, resolution of bone scans, and reductions in bone turnover markers, pain, and narcotic use.

Indexed as

AgedAged, 80 and overAlkaline PhosphataseAnilidesAntineoplastic AgentsBiomarkers, TumorBone NeoplasmsBone RemodelingCollagen Type IDisease-Free SurvivalFollow-Up StudiesHumansKaplan-Meier EstimateLymphatic MetastasisMaleMiddle AgedAlkaline PhosphataseAnilidesAntineoplastic AgentsBiomarkers, TumorcabozantinibCollagen Type Icollagen type I trimeric cross-linked peptidePeptidesPyridinesReceptor Protein-Tyrosine Kinases

Identifiers

PMID23169517
PMCPMC4110249
OpenAlexW2158011521

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.