Evidence map›Paper›PMID 23553848›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2013

A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases.

Richard J Lee, Philip J Saylor, M Dror Michaelson, S Michael Rothenberg, Malgorzata E Smas, David T Miyamoto, Carol A Gurski, Wanling Xie, Shyamala Maheswaran, Daniel A Haber and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01347788 (Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases), which is not on this map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
–field-weighted citation impact
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.

NCT01347788 phase1completednot on this map

Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases

TypeinterventionalSponsorMassachusetts General HospitalRan2011 to 2013Enrolled34ConditionsProstate AdenocarcinomaArmscabozantinib
3 · Its place in the literature

Who cites it

44 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. 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
    Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Bone Metastases: An Overview.Oncology reviews · 2017
    Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Cabozantinib (XL184) Inhibits Growth and Invasion of Preclinical TNBC Models.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Article
  20. 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

12 authors.

Richard J LeeMassachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA. rjlee@partners.org
Philip J Saylor
M Dror Michaelson
S Michael Rothenberg
Malgorzata E Smas
David T Miyamoto
Carol A Gurski
Wanling Xie
Shyamala Maheswaran
Daniel A Haber
Jonathan G Goldin
Matthew R Smith

Funding

Midcareer Investigator AwardK24CA121990 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI SMITH, MATTHEW RAYMOND · 2007 to 2016
$1.9M
PARD3 Alterations, Circulating Tumors Cells and Metastasis in Head and Neck CanceK08DE020139 · NIDCR · MASSACHUSETTS GENERAL HOSPITAL · PI ROTHENBERG, STEPHEN MICHAEL · 2010 to 2014
$684k
NCI NIH HHS 5K24CA121990NCI NIH HHS K24 CA121990NIDCR NIH HHS K08 DE020139
6 · The paper itself

Abstract

backgroundCabozantinib is an oral MET/VEGFR2 inhibitor. A recent phase II study of cabozantinib (100 mg daily) showed improved bone scans in subjects with metastatic castration-resistant prostate cancer (mCRPC), but adverse events (AE) caused frequent dose reductions. This study was designed to determine the efficacy and tolerability of cabozantinib at lower starting doses. EXPERIMENTAL

designAn adaptive design was used to determine the lowest active daily dose among 60, 40, and 20 mg. The primary endpoint was week 6 bone scan response, defined as ≥30% decrease in bone scan lesion area. The secondary endpoint was change in circulating tumor cells (CTC).

resultsAmong 11 evaluable subjects enrolled at 40 mg, there were 9 partial responses (PR), 1 complete response, and 1 stable disease (SD). Of 10 subjects subsequently enrolled at 20 mg, there were 1 PR, 5 SDs, and 4 with progressive disease. Among 13 subjects enrolled on the 40 mg expansion cohort, there were 6 PRs and 7 SDs. No subjects required dose reduction or treatment interruption at 6 or 12 weeks; 3 subjects at dose level 0 discontinued due to AEs by 12 weeks. At 40 mg, median treatment duration was 27 weeks. 58% of subjects with ≥5 CTCs/7.5 mL at baseline converted to <5.

conclusionsCabozantinib 40 mg daily was associated with a high rate of bone scan response. Cabozantinib 40 mg daily was associated with better tolerability than previously reported for cabozantinib 100 mg daily. These observations informed the design of phase III studies of cabozantinib in mCRPC.

Indexed as

AgedAged, 80 and overAnilidesAntineoplastic AgentsBone NeoplasmsCohort StudiesHumansMaleMiddle AgedNeoplastic Cells, CirculatingOrchiectomyProstate-Specific AntigenProstatic NeoplasmsProtein Kinase InhibitorsPyridinesTreatment OutcomeAnilidesAntineoplastic AgentscabozantinibProstate-Specific AntigenProtein Kinase InhibitorsPyridines

Identifiers

PMID23553848
PMCPMC3684567

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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.