Evidence map›Paper›PMID 28199818›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial.

Toni K Choueiri, Susan Halabi, Ben L Sanford, Olwen Hahn, M Dror Michaelson, Meghara K Walsh, Darren R Feldman, Thomas Olencki, Joel Picus, Eric J Small and 3 more

Erratum issued 5 registry-linked trialsAbstract 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, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 5 registered trials, which are not on this map. Cited by 355 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
355citing papers in PubMed, 9 pooled it
75.9field-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.

NCT03149822 phase1 / phase2completednot on this map

Phase I/II Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma

TypeinterventionalSponsorUniversity of Colorado, DenverRan2017 to 2024Enrolled45ConditionsMetastatic Renal Cell CarcinomaArmsCabozantinib, Pembrolizumab
NCT03354884 phase2completednot on this mapstarted 2018, after this paper: background citation

caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2018 to 2020Enrolled23ConditionsCollecting Duct Carcinoma (Kidney)Armscabozantinib
NCT03463681 phase2completednot on this mapstarted 2018, after this paper: background citation

A Phase 2 Open Label Study of CaBozantinib in Patients With Advanced or Unresectable Renal cEll cArcinoma Pretreated With One immunochecKPOint INhibiTor (Anti PD1/PDL1): the BREAKPOINT Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2018 to 2021Enrolled49ConditionsMetastatic Renal Cell CarcinomaArmsCabometyx
NCT04131543 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

"Phase II Study to Evaluate the Activity and Safety of Cabozantinib in Pretreated, Advanced RET-rearranged Non-small Cell Lung Cancer Patients: CRETA Trial"

TypeinterventionalSponsorUniversity of BolognaRan2019 to 2022Enrolled25ConditionsNon Small Cell Lung CancerArmsCabozantinib 20 MG, Cabozantinib 40 MG, Cabozantinib 60 MG
NCT05163249 phase2active not recruitingnot on this mapstarted 2022, after this paper: background citation

A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS)

TypeinterventionalSponsorGuangdong Association of Clinical TrialsRan2022 to 2026Enrolled44ConditionsCarcinoma, Non-Small-Cell LungArmsOsimertinib, Savolitinib
3 · Its place in the literature

Who cites it

355 citing papers in PubMed, 9 syntheses or guidelines pooled it, 709 citations in OpenAlex.

  1. Pooled it
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  5. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
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  7. Targeted therapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2020
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  20. Cabozantinib in advanced renal cell carcinoma: A phase II, open-label, single-arm study of Japanese patients.International journal of urology : official journal of the Japanese Urological Association · 2020
    Trial

295 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 1 institution in 1 country.

Toni K ChoueiriToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Susan HalabiToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Ben L SanfordToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Olwen HahnToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
M Dror MichaelsonToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Meghara K WalshToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Darren R FeldmanToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Thomas OlenckiToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Joel PicusToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Eric J SmallToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Shaker DakhilToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Daniel J GeorgeToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Michael J MorrisToni K. Choueiri and Meghara K. Walsh, Dana-Farber Cancer Institute; M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Susan Halabi and Ben L. Sanford, Alliance Statistics and Data Center and Duke University; Daniel J. George, Duke Cancer Institute, Duke University Medical Center, Durham, NC; Olwen Hahn, Alliance Protocol Operations Office, Chicago, IL; Darren R. Feldman and Michael J. Morris, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University Medical Center, Columbus, OH; Joel Picus, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; Eric J. Small, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; and Shaker Dakhil, University of Kansas Wichita, Wichita, KS.
Dana-Farber Cancer Institute · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

Purpose Cabozantinib is an oral potent inhibitor of vascular endothelial growth factor receptor 2, MET, and AXL and is a standard second-line therapy for metastatic renal cell carcinoma (mRCC). This randomized phase II multicenter trial evaluated cabozantinib compared with sunitinib as first-line therapy in patients with mRCC. Patients and Methods Eligible patients had untreated clear cell mRCC and Eastern Cooperative Oncology Group performance status of 0 to 2 and were intermediate or poor risk per International Metastatic Renal Cell Carcinoma Database Consortium criteria. Patients were randomly assigned at a one-to-one ratio to cabozantinib (60 mg once per day) or sunitinib (50 mg once per day; 4 weeks on, 2 weeks off). Progression-free survival (PFS) was the primary end point. Objective response rate (ORR), overall survival, and safety were secondary end points. Results From July 2013 to April 2015, 157 patients were randomly assigned (cabozantinib, n = 79; sunitinib, n = 78). Compared with sunitinib, cabozantinib treatment significantly increased median PFS (8.2 v 5.6 months) and was associated with a 34% reduction in rate of progression or death (adjusted hazard ratio, 0.66; 95% CI, 0.46 to 0.95; one-sided P = .012). ORR was 33% (95% CI, 23 to 44) for cabozantinib versus 12% (95% CI, 5.4 to 21) for sunitinib. All-causality grade 3 or 4 adverse events were 67% for cabozantinib and 68% for sunitinib and included diarrhea (cabozantinib, 10% v sunitinib, 11%), fatigue (6% v 15%), hypertension (28% v 22%), palmar-plantar erythrodysesthesia (8% v 4%), and hematologic adverse events (3% v 22%). Conclusion Cabozantinib demonstrated a significant clinical benefit in PFS and ORR over standard-of-care sunitinib as first-line therapy in patients with intermediate- or poor-risk mRCC.

Indexed as

AdultAgedAged, 80 and overAnilidesAntineoplastic AgentsCarcinoma, Renal CellDisease-Free SurvivalDrug Administration ScheduleFemaleHumansIndolesKidney NeoplasmsMaleMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisAnilidesAntineoplastic AgentscabozantinibIndolesPyridinesPyrrolesSunitinib

Identifiers

PMID28199818
PMCPMC5455807
OpenAlexW2558408743

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.