Evidence map›Paper›PMID 36259380›Full record

Trial reportCancer2022

Cabozantinib for previously treated radioiodine-refractory differentiated thyroid cancer: Updated results from the phase 3 COSMIC-311 trial.

Marcia S Brose, Bruce G Robinson, Steven I Sherman, Barbara Jarzab, Chia-Chi Lin, Fernanda Vaisman, Ana O Hoff, Erika Hitre, Daniel W Bowles, Suvajit Sen and 4 more

Erratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2022. 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 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
8.4field-weighted citation impact, top 2% 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

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Review
  12. Article
  13. Clinical and treatment patterns of advanced and radioiodine-refractory differentiated thyroid cancer. ERUDIT study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 12 institutions in 8 countries.

Marcia S BroseAbramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Bruce G RobinsonSydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
Steven I ShermanDepartment of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Barbara JarzabDepartment of Nuclear Medicine and Endocrine Oncology, Maria Sklodowska Curie National Research Institute of Oncology, Gliwice, Poland.
Chia-Chi LinDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Fernanda VaismanEndocrinology Service, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.
Ana O HoffDepartment of Endocrinology, Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, São Paulo, Brazil.
Erika HitreDepartment of Medical Oncology and Clinical Pharmacology "B", Országos Onkológiai Intézet, Budapest, Hungary.
Daniel W BowlesDivision of Medical Oncology, Department of Medicine, Anschutz Medical Campus, University of Colorado, Aurora, Colorado, USA.
Suvajit SenExelixis, Inc., Alameda, California, USA.
Jennifer W OliverExelixis, Inc., Alameda, California, USA.
Kamalika BanerjeeExelixis, Inc., Alameda, California, USA.
Bhumsuk KeamDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.ORCID 0000-0001-8196-4247
Jaume CapdevilaMedical Oncology Department Gastrointestinal and Endocrine Tumor Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.
Exelixis (United States) · USInstituto Nacional de Câncer - INCA · BRNational Institute of Criminology · HUNational Institute of Oncology · HUNational Taiwan University Hospital · TWSeoul National University Hospital · KRThe University of Sydney · AUThe University of Texas MD Anderson Cancer Center · USThomas Jefferson University Hospital · USUniversidade de São Paulo · BRUniversitat Autònoma de Barcelona · ESUniversity of Colorado Anschutz Medical Campus · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAt an interim analysis (median follow-up, 6.2 months; n = 187), the phase 3 COSMIC-311 trial met the primary end point of progression-free survival (PFS): cabozantinib improved PFS versus a placebo (median, not reached vs. 1.9 months; p < .0001) in patients with previously treated radioiodine-refractory differentiated thyroid cancer (RAIR-DTC). The results from an exploratory analysis using an extended datacut are presented.

methodsPatients 16 years old or older with RAIR-DTC who progressed on prior lenvatinib and/or sorafenib were randomized 2:1 to oral cabozantinib tablets (60 mg/day) or a placebo. Placebo patients could cross over to open-label cabozantinib upon radiographic disease progression. The objective response rate (ORR) in the first 100 randomized patients and the PFS in the intent-to-treat population, both according to Response Evaluation Criteria in Solid Tumors version 1.1 by blinded, independent review, were the primary end points.

resultsAt the data cutoff (February 8, 2021), 258 patients had been randomized (cabozantinib, n = 170; placebo, n = 88); the median follow-up was 10.1 months. The median PFS was 11.0 months (96% confidence interval [CI], 7.4-13.8 months) for cabozantinib and 1.9 months (96% CI, 1.9-3.7 months) for the placebo (hazard ratio, 0.22; 96% CI, 0.15-0.32; p < .0001). The ORR was 11.0% (95% CI, 6.9%-16.9%) versus 0% (95% CI, 0.0%-4.1%) (p = .0003) with one complete response with cabozantinib. Forty placebo patients crossed over to open-label cabozantinib. Grade 3/4 treatment-emergent adverse events occurred in 62% and 28% of the cabozantinib- and placebo-treated patients, respectively; the most common were hypertension (12% vs. 2%), palmar-plantar erythrodysesthesia (10% vs. 0%), and fatigue (9% vs. 0%). There were no grade 5 treatment-related events.

conclusionsAt extended follow-up, cabozantinib maintained superior efficacy over a placebo in patients with previously treated RAIR-DTC with no new safety signals.

Indexed as

AdenocarcinomaAntineoplastic AgentsThyroid NeoplasmsAdolescentAnilidesHumansIodine RadioisotopesPyridinesAnilidesAntineoplastic AgentscabozantinibIodine RadioisotopesPyridinescabozantinibCOSMIC-311differentiated thyroid cancerphase 3placebotyrosine kinase inhibitor

Identifiers

PMID36259380
PMCPMC10092751
OpenAlexW4306777542

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.