Evidence map›Paper›PMID 28511673›Full record

Trial reportBMC cancer2017

Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.

Aleksandar Sekulic, Michael R Migden, Nicole Basset-Seguin, Claus Garbe, Anja Gesierich, Christopher D Lao, Chris Miller, Laurent Mortier, Dedee F Murrell, Omid Hamid and 8 more

Erratum issued 2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 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 2 registered trials, which are not on this map. Cited by 165 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
165citing papers in PubMed, 6 pooled it
16.8field-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.

NCT00833417 phase2completednot on this map

A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma

TypeinterventionalSponsorGenentech, Inc.Ran2009 to 2014Enrolled104ConditionsBasal Cell CarcinomaArmsVismodegib 150 mg
NCT05463757 recruitingnot on this mapstarted 2021, after this paper: background citation

Registration of Oral Hedgehog Inhibitors Vismodegib and Sonidegib in the Treatment of Advanced and Multiple Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study.

Typeobservational_patient_registrySponsorMaastricht University Medical CenterRan2021 to 2026Enrolled80ConditionsBasal Cell Carcinoma, Locally Advanced Basal Cell Carcinoma, Metastatic Basal Cell Carcinoma, Gorlin SyndromeArmsVismodegib, Sonidegib
3 · Its place in the literature

Who cites it

165 citing papers in PubMed, 6 syntheses or guidelines pooled it, 407 citations in OpenAlex.

  1. Pooled it
  2. S2k guideline basal cell carcinoma of the skin (update 2023).Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2024
    Guideline
  3. Pooled it
  4. Guideline
  5. Teledermatology for diagnosing skin cancer in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Article
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  18. Modeling CAF-tumor interactions to overcome therapy resistance.Journal of experimental & clinical cancer research : CR · 2026
    Review
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  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 10 institutions in 5 countries.

Aleksandar SekulicMayo Clinic Scottsdale, 13400 East Shea Boulevard, Scottsdale, AZ, 85259, USA. sekulic.aleksandar@mayo.edu.
Michael R MigdenDepartments of Dermatology and Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Houston, TX, 77030, USA.
Nicole Basset-SeguinService de Dermatologie, Hôpital Saint-Louis, 1 av claude Vellefaux, 75010, Paris, France.
Claus GarbeStudienzentrum Dermatologische Onkologie, Universitätsklinikum Tübingen, Liebermeisterstr. 25, 72074, Tübingen, Germany.
Anja GesierichKlinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg, Josef-Schneider-Str. 2, 97080, Würzburg, Germany.
Christopher D LaoUniversity of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.
Chris MillerDepartment of Dermatology, University of Pennsylvania Medical Center, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Laurent MortierClinique de Dermatologie, Hôpital Claude Huriez, Inserm U1189, Lille, France.
Dedee F MurrellDermatology Department, St George Clinical School, University of New South Wales, Grey Street, Sydney, 2217, Australia.
Omid HamidThe Angeles Clinic and Research Institute, 1818 Wilshire Boulevard, Los Angeles, California, USA.
Jorge F QuevedoMayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Jeannie HouGenentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.
Edward McKennaGenentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.
Natalie DimierRoche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.
Sarah WilliamsRoche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.
Dirk SchadendorfKlinikum für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstrabe 55, 45147, Essen, Germany.
Axel HauschildUniversitätsklinikum Schleswig-Holstein, Schittenhelmstr, 7, D-24 105, Kiel, Germany.
ERIVANCE BCC Investigators
Inserm · FRMayo Clinic · USRoche (United Kingdom) · GBRuhrlandklinik · DEThe University of Texas MD Anderson Cancer Center · USUniversitätsklinikum Tübingen · DEUniversity of Michigan · USMayo Clinic in Arizona · USUniversity Hospital Schleswig-Holstein · DEUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the primary analysis of the ERIVANCE BCC trial, vismodegib, the first US Food and Drug Administration-approved Hedgehog pathway inhibitor, showed objective response rates (ORRs) by independent review facility (IRF) of 30% and 43% in metastatic basal cell carcinoma (mBCC) and locally advanced BCC (laBCC), respectively. ORRs by investigator review were 45% (mBCC) and 60% (laBCC). Herein, we present long-term safety and final investigator-assessed efficacy results in patients with mBCC or laBCC.

methodsOne hundred four patients with measurable advanced BCC received oral vismodegib 150 mg once daily until disease progression or intolerable toxicity. The primary end point was IRF-assessed ORR. Secondary end points included ORR, duration of response (DOR), progression-free survival, overall survival (OS), and safety.

resultsAt data cutoff (39 months after completion of accrual), 8 patients were receiving the study drug (69 patients in survival follow-up). Investigator-assessed ORR was 48.5% in the mBCC group (all partial responses) and 60.3% in the laBCC group (20 patients had complete response and 18 patients had partial response). ORRs were comparable across patient subgroups, including aggressive histologic subtypes (eg, infiltrative BCC). Median DOR was 14.8 months (mBCC) and 26.2 months (laBCC). Median OS was 33.4 months in the mBCC cohort and not estimable in the laBCC cohort. Adverse events remained consistent with clinical experience. Thirty-three deaths (31.7%) were reported; none were related to vismodegib.

conclusionsThis long-term update of the ERIVANCE BCC trial demonstrated durability of response, efficacy across patient subgroups, and manageable long-term safety of vismodegib in patients with advanced BCC.

trial registrationThis study was registered prospectively with Clinicaltrials.gov , number NCT00833417 on January 30, 2009.

Indexed as

AnilidesAntineoplastic AgentsATP-Binding Cassette TransportersBasal Cell CarcinomaDisease-Free SurvivalDisease ProgressionFemaleHedgehog ProteinsHumansMaleProspective StudiesPyridinesSignal TransductionSkin NeoplasmsAnilidesAntineoplastic AgentsATP-Binding Cassette TransportersHedgehog ProteinsHhAntag691PyridinesBasal cell carcinoma (BCC)EfficacyLong-termSafetyVismodegib

Identifiers

PMID28511673
PMCPMC5433030
OpenAlexW2615693675

What OpenQuestion holds

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LicenceCC BY
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.