Evidence map›Paper›PMID 33997740›Full record

ArticleEClinicalMedicine2021

Vismodegib in neoadjuvant treatment of locally advanced basal cell carcinoma: First results of a multicenter, open-label, phase 2 trial (VISMONEO study): Neoadjuvant Vismodegib in Locally Advanced Basal Cell Carcinoma.

Nicolas Bertrand, Pierre Guerreschi, Nicole Basset-Seguin, Philippe Saiag, Alain Dupuy, Sophie Dalac-Rat, Véronique Dziwniel, César Depoortère, Alain Duhamel, Laurent Mortier

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02667574 (Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma), which is not on this map. Cited by 58 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 3% 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.

NCT02667574 phase2completednot on this map

Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)

TypeinterventionalSponsorUniversity Hospital, LilleRan2014 to 2020Enrolled55ConditionsBasal Cell CarcinomaArmsERIVEDGE
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 2 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. 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
  2. Pooled it
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  18. Managing Advanced Basal Cell Carcinoma: A Guide for the Dermatology Clinician.The Journal of clinical and aesthetic dermatology · 2025
    Review
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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

10 authors at 7 institutions in 1 country.

Nicolas BertrandUniv. Lille, CHU Lille, Oncology Department, Lille, France.
Pierre GuerreschiUniv. Lille, CHU Lille, Plastic and Reconstructive Surgery Department, Lille, France.
Nicole Basset-SeguinHôpital Saint Louis AP-HP, Dermatology Department, Paris, France.
Philippe SaiagHôpital Ambroise Paré AP-HP, Dermatology Department, Boulogne-Billancourt, France.
Alain DupuyCHU Rennes, Dermatology Department, Rennes, France.
Sophie Dalac-RatCHU Dijon, Dermatology Department, Dijon, France.
Véronique DziwnielCentrale Lille, Languages Department, Villeneuve d'Ascq, France.
César DepoortèreUniv. Lille, CHU Lille, Plastic and Reconstructive Surgery Department, Lille, France.
Alain DuhamelCHU Lille, Biostatistics Department, Lille, France.
Laurent MortierUniv. Lille, INSERM U1189, CHU Lille, Dermatology Department, Lille, France.
Assistance Publique – Hôpitaux de Paris · FRInserm · FRUniversité de Lille · FRCentre Hospitalier Universitaire de Lille · FRCentre Hospitalier Universitaire de Rennes · FRCHU Dijon Bourgogne · FRÉcole Centrale de Lille · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSurgery is the primary treatment for basal cell carcinoma (BCC). In locally advanced basal cell carcinoma (laBCC), surgery may cause functional or aesthetic damage. In laBCC, neoadjuvant administration of vismodegib, an inhibitor of the Hedgehog signaling pathway, may reduce tumor size, facilitate resection, and reduce functional and aesthetic consequences of surgery. The VISMONEO study assessed efficacy and safety of vismodegib in neoadjuvant treatment of laBCC.

methodsVISMONEO (NCT02667574) is an open-label, noncomparative, multicenter, phase 2 study. Patients with ≥1 histologically confirmed facial BCC, inoperable or operable with functional or major aesthetic sequelae risk, were included. Oral vismodegib 150 mg was administered once daily for 4 to 10 months before planned surgery, which was performed once the best response under vismodegib was observed. Primary endpoint was percentage of patients with BCC with tumor downstaging following surgical resection after neoadjuvant vismodegib. Downstaging was defined according to a 6-stage surgical classification related to the aesthetic and functional consequences of surgery.

findings55 patients (median age: 73 years) with laBCC were included from November 2014 to June 2015. At inclusion, 4 patients were inoperable, 15 were operable with a major functional risk, and 36 were operable with a minor functional risk or a major aesthetic risk. Mean size of target lesion was 47.3 mm (SD: 27.2 mm). 44 patients presented with downstaging after vismodegib treatment (80%; 95% confidence interval [CI], 67 to 90). Of these 44 patients, 27 had a complete response (25 proved by biopsy). Mean treatment duration was 6.0 months. Overall Response Rate according to RECIST 1.1 criteria was 71% (95% CI, 59 to 88). At 3-years of follow-up, 16/44 patients had known recurrence (36%; 95%CI, 22 to 51).

interpretationNeoadjuvant vismodegib allows for a downstaging of the surgical procedure for laBCCs in functionally sensitive locations.

fundingVISMONEO was funded by F. Hoffmann-La Roche Ltd.

Indexed as

Locally advanced basal cell carcinomaNeoadjuvantVismodegib

Identifiers

PMID33997740
PMCPMC8093898
OpenAlexW3159164282

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.