Evidence map›Paper›PMID 31851776›Full record

Trial reportCancer medicine2020

VITAL phase 2 study: Upfront 5-fluorouracil, mitomycin-C, panitumumab and radiotherapy treatment in nonmetastatic squamous cell carcinomas of the anal canal (GEMCAD 09-02).

Jaime Feliu, Rocio Garcia-Carbonero, Jaume Capdevila, Inmaculada Guasch, Vicente Alonso-Orduna, Carlos Lopez, Pilar Garcia-Alfonso, Carmen Castanon, Isabel Sevilla, Laura Cerezo and 10 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Maintenance of angiogenesis inhibition with aflibercept after progression to bevacizumab in metastatic colorectal cancer: real life study in the Valencian community.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Observational
  6. Review
  7. Article
  8. Squamous cell anal cancer: Management and therapeutic options.Annals of medicine and surgery (2012) · 2020
    Review
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

20 authors at 17 institutions in 1 country.

Jaime FeliuDepartment of Medical Oncology, CIBERONC, Catedra UAM-AMGEN, Hospital Universitario La Paz, Madrid, Spain.ORCID 0000-0003-4867-1420
Rocio Garcia-CarboneroDepartment of Medical Oncology, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
Jaume CapdevilaDepartment of Medical Oncology, Hospital Universitari Vall d'Hebron, Vall Hebron Institute of Oncology (VHIO), Barcelona, Spain.ORCID 0000-0001-8017-9941
Inmaculada GuaschDepartment of Medical Oncology, Hospital Althaia-Manresa, Manresa, Spain.
Vicente Alonso-OrdunaDepartment of Medical Oncology, Instituto de Investigacion Sanitaria de Aragon, Hospital Universitario Miguel Servet, Zaragoza, Spain.
Carlos LopezDepartment of Medical Oncology, Hospital Universitario Marques de Valdecilla, Santander, Spain.
Pilar Garcia-AlfonsoDepartment of Medical Oncology, Hospital General Universitario Gregorio Maranon, Madrid, Spain.
Carmen CastanonDepartment of Medical Oncology, Hospital Virgen Blanca, Leon, Spain.
Isabel SevillaInvestigacion Clinica y Traslacional en Cancer, Instituto de Investigaciones Biomedicas de Malaga (IBIMA), Hospitales Universitarios Regional y Virgen de la Victoria, Malaga, Spain.
Laura CerezoDepartment of Radiation Oncology, Hospital Universitario de La Princesa, Madrid, Spain.
Carles ConillDepartment of Radiation Oncology, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain.
Begona Quintana-AngelDepartment of Radiation Oncology, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
Maria E SanchezDepartment of Oncology, Hospital Universitario La Paz, Madrid, Spain.
Ismael GhanemDepartment of Medical Oncology, CIBERONC, Catedra UAM-AMGEN, Hospital Universitario La Paz, Madrid, Spain.
Marta Martin-RichardDepartment of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Miriam Lopez-GomezDepartment of Medical Oncology, Hospital Universitario Infanta Sofia, Madrid, Spain.
Ana LeonDepartment of Medical Oncology, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain.
Monica CaroDepartment of Radiation Oncology, ICO Badalona, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Teresa FernandezDepartment of Medical Oncology, Hospital Son Llatzer, Palma de Mallorca, Spain.
Joan MaurelDepartment of Medical Oncology, Hospital Clinic, Translational Genomics and Targeted Therapeutics in Solid Tumours Group, IDIBAPS, University of Barcelona, Barcelona, Spain.
Hospital Universitario La Paz · ESAlthaia · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESHospital Clínic de Barcelona · ESHospital de Sant Pau · ESHospital General Universitario Gregorio Marañón · ESHospital Son Llatzer · ESHospital Universitari Germans Trias i Pujol · ESHospital Universitario 12 De Octubre · ESHospital Universitario de La Princesa · ESHospital Universitario Fundación Jiménez Díaz · ESHospital Universitario Infanta Sofía · ESHospital Universitario Miguel Servet · ESHospital Universitario Virgen del Rocío · ESInstituto de Investigación Biomédica de Málaga · ESMarqués de Valdecilla University Hospital · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimVITAL, a phase II single-arm study, aimed to evaluate efficacy and safety of panitumumab addition to 5-fluorouracil (5-FU), mitomycin-C (MMC) and radiotherapy (RT) in patients with localized squamous cell carcinoma of the anal canal (SCCAC).

methodsAdult, treatment-naïve SCCAC patients (Stage T2-T4, any N, M0) and ECOG-PS ≤2, received panitumumab (6 mg/kg, day 1 and Q2W; 8 weeks), 5-FU (1000 mg/m

resultsFifty-eight patients (31 women; median age: 59 years; ECOG-PS 0-1:98%; TNM II [29%] (T2 or T3/N0/M0)/IIIA (T1-T3/N1/M0 or T4/N0/M0) [21%]/IIIB (T4/N1/M0 or any T/N2 or N3/M0) [47%]/nonevaluable [4%]) were included. The median follow-up was 45 months. The 3-year DFS rate was 61.1% (95% CI: 47.1, 72.4). The 3-year overall survival rate was 78.4% (95% CI: 65.1, 87.1). Eighteen patients (31.0%) required a colostomy within 2 years posttreatment. Grade 3-4 toxicities were experienced by 53 (91%) patients. Most common grade 3-4 treatment-related events were radiation skin injury (40%) and neutropenia (24%). No toxic deaths occurred. Improved efficacy in colostomy-free survival and complete response rate was observed in human papilloma virus positive patients.

conclusionsPanitumumab addition to MMC-5FU regimen in SCCAC patients increases toxicity and does not improve patients' outcomes. RT plus MMC-5FU remains the standard of care for localized SCCAC patients.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAnus NeoplasmsChemoradiotherapy, AdjuvantDisease-Free SurvivalFemaleFluorouracilFollow-Up StudiesHumansMaleMiddle AgedMitomycinNeoadjuvant TherapyNeutropeniaFluorouracilMitomycinPanitumumabchemotherapyradiotherapyrectal cancertarget therapy

Identifiers

PMID31851776
PMCPMC6997048
OpenAlexW2995952748

What OpenQuestion holds

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Registered trials

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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.