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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorFeliu, Jaime
dc.contributor.authorGarcia-Carbonero, Rocio
dc.contributor.authorCapdevila Castillon, Jaume
dc.contributor.authorGuasch, Inmaculada
dc.contributor.authorAlonso-Orduna, Vicente
dc.contributor.authorLópez Gil, Carlos
dc.date.accessioned2021-10-22T06:14:46Z
dc.date.available2021-10-22T06:14:46Z
dc.date.copyright2019
dc.date.issued2020-02
dc.identifier.citationFeliu J, Garcia-Carbonero R, Capdevila J, Guasch I, Alonso-Orduna V, Lopez C, et al. 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). Cancer Med. 2020 Feb;9(3):1008–16.
dc.identifier.issn2045-7634
dc.identifier.urihttp://hdl.handle.net/11351/6438
dc.descriptionChemotherapy; Radiotherapy; Rectal cancer
dc.description.abstractAim VITAL, 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). Methods Adult, 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/m2/d, days 1-4 and 29-32), MMC (10 mg/m2, days 1 and 29) and RT 45 Gy (1.8 Gy/fraction) to the primary tumor and mesorectal, iliac and inguinal lymph nodes, plus 10-15 Gy boost dose to the primary tumor and affected lymph nodes. The primary objective was disease free survival rate (DFS) at 3-years (expected 3-year DFS rate: 73.7 ± 12%). Results Fifty-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. Conclusions Panitumumab 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.
dc.language.isoeng
dc.publisherWiley
dc.relation.ispartofseriesCancer Medicine;9(3)
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectRecte - Càncer - Quimioteràpia
dc.subjectRecte - Càncer - Radioteràpia
dc.subject.meshCarcinoma, Squamous Cell
dc.subject.meshAnus Neoplasms
dc.subject.meshChemoradiotherapy, Adjuvant
dc.titleVITAL phase 2 study: Upfront 5-fluorouracil, mitomycin-C, panitumumab and radiotherapy treatment in nonmetastatic squamous cell carcinomas of the anal canal (GEMCAD 09-02)
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1002/cam4.2722
dc.subject.decscarcinoma de células escamosas
dc.subject.decsneoplasias del ano
dc.subject.decsquimiorradioterapia complementaria
dc.relation.publishversionhttps://doi.org/10.1002/cam4.2722
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Feliu J] Department of Medical Oncology, CIBERONC, Catedra UAM-AMGEN, Hospital Universitario La Paz, Madrid, Spain. [Garcia-Carbonero R] Department of Medical Oncology, Hospital Universitario Virgen del Rocio, Sevilla, Spain. Department of Medical Oncology, imas12, UCM, CNIO, CIBERONC, Hospital Universitario 12 de Octubre, Madrid, Spain. [Capdevila J] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Guasch I] Department of Medical Oncology, Hospital Althaia-Manresa, Manresa, Spain. [Alonso-Orduna V] Department of Medical Oncology, Instituto de Investigacion Sanitaria de Aragon, Hospital Universitario Miguel Servet, Zaragoza, Spain. [Lopez C] Department of Medical Oncology, Hospital Universitario Marques de Valdecilla, Santander, Spain
dc.identifier.pmid31851776
dc.identifier.wos000503116400001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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