dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Feliu, Jaime |
dc.contributor.author | Guasch, Inmaculada |
dc.contributor.author | Alonso-Orduna, Vicente |
dc.contributor.author | López Gil, Carlos |
dc.contributor.author | Capdevila Castillon, Jaume |
dc.contributor.author | Garcia-Carbonero, Rocio |
dc.date.accessioned | 2021-10-22T06:14:46Z |
dc.date.available | 2021-10-22T06:14:46Z |
dc.date.copyright | 2019 |
dc.date.issued | 2020-02 |
dc.identifier.citation | Feliu 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.issn | 2045-7634 |
dc.identifier.uri | https://hdl.handle.net/11351/6438 |
dc.description | Chemotherapy; Radiotherapy; Rectal cancer |
dc.description.abstract | Aim
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.iso | eng |
dc.publisher | Wiley |
dc.relation.ispartofseries | Cancer Medicine;9(3) |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Recte - Càncer - Quimioteràpia |
dc.subject | Recte - Càncer - Radioteràpia |
dc.subject.mesh | Carcinoma, Squamous Cell |
dc.subject.mesh | Anus Neoplasms |
dc.subject.mesh | Chemoradiotherapy, Adjuvant |
dc.title | 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) |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1002/cam4.2722 |
dc.subject.decs | carcinoma de células escamosas |
dc.subject.decs | neoplasias del ano |
dc.subject.decs | quimiorradioterapia complementaria |
dc.relation.publishversion | https://doi.org/10.1002/cam4.2722 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut 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.pmid | 31851776 |
dc.identifier.wos | 000503116400001 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |