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)
Feliu, Jaime (Hospital Universitario La Paz (Madrid))
Garcia-Carbonero, Rocio (Hospital Universitario 12 de Octubre (Madrid))
Capdevila, J (Vall d'Hebron Institut d'Oncologia)
Guasch, Inmaculada (Hospital Althaia Assistencial de Manresa)
Alonso-Orduña, Vícente (Hospital Universitario Miguel Servet (Saragossa))
López-López, Carlos A. (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
García-Alfonso, Pilar (Hospital General Universitario Gregorio Marañón)
Castañón, Carmen (Hospital Virgen Blanca)
Sevilla, Isabel Ñíguez (Hospital Universitario Virgen de la Victoria (Màlaga, Andalusia))
Cerezo, Laura (Hospital Universitario de la Princesa (Madrid))
Conill, Carlos (Universitat de Barcelona)
Quintana Ángel, Begoña (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Sánchez, María E. (Hospital Universitario La Paz (Madrid))
Ghanem, Ismael (Hospital Universitario La Paz (Madrid))
Martín-Richard, Marta (Institut d'Investigació Biomèdica Sant Pau)
Lopez-Gomez, Miriam (Hospital Universitario Infanta Sofía (San Sebastián de los Reyes))
León, Ana Isabel (Hospital Universitario Fundacion Jimenez Diaz)
Caro, Monica (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Fernandez, Teresa López (Hospital Universitari Son Llàtzer (Palma de Mallorca, Balears))
Maurel, Joan (Universitat de Barcelona)
Universitat Autònoma de Barcelona

Date:	2020
Abstract:	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). 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/m/d, days 1-4 and 29-32), MMC (10 mg/m, 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%). 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. 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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Chemotherapy ; Radiotherapy ; Rectal cancer ; Target therapy
Published in:	Cancer Medicine, Vol. 9 Núm. 3 (january 2020) , p. 1008-1016, ISSN 2045-7634

DOI: 10.1002/cam4.2722
PMID: 31851776

9 p, 267.6 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles