Feliu, JaimeGarcia-Carbonero, RocioCapdevila, JaumeGuasch, InmaculadaAlonso-Orduna, VicenteLopez, CarlosGarcia-Alfonso, PilarCastanon, CarmenSevilla, IsabelCerezo, LauraConill, CarlesQuintana-Angel, BegonaSanchez, Maria EGhanem, IsmaelMartin-Richard, MartaLopez-Gomez, MiriamLeon, AnaCaro, MonicaFernandez, TeresaMaurel, Joan2023-02-082023-02-082019-12-18http://hdl.handle.net/10668/14847VITAL, 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/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%). 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.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/chemotherapyradiotherapyrectal cancertarget therapyAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAnus NeoplasmsChemoradiotherapy, AdjuvantDisease-Free SurvivalFemaleFluorouracilFollow-Up StudiesHumansMaleMiddle AgedMitomycinNeoadjuvant TherapyNeutropeniaPanitumumabProctectomyRadiodermatitisSeverity of Illness IndexSurvival Rateresearch article31851776open access10.1002/cam4.27222045-7634PMC6997048https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cam4.2722https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6997048/pdf