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oai:repisalud.isciii.es:20.500.12105/179422024-02-10T20:02:39Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16938col_20.500.12105_16927col_20.500.12105_16961col_20.500.12105_16973

00925njm 22002777a 4500 dc Feliu, Jaime author Garcia-Carbonero, Rocio author Capdevila, Jaume author Guasch, Inmaculada author Alonso-Orduna, Vicente author Lopez, Carlos author Garcia-Alfonso, Pilar author Castanon, Carmen author Sevilla, Isabel author Cerezo, Laura author Conill, Carles author Quintana-Angel, Begona author Sanchez, Maria E author Ghanem, Ismael author Martin-Richard, Marta author Lopez-Gomez, Miriam author Leon, Ana author Caro, Monica author Fernandez, Teresa author Maurel, Joan author 2019-12-18 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/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. http://hdl.handle.net/10668/14847 http://hdl.handle.net/20.500.12105/17942 31851776 10.1002/cam4.2722 2045-7634 Cancer medicine Chemotherapy Radiotherapy Rectal cancer Target therapy 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).