RT Journal Article
T1 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).
A1 Feliu, Jaime
A1 Garcia-Carbonero, Rocio
A1 Capdevila, Jaume
A1 Guasch, Inmaculada
A1 Alonso-Orduna, Vicente
A1 Lopez, Carlos
A1 Garcia-Alfonso, Pilar
A1 Castanon, Carmen
A1 Sevilla, Isabel
A1 Cerezo, Laura
A1 Conill, Carles
A1 Quintana-Angel, Begona
A1 Sanchez, Maria E
A1 Ghanem, Ismael
A1 Martin-Richard, Marta
A1 Lopez-Gomez, Miriam
A1 Leon, Ana
A1 Caro, Monica
A1 Fernandez, Teresa
A1 Maurel, Joan
K1 chemotherapy
K1 radiotherapy
K1 rectal cancer
K1 target therapy
AB 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.
YR 2019
FD 2019-12-18
LK http://hdl.handle.net/10668/14847
UL http://hdl.handle.net/10668/14847
LA en
DS RISalud
RD Apr 6, 2025