614TiPDOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, RANDOMIZED, PHASE II STUDY OF NIMOTUZUMAB IN COMBINATION WITH MITOMYCIN, 5-FLUOROURACIL AND RADIATION IN IMMUNOCOMPETENT PATIENTS WITH ANAL CARCINOMA

• Published in: Annals of oncology Vol. 25; no. suppl_4; p. iv209
• Main Authors: González, U. Pérez, Llano, F.F. Llorente, Suzarte, M. Ramos, Reigosa, J.E. Rodríguez, Fernández, B.F. Mestre, Rodríguez, M. Osorio, Medina, E.A. Gracia, Alvarado, M.R. Orellana, Feliú, I. Leonard, Abizaid, Y.T. Ojeda, Silva, J. Alert, Balmaseda, A.M. Ulloa, Barallobre, N.Y. González, Barrios, E. Galá, Sevillano, N. Curbelo, García, R.B. Jiménez, Flores, B.B. Brunet, Arias, M. Cedeño, Santana, R. Blanco
• Format: Journal Article
• Language: English
• Published: Oxford University Press 01.09.2014
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdu333.115

Abstract Background: Anal carcinoma is an uncommon malignancy associated principally with human papilloma virus. The epidermal growth factor receptor (EGFR) protein expression in this localization is frequent and a low rate of KRAS mutation has been described, as a result, the use of an EGFR inhibitor has been considered to be a promising avenue of investigation. Nimotuzumab is a humanized monoclonal antibody that recognizes the EGFR with high affinity and specificity. It has shown antitumor activity similar to other anti-EGFR monoclonal antibodies with low rate of adverse events in different clinical settings. There is no clinical data regarding the impact of nimotuzumab in anal carcinoma. Trial design: Immunocompetent patients with histologically confirmed anal carcinoma (stage I-IIIB) received concurrent chemoradiotherapy with Mitomycin (10 mg/m2 IV bolus days 1 and 29) and continuous infusion of 5-FU (1000 mg/m2/d IV days 1-4 and 29-32) concurrently with RT (45-54 Gy) and combination with weekly Nimotuzumab (200 mg) for 12 doses. Treatment with nimotuzumab will be continue monthly up to one year treatment. The trial was designed to evaluate the safety and antitumor effect of nimotuzumab and chemoradiotherapy as primaries end points. Two years progression-free survival (PFS), overall survival (OS), colostomy rate, and over-expression of the EGFR and the correlation with the response rate and survival will be evaluated too. Disclosure: All authors have declared no conflicts of interest.