614TiP - Double-blind, placebo-controlled, multicenter, randomized, phase ii study of nimotuzumab in combination with mitomycin, 5-fluorouracil and radiatio...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Anal Cancer
Cancer in Special Situations
Surgical Oncology
Biological Therapy
Radiation Oncology
Presenter Urbicio Pérez González
Citation Annals of Oncology (2014) 25 (suppl_4): iv167-iv209. 10.1093/annonc/mdu333
Authors U. Pérez González1, F.F. Llorente Llano2, M.F. Ramos Suzarte3, J.E. Rodríguez Reigosa4, B.F. Mestre Fernández4, M. Osorio Rodríguez4, E.A. Gracia Medina4, M.R. Orellana Alvarado5, I. Leonard Feliú6, Y.T. Ojeda Abizaid6, J. Alert Silva7, A.M. Ulloa Balmaseda7, N.Y. González Barallobre2, E. Galá Barrios2, N. Curbelo Sevillano2, R.B. Jiménez García2, B.B. Brunet Flores2, M. Cedeño Arias8, R. Blanco Santana8
  • 1Medical Oncology, National Institute of Oncology and Radiobiology, 10400 - Havana/CU
  • 2Colorectal Surgery, Manuel Fajardo Clinical and Teaching Hospital, Havana/CU
  • 3Clinical Immunology, Center of Molecular Immunology, Havana/CU
  • 4Medical Oncology, National Institute of Oncology and Radiobiology, Havana/CU
  • 5Clinical Research, National Institute of Oncology and Radiobiology, Havana/CU
  • 6Gastroenterology, National Institute of Oncology and Radiobiology, Havana/CU
  • 7Radiation Oncology, National Institute of Oncology and Radiobiology, Havana/CU
  • 8Immunohistochemistry, Center of Molecular Immunology, Havana/CU



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.


All authors have declared no conflicts of interest.