Clinical Study

Nimotuzumab plus radiotherapy for unresectable squamous-cell carcinoma of the head and neck

Volume 9, Issue 5   March 1, 2010
Pages 343 - 349
http://dx.doi.org/10.4161/cbt.9.5.10981
Authors: Marta Osorio Rodríguez, Teresa Cruz Rivero, Ramón Del Castillo Bahi, Carlos Roca Muchuli, Miguel Azcue Bilbao, Elia Neninger Vinageras, José Alert, Julio Jiménez Galainena, Edmundo Rodríguez, Elías Gracia, Bárbara Mulén, Bárbara Wilkinson, Esther Lucía de Armas, Kirenia Pérez, Idael Pineda, Milagros Frómeta, Idrissa Leonard, Vladimir Mullens, Carmen Viada, Patricia Luaces, Olga Torres, Normando Iznaga and Tania Crombet

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Abstract:

The prognosis of patients with advanced head and neck cancer remain dismal. For this tumor type, elevated levels of EGFR are associated with a shorter disease free survival and time to treatment failure, reflecting a more aggressive phenotype. Nimotuzumab is a humanized monoclonal antibody that recognizes domain III of the extracellular region of the EGFR, within an area that overlaps with both the surface patch recognized by cetuximab and the binding site for EGF. In order to assess the efficacy of nimotuzumab in combination with radiotherapy, a controlled, double blind, randomized clinical trial was conducted in 106 advanced squamous cell carcinoma of the head and neck patients, mostly, unfit for chemo-radiotherapy. Control patients received a placebo and radiotherapy.
Treatment was safe and the most frequent adverse events consisted on grade I or II asthenia, fever, headache and chills. No skin rash was detected. A significant complete response rate improvement was found in the group of patients treated with nimotuzumab as compared to the placebo. In the intent to treat analysis, a trend towards survival benefit for nimotuzumab treated subjects was found. The survival benefit became significant when applying the Harrington-Fleming test, a weighted log-rank that underscores the detection of differences deferred on time.  In addition, a preliminary biomarker investigation showed a significant survival improvement for nimotuzumab treated patients as compared to controls for subjects with EGFR positive tumors. All patients showed a quality of life improvement and a reduction of the general and specific symptoms of the disease.

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