Cetuximab in non-small-cell lung cancer

Guido Carillio, Agnese Montanino, Raffaele Costanzo, Claudia Sandomenico, Maria Carmela Piccirillo, Massimo Di Maio, Gennaro Daniele, Pasqualina Giordano, Jane Bryce, Nicola Normanno, Gaetano Rocco, Francesco Perrone, Alessandro Morabito

Research output: Contribution to journalArticlepeer-review


Cetuximab is a chimeric human-mouse anti-EGF receptor monoclonal antibody. In Phase I studies, no dose-limiting toxicities were observed with cetuximab as a single agent or combined with chemotherapy; pharmacokinetic and pharmacodynamic analyses supported 250 mg/m 2 weekly administration. Skin toxicity, diarrhea and fatigue were the most common toxicities. The positive results obtained in Phase II trials in patients with advanced non-small-cell lung cancer prompted two randomized Phase III trials evaluating cetuximab in addition to first-line chemotherapy. Both trials showed a small benefit in overall survival for the experimental treatment, which was considered insufficient by the EMA for marketing approval. However, a subgroup analysis of the FLEX Phase III trial recently demonstrated a larger survival benefit from the experimental treatment in patients with high immunohistochemical EGF receptor expression. This finding, if confirmed prospectively, could represent a new opportunity for positioning cetuximab into the standard treatment of advanced non-small-cell lung carcinoma.

Original languageEnglish
Pages (from-to)163-175
Number of pages13
JournalExpert Review of Anticancer Therapy
Issue number2
Publication statusPublished - Feb 2012


  • cetuximab
  • clinical trials
  • EGFR

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Oncology


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