Continued Response Following Treatment with IMC-C225, an EGFr MoAb, Combined with RT in Advanced Head and Neck Malignancies.

Jason Lee, MD
OncoLink Assistant Editor
Last Modified: May 23, 2000

Presenter: James A. Bonner
Affiliation: University of Alabama, ImClone


  • Radiation therapy with or without chemotherapy is standard therapy for locally advanced head and neck squamous cell cancer

  • Because of the relatively poor outcome with nonoperative therapy, newer systemic agents are being investigated which may improve the local response to radiation therapy as well as improve distant control of disease

  • Head and neck cancers commonly overexpress epidermal growth factor receptors (EGFr), which may lead to increased angiogenesis and tumor growth

  • A monoclonal antibody to EGFr (C225, ImClone) has been developed which appears to be efficacious in blocking EGFr activity

  • A single arm trial was conducted to assess tolerability and efficacy of C225 with radiation therapy for advanced head and neck cancer

Materials and Methods:

  • 16 patients with locally advanced head and neck cancer (2 oral cavity, 11 oropharynx, 2 hypopharynx, 1 larynx) were enrolled at the Univ. of Alabama

  • All patients expressed EGFr, and the majority had high levels of receptor expression

  • Patients received standard external beam radiation therapy in conjunction with intravenous C225 for 8 weeks

  • Patients were assessed for clinical response and toxicity

  • All 15 evaluable patients achieved a major objective clinical response, and all but 1 experienced a complete response (1 patient with hypopharyngeal cancer was inevaluable for response)

  • The median duration of response has been over 16.9 months

  • At last followup, 9 patients are alive and without evidence of disease, whereas 6 patients with local failures all died of disease

  • The 2-year overall survival is 60%

  • Non-dose-limiting toxicity included a follicular rash over the face and back which resembles acne as well as an allergic reaction

  • The toxicity profile was similar to that expected with radiation therapy alone for head and neck cancer; the additional follicular rash did not contribute to increased radiodermatitis
Authors' Conclusions

  • Radiation therapy and monoclonal antibody to EGFr C225 is a well-tolerated regimen for locally advanced head and neck cancer and appears to result in a high level of clinical responses

  • Because this is not a randomized trial, the additive effect of C225 cannot be determined from this trial
Clinical/Scientific Implications:
    A randomized trial of C225 for head and neck cancer is warranted and underway, which enrolled about 120 patients thus far.