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Efficacy And Safety Of The Anti-Epidermal Growth Factor Antibody (EGFR) IMC-C225, In Combination With Cisplatin In Patients With Recurrent Squamous Cell Carcinoma Of The Head And Neck (SCCHN) Refractory To Cisplatin Containing Chemotherapy

Diana Stripp, MD

University of Pennsylvania Cancer
Last Modified: May 13, 2001

Presenter: Waun Ki Hong/Roy S. Herbst
Affiliation: Anderson Cancer Center

Background:

• Patients with recurrent SCCHN who fail to respond to platinum-based therapy rarely respond to second-line treatment
• This study was performed to evaluate IMC-C225 in patients that have failed standard chemotherapy.

Materials and Methods:

• Patients (pts) with recurrent SCCHN received 2 cycles of a cisplatin (CDDP) containing regimen.
• Those with either progressive or stable disease went on to receive CDDP + IMC-C225 (41 patients).
• Pts received IMC-C225, 400 mg/m2 loading dose followed by 250 mg/m2, weekly, plus intravenous cDDP at the same dose and schedule previously administered.
• This study only addresses the 41 patients with stable disease who went on to receive CDDP+IMC-C225

Results:

• Seventy-five percent of the patients were male, the mean age was 54.4 years (range 39-76 years)
• The most commonly reported adverse events related to IMC-C225 therapy were folliculitis/acne and allergic reactions (5%).
• Ten (24%) patients achieved an objective response to therapy (one complete response and nine partial responses), and 25 (61%) patients maintained stable disease.
• The trial for the progressive disease subgroup is still ongoing and will be presented at a future time.

Authors' Conclusions

• IMC-C225 in combination with CDDP appears to be well tolerated and the response rate suggests clinical activity for this combination of biologic and cytotoxic therapy.
• IMC-C225 has potential for treatment of all advanced stage of disease

Clinical/Scientific Implications:

• In analyses of the 22 pts with progression of disease after the induction chemotherapy regimen which were not reported in the abstract, it was reported 23% achieved an objective response to therapy.
• This is a promising molecular targeting strategy that has potential to become and important avenue for cancer treatment in the future.