• 8/24/2005
  • staff
  • cancerconsultants.com

According to two articles published in the Journal of Clinical Oncology, the addition of the targeted agent Erbitux (cetuximab) to chemotherapy improves anti-cancer responses in patients with advanced head and neck cancer that has stopped responding to standard therapies.

Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer; these include the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx, and other sites throughout the head and neck area. According to the American Cancer Society, 11,000 people died from head and neck cancer in 2004. Standard treatment for head and neck cancer is largely determined by the stage (extent to which the cancer has spread) and by the specific locations within the head or neck area where the cancer has spread. The patient’s overall medical condition is also a deciding factor.

Treatment typically consists of radiation therapy, chemotherapy with surgery, or surgery alone. Once head and neck cancer has spread from its site of origin or once the cancer has recurred or stopped responding to standard therapies (refractory), long-term outcomes are generally suboptimal. In fact, there are no standard therapies designated for patients with advanced, refractory head and neck cancer. Furthermore, treatment for head and neck cancer often results in a compromised quality of life. Research and development of new therapeutic approaches that will improve long-term outcomes and quality of life for patients with this disease continues.

The epidermal growth factor receptor (EGFR) pathway is a focus of this research. This biologic pathway plays a role in cellular replication and is often over expressed in cancer. Erbitux, a monoclonal antibody (or protein), has been produced in a laboratory with the purpose of binding to the EGFR and inhibiting the receptor’s effects on cellular replication. Erbitux is currently FDA-approved in combination with the chemotherapy agent Camptosar® (irinotecan) for the treatment of colorectal cancer that has stopped responding to irinotecan-based chemotherapy. The drug is also approved as a single agent in patients who are not able to tolerate treatment with irinotecan. Erbitux is currently being evaluated in clinical trials for the treatment of various types of cancers.

Researchers from Europe recently conducted a clinical trial to further evaluate the effectiveness of Erbitux in combination with platinum-based (Paraplatin®, Platinol®) chemotherapy.[1] This study included 96 patients with advanced head and neck cancer that had stopped responding to previous treatment with platinum-based chemotherapy. Overall, the addition of Erbitux to platinum-based chemotherapy provided significant anticancer activity in these patients. Over half (53%) of patients achieved either a partial or complete disappearance of detectable cancer or disease stabilization following Erbitux/chemotherapy. Cancer did not progress for an average of approximately 85 days, and the average overall survival was approximately 183 days. Treatment was well tolerated. Skin reactions were the most common side effect attributed to Erbitux.

A second trial, including multiple institutions in the United States, was also conducted to evaluate the addition of Erbitux to cisplatin (Platinol)-based chemotherapy in patients with advanced refractory head and neck cancer.[2] The trial included 76 patients who had previously received cisplatin-based chemotherapy alone. Of the participants, 25 patients’ cancer had progressed during this treatment, and 51 patients’ cancer had stabilized. None of these patients achieved an anticancer response while receiving cisplatin-based chemotherapy alone. For the trial, these patients were given Erbitux in addition to cisplatin-based chemotherapy. Twenty-six percent of patients whose cancer had progressed while being treated with cisplatin-based therapy alone achieved anti-cancer responses with the addition of Erbitux to cisplatin-based chemotherapy. Of the patients who achieved disease stabilization on cisplatin-based chemotherapy alone, 18% achieved anticancer responses with the addition of Erbitux. Again, skin-like reactions appeared to be the most common side effects of treatment with Erbitux.

The researchers concluded that the addition of Erbitux to platinum-based chemotherapy regimens appears to provide anticancer responses and possibly improves long-term outcomes in patients with head and neck cancer that had stopped responding to platinum-based chemotherapy alone. Patients with refractory head and neck cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating Erbitux or other novel therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (www.cancer.gov) or www.cancerconsultants.com.

References:

[1] Baselga J, Trigo J, Bourhis J, et al. Phase II Multicenter Study of the Antiepidermal Growth Factor Receptor Monoclonal Antibody Cetuximab in Combination With Platinum-Based Chemotherapy in Patients With Platinum-Refractory Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck. Journal of Clinical Oncology. 2005; 23: 5568–5577.
[2] Herbst R, Arquette M, Shin D, et al. Phase II Multicenter Study of the Epidermal Growth Factor Receptor Antibody Cetuximab and Cisplatin for Recurrent and Refractory Squamous Cell Carcinoma of the Head and Neck. Journal of Clinical Oncology. 2005;23: 5578–5587