Erbitux

Esophageal Cancer News



Erbitux® May Improve Treatment of Squamous Cell Carcinoma of the Esophagus
Researchers from Germany have reported that Erbitux® (cetuximab) improves response rate, time to disease progression, and overall survival of patients with metastatic squamous cell carcinoma receiving Platinol® (cisplatin) and 5-FU. The details of this study appeared in the October 2009 issue of Annals of Oncology.[1]

Esophageal cancer is relatively common and is very deadly. It 1998 there were approximately 12,300 new cases of esophageal cancer diagnosed in the United States and nearly 12,000 esophageal cancer deaths, making esophageal cancer one of the most deadly of all cancers. Most cancers of the upper two-thirds of the esophagus arise from squamous cells. Cancers of the lower esophagus most often arise from columnar epithelium and are adenocarcinomas. In the recent past, squamous cell cancers made up more than 80% of all esophageal cancers. Over the past two decades, there has been a dramatic increase in the incidence of adenocarcinomas, which now account for one-third to one-half of all esophageal cancers. However, squamous cell carcinoma of the esophagus remains a major problem and is difficult to treat when metastatic. Usual treatment for metastatic squamous cell carcinoma of the esophagus includes a platinum compound and 5-FU.

Erbitux is a chimeric monoclonal antibody that binds to the outer domain of the epidermal growth factor receptor (EGFR). It is currently approved, in combination with radiation therapy, for the treatment of locally or regionally advanced head and neck cancer, or as a single agent in the treatment of advanced, EGFR-expressing head and neck cancer that has failed prior platinum-based therapies. Early studies have suggested activity for Erbitux for treating squamous cell carcinoma of the esophagus.

The current study randomly allocated 62 patients with metastatic squamous cell carcinoma of the esophagus to treatment with Platinol and 5-FU with or without Erbitux. Toxicity of Erbitux included skin rash and diarrhea. The overall response rate of patients receiving Erbitux was 19% compared with 13% for the chemotherapy-alone group. Disease-control rate was 75% for patients receiving Erbitux and 57% for patients receiving chemotherapy alone. The median progression-free survival was 5.9 months for patients receiving Erbitux and 3.6 months for patients receiving chemotherapy alone. Median survival was 9.5 months for patients receiving Erbitux and 5.5 months for patients receiving chemotherapy alone. No KRAS mutations were identified in 37 specimens.

Comments: Erbitux appears to be active for the treatment of squamous cell carcinoma of the esophagus.


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ASCO GI: Advanced Esophageal Cancer Benefits from Multimodality Neoadjuvant Therapy
By Charles Bankhead, Staff Writer, MedPage Today
Published: January 16, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.


SAN FRANCISCO, Jan. 16 -- Patients with locally advanced esophageal and gastric cancer had a high rate of pathologic complete response and resectability with neoadjuvant cetuximab (Erbitux) and chemoradiation, according to a study reported here. Action Points
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Explain to patients that combining a biologic agent, chemotherapy, and radiation may allow more patients with advanced esophageal cancer to have surgery, which is associated with improved survival.


Point out that the findings are based on a relatively small group of patients.


Note that this study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Between 40% and 50% of the patients achieved complete or near-complete pathologic response by clinical and surgical criteria, Harold Wanebo, M.D., of City of Hope in Duarte, Calif., said at the Gastrointestinal Cancers Symposium.


The patient population had an overall survival of 29 months and disease-free survival of 24 months.


"Cetuximab-based neoadjuvant therapy of high-staged esophageal cancer is associated with a high rate of clinical-pathologic complete response and surgical resectability with low toxicity and warrants further study," Dr. Wanebo concluded.


In studies involving patients with colon and head and neck cancer, cetuximab improved survival when combined with chemotherapy and radiation. Following those encouraging results, Dr. Wanebo and colleagues conducted a phase II clinical trial of cetuximab-based chemoradiation in patients with locally advanced esophageal and gastric cancer.


The trial focused on downstaging, surgical resectability, and disease-free survival.


The study group included 55 patients with esophageal cancer and five with gastric cancer. The neoadjuvant protocol consisted of five weekly doses of cetuximab, six weekly rounds of paclitaxel and carboplatin, and a 50-Gy cumulative dose of radiation.


Dr. Wanebo presented findings on 55 evaluable patients, 44 (80%) who had surgery and 11 who had only endoscopic staging. Three of the 11 patients had borderline operable disease, and the other eight declined surgery.


In the surgery group, 28 (64%) had endoscopic complete responses to neoadjuvant therapy, as did nine (82%) of the patients who had endoscopy only.


Of 39 patients evaluated for clinical/pathologic response to neoadjuvant therapy, 19 (49%) had complete responses, 11 (28%) had partial responses, and the remaining nine had stable disease.


Postsurgical pathologic assessment of response to neoadjuvant therapy revealed:


Complete pathologic responses in 11 of 44 (25%) patients
Near-complete pathologic response (microscopic residuals) in eight patients (18%)
Clinical/pathologic partial responses in 10 patients (23%)
Stable disease in 15 patients (34%)

Surgery was associated with a two-fold improvement in overall survival, 29 months versus 14 months in patients who did not have surgery (P=0.002).


Major toxicities were grade 3-4 esophageal mucositis in 10 patients, grade 3-4 dehydration in five patients, and drug hypersensitivity in two patients.


Initial disease stage and type of surgical resection did not significantly influence the principal outcomes.


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