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Title: Targeted Therapy Plus Irinotecan and Cisplatin Appears Effective in Metastatic Gastric Cancer: Presented at ASCO-GI

"Targeted Therapy Plus Irinotecan and Cisplatin Appears Effective in Metastatic Gastric Cancer: Presented at ASCO-GI"

By Ed Susman HOLLYWOOD, FL -- January 27, 2005 -- Preliminary results indicate that treatment with the chemotherapeutic agents irinotecan and cisplatin in combination with bevacizumab, a drug that targets blood vessel growth, offers patients durable control of metastatic gastric and esophageal cancer. "About 76% of our patients have not progressed in more than 6 months," said Manish Shah, MD, assistant attending physician, Memorial Sloan-Kettering Cancer Center, New York, New York. "We have yet to reach a median time to progression," he said during his poster presentation here on January 27[^th at the 2005 Gastrointestinal Cancers Symposium.

Dr. Shah said the goal of the trial is to improve survival by about 50% -- from a median of 5 months to at least 7.5 months. "We realize this is an ambitious goal," he said, "but we believe that we are going to achieve the goal." Patient follow-up at the time of presentation was 4.5 months, he said.

The researchers have enrolled 20 patients in the study and Dr. Shah reported on 16 evaluable patients. He said that 12 of those patients achieved objective partial responses on the regimen. Three of the remaining 4 evaluable patients were able to achieve durable disease stabilization of at least 6 weeks. Four patients have progressed.

Patients were first treated with bevacizumab, a monoclonal antibody that targets vascular endothelial growth factor -- a protein that is vital for development of blood vessels required for growth and spread of the malignancy. They received an infusion of bevacizumab in a dose of 15 mg/kg on day 1; irinotecan 65 mg/m² and cisplatin 30 mg/m² on days 1 and 8. The cycle was repeated every 21 days.

"The combination of irinotecan, cisplatin, and bevacizumab is safe and feasible in the treatment of gastric and esophageal cancer, even without resection of the primary tumor," Dr. Shah said. "Though preliminary, the high disease control rate is noteworthy."

The treatment was well tolerated, he said, and noted that there were some thromboembolic events, although the researchers could not determine whether these events were caused by treatment or due to the thrombogenic nature of the disease process itself. No excess neuropathy or excessive bleeding was noted, Dr. Shah said.

The symposium was cosponsored by the American Society of Clinical Oncology, the American Gastroenterological Association, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

[Presentation title: A Multicenter Phase II Study Of Irinotecan, Cisplatin and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma. Abstract 26]

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