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Title: Metastatic Gastric Cancer Patients Respond to Cetuximab Plus FOLFIRI Regimen: Presented at ASCO-GI

"Metastatic Gastric Cancer Patients Respond to Cetuximab Plus FOLFIRI Regimen: Presented at ASCO-GI"

By Ed Susman SAN FRANCISCO, CA -- January 30, 2006 -- At least 80% of patients with metastatic gastric cancer appear to achieve some clinical benefit from a chemotherapy regimen in which cetuximab is added to the standard FOLFIRI (5-fluorouracil, leucovorin and irinotecan) regimen. "The combination of cetuximab and FOLFIRI appears to be active in nonresectable/metastatic gastric and gastroesophageal junction adenocarcinoma," said Carmine Pinto, MD, medical oncologist, S. Orsola-Malpighi Hospital, Bologna, Italy. Dr. Pinto presented his poster here on January 26[^th at the 42^nd Annual Meeting of the American Society of Clinical Oncology - Gastrointestinal Cancer Symposium (ASCO-GI).

His team of researchers conducted a phase 2 study to test the combination in 38 patients with advanced gastric cancer and overexpression of epidermal growth factor receptors in the primary or metastatic tumors.

Patients were started on the FOLFIRI regimen in 2-week cycles while receiving cetuximab 400 mg/m² as a loading dose in the first week, followed by 250 mg/m² weekly through 24 weeks. Patients who achieved a complete or partial remission or experienced disease stabilization at 6 months continued on cetuximab 250 mg/m² weekly.

Twenty-five patients were evaluable for response and 28 were evaluable for toxicity. Three of the patients, 12%, achieved a complete response, confirmed through positron emission tomography (PET). Another 11 patients had partial responses; 11 other patients had stable disease for at least 3 months.

"The progression-free survival at 3 months is 80%," Dr. Pinto said. One of the patients died of febrile neutropenia. Overall 53.6% of patients experienced grade 3 neutropenia. Two patients developed thrombocytopenia.

"The treatment was well tolerated," Dr. Pinto said. "The major toxicity appears to be limited to neutropenia."

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

[Presentation title: Phase II Study of Cetuximab in Combination With FOLFIRI as First-Line Treatment in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction adenocarcinoma (FOLCETUX Study): Preliminary Results. Abstract 63]

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