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Title: Pancreatic Cancer Patients Respond in Phase 2 Study of Gemcitabine, Cisplatin, and Bevacizumab: Presented at ASCO-GI

"Pancreatic Cancer Patients Respond in Phase 2 Study of Gemcitabine, Cisplatin, and Bevacizumab: Presented at ASCO-GI"

By Ed Susman SAN FRANCISCO, CA -- January 30, 2006 -- Researchers reported a 39% 1-year survival rate among patients with metastatic pancreatic who were treated with an experimental protocol that included gemcitabine, cisplatin, and the molecular targeting agent bevacizumab (Avastin). "We think these results are promising," said Andrew Ko, MD, assistant clinical professor of hematology/oncology, University of California, San Francisco, California, during his poster presentation here on January 27[^th at the 42^nd Annual Meeting of the American Society of Clinical Oncology - Gastrointestinal Cancer Symposium (ASCO-GI).

Of the 35 patients enrolled into the single-institution phase 2 study, 1 person achieved a complete response that lasted for more than 1 year, Dr. Ko said. In addition, 6 patients achieved partial responses and 15 patients had stable disease.

"Disease control -- complete response plus partial response plus stable disease -- was achieved by 66.7% of the patients in this study," he said.

Median survival was evaluated after 288 days, and was 8 months for the cohort as a whole. "The estimated 1-year survival is 39%," Dr. Ko said, noting that all the patients in the study had either been diagnosed when the disease was already metastatic or had cancer recurrence after undergoing a Whipple procedure, in which the head of the pancreas, the duodenum, a portion of the stomach, and other nearby tissues are removed.

"The combination of fixed-dose rate gemcitabine, low-dose cisplatin, and bevacizumab appears to be very active in patients with metastatic pancreatic cancer," Dr. Ko said. "However, the potential benefits of this regimen need to be carefully weighed against the considerable toxicity observed on the study."

Patients were given gemcitabine 1000 mg/m², cisplatin 20 mg/m², and bevacizumab 10 mg/kg on day 1 and day 15 of a 28-day cycle. Computer-assisted tomography scans were performed every 2 cycles.

About 25% of patients developed grade 3 or worse liver toxicity; 11% developed hypertension, and major bleeding events occurred in 8.6% of patients. Two patients had bowel perforation and 1 person suffered a stroke-like event.

Dr. Ko said better patient selection such as excluding patients with tumors that were protruding through organ walls might reduce some of those complications.

"The high response rate in this single-institution study is encouraging," said A. William Blackstock, MD, associate professor in radiology oncology, Wake Forest University, Winston-Salem, North Carolina.

The conference was cosponsored by the American Society of Clinical Oncology, the American Gastrointestinal Associations, the Society of Surgical Oncology, and the American Society for Therapeutic Radiology and Oncology.

[Presentation title: A Phase II Study of Gemcitabine Given at Fixed-Dose Rate Infusion, Low-Dose Cisplatin and Bevacizumab for Metastatic Adenocarcinoma of the Pancreas. Abstract 115]

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