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        Interferon Therapy Improves Pancreatic Cancer Survival in Phase 2 Study: Presented at SSO

        By John Gever

        WASHINGTON, DC -- March 19, 2007 -- Adjuvant chemoradiation therapy including interferon-alpha and gemcitabine produced modest improvements in overall survival in pancreatic adenocarcinoma relative to conventional treatments, according to research presented here at the 60th annual meeting of the Society of Surgical Oncology (SSO).

        However, the regimen was about as toxic as other chemoradiation therapies.

        Marcus Tan, MD, clinical research fellow, department of surgery, Washington University, St. Louis, Missouri, United States, reported on a new phase 2 trial in which interferon-alpha was added to conventional radiation and chemotherapy.

        The trial enrolled 53 patients with pancreatic tumours, most with stage IIb or III disease, who initially underwent curative resection. They then received 6 weeks of chemoradiation, including 5,040 cGy external beam radiation, continuous infusion of 5-fluorouracil at 175 mg/m2, intravenous cisplatin 25 mg/m2 weekly, and 3 million units subcutaneous interferon-alpha 3 times weekly. This was followed by 2 4-week cycles of gemcitabine.

        In an oral presentation on March 16th, Dr. Tan said the study's primary endpoint was 2-year overall survival, with 2-year disease-free survival and frequency of grade 3/4 toxicities as secondary measures.

        With median follow-up of 38 months, the 2-year overall survival rate was 56%. Median survival time was 25 months. These results compared favourably to conventional therapies without interferon, with which 2-year survival rates of 37% to 48% have been obtained.

        Perhaps more encouraging, most long-term survivors remained in complete remission, with a 2-year disease-free survival rate of 51%.

        Grade 3/4 toxicities occurred in more than 90% of patients in the trial, Dr. Tan said. These were primarily haematological and gastrointestinal in nature. Nine patients did not complete the scheduled therapy due to toxicity. Interestingly, Dr. Tan said, some of these patients survived past the median.

        "We were surprised that we had a different spectrum of toxicities" relative to an earlier trial, he also noted. That trial, conducted at the Virginia Mason Cancer Center in Seattle, Washington, United States, involved a similar regimen but without gemcitabine. The different toxicities rates were not fully explained by the addition of the latter drug, Dr. Tan indicated. The Virginia Mason study had obtained a higher response rate (2-year overall survival of 64%) but with shorter median follow-up.

        Schering-Plough Corp. provided funding for the trial.


        [Presentation title: A Phase II trial of Interferon- and Gemcitabine-based Chemoradiation Therapy After Resection for Pancreatic Adenocarcinoma. Abstract no. 2]



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