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Phase II trial results suggest that therapeutic vaccine for pancreatic cancer may be beneficial when given with postoperative chemoradiotherapy

Phase II trial results suggest that a therapeutic vaccine for pancreatic cancer may be beneficial when given with postoperative chemoradiotherapy, according to a presentation at the 2007 Gastrointestinal Cancers Symposium.

The US study involved 60 patients, all of whom were treated at Johns Hopkins University School of Medicine and had operable disease that had spread to nearby tissue and organs, blood vessels, or lymph nodes. All patients received their first vaccine 8 to 10 weeks after surgery, followed by chemoradiotherapy.

Patients who were disease-free one month after chemoradiotherapy received three additional vaccine doses one month apart, followed by a fifth booster six months later.

For patients in the study, the one-year survival rate was 88 percent, and the two-year survival rate was 76 percent. After a median follow-up of three years, the median overall survival of patients in the current study was 26 months. The researchers compared survival rates to past studies of patients treated with surgery alone, which showed average one-year survival of 63 percent and two-year survival of 42 percent.

“We are now comparing the patients in this study to a separate database of patients who received adjuvant chemoradiation therapy alone after surgery,” said Daniel A. Laheru, MD, Assistant Professor at Johns Hopkins and the study’s lead author. “Our initial review suggests that the vaccine could provide additional benefit over chemoradiotherapy, but prospective randomized trials are needed to confirm this observation.”

The investigators are also evaluating whether the vaccine is most effective in combination with chemotherapy alone or with chemotherapy and radiation together.
The vaccine was made using cells derived from pancreatic cancer cells that were irradiated and engineered to secrete the molecule granulocyte-macrophage colony stimulating factor, or GM-CSF. GM-CSF attracts immune cells to the vaccine site, where the immune cells encounter pancreas cancer antigens. They then patrol the rest of the patient’s body to destroy pancreas tumor cells with the same antigen profile. Vaccine side effects were limited to local reactions at the injection site?including itching, redness, and swelling?and typically went away within a week to 10 days.


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