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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