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Key Words

Pancreatic cancer, gemcitabine, chemotherapy. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Patients with operable pancreatic cancer who got additional (adjuvant) therapy with the drug gemcitabine lived nearly twice as long before their disease recurred as patients who were treated with surgery alone. This is the first large randomized clinical trial to show a benefit from adding chemotherapy to the treatment of patients with operable pancreatic cancer.

Source

American Society of Clinical Oncology annual meeting, Orlando, Florida, May 14, 2005.

Background

About 20 percent of patients with pancreatic cancer survive for five years when their tumors are small and are detected early, before they have spread beyond the pancreas. Unfortunately, fewer than one in five tumors are detected at this early stage. Most patients do not have specific symptoms until the disease is advanced. Overall, only four percent of patients with pancreatic cancer are alive five years after diagnosis.

Researchers hoping to improve those numbers have tried treating pancreatic cancer patients with chemotherapy after their tumors were removed, but none of the drugs tested so far have helped patients to live longer.

Since 1997, chemotherapy with the drug gemcitabine has been a standard treatment option for patients with advanced pancreatic cancer that cannot be removed by surgery. The purpose of the current study was to determine whether additional therapy with gemcitabine would benefit patients whose tumors could be removed with surgery.

The Study

The study involved 368 patients with operable pancreatic cancer. Researchers randomly assigned half of the patients to receive six months of treatment with gemcitabine, beginning within six weeks of their surgery. The other half were simply observed after surgery. Peter Neuhaus, M.D., Ph.D., of Charité University Medical School in Berlin, led the team of German and Austrian researchers.

(Note: final data from the trial were subsequently published in the January 17, 2007, Journal of the American Medical Association; see the journal abstract.)

Results

Gemcitabine delayed progression of disease. Cancer recurred after a median of 13.4 months for patients treated with gemcitabine compared with 6.9 months for those who were simply observed after surgery. However, there was no difference in terms of overall survival between the two groups.

A few patients suffered side effects from gemcitabine such as a low white blood cell count, a low platelet count, diarrhea, and nausea. These side effects were generally not severe.

Comments

“This is the first randomized controlled trial to show that patients with operable pancreatic cancer can benefit from adjuvant chemotherapy,” said Neuhaus. Also encouraging, he added, is that side effects from gemcitabine were rare and relatively mild, making the drug easy for patients to take.

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