Gemcitabine and Pancreatic Head Tumors

by National Cancer Institute

Gemcitabine Plus Standard Chemoradiation Improves Survival in Patients with Pancreatic Head Tumors

The combination of radiation therapy and the drug 5-flurouracil (5-FU) is frequently used in addition to surgery in the treatment of pancreatic cancer. In this trial, adding gemcitabine to this standard chemoradiation regimen improved overall survival in patients with the most common kind of pancreatic tumors: those located in the head of the pancreas.

Source

American Society of Clinical Oncology (ASCO) annual meeting, Atlanta, June 4, 2006.

Background

Fewer than 20 percent of pancreatic tumors can be removed surgically, and surgery alone rarely provides a cure. Because pancreatic tumors almost always recur after surgery, researchers are looking for new therapies that can delay recurrence and improve survival.

In the United States, the combination of radiation therapy and the drug 5-flurouracil (5-FU) - a kind of treatment called chemoradiation - is frequently used after surgery for pancreatic adenocarcinoma, the most common form of pancreatic cancer. However, the delay in tumor recurrence offered by this treatment is minimal, and investigators are looking for additional drugs that could help patients live longer.

The Study

The phase III trial (RTOG 9704) examined whether the drug gemcitabine, when added to standard chemoradiation treatment after surgery, could extend overall survival for patients with pancreatic adenocarcinoma. From 1998 to 2002, investigators enrolled 442 eligible patients into the trial. The patients were randomly assigned to one of two groups.

• surgery, followed by gemcitabine given both before and after chemoradiation, or
• surgery, followed by 5-FU given both before and after chemoradiation

Patients with tumors in the pancreatic head (the most common location) as well as patients with tumors in the pancreatic body or tail were included in the trial.

The trial was a cooperative effort of the Radiation Therapy Oncology Group (RTOG), the Eastern Cooperative Oncology Group (ECOG), and the Southwest Oncology Group (SWOG). The study's lead author is William Regine, M.D., from the University of Maryland, Baltimore.

Results

Patients with pancreatic head tumors who received the gemcitabine-based chemoradiation regimen had a median survival of 20.6 months; 32 percent were alive at three years. By comparison, patients with pancreatic head tumors who received the 5-FU-based chemoradiation regimen had a median survival of 16.9 months and a 21 percent three-year survival rate.

When data for all of the patients were analyzed - that is, from patients with head, body, or tail pancreatic tumors - researchers found no statistically significant overall survival benefit from adding gemcitabine to the mix.

Limitations

Patients receiving gemcitabine were significantly more likely to experience high-grade side effects, usually a decrease in the level of blood cells. However, decreases in blood cell levels were managed efficiently with supportive drugs.

Comments

"The addition of gemcitabine to postoperative adjuvant 5-FU chemoradiotherapy improves survival in patients with pancreatic head adenocarcinoma," stated Regine, the study's lead author, in his closing remarks at ASCO, adding that this combination therapy now provides a new platform for developing future clinical trials.

"This confirms the value of gemcitabine in the adjuvant (postoperative) treatment of pancreatic cancer patients," says Margaret Mooney, M.D., a pancreatic cancer specialist at the National Cancer Institute's Cancer Therapy Evaluation Program.

About the Author

www.nci.nih.gov
The National Cancer Institute's research programs are extensive and contain many innovative initiatives. I invite you to explore our Web site to find out more about the exciting work being conducted here at NCI and by NCI-supported scientists throughout the country.