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According to a press release from Roche, results of a phase III clinical trial indicate that treatment of pancreatic cancer with the combination of Xeloda® (capecitabine) and gemcitabine results in better survival than treatment with gemcitabine alone.

The pancreas is a gland located in the abdomen. It produces juices that help digest foods as well as the hormones that help regulate blood sugar levels. Pancreatic cancer is the fourth leading cause of cancer deaths in the U.S. Unfortunately, most cases of pancreatic cancer are not curable and only some cases are operable.

Current treatment options for pancreatic cancer include surgery, radiation, and chemotherapy. Although single-agent chemotherapy with gemcitabine has been a standard treatment for pancreatic cancer, research has increasingly focused on the development of combination regimens. Recently, the U.S. Food and Drug Administration approved the combination of the targeted therapy Tarceva ® (erlotinib) and gemcitabine for the treatment of locally advanced, inoperable, or metastatic pancreatic cancer.

Xeloda is an oral chemotherapy drug that belongs to a class of drugs called antimetabolites. Antimetabolites fight cancer by inhibiting the ability of a cell to produce or repair DNA, thereby making the cell unable to replicate or repair itself and ultimately causing cellular death.

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To evaluate the combination of Xeloda and gemcitabine in the treatment of pancreatic cancer, researchers conducted a phase III clinical trial among 533 previously untreated patients with locally advanced or metastatic pancreatic cancer. Patients were randomly assigned to treatment with both Xeloda and gemcitabine or treatment with gemcitabine alone.

Treatment with the combination of Xeloda and gemcitabine significantly improved survival.

  • Median survival was 7.4 months among patients treated with Xeloda plus gemcitabine, compared to 6 months among patients treated with gemcitabine alone.
  • 26% of patients treated Xeloda and gemcitabine survived for at least one year, compared to 19% of patients treated with gemcitabine alone.

The lead investigator of the study notes, “This is the first time that adding another cytotoxic drug to gemcitabine has improved the outcome for patients with inoperable pancreatic cancer and the trial results are therefore an important milestone.”

Reference: Roche Media News. Xeloda Now Shown to Extend Survival For Patients With Pancreatic Cancer. First Xeloda Data to Show Survival Benefit in this Deadly Cancer. November 2, 2005.