Researchers affiliated with the Swiss Group for Clinical Cancer Research (SAKK) and the Central European Cooperative Oncology Group (CECOG) have reported that the addition of Xeloda® (capecitabine) to Gemzar® (gemcitabine) improves outcomes of patients with advanced or metastatic pancreatic cancer. The details of this study appeared early online October 26, 2009 in the Journal of Clinical Oncology.[1] 

Gemzar is considered the standard of care for patients with advanced pancreatic cancer. However, several recent studies have suggested that the addition of a second agent to Gemzar improves outcome. Researchers from France have reported that the combination of Gemzar with a second chemotherapy agent provides a small but significant improvement in survival compared with Gemzar only in the treatment of metastatic pancreatic cancer. This conclusion was based on data from 23 clinical trials, which included 5,886 patients with advanced pancreatic cancer who were treated with either a Gemzar-based doublet or Gemzar alone. 

Preliminary results of the current study were reported at the 2005 annual meeting of the American Society of Clinical Oncology. This Phase III multi-institution randomized trial directly compared Gemzar plus Xeloda to Gemzar alone as initial therapy for locally advanced or metastatic pancreatic cancer. Patients were randomized to Gemzar (1 g/m2 days 1 and 8) plus Xeloda (650 mg/m2 orally every 12 hours days 1-14 every three weeks) or to Gemzar alone (1 g/m2 weekly X 7, followed by one week of rest and then weekly X 3, and then every four weeks). Patients were stratified according to tumor stage, absence or presence of pain, institution, and Karnofsky Performance Status (KPS 60-80 or 90-100).

This study included 533 patients. The results are summarized in the following table:

Table 1: Gemzar Versus Gemzar plus Xeloda in Pancreatic Cancer

The effect of Xeloda on survival showed a trend for benefit with a p of 0.08. These authors also stated, “Moreover, the meta-analysis of two additional studies involving 935 patients showed a significant survival benefit in favor of GEM-CAP (p=0.02).” These authors suggest: “On the basis of our trial and the meta-analysis, GEM-CAP should be considered as one of the standard first-line options in locally advanced and metastatic pancreatic cancer.”

Comments: This definitive analysis of this study clearly shows that the addition of Xeloda to Gemzar modestly improves the palliative treatment of patients with locally advanced or metastatic pancreatic cancer. However, it is not clear that the addition of Xeloda is better than the addition of a number of other agents to Gemzar.

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