According to research published early online in the Journal of Clinical Oncology, gemcitabine in combination with capecitabine (GEM-CAP) should be considered as one of the standard first-line options in locally advanced and metastatic pancreatic cancer.

The open-label study involved 533 patients with previously untreated histologically or cytologically proven advanced metastatic carcinoma of the pancreas. Patients were randomly assigned to treatment with gemcitabine intravenously 1,000 mg/m2 over 30 minutes weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks (GEM n=266), or gemcitabine in combination with capecitabine where patients received gemcitabine intravenously at 1,000 mg/m2  weekly for 3 weeks every 4 weeks and capecitabine orally at 1,660mg/m2/day (830mg/m2 twice daily) for 3 weeks followed by 1 week rest (GEM-CAP, n=267). The primary outcome measure was survival, and a meta-analysis of published studies was also conducted. All treatment was given until disease progression or intolerable toxicity.

The researchers reported that GEM-CAP was associated with a trend toward improved overall survival (HR, 0.86; 0.72 to 1.02; P = 0.08 – not statistically significant) compared with GEM alone (primary outcome), and GEM-CAP statistically significantly improved the secondary outcomes of objective response rate (19.1% v 12.4%; P = 0.034) and progression-free survival (hazard ratio [HR], 0.78; 0.66 to 0.93; P = 0.004).

Treatment with GEM-CAP was associated with a higher incidence of neutropenia and hand-foot syndrome.

Additionally, the researchers reported that a meta-analysis of two additional studies involving a total of 935 patients showed a survival benefit in favour of the GEM-CAP combination (HR, 0.86; 0.75 to 0.98; P = 0.02).