Between May 2003 and January 2005, 533 patients with previously untreated or cytological proven locally advanced/metastatic carcinoma of the pancreas were randomised to receive either gemcitabine treatment alone, or gemcitabine and capecitabine treatment. Treatment continued until the disease progressed or the side effects/toxicity effects became intolerable. The primary outcome was survival.
At the time of the interim analysis in May 2005, 70% of deaths had occurred. The median survival for gemcitabine alone and gemcitabine and capecitabine was 6 months and 7.4 months respectively but 1-year survival rates were 19% and 26% respectively. Toxicity effects recorded in both treatment groups included anaemia, neutropenia, thrombocytopenia, fever, diarrhoea and vomiting.
The investigators concluded there was a significant improvement in overall survival by the addition of capecitabine to gemcitabine over gemcitabine alone in advanced pancreatic cancer with acceptable levels of toxicity.
Dr Ian Chau from the Royal Marsden Hospital, UK, commented, “The combination of gemcitabine and capecitabine confers a survival advantage over standard gemcitabine monotherapy and may be considered as a new standard of care in advanced pancreatic cancer. Patients will enjoy an improvement in survival with an acceptable level of side effects. This combination could form a new treatment platform to which novel molecular targeted therapy can be added.”
MEDICA.de; Source: Federation of European Cancer Societies (FECS)