Gemcitabine as first line therapy: Until Phase II studies with existing or new drugs, alone or in combination, demonstrate significant improved benefit in pancreatic cancer, randomised studies are likely to be directed towards toxicity, QoL and any small survival benefits that may be obtained with gemcitabine alone compared with a modern 5-FU-based protocol or a combination of the two.
The evidence for QoL benefits of gemcitabine is particularly poor. There is widespread acknowledgement of the need for a RCT to confirm the survival benefits of gemcitabine and, particularly, to enable the collation of acceptable QoL data.
Gemcitabine as second line therapy: Further high-quality randomised trial evidence is required to determine fully the value of gemcitabine as a second line treatment.