Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours
Status:
Completed
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their
therapeutic management is complex and must be multidisciplinary in nature. Most of the time,
an endoscopic or radiological biliary drainage is necessary before any tumour treatment.
Their prognosis is poor due to the fact that they are normally diagnosed late, which makes
curative surgery impossible. A population study in the Côte d'Or region of France reported a
survival rate at 5 years of approximately 10%.
For the locally advanced or metastatic forms, treatment has not been properly codified. With
respect to chemotherapy, prospective studies, most often phase II, are difficult to interpret
due to a limited number of patients and due to the heterogeneity of this type of tumour (bile
duct and pancreas tumours). Treatment with 5FU alone provides an objective response in
approximately 10% of cases. In combination with mitomycin or carboplatin, the objective
response rate is 20%, with a median survival period of 5 months. Interferon combined with 5FU
has a better response rate (30%), but occurrences of different types of toxicity are more
frequent.
More recently, gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour
control in 50% of patients with a median survival period of 10 months. Gemcitabine combined
with oxiplatin or with cisplatin has shown the same response rate but a median survival
period of approximately 12 months.
The benefit of this combination has been confirmed in a phase III trial that compared the
gemcitabine-cisplatin combination to gemcitabine alone, in 410 patients with locally advanced
unresectable and/or metastatic bile duct cancer. The results were in favour of the combined
treatment with a median survival period of 11.7 months (versus 8.1 months - HR 0.64 [0.52 -
0.80]). This combination is currently the reference first-line treatment.