A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial
Up to date no standard treatment is available for pancreatic cancer. Although gemcitabine
is commonly used in patients with pancreatic cancer with the purpose of symptom palliation,
there is no clear evidence of efficacy in terms of survival increase or progression
control. Furthermore, attempts at improving results by combining gemcitabine with other
cytotoxic drugs failed to obtain any advantage. Recently, an EGFR inhibitor (erlotinib)
showed a small survival advantage when combined with gemcitabine. results obtained with a
combination of gemcitabine and oxaliplatin seem more promising. A meta-analysis of
randomised trials comparing gemcitabine versus gemcitabine and platinum analogues showed a
statistical significant survival advantage for the combination.
Sorafenib is an inhibitor of the RAS/RAF signalling pathway. Furthermore, sorafenib is able
to inhibit both VEGFR and PDGFR.
Since RAS and RAF mutations are quite common in pancreatic cancer, Sorafenib could be useful
in the management of these tumours. Furthermore, it may be combined with gemcitabine and
cisplatin without any pharmacokinetic interaction or enhanced toxicity.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
time from randomization date to date of local or regional relapse
Stefano Cascinu, M.Professor
Italy: The Italian Medicines Agency