RIFTOS MKI was designed to compare the time to symptomatic progression from study entry in patients with RAI-R DTC for whom there was a decision to treat or not to treat with an MKI in the real-life setting. Here, we report interim baseline characteristics for a subgroup of patients from Europe.
RIFTOS MKI is a non-interventional study enrolling patients from USA, Japan, Europe, and rest of the world with asymptomatic RAI-R DTC. The decision to initiate MKIs at study entry was at the discretion of the treating physician. Final analysis will be performed once 700 patients have been enrolled and the last enrolled patient has been followed for 24 months.
Of the 80 patients enrolled from Europe, the median duration of observation was 165 days; 51% were male and the median age was 67 years. Most patients had an ECOG performance status of 0 or 1 (96%) and distant metastasis at initial visit (81%). The most frequent histology was papillary (61%). The median time from initial diagnosis of DTC to study entry was 7.7 years. RAI refractoriness was mainly due to lack of RAI uptake (70%) and the median time from RAI classification to initial visit was 25 months. The average dose per RAI treatment and median cumulative activity of RAI were 4.6 and 13.0 GBq, respectively.
The interim baseline characteristics results presented here are similar to those previously reported in phase III studies. The study is ongoing.
Clinical trial identification
Legal entity responsible for the study
M.S. Brose: Research funding, honoraria and consulting: Bayer F. Pitoia: Honoraria, advisory board attendance and consultancy: Genzyme/Sanofi, Bayer and AztraZeneca. I. Sugitani: Research funding: Eisai Consulting: Bayer Speaker fees: Sanofi, Bayer and Eisai. M. Alevizaki: Honoraria: Bayer and Genzyme Advisory board attendance: Sanofi. J. Aller: Advisory board attendance: Bayer, Eisai and Genzyme/Sanofi Lecture fees: Bayer, Eisai and Genzyme/Sanofi. R.P. Peeters: Honoraria: Genzyme Adboard attendance: Eisai and Genzyme. K. Pazaitou-Panayiotou: Honoraria: Novartis Advisory board attendance: Novartis. L. Leenhardt: Honoraria and speaker fees: Bayer. M.M. Fellous, Y. De Sanctis: Employee and stock ownership: Bayer. M. Schlumberger: Consulting: Bayer, Genzyme/Sanofi, Ipsen, Eisai. All other authors have declared no conflicts of interest.