465P - Interim baseline characteristics from RIFTOS MKI, a global non-interventional study assessing the use of multikinase inhibitors (MKIs) in the treat...

Date 10 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Thyroid Cancer
Endocrine Cancers
Presenter Johannes Smit
Citation Annals of Oncology (2017) 28 (suppl_5): v142-v157. 10.1093/annonc/mdx368
Authors J.W.A. Smit1, M.S. Brose2, F. Pitoia3, C. Lin4, I. Sugitani5, M. Alevizaki6, Y. Godbert7, J. Aller8, R.P. Peeters9, K. Pazaitou-Panayiotou10, L. Leenhardt11, M.M. Fellous12, Y. De Sanctis13, M. Schlumberger14
  • 1Department Of Medicine, Radboud University Nijmegen Medical Center, 6500 HB - Nijmegen/NL
  • 2Department Of Otorhinolaryngology: Head And Neck Surgery, Abramson Cancer Center of the University of Pennsylvania, 19104 - Philadelphia/US
  • 3Department Of Endocrinology, Universidad de Buenos Aires, Buenos Aires/AR
  • 4Department Of Oncology, National Taiwan University Hospital, Taipei/TW
  • 5Department Of Endocrine Surgery, Nippon Medical School Graduate School of Medicine, Tokyo/JP
  • 6Clinical Therapeutics, Alexandra Hospital, Kapodistrian University of Athens, Athens/GR
  • 7Department Of Nuclear Medicine, Institut Bergonié, Bordeaux/FR
  • 8Department Of Endocrinology, Hospital Puerta de Hierro Majadahonda, Madrid/ES
  • 9Internal Medicine, Erasmus Medical Center, Rotterdam/NL
  • 10Unit Of Endocrinology And Endocrine Oncology, Theagenio Anticancer Hospital of Thessaloniki, Thessaloniki/GR
  • 11Department Of Thyroid Diseases And Endocrine Tumors, Pitie-Salpetriere Hospital, APHP, Paris VI University, Paris/FR
  • 12Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Whippany/US
  • 13Medical Writing And Statistics, Oncology Sbu, Bayer HealthCare Pharmaceuticals, Whippany/US
  • 14Department Of Oncology, Gustave Roussy, 94805 - Villejuif/FR

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

The interim baseline characteristics results presented here are similar to those previously reported in phase III studies. The study is ongoing.

Clinical trial identification

NCT0230344

Legal entity responsible for the study

Bayer

Funding

Bayer

Disclosure

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.