Thomas J. Ettrich: Final results of our NIFE trial now published in ‘Journal of Clinical Oncology’

Thomas J. Ettrich, Senior Physician, Department of Internal Medicine, University of Ulm, shared a post on LinkedIn:

“Final results of our NIFE trial now published in ‘Journal of Clinical Oncology‘.

‘Nanoliposomal Irinotecan With Fluorouracil and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Cholangiocarcinoma: A Prospective, Randomized, Multicenter Phase II Study of the AIO Hepatobiliary-YMO Cancer Groups (NIFE-AIO-YMO HEP-0315)’

We are very proud to present the final results of our NIFE trial in JCO and to have the opportunity to contribute to the treatment of cholangiocarcinoma, an increasingly exciting and rapidly developing area of GI oncology in the last few years. Our heartfelt thanks go to all patients and their relatives. Many thanks to all collaborating colleagues, the AIO Hepatobiliary/YMO cancer groups, the AIO-Studien gGmbH, the IKF-Institute of Clinical Cancer Research and of course Servier for funding the trial.

Key Objective:
The NIFE trial aims to evaluate nanoliposomal Irinotecan/5-FU/leucovorin (nal-IRI/FU/LV) as an alternative palliative first-line therapy in advanced cholangiocarcinoma (CCA).

Knowledge Generated:
NIFE is the first prospective trial demonstrating clinical efficacy of nal-IRI/FU/LV in the first-line therapy setting of advanced CCA. The treatment was feasible and the toxicity profile manageable. This regimen merits further validation in a larger phase III trial.

Relevance (Eileen M. O’Reilly, MD,  JCO Associate Editor):
‘This study evaluates a non-platinum regimen in the front-line treatment and demonstrates a signal of interest relative to standard of care cisplatin and gemcitabine in a small randomized phase II trial. Further development of nal-IRI/FU/LV in this disease setting appears justified.'”

Source: Thomas J. Ettrich/LikedIn