1. Medical Oncology, Universitätsspital Basel, Petersgraben 4, 4031 Basel;
2. Medical Oncology, Kantonsspital St. Gallen, Rorschacher Strasse 95, 9007 St. Gallen;
3. Medical Oncology, Clinica Luganese, Via Monucco 10-11, 6900 Lugano;
4. Medical Oncology, Kantonsspital Graubünden, Loëstrasse 170, 7000 Chur;
5. Medical Oncology, Centre hospitalier universitaire vaudois, Rue de Bugnon 46, 1011 Lausanne;
6. Medical Oncology, Stadtspital Triemli, Birmensdorferstrasse 497, 8063 Zürich;
7. Clinique de médecine Hémato-oncologie, HFR Fribourg - Hôpital cantonal, 1708 Fribourg;
8. Nuklearmedizin, Inselspital Bern, Freiburgstrasse 8, 3010 Bern;
9. Medical Oncology, Kantonsspital Winterthur, Brauerstrasse 15, 8401 Winterthur.
* contributed equally
Purpose: Differentiated thyroid cancer (DTC) accounts for approximately 95% of thyroid carcinomas. In the metastatic RAI-refractory disease, chemotherapy has very limited efficacy and is associated with substantial toxicity. With increasing knowledge of the molecular pathogenesis of DTC, novel targeted therapies have been developed. Lenvatinib is a tyrosine kinase inhibitor (TKI) with promising clinical activity based on the randomized phase III SELECT trial. In Switzerland, a Named Patient Program (NPP) was installed to bridge the time gap to Swissmedic approval. Here, we report the results from the Swiss Lenvatinib NPP including patients with metastatic RAI-refractory DTC.
Methods: Main inclusion criteria for the Swiss NPP were RAI-refractory DTC, documented disease progression, Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The number of previous therapies was not limited. The Swiss Lenvatinib NPP was initiated in June 2014 and was closed in October 2015 with the approval of the drug.
Results: Between June 2014 and October 2015, 13 patients with a median age of 72 years have been enrolled. Most patients (69%) had at least one prior systemic therapy, mainly sorafenib. 31% of patients showed a PR and 31% SD. Median progression free survival was 7.2 months and the median overall survival was 22.7 months. Dose reduction due to adverse events was necessary in 7 patients (53%). At the time of analysis 6 patients (47%) were still on treatment with a median time on treatment of 9.98 months.
Conclusions: Our results show that lenvatinib has reasonable clinical activity in unselected patients with RAI-refractory thyroid cancer with nearly two-third of patients showing clinical benefit. The toxicity profile of lenvatinib is manageable.
Keywords: differentiated thyroid cancer, radioiodine refractory, tyrosine kinase inhibitors, lenvatinib, sorafenib.