J Cancer 2018; 9(2):250-255. doi:10.7150/jca.22318
Lenvatinib in Advanced Radioiodine-Refractory Thyroid Cancer - A Retrospective Analysis of the Swiss Lenvatinib Named Patient Program
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.
Balmelli C, Railic N, Siano M, Feuerlein K, Cathomas R, Cristina V, Güthner C, Zimmermann S, Weidner S, Pless M, Stenner F, Rothschild SI. Lenvatinib in Advanced Radioiodine-Refractory Thyroid Cancer - A Retrospective Analysis of the Swiss Lenvatinib Named Patient Program. J Cancer 2018; 9(2):250-255. doi:10.7150/jca.22318. Available from http://www.jcancer.org/v09p0250.htm