J Cancer 2018; 9(2):250-255. doi:10.7150/jca.22318 This issue

Research Paper

Lenvatinib in Advanced Radioiodine-Refractory Thyroid Cancer - A Retrospective Analysis of the Swiss Lenvatinib Named Patient Program

Catharina Balmelli1*, Nikola Railic1*, Marco Siano2, Kristin Feuerlein3, Richard Cathomas4, Valerie Cristina5, Christiane Güthner6, Stefan Zimmermann7, Sabine Weidner8, Miklos Pless9, Frank Stenner1, Sacha I. Rothschild1✉

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

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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 https://www.jcancer.org/v09p0250.htm

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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.