Schlumberger, Martin1; Berdelou, Amandine1,2; Borget, Isabelle3; Godbert, Yann4; Nguyen, Thierry5; Garcia, Marie-Eve6; N. Chougnet; Cécile7; Ferru, Aurélie8; Leenhardt Laurence9; Chabre, Olivier10; Huillard, Olivier11; Leboulleux, Sophie1
1 Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy and Université Paris Saclay, Villejuif, France
2 Department of Nuclear Medicine and Endocrine Oncology, Curie, Saint-Cloud, France
3 Department of Biostatistics and Epidemiology, Gustave Roussy and Université Paris Saclay, Villejuif, France
4 Department of Nuclear Medicine, Institut Bergonié, Bordeaux, France
5 Department of Medical Oncology, CHRU Minjoz, Besançon, France
6 Department of Multidisciplinary Oncology and Therapeutic Innovations, Assistance Publique-Hôpitaux de Marseille, Marseille, France
7 Department of Nuclear Medicine and Endocrine Oncology, Hôpital Saint Louis, Paris, France
8 Department of Medical Oncology, CHU de Poitiers , Poitiers, France
9 Department of Endocrinology, Hôpital de la Pitié Salpêtrière Paris, France
10 Department of endocrinology, Centre Hospitalier Universitaire de Grenoble, France
11 Department of Medical Oncology, Hopital Cochin APHP, Université Paris Descartes, Paris, France
Background: In the SELECT phase III trial on radio-iodine refractory differentiated thyroid cancer (rDTC), lenvatinib improved median progression free survival (PFS) over placebo. The present study evaluates the efficacy and toxicity of lenvatinib treatment in real-life.
Methods: Clinical charts of 88 patients treated with lenvatinib from July 2015 to June 2016 in 24 French centers were retrospectively reviewed. Patients treated for other type of cancer (n=11) or previously treated with lenvatinib within a trial (n=2) were excluded.
Results: Among the 75 rDTC analyzed (33 female, median age: 65 years [35-88]), 12 had ECOG performance status > 1.They received lenvatinib as a first line systemic treatment in 24 cases. Forty seven (63%) patients had documented progressive disease prior initial treatment. Distant metastases were located in lung, bone and lymph nodes in 89%, 60% and 69%, respectively. The mean follow-up was 7 months, with a median duration of treatment of 6 months [0.3-15]. Median PFS was 10 months [0.1-14.8]. Best tumor response was a partial response in 23 patients (30.6%) and stable disease in 38 (50.6%) in the intention to treat population. Eleven patients (14.7%) discontinued lenvatinib for disease progression. Forty-four (59%) and 23 (31%) patients experienced dose reduction or discontinuation of lenvatinib for adverse events (AE). The most frequent AEs were fatigue, weight loss, hypertension and diarrhea. Eleven deaths occurred during the study (one considered to be drug related).
Conclusions: Lenvatinib is an effective drug for patients with rDTC in real-life. AEs are frequent and should be closely monitored.
- Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, et al.: Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med 2015 Feb 12;372:621–630.