L D Locati1, A Piovesan2, C Durante3, M Bregni4, M G Castagna5, S Zovato6, M Giusti7, T Ibrahim8, E Puxeddu9, G Fedele10, G Pellegriti11, G Rinaldi12, D Giuffrida13, F Verderame14, F Bertolini15, C Bergamini16, A Nervo17, G Grani18, S Rizzati19, S Morelli20, I Puliafito21, R Elisei22. 1. Head and Neck Medical Oncology; Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. Electronic address: laura.locati@istitutotumori.mi.it. 2. Dept. Oncology, Oncological Endocrinology, A.O.U. Città della Salute e della Scienza, Ospedale Molinette, Torino, Italy. Electronic address: apiovesan@cittadellasalute.to.it. 3. Dept Internal Medicine and Medical Specialties, Policlinico Umberto I, Roma, Italy. Electronic address: cosimo.durante@uniroma1.it. 4. Dept Medical Oncology, Ospedale Busto Arsizio-ASST Valle Olona, Busto Arsizio, Italy. Electronic address: mbregni@aobusto.it. 5. Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy. Electronic address: m.g.castagna@ao-siena.toscana.it. 6. Familial Cancer Clinic and Oncoendocrinology Veneto Institute of Oncology IOV- IRCCS, Padua, Italy. Electronic address: stefania.zovato@ioveneto.it. 7. Dept Internal Medicine and Medical Specialties, Clinical Endocrinology, IRCCS San Martino Hospital, Genova, Italy. Electronic address: magius@unige.it. 8. Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. Electronic address: toni.ibrahim@irst.emr.it. 9. Department of Medicine, University of Perugia, Perugia, Italy. 10. High Research Srl, Milano, Italy. Electronic address: guido.fedele@fastwebnet.it. 11. Endocrinology Division, Garibaldi Nesima Hospital, Catania, Italy. Electronic address: g.pellegriti@unict.it. 12. Dept Surgical and Oncological Sciences, Policlinico Paolo Giaccone, Palermo, Italy. Electronic address: taniarinaldi02@gmail.com. 13. Dept Medical Oncology, Istituto Oncologico del Mediterraneo, Viagrande, Italy. Electronic address: giuffridadario@alice.it. 14. Dept Hematology and Oncology, Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy. Electronic address: f.verderame@villasofia.it. 15. Dept Oncology and Haematology, Modena University Hospital, Modena, Italy. Electronic address: bertolini.federica@policlinico.mo.it. 16. Head and Neck Medical Oncology; Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. Electronic address: cristiana.bergamini@istitutotumori.mi.it. 17. Dept. Oncology, Oncological Endocrinology, A.O.U. Città della Salute e della Scienza, Ospedale Molinette, Torino, Italy. Electronic address: alice.nervo@cittadellasalute.to.it. 18. Dept Internal Medicine and Medical Specialties, Policlinico Umberto I, Roma, Italy. Electronic address: giorgio.grani@uniroma1.it. 19. Familial Cancer Clinic and Oncoendocrinology Veneto Institute of Oncology IOV- IRCCS, Padua, Italy. Electronic address: silvia.rizzati@ioveneto.it. 20. Department of Medicine, University of Perugia, Perugia, Italy. Electronic address: silvia.morelli@unipg.it. 21. Dept Medical Oncology, Istituto Oncologico del Mediterraneo, Viagrande, Italy. Electronic address: dott.ssapuliafito@gmail.com. 22. Dept Clinical and Experimental Medicine, A.O Universitaria Pisana, Pisa, Italy. Electronic address: rossella.elisei@med.unipi.it.
Abstract
BACKGROUND: Lenvatinib is a multi-kinase inhibitor approved for patients with radioactive iodine (RAI)-resistant differentiated thyroid cancer (DTC). Before the drug approval from the Italian National Regulatory Agency, a compassionate use programme has been run in Italy. This retrospective study aimed to analyse data from the first series of patients treated with lenvatinib in Italy. METHODS: The primary aim was to assess the response rate (RR) and progression-free survival (PFS). Secondary end-points include overall survival (OS) and toxicity data. RESULTS: From November 2014 to September 2016, 94 patients were treated in 16 Italian sites. Seventeen percent of patients had one or more comorbidities, hypertension being the most common (60%). Ninety-eight percent of patients were treated by surgery, followed by RAI in 98% of cases. Sixty-four percent of patients received a previous systemic treatment. Lenvatinib was started at 24 mg in 64 subjects. Partial response and stable disease were observed in 36% and in 41% of subjects, respectively; progression was recorded in 14% of patients. Drug-related side-effects were common; the most common were fatigue (13.6%) and hypertension (11.6%). Overall, median PFS and OS were 10.8 months (95% confidence interval [CI], 7.7-12.6) and 23.8 months (95% CI, 19.7-25.0) respectively. CONCLUSION: Lenvatinib is active and safe in unselected, RAI-refractory, progressive DTC patients in real-life setting. RR and PFS seem to be less favourable than those observed in the SELECT trial, likely due to a negative selection that included heavily pretreated patients or with poor performance status.
BACKGROUND:Lenvatinib is a multi-kinase inhibitor approved for patients with radioactive iodine (RAI)-resistant differentiated thyroid cancer (DTC). Before the drug approval from the Italian National Regulatory Agency, a compassionate use programme has been run in Italy. This retrospective study aimed to analyse data from the first series of patients treated with lenvatinib in Italy. METHODS: The primary aim was to assess the response rate (RR) and progression-free survival (PFS). Secondary end-points include overall survival (OS) and toxicity data. RESULTS: From November 2014 to September 2016, 94 patients were treated in 16 Italian sites. Seventeen percent of patients had one or more comorbidities, hypertension being the most common (60%). Ninety-eight percent of patients were treated by surgery, followed by RAI in 98% of cases. Sixty-four percent of patients received a previous systemic treatment. Lenvatinib was started at 24 mg in 64 subjects. Partial response and stable disease were observed in 36% and in 41% of subjects, respectively; progression was recorded in 14% of patients. Drug-related side-effects were common; the most common were fatigue (13.6%) and hypertension (11.6%). Overall, median PFS and OS were 10.8 months (95% confidence interval [CI], 7.7-12.6) and 23.8 months (95% CI, 19.7-25.0) respectively. CONCLUSION:Lenvatinib is active and safe in unselected, RAI-refractory, progressive DTC patients in real-life setting. RR and PFS seem to be less favourable than those observed in the SELECT trial, likely due to a negative selection that included heavily pretreated patients or with poor performance status.
Authors: Matti L Gild; Venessa H M Tsang; Roderick J Clifton-Bligh; Bruce G Robinson Journal: Nat Rev Endocrinol Date: 2021-02-18 Impact factor: 43.330
Authors: José F Carrillo; Jesús Manuel Flores; Gilberto Espinoza; Rafael Vázquez-Romo; Margarita C Ramírez-Ortega; Liliana C Carrillo; Beatriz Y Cortés-García; Francisco J Ochoa-Carrillo; Luis F Oñate-Ocaña Journal: Front Oncol Date: 2021-01-19 Impact factor: 6.244
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