PMID- 32907501 OWN - NLM STAT- MEDLINE DCOM- 20211111 LR - 20211111 IS - 1557-9077 (Electronic) IS - 1050-7256 (Linking) VI - 31 IP - 2 DP - 2021 Feb TI - Safety and Quality-of-Life Data from an Italian Expanded Access Program of Lenvatinib for Treatment of Thyroid Cancer. PG - 224-232 LID - 10.1089/thy.2020.0276 [doi] AB - Background: Lenvatinib, a multikinase inhibitor, is for progressive radioiodine-refractory-differentiated thyroid cancer (RR-DTC) patients. However, there are a lot of drug-related adverse events (AEs) that can affect the quality of life (QoL) of patients. The aims of this study were (a) to evaluate, and compared with other series, the safety of lenvatinib used in RR-DTC patients enrolled in an Italian expanded access program (EAP), and (b) to evaluate their QoL during treatment with lenvatinib. Methods: To evaluate the safety, we recorded and graded all AEs during the 6 months of lenvatinib treatment in 39 RR-DTC patients. We compared the safety profile of lenvatinib observed in our patients with that reported in the study of (E7080) levatinib in differentiated cancer of the thyroid (SELECT) and tumeurs thyroidiennes refractaires (TUTHYREF) network studies. Moreover, we evaluated the QoL in our series by using the European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 and the pain visual analogue scale (VAS). Results: The most frequent AEs among our 39 RR-DTC patients were hypertension (80.5%), fatigue (58.3%), diarrhea (36.1%), stomatitis (33.3%), hand/foot syndrome (33.3%), and weight loss (30.5%). The most prevalent grade 3/4 AE was hypertension (25%). When compared with previous studies (i.e., SELECT and TUTHYREF), a significantly lower percentage of our patients experienced diarrhea, nausea, proteinuria, and weight loss. No statistically significant differences in the QoL of our patients evaluated before, during, and at the end of follow-up (6 months after starting the therapy) were found. However, a slight improvement of the general health and emotional and cognitive status associated with a slightly worsening of physical role and social functioning was observed during these 6 months. Pain, dyspnea, insomnia, and constipation moved toward better values, while fatigue, nausea and vomiting, appetite loss, and diarrhea worsened. By comparing the pain VAS, an overall reduction of the level of pain was found. Conclusions: The safety profile of the drug was similar to that already reported with some differences in the prevalence and severity of the AEs. Regarding the QoL, the EAP showed a trend of improvement of the global health status and a reduction of symptoms correlated to the disease. The clinical impact of fatigue, anorexia/weight loss and stomatitis, mainly due to the drug itself, continues to represent the major issue in the management of these patients. FAU - Giani, Carlotta AU - Giani C AD - Endocrinology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. FAU - Valerio, Laura AU - Valerio L AD - Endocrinology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. FAU - Bongiovanni, Alberto AU - Bongiovanni A AD - Osteoncology and Rare Tumors Center Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST, IRCCS, Meldola, Italy. FAU - Durante, Cosimo AU - Durante C AD - Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy. FAU - Grani, Giorgio AU - Grani G AD - Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy. FAU - Ibrahim, Toni AU - Ibrahim T AD - Osteoncology and Rare Tumors Center Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST, IRCCS, Meldola, Italy. FAU - Mariotti, Stefano AU - Mariotti S AD - Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. FAU - Massa, Michela AU - Massa M AD - Department of Medical Science, Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. FAU - Pani, Fabiana AU - Pani F AD - Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. FAU - Pellegriti, Gabriella AU - Pellegriti G AD - Endocrinology Division, Garibaldy Nesima Hospital, Catania, Italy. FAU - Porcelli, Tommaso AU - Porcelli T AD - Department of Public Health, University of Naples "Federico II," Naples, Italy. FAU - Salvatore, Domenico AU - Salvatore D AD - Department of Public Health, University of Naples "Federico II," Naples, Italy. FAU - Tavarelli, Martina AU - Tavarelli M AD - Endocrinology Division, Garibaldy Nesima Hospital, Catania, Italy. FAU - Torlontano, Massimo AU - Torlontano M AD - Department of Medical Science, Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. FAU - Locati, Laura AU - Locati L AD - Head and Neck Cancer Medical Oncology Unit, Fondazione IRCCS "Istituto Nazionale dei Tumori," Milan, Italy. FAU - Molinaro, Eleonora AU - Molinaro E AD - Endocrinology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. FAU - Elisei, Rossella AU - Elisei R AD - Endocrinology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20201022 PL - United States TA - Thyroid JT - Thyroid : official journal of the American Thyroid Association JID - 9104317 RN - 0 (Antineoplastic Agents) RN - 0 (Phenylurea Compounds) RN - 0 (Protein Kinase Inhibitors) RN - 0 (Quinolines) RN - EE083865G2 (lenvatinib) SB - IM MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology MH - Female MH - *Health Services Accessibility MH - Humans MH - Italy/epidemiology MH - Male MH - Middle Aged MH - Phenylurea Compounds/adverse effects/*therapeutic use MH - Prevalence MH - Protein Kinase Inhibitors/adverse effects/*therapeutic use MH - *Quality of Life MH - Quinolines/adverse effects/*therapeutic use MH - Thyroid Neoplasms/*drug therapy/epidemiology/pathology MH - Time Factors MH - Treatment Outcome OTO - NOTNLM OT - adverse events OT - lenvatinib OT - quality of life OT - safety OT - thyroid cancer EDAT- 2020/09/11 06:00 MHDA- 2021/11/12 06:00 CRDT- 2020/09/10 05:25 PHST- 2020/09/11 06:00 [pubmed] PHST- 2021/11/12 06:00 [medline] PHST- 2020/09/10 05:25 [entrez] AID - 10.1089/thy.2020.0276 [doi] PST - ppublish SO - Thyroid. 2021 Feb;31(2):224-232. doi: 10.1089/thy.2020.0276. Epub 2020 Oct 22.