Real-world efficacy and safety of lenvatinib: data from a compassionate use in the treatment of radioactive iodine-refractory differentiated thyroid cancer patients in Italy

L. D. Locati, A. Piovesan, C. Durante, M. Bregni, M. G. Castagna, S. Zovato, M. Giusti, T. Ibrahim, E. Puxeddu, G. Fedele, G. Pellegriti, G. Rinaldi, D. Giuffrida, F. Verderame, F. Bertolini, C. Bergamini, A. Nervo, G. Grani, S. Rizzati, S. MorelliI. Puliafito, R. Elisei

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)35-40
Number of pages6
JournalEuropean Journal of Cancer
Volume118
DOIs
Publication statusPublished - Sep 1 2019

Fingerprint

Compassionate Use Trials
Thyroid Neoplasms
Iodine
Italy
Safety
Disease-Free Survival
Therapeutics
Confidence Intervals
Hypertension
Drug Approval
lenvatinib
Survival
Drug-Related Side Effects and Adverse Reactions
Fatigue
Comorbidity
Phosphotransferases
Retrospective Studies

Keywords

  • Lenvatinib
  • RAI refractory
  • Real life
  • Thyroid cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Real-world efficacy and safety of lenvatinib : data from a compassionate use in the treatment of radioactive iodine-refractory differentiated thyroid cancer patients in Italy. / Locati, L. D.; Piovesan, A.; Durante, C.; Bregni, M.; Castagna, M. G.; Zovato, S.; Giusti, M.; Ibrahim, T.; Puxeddu, E.; Fedele, G.; Pellegriti, G.; Rinaldi, G.; Giuffrida, D.; Verderame, F.; Bertolini, F.; Bergamini, C.; Nervo, A.; Grani, G.; Rizzati, S.; Morelli, S.; Puliafito, I.; Elisei, R.

In: European Journal of Cancer, Vol. 118, 01.09.2019, p. 35-40.

Research output: Contribution to journalArticle

Locati, L. D. ; Piovesan, A. ; Durante, C. ; Bregni, M. ; Castagna, M. G. ; Zovato, S. ; Giusti, M. ; Ibrahim, T. ; Puxeddu, E. ; Fedele, G. ; Pellegriti, G. ; Rinaldi, G. ; Giuffrida, D. ; Verderame, F. ; Bertolini, F. ; Bergamini, C. ; Nervo, A. ; Grani, G. ; Rizzati, S. ; Morelli, S. ; Puliafito, I. ; Elisei, R. / Real-world efficacy and safety of lenvatinib : data from a compassionate use in the treatment of radioactive iodine-refractory differentiated thyroid cancer patients in Italy. In: European Journal of Cancer. 2019 ; Vol. 118. pp. 35-40.
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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.",
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T2 - data from a compassionate use in the treatment of radioactive iodine-refractory differentiated thyroid cancer patients in Italy

AU - Locati, L. D.

AU - Piovesan, A.

AU - Durante, C.

AU - Bregni, M.

AU - Castagna, M. G.

AU - Zovato, S.

AU - Giusti, M.

AU - Ibrahim, T.

AU - Puxeddu, E.

AU - Fedele, G.

AU - Pellegriti, G.

AU - Rinaldi, G.

AU - Giuffrida, D.

AU - Verderame, F.

AU - Bertolini, F.

AU - Bergamini, C.

AU - Nervo, A.

AU - Grani, G.

AU - Rizzati, S.

AU - Morelli, S.

AU - Puliafito, I.

AU - Elisei, R.

PY - 2019/9/1

Y1 - 2019/9/1

N2 - 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.

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