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.

Adult Aged Aged, 80 and over Antineoplastic Agents / adverse effects Cell Differentiation Compassionate Use Trials Disease Progression Female Humans Iodine Radioisotopes / therapeutic use Italy Male Middle Aged Patient Safety Phenylurea Compounds / adverse effects Progression-Free Survival Protein Kinase Inhibitors / adverse effects Quinolines / adverse effects Radiation Tolerance Radiopharmaceuticals / therapeutic use Retrospective Studies Risk Factors Thyroid Neoplasms / drug therapy Time Factors Young Adult

Lenvatinib RAI refractory Real life Thyroid cancer

Journal

European journal of cancer (Oxford, England : 1990)

ISSN: 1879-0852

Titre abrégé: Eur J Cancer

Pays: England

ID NLM: 9005373

Informations de publication

Date de publication:
09 2019

Historique:

received: 25 02 2019

revised: 22 05 2019

accepted: 26 05 2019

pubmed: 13 7 2019

medline: 9 6 2020

entrez: 13 7 2019

Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND

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.

Identifiants

DOI: 10.1016/j.ejca.2019.05.031 PMID: 31299580

pubmed: 31299580

pii: S0959-8049(19)30358-2

doi: 10.1016/j.ejca.2019.05.031

pii:

doi:

Substances chimiques

Antineoplastic Agents 0

Iodine Radioisotopes 0

Phenylurea Compounds 0

Protein Kinase Inhibitors 0

Quinolines 0

Radiopharmaceuticals 0

lenvatinib EE083865G2

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

35-40