Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lenvatinib.
- Who it may be relevant to
- Registry conditions: Differentiated Thyroid Cancer, Gender. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational Study on Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer
Overview
Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer. The primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.
Detailed description
Lenvatinib is an orally available potent inhibitor of the split-kinase family of transmembrane growth factor receptors including Flt-1/VEGFR-1 and KDR/VEGFR. Lenvatinib has been investigated in hepatocellular carcinoma and in RAI-resistant thyroid cancer (Phase III trials) and in other malignancies, showing high rates of activity. In RAI-resistant thyroid cancer, lenvatinib showed a remarkable response rate over placebo (65% vs 2), combined with a prolonged progression free survival (18.3 vs 3.6 months). It has been approved for the treatment of locally recurrent or metastatic, progressive RAI resistance-DTC in the United States, Europe, and Japan, based on the results from SELECT trial. Moreover, lenvatinib demonstrated a meaningful clinical activity (response rate 64.8% in treatment arm vs 1.5% in placebo arm, p\<0.001;) significantly reducing the tumour burden, with a median maximum percentage change in tumour size of -42.9%. Response was mostly pronounced at the first assessment (median -24.7% at 8 weeks after randomization) but it has been observed even in the following months (-1.3% per month). Recently, the efficacy of lenvatinib was confirmed in specific patient population, such as elderly. Although the efficacy is remarkable toxic effects are considerable and not all patients have the same risk to benefit ratio from lenvatinib treatment. Results derived from controlled clinical trials are rarely replicable in the real-life because these trials are usually conducted in selected populations, in a highly controlled setting, optimized to show the effect of the drug.
In this context growing evidences are showing gender associated functions playing a role in cancer incidence, progression and response to therapy; gender disparities in toxicities and effectiveness of certain drugs used in the treatment of the most common cancer is already well known.The aim of the present study is to evaluate the safety and efficacy profile of Lenvatinib based on gender in patients with refractory iodine DTC.
Interventions
- Drug Lenvatinib
Patients will be treated by lenvatinib as recommended by good clinical practice
Primary outcome measures
- Gender difference in Safety profile of lenvatinib treatment [Time frame: 1 year]
Secondary outcome measures (3)
- Gender difference in lenvatinib side effects incidence [Time frame: 1 year]
- Gender difference in lenvatinib response rate [Time frame: 1 year]
- Gender difference progression free survival and overall survival of patients treated with lenvatinib [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients with refractory iodine DTC treated with lenvatinib
- Signed written informed consent
Exclusion criteria
\- Age < 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Regina Elena National Cancer Institute — Rome
Identifiers
NCT: NCT05789667 · RS1316/20(2312)