Clinical trial NCT05789667: Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer
Official title: Observational Study on Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Radioiodine Refractory Differentiated Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Differentiated Thyroid Cancer
Gender
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
name: University of Roma La Sapienza
name: University of Siena
name: University of Pisa
name: Istituto Oncologico Veneto IRCCS
name: University of Catania
name: Istituto Auxologico Italiano
First posted: 2023-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by radio-refractory iodine differentiated thyroid cancer

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with refractory iodine DTC treated with lenvatinib
* Signed written informed consent

Exclusion Criteria:

- Age \< 18 years

Primary outcomes:
measure: Gender difference in Safety profile of lenvatinib treatment
timeFrame: 1 year
Secondary outcomes:
measure: Gender difference in lenvatinib side effects incidence
timeFrame: 1 year
measure: Gender difference in lenvatinib response rate
timeFrame: 1 year
measure: Gender difference progression free survival and overall survival of patients treated with lenvatinib
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena National Cancer Institute
Study officials:
affiliation: Regina Elena Cancer Institute
name: Marialuisa Appetecchia, Prof
role: PRINCIPAL_INVESTIGATOR
References: