Gender impact on safety and efficacy in lenvatinib treated patients with radioiodine-refractory differentiated thyroid cancer (GISEL study)
Authors' conclusion
Lenvatinib is effective in both sexes and exhibits a good safety profile, with a sex difference in the frequencies of some adverse events.
Study context
- Population
- Patients with radioiodine-refractory DTC treated with lenvatinibmedian follow-up 26 months (2–72)
- Participants
- 138 patients
- Exposure
- Females vs males treated with lenvatinib
- Femalesn = 64
- Outcome
- Safety and efficacy by sex
Methodological detailsreal-world, multicentre, Italian
- Real-world
- Multicentre
- Italian
Main finding
As reported in the abstract
- No sex differences in PFS, overall survival or disease control rate
Observational data: associations, not effects.
Further findings
Liver metastases and disease progression (females only)
| HR (95% CI) | P value | ||
|---|---|---|---|
| Liver metastasesAssociation only in females | 3.73 (1.06–13.12) | P = 0.040 | |
| 0.050.21520Hazard ratio (log scale) |
Liver metastases and death (females only)
| HR (95% CI) | P value | ||
|---|---|---|---|
| Liver metastasesAssociation only in females | 4.82 (1.75–13.25) | P = 0.002 | |
| 0.050.21520Hazard ratio (log scale) |
| Outcome | P value |
|---|---|
| Physical activityMore men performed physical activities | P = 0.024 |
| SmokingHigher in men | P = 0.003 |
| Alcohol consumptionHigher in men | P = 0.001 |
Physical activity
- More men performed physical activities
Smoking
- Smoking frequency higher in men
Alcohol consumption
- Alcohol consumption frequency higher in men
PFS, OS and disease control rate by sex
- No sex differences in progression-free survival, overall survival or disease control rate
Safety
Lenvatinib dose reduction due to AEs
Severe AEs
P = 0.398
Stomatitis/mucositis
P = 0.016
Hematological disorders
P = 0.011
Gastrointestinal disorders
P = 0.010
- Severe adverse events (AEs) — Mean dose
- 18.2 mg (±5.7)
- Severe AEs — Median time to first serious adverse event (AE)
- 9 weeks (1-154)
Lenvatinib dose reduction due to AEs
- No sex differences
At least one AE
- Patients with at least one AE
- 99%
- No sex difference in number of AEs and time to first AE
Interruption and discontinuation
- Interrupted lenvatinib due to AEs
- 87 patients
- Median time to interruption
- 3 months (0-48)
- Mean dose at interruption
- 17 mg ±5.5
- Discontinuation
- 21 patients
- Discontinuation for severe AEs
- 5 patients
Original publication
Gender impact on safety and efficacy in lenvatinib treated patients with radioiodine-refractory differentiated thyroid cancer (GISEL study). Eur Thyroid J. Published 8 April 2025. doi:10.
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