Letrozole may be a valuable maintenance treatment in high-grade serous ovarian cancer patients

Trial ID # Letrozole University Hospital Basel
Phase Single-site
Drug Class Hormonal Therapy: Aromatase
Drug Name Letrozole
Alternate Drug Names Femara
Drugs in Trial Letrozole
Eligible Participant
Patients Enrolled

50

Therapy Setting

Maintenance

Study Design

Open-Label, Non-randomized

Endpoints

RFS, evaluated per RECIST

Biomarkers

ER protein

Efficacy

Let maint vs Placebo, at 24 months follow-up:

All patients:
RFS: NR (n=23) vs 13.2 months (n=27, p=0.035)
Patients w/o residual disease:
RFS: NR (n=16) vs 20.8 months (n=21, p=0.11)
Patients w/ residual disease:
RFS: 21.6 (n=7) vs 8.8 months (n=6, p=0.026)

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: none
Grade 1-2 AE: hot flashes, fatigue, bone pain (6.4%)

Conclusion

Promising activity with minimal toxicity in ER-positive patients

Reference

Heinzelmann-Schwarz et al. Letrozole may be a valuable maintenance treatment in high-grade serous ovarian cancer patients. Gynecol Oncol (2018) 148(1):79-85.
https://www.ncbi.nlm.nih.gov/pubmed/29157627