This phase I/II clinical trial evaluated the efficacy and safety of Vistusertib, an mTOR inhibitor, combined with Arimidex in patients with hormone receptor–positive, HR+, recurrent or metastatic endometrial cancer.
About the VICTORIA Study in Endometrial Cancer Patients
Patients were recruited to the study from 12 cancer centers in France in April 2016 to October 2019.
Patients were randomized to two arms: Oral Vistusertib (125 mg twice daily 2 days per week) and oral Arimidex (1 mg daily) in the combination Vistusertib with Arimidex arm (V+A arm) or oral Arimidex alone (A arm).
Results of the Study
Of the 75 patients, 73 were treated:
V+A arm: 49 patients
A arm: 24 patients
In the V+A arm, 67.3% of patients were did not progress after 8 weeks and in the A arm, 39.1% did not progress.
No significant serious side effects were reported.
The overall Response Rate was 24.5% in the V+A arm vs 17.4% in the A arm.
Median Progression Free Survival, PFS, was 5.2 months in the V+A arm and 1.9 months in the A arm.
Fatigue, lymphopenia, hyperglycemia, and diarrhea were the most common side effects associated with Vistusertib.
Conclusions for Endometrial Cancer Patients
Vistusertib plus Arimidex had manageable side effects.
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