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DOI: 10.1055/s-0034-1388557
Temsirolimus in women with platinum-resistant ovarian cancer or advanced/recurrent endometrial cancer: a multicenter phase II trial of the AGO Study Group (AGO-GYN 8)
Background: Inhibition of mTOR with temsirolimus (T) might be an efficacious treatment of patients with epithelial ovarian cancer (OC) or endometrial cancer (EC).
Methods: Patients (pts) with platinum and taxane resistant OC (n = 22) or with advanced/recurrent EC, who had not received previous chemotherapy (n = 22) were treated with weekly IV infusions of T (25 mg). Primary endpoint was progression free survival after 4 months (OC) or 6 months (EC). A two stage design was used with second stage of accrual if < 10 of the first 22 pts (OC) or < 7 of the first 22 pts (EC) had progressive disease after the first 8 weeks of T-treatment.
Results: 22 pts each were treated in the OC and the EC cohort respectively. Median age was 56 years (OC) or 63 years (EC). After 8 weeks of treatment with T, 10 pts in the OC cohort and 7 pts in the EC group had progressive disease. Toxicity of T was mild: grade 4: 1 ileus (OC), grade 3: anemia 1, abdominal pain 1, ALT elevation 1, ascites 3 (OC), diarrhea 1, vomiting 2.
Conclusions: T-treatment was well tolerated in our patients. It did, however, not meet the predefined efficacy criteria with 10 of 22 pts (OC) and 7 of 22 pts (EC) having progressive disease after 8 weeks of treatment.