Abstract
Objectives To evaluate activity and toxicity of mTOR inhibitor temsirolimus in patients with platinum-refractory/resistant ovarian cancer (OC) or advanced/recurrent endometrial carcinoma (EC). Methods Women with epithelial ovarian, fallopian tube or primary peritoneal cancer were eligible, when they had progression during treatment with a platinum based regimen or within 6 months after receiving a platinum based regimen and a previous taxane treatment. Women with advanced/recurrent EC, no longer amenable to curative surgery and/or radiotherapy were eligible when they had no previous or only adjuvant chemotherapy. Preceding endocrine therapy for metastatic/recurrent disease was allowed. Patients received weekly IV infusions of 25 mg temsirolimus. Primary endpoint was progression free survival rate after 4 months (OC) or 6 months (EC). A two stage design was applied. Results Forty-four patients (OC: n = 22; EC: n = 22) were enrolled and received temsirolimus treatment. Median age was 56 years (OC) or 63 years (EC). After eight weeks of treatment, 10 of 21 evaluable patients in the OC cohort and 8 of 20 evaluable patients in the EC cohort had progressive disease. Thus efficacy did not meet the predefined levels during the first stage of recruitment and the trial was stopped. Some patients in both cohorts had long lasting PFS (> 7 months). Toxicity of temsirolimus was mild. Conclusions Temsirolimus treatment was well tolerated in our patients, but did not meet the predefined efficacy criteria. In our study as in other trials on rapalogs in OC or EC, a few patients had long lasting disease stabilisations.
| Original language | English |
|---|---|
| Journal | Gynecologic Oncology |
| Volume | 140 |
| Issue number | 3 |
| Pages (from-to) | 450-456 |
| Number of pages | 7 |
| ISSN | 0090-8258 |
| DOIs | |
| Publication status | Published - 01.03.2016 |
Funding
This investigator initiated trial was performed after approval of the study by the German Regulatory Authorities and Independent Ethics Committees. Informed consent was obtained from each participant prior to inclusion into the study. The study was sponsored by AGO Research GmbH and supported by an unrestricted grand of Pfizer, Germany, EudraCT No: 2011–000299-33. The corresponding author reports other from AGO-Study Group non-financial support from Pfizer during the conduct of the study, other from Aeterna Zentaris, grants from Ferring, personal fees from Roche, personal fees from ASTRA-Zeneca outside the submitted work. In addition, the corresponding author has a patent GnRH-receptor 2-antagonists issued and is a coordinator of the German group for the development of evidence based guideline for diagnosis and treatment of endometrial cancer (funded by German Cancer Society and German Cancer Help).
Research Areas and Centers
- Research Area: Luebeck Integrated Oncology Network (LION)
