Temsirolimus in women with platinum-refractory/resistant ovarian cancer or advanced/recurrent endometrial carcinoma. A phase II study of the AGO-study group (AGO-GYN8)

• Published in: Gynecologic oncology Vol. 140; no. 3; pp. 450 - 456
• Main Authors: Emons, Günter, Kurzeder, Christian, Schmalfeldt, Barbara, Neuser, Petra, de Gregorio, Nikolaus, Pfisterer, Jacobus, Park-Simon, Tjoung-Won, Mahner, Sven, Schröder, Willibald, Lück, Hans-Joachim, Heubner, Martin Leonhard, Hanker, Lars, Thiel, Falk, Hilpert, Felix
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-03-2016
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Carcinoma - drug therapy; Disease-Free Survival; Drug Resistance, Neoplasm; Early Termination of Clinical Trials; Endometrial cancer; Endometrial Neoplasms - drug therapy; Female; Hematology, Oncology and Palliative Medicine; Humans; Middle Aged; mTOR inhibitor; Neoplasm Recurrence, Local - drug therapy; Obstetrics and Gynecology; Ovarian cancer; Ovarian Neoplasms - drug therapy; Platinum Compounds - therapeutic use; Rapalog; Response Evaluation Criteria in Solid Tumors; Retreatment; Sirolimus - adverse effects; Sirolimus - analogs & derivatives; Sirolimus - therapeutic use; Temsirolimus; Young Adult; mTOR inhibitor; Temsirolimus; Rapalog; Endometrial cancer; Ovarian cancer
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1016/j.ygyno.2015.12.025

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.