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)
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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). / 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.
in: GYNECOL ONCOL, Jahrgang 140, Nr. 3, 03.2016, S. 450-6.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - 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)
AU - Emons, Günter
AU - Kurzeder, Christian
AU - Schmalfeldt, Barbara
AU - Neuser, Petra
AU - de Gregorio, Nikolaus
AU - Pfisterer, Jacobus
AU - Park-Simon, Tjoung-Won
AU - Mahner, Sven
AU - Schröder, Willibald
AU - Lück, Hans-Joachim
AU - Heubner, Martin Leonhard
AU - Hanker, Lars
AU - Thiel, Falk
AU - Hilpert, Felix
N1 - Copyright © 2015. Published by Elsevier Inc.
PY - 2016/3
Y1 - 2016/3
N2 - 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 6months 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 25mg temsirolimus. Primary endpoint was progression free survival rate after 4months (OC) or 6months (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 56years (OC) or 63years (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 (>7months). 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.
AB - 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 6months 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 25mg temsirolimus. Primary endpoint was progression free survival rate after 4months (OC) or 6months (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 56years (OC) or 63years (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 (>7months). 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.
U2 - 10.1016/j.ygyno.2015.12.025
DO - 10.1016/j.ygyno.2015.12.025
M3 - SCORING: Journal article
C2 - 26731724
VL - 140
SP - 450
EP - 456
JO - GYNECOL ONCOL
JF - GYNECOL ONCOL
SN - 0090-8258
IS - 3
ER -
