890TiP - Phase II study of everolimus (E) in refractory germ cell tumors (GCTs)

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer Agents
Germ Cell Tumours
Biological Therapy
Presenter Maria Reckova
Authors M. Reckova1, M. Mego1, D. Svetlovska2, V. Miskovska'3, J. Obertova4, Z. Sycova-Mila4, P. Palacka5, J. Rajec4, S. Liskova4, J. Mardiak4
  • 1National Cancer Institute, Slovakia, 83310 - Bratislava/SK
  • 2Clinical Research, National Cancer Institute, 83310 - Bratislava/SK
  • 3Medical Oncology, St. Elisabeth Cancer Institute, SK-81250 - Bratislava/SK
  • 4Medical Oncology, National Cancer Institute, Slovakia, 83310 - Bratislava/SK
  • 52nd Oncology, National Cancer Institute, Slovakia, 83310 - Bratislava/SK



GCTs represent a model for the cure of cancer. Nonetheless, a small proportion of patients (pts) develop disease recurrence. Loss of the tumor suppressor gene PTEN (phosphatase and tensin homolog) marks the transition from intratubular germ cell neoplasias (ITGCN) to invasive GCTs. PTEN inactivation is associated with dysregulation of PI3K/Akt pathway and increased mTOR signalling. We hypothesize that dysregulation of PI3K/Akt pathway due to PTEN inactivation in GCTs suggests that these pts would have greater benefit from mTOR inhibition.


In December 2011, National Cancer Institute of Slovakia launched a one arm, two-staged phase II study aimed to evaluate the efficacy and toxicity of Everolimus (E) in pts with refractory GCTs. The primary objective is to determine the efficacy of E in pts with refractory GCTs. The pts with radiological and/or serological proof of relapsed GCTs, who were not amenable to be cured by chemotherapy or surgery and who failed at least two platinum-based regimens or one platinum regimen in case of platinum-refractory disease or primary mediastinal non-seminomatous GCTs have been eligible. E has been administered at a dose of 10mg daily until progression or unacceptable toxicity.


From December 2011, 4 patients have been enrolled. Median age of patients is 28 years. All patients were pretreated with at least 3 cisplatin-based therapy, three patients were absolute cisplatin refractory, progressed directly on cisplatin-based therapy. We observed no unexpected toxicity. One patient experienced pneumonitis grade 3, and dose reduction was needed. One patient progressed early, while three patients are still on treatment for 1 + , 3+ and 5+ months.


Our preliminary data suggests that, Everolimus is safe and well tolerated drug in patients with GCT. Efficacy data is warranted.


All authors have declared no conflicts of interest.