1023PD - Temsirolimus is active in refractory squamous cell carcinoma of the head and neck (SCCHN) failing platinum-based chemotherapy and cetuximab: efficac...

Date 30 September 2012
Event ESMO Congress 2012
Session Head and neck cancer
Topics Cytotoxic agents
Head and Neck Cancers
Therapy
Biological therapy
Presenter Viktor Grünwald
Authors V. Grünwald1, U. Keilholz2, A. Boehm3, O. Guntinas-Lichius4, B. Hennemann5, H.J. Schmoll6, P. Ivanyi7, A. Zörner8, A. Zapf9, T.C. Gauler10
  • 1Clinic For Hematology, Hemostasis, Oncology, Hannover Medical School, 30625 - Hannover/DE
  • 2Charite, DE-12200 - Berlin/DE
  • 3Clinic And Policlinic For Ear, Nose And Thorat, Universitätsklinikum Leipzig, 04103 - Leipzig/DE
  • 4Clinic For Ear, Nose And Throat, Universitätsklinikum Jena, Jena/DE
  • 5Clinic For Heamatology And Medical Oncology, Ev. Bethesda- Johanniter Klinikum GmbH, Duisburg/DE
  • 6Dept. Hematology/ Oncology, University of HalleMartin Luther University Hospital, DE-06120 - Halle/DE
  • 7Clinic For Hematology, Hemostaseology, Oncology, Hannover Medical School, 30625 - Hannover/DE
  • 8Clinical Pharmacology, Medical School Hannover, Hannover/DE
  • 9Biostatistics, Medical School Hannover, Hannover/DE
  • 10Dept. Of Medicine (cancer Research), University Hospital EssenWestdeutsches Tumorzentrum, DE-45122 - Essen/DE

Abstract

Background

Prognosis of patients with failure of cisplatin-based 1st line chemotherapy for recurrent or metastatic SCCHN remains poor. We therefore evaluated temsirolimus after failure of cisplatin and cetuximab in SCCHN.

Methods

Patients with progressive SCCHN and failure of platinum-based chemotherapy and cetuximab were eligible. Patients with loco-regional recurrence as the sole lesion had to have a progression free survival (PFS) of at least 6 months from last therapy. 18 years of age, ECOG 0-2, life expectancy of at least 3 months, and adequate organ function are key inclusion criteria. Brain metastases were allowed, provided local therapy has been completed successfully. Tumor assessment was performed every 6 weeks and assessed according to RECIST 1.0. Primary endpoint was the progression free survival rate (PFR) at 12 weeks >20%. Secondary endpoints were time to progression (TTP), objective response rate (ORR), overall survival and toxicity (according CTCAE 3.0). 25 mg temsirolimus was given i.v. weekly until progression or toxicity prevail. PFS, PFR, and OS estimates were calculated by Kaplan-Meier-Curves.

Results

A total of 42 patients entered the trial, of whom 40 were eligible. ECOG performance status of 0/1/2 was found in 7/29/5 pts and missing in 1 patient. Mean age was 61.6y (range: 42-79y) with male predominance (31 pts; 74%). Progression free survival rate at 12 weeks was 40% (CI95% 25-55%), TTP was 56 d (CI95% 36-113d), and OS 152d (CI95% 76-256d). Stable disease (SD) was obtained in 19 pts. (56%), progressive disease (PD) in 10 pts. (29%), 1 pts. was not evaluable for response, and 10 pts. had missing scans. Treatment with temsirolimus was well tolerated. Safety data will be presented at the meeting.

Conclusions

Temsirolimus reaches its prespecified endpoint with a PFR at 12weeks of 40%. Efficacy data is encouraging and compare to single agent cetuximab activity in platinum-refractory SCCHN. Further studies with this drug in SCCHN are warranted.

Disclosure

V. Grünwald: research funding: Pfizer Advisory Board: Merck KG

U. Keilholz: Research support and honorarium Whyeth / Pfizer.

T.C. Gauler: ADVISORY BOARD: MERCK KG, Pfizer HONORARIA: Pfizer

All other authors have declared no conflicts of interest.