Treatment > Temozolomide Clinical Trials  

Meeting Abstract

Temozolomide for recurrent ependymomas of the adult

Riccardo Soffietti, Alessandra Costanza, Mauro Nobile, Roberta Ruda', Roberto Mutani

Dept Neuroscience, University, Torino, Italy

The efficacy of most chemotherapeutic regimens in ependymomas of the adult is limited. 
Xenograft models have documented temozolomide's activity against ependymoma and no data are available in the clinical setting. 
We are conducting a Phase II study to assess the response rate and time to tumor progression (TTP) after salvage chemotherapy with temozolomide in patients with ependymomas relapsed after conventional treatments. 
Since 1999, 9 patients (pts) have been included and 7 are evaluable. 
There were 5 females and 2 males with a median age of 43 years (range 26-59). 
According to WHO classification the histological diagnosis at initial surgery was anaplastic ependymoma in 5 pts and ependymoma in 2 pts. 
Tumor site was supratentorial in 4 pts and infratentorial in 3. 
Two pts had a concomitant leptomeningeal disease at the time of recurrence. 
All pts had received surgery, conventional radiotherapy and in 3 of them a first line chemotherapy had been administered. 
All tumors were contrast-enhancing on MRI and the Karnofsky Score ranged from 60 to 90 (median 70). 
Treatment consisted of oral temozolomide 150-200 mg/sqm daily on day 1-5 in cycles of 28 days, up to 18 cycles in responding or stable pts when toxicity was acceptable. 
A 50% decrease of contrast enhancing area was defined as partial response (PR). 

Responses were as follows: complete response (CR) in 1/7 pts with anaplastic ependymoma (TTP 21+ mos); PR in 2/7 pts with anaplastic ependymoma (TTP 4, 15 mos); stable disease (SD) in 4/7 pts (TTP 7-15+ mos), including 2 minor responses with a decrease of tumor area of 40%; progressive disease (PD) in 0/7 pts. 
In 2 pts the response was delayed (1 PR after 6 cycles and 1 CR after 9 cycles). 
Two pts unresponsive to previous chemotherapy and 1 unresponsive to radiotherapy responded to temozolomide. 
In 4/5 responding pts the neurologic improvement was significant. 
Grade III myelotoxicity was observed in 4/7 pts. 

Conclusions. Temozolomide is active (43% CR+PR) in anaplastic ependymomas. 
Patients unresponsive to previous chemotherapeutic regimens or radiotherapy may respond to temozolomide. 
Further studies are warranted in larger number of patients. 
Our Phase II study is ongoing.

© Copyright 2002 American Society of Clinical Oncology