Treatment > PCV · Temozolomide Clinical Trials

Meeting Abstract

EORTC Study 26972: Second Line Temozolomide Chemotherapy in Recurrent Oligodendroglial Tumors After PCV Chemotherapy: a Phase II Study

M J van den Bent, O Chinot, W Boogerd, J Bravo-Marques, MJB Taphoorn, JM Kros, CDD van de Rijt, N de Beule, B Baron, On Behalf of the EORTC Brain Tumor Group.

University Hospital Rotterdam/Rotterdam Cancer Center, Rotterdam, Netherlands; CHU de la Timone, Marseille, France; Netherlands Cancer Institute, Amsterdam, Netherlands; I.P.O. Francisco Gentil, Lisboa, Portugal; University Hospital Utrecht, Utrecht, Netherlands; EORTC Datacenter, Bruxelles, Belgium; Bruxelles, Belgium

Introduction. Oligodendroglial tumors (OD) are chemosensitive tumors. 
Temozolomide (TMZ) showed good activity in recurrent anaplastic astrocytoma. 
We investigated TMZ in recurrent OD after prior radiation therapy and PCV chemotherapy. 

Objectives. To estimate the activity (Response Rate-RR) and toxicity of temozolomide in recurrent OD after prior PCV chemotherapy. 

Methods. Prospective multicenter Phase II trial. 
Eligible were patients with recurrent oligodendroglioma or mixed oligoastrocytoma after prior RT and PCV chemotherapy, with an enhancing tumor with a diameter lcm. 
Pts were treated with 150 mg/m2 on day 1-5 in cycles of 28 days. 
Response assessment was performed according to McDonald's criteria. 
Responses, i.e. 50% decrease in contrast enhancing area, required confirmation with a second scan after an interval of at least 1 month. 
Histology was reviewed for all pts, and the scans of all responding patients were centrally reviewed. 
Toxicity was assessed with the CTC criteria. 

Results. Between April'98 and February 2000, 35 patients (pts) were included, 32 met the eligibility criteria. 
Sixty percent were males, median age was 43.5 years. 
Ten of the 21 pts assessable for response to first line PCV had responded to PCV. 
Thirty pts were assessable for response to TMZ: 1 complete and 6 partial responses were observed (RR: 7/30=23%; 95% CI[10-42%]); 9 pts had stable disease. 
Median duration of response was 6.2 months (range:3-15 months. A median four cycles of TMZ were administered (range:1-12). 
Because of limited number of responders, no clear relation was present between response to prior chemotherapy and to TMZ. 
Toxicity was very modest and consisted mainly of myelosuppression and nausea/vomiting. 

Conclusions. Temozolomide shows a clear but modest activity in OD as second line chemotherapy after prior PCV, and is well tolerated. 
Future trials in OD combining TMZ with other drugs are indicated.

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