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Concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) for newly diagnosed glioblastoma multiforme (GBM). Conclusive results of a randomized phase III trial by the EORTC Brain & RT Groups and NCIC Clinical Trials Group.



Website: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-001655,00.asp

Posted on: 06/08/2004

Concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) for newly diagnosed glioblastoma multiforme (GBM). Conclusive results of a randomized phase III trial by the EORTC Brain & RT Groups and NCIC Clinical Trials Group.

Abstract No: 2

Author(s): R. Stupp, W. P. Mason, M. J. Van Den Bent, M. Weller, B. Fisher, M. Taphoorn, A. A. Brandes, G. Cairncross, D. Lacombe, R. O. Mirimanoff; University Hospital (CHUV), Lausanne, Switzerland; Princess Margaret Hospital, Toronto, ON, Canada; University Hospital/Rotterdam Cancer Center, Rotterdam, Netherlands; University of Tübingen Medical School, Tübingen, Germany; University of Western Ontario, London, ON, Canada; University Medical Center, Utrecht, Netherlands; Azienda Ospedale-Università, Ospedale Busonera, Padova, Italy; University of Calgary, Calgary, AB, Canada; EORTC Data Center, Brussels, Belgium

Abstract: Background: Standard therapy of GBM after biopsy or resection is RT. TMZ, a novel methylating agent demonstrated some activity against recurrent glioma. In a phase II trial we observed a potential survival advantage by adding TMZ concomitantly and adjuvant to RT (Stupp et al. JCO 2002). In this randomized trial we tested this novel regimen against RT. Methods: Patients (pts) age 18-70 years with histologically proven newly diagnosed GBM (WHO grade IV) were eligible. Pts were randomized between standard RT (60 Gy in 30 daily fractions of 2 Gy) versus the same RT and concomitant (TMZ 75 mg/m2/d, daily up to 42 days) followed by up to 6 cycles of adjuvant TMZ (150-200 mg/m2, daily x 5d, q28 d). Survival (intent to treat) was the primary endpoint aiming at a 30% improvement (log-rank). Pathology was centrally reviewed. Results: Five hundred and seventy-three pts from 85 centers were randomized. Median follow-up is 2 years, 436 patients have died. Median time between histological diagnosis and treatment start was 5 weeks. RT was delivered as prescribed in 93% of pts. Concomitant TMZ was administered without interruption in 76%, temporarily interrupted in 11% and prematurely discontinued in 12%. Adjuvant TMZ was given to 76% of pts, 36% completed all 6 cycles for a total of 924 cycles. The increase in median survival is 3 months. The log-rank test is significant with a p-value of < .0001. The hazard ratio is 0.62 (95% c.i. 0.51-0.75). Grade 3/4 hematotoxicity was observed in 7% of pts during concomitant TMZ/RT treatment, and in 16% (5.2% of cycles) of the adjuvant TMZ. Patients continue to be followed to evaluate long term effects of treatment.


RT (n=286)
RT/TMZ (n=287)
p-value
Age, median (range) [years]
56.6 (23.1-70.8)
55.7 (19-70.5)
NS
Tumor resection
70%
68%
NS
WHO PS : 0 / 1 / 2
39% / 49% / 12%
39% / 48% / 13%
NS
Steroids at baseline
75%
67%
p=0.041
Progr.-free surv. (95% c.i.)
5.0 mo (4.2-5.5)
7.2 mo (5.8-8.3)
p< .0001
Median survival (95% c.i.)
12 mo (11.2-13.2)
15 mo (13.6-16.8)
p< .0001
2-year survival (95% c.i.)
8% (4-12%)
26% (20-32%)
p< .0001


Conclusions: Concomitant and adjuvant TMZ chemotherapy significantly improves PFS and overall survival in GBM pts. This treatment is safe and well tolerated.


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