Protracted Adjuvant Temozolomide in Glioblastoma MultiformeReport as inadecuate

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Purpose: Radiotherapy with concurrenttemozolomide TMZ, followed by 6 cycles of adjuvant TMZ, is the standard ofcare for newly diagnosed Glioblastoma Mulltiforme GBM. However tumorprogression is the role with median survival of almost 14 months. With lack ofeffective second line chemotherapy, many physicians and some guidelinesadvocate prolonged use of adjuvant TMZ more than 6 months. We conduct thisstudy to test the efficacy of protracted adjuvant conventional dose TMZ overthe standard 6 doses of adjuvant TMZ. Material and Methods: This phase II trialenrolled patients newly diagnosed as GBM, older than age 18 years, with aKarnofsky performance score KPS of ≥60, Neurological Performance Scale NPSof ≤3. Patients were randomly assigned to the standard concurrentchemoradiotherapy CCRT followed by 6 cycles of adjuvant TMZ or the sametreatment with more than 6 cycles of adjuvant chemotherapy extended as long asthe patient in good performance, with no unacceptable toxicity, no signs ofdisease progression. The primary end point was OS. Results: A total of 59patients were recruited in the study and were randomized in two arms. 29patients joined arm 1 aiming at receiving CCRT followed by adjuvant 6 cyclesTMZ 6 cycles arm and 30 joined arm 2 aiming at receiving the same treatmentwith more than 6 cycles of TMZ >6 cycles. 16 patients managed to completethe adjuvant 6 cycles in arm 1. 19 patients in arm 2, completed the 6 cycleswith additive more doses with a median of 11 cycles range: 8 - 23 cycles.Median PFS was 12.1 months for 6 cycles arm, and 18.8 months for >6cycles arm, HR 0.88 95% CI: 1.185 - 4.901 P 0.015; the overall survivalfor 6 cycles arm was 18.1 months, versus 24.1 months, HR 0.70 95% CI: 1.007- 4.037 P 0.048. No significant added toxicity was notice and the 4 weeklyTMZ was well tolerated. Conclusion: This study concluded that protractedadjuvant TMZ after concurrent chemoradiotherapy could be a feasible strategyfor GBM. This strategy warrants a large phase III randomized trial.


Glioblastoma Multiforme, Timozolomide, Protracted Course, Efficacy

Cite this paper

Refae, A. , Ezzat, A. , Salem, D. and Mahrous, M. 2015 Protracted Adjuvant Temozolomide in Glioblastoma Multiforme. Journal of Cancer Therapy, 6, 748-758. doi: 10.4236-jct.2015.68082.

Author: Ahmed A. Refae1, Ahmed Ezzat1, Dina Ahmed Salem1, Mervat Mahrous2



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