1O - Extended dosing vs conventional dosing of adjuvant temozolomide in adults with newly diagnosed high grade gliomas: A randomized, single-blind, two-arm, parallel-group controlled trial

Background

Maximum safe surgical resection followed by adjuvant chemoradiation and temozolomide chemotherapy is the current standard of care in the management of newly diagnosed high grade glioma. However, there are controversies about the optimal number of adjuvant temozolomide cycles. This study aimed to compare the survival benefits of 12 cycles against 6 cycles of adjuvant temozolomide adults with newly diagnosed high grade gliomas.

Methods

Adult patients with newly diagnosed high grade gliomas, and a Karnofsky performance status >60%, were randomized to receive either 6 cycles or 12 cycles of adjuvant temozolomide. Patients were followed-up for assessment of overall survival (OS) and disease-free survival (DFS) by brain MRI every 3 months within the first year after treatment and then every six months.

Results

A total of 100 patients (6 cycles, n=50; 12 cycles, n=50) were entered. The rate of treatment completion in 6 cycles and 12 cycles groups were 91.3% and 55.1%, respectively. With a median follow-up of 26 months, the 12-, 24-, 36, and 48-month OS rates in 6 cycles and 12 cycles groups were 81.3% vs 78.8%, 58.3% vs 49.8%, 47.6% vs 34.1%, and 47.6% vs 31.5%, respectively (p-value=.19). Median OS of 6 cycles and 12 cycles groups were 35 months (95% confidence interval (CI), 11.0 to 58.9) and 23 months (95%CI, 16.9 to 29.0). The 12-, 24-, 36-, and 48- month DFS rates in 6 cycles and 12 cycles groups were 70.8% vs 56.9%, 39.5% and 32.7%, 27.1% vs 28.8%, and 21.1% vs 28.8%, respectively (p=.88). The Median PFS of 6 cycles and 12 cycles groups was 18 months (95% CI, 14.8 to 21.1) and 16 (95% CI, 11.0 to 20.9) months.

Table: 1O

The characteristics of the patients at baseline

Conclusions

Patients with newly diagnosed high grade gliomas treated with adjuvant temozolomide after maximum safe surgical resection and adjuvant chemoradiation do not benefit from extended adjuvant temozolomide beyond 6 cycles.

Clinical trial identification

IRCT20160706028815N3.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Mashhad University of Medical Sciences.

Disclosure

All authors have declared no conflicts of interest.