Efficacy
At the time of second interim analysis and median follow up of 55.7 months, median OS was significantly longer with adjuvant temozolomide vs without adjuvant temozolomide (HR=0.64, 95% CI 0.52-0.79, p<0.0001). The median OS was 82.3 months (95% CI 67.2-116.6) with adjuvant temozolomide as compared with 46.9 months (95% CI 37.9-56.9) without adjuvant temozolomide. OS at 5 years was 58.5% (95% CI 52.8-63.8) with adjuvant temozolomide, and 44.3% (95% CI 38.6-49.9) without adjuvant temozolomide (HR=0.67, 95% CI 0.55-0.83, p<0.0001).r
The data at second interim analysis confirmed that concurrent temozolomide had no beneficial effects. The median OS was 66.9 months (95% CI 45.7-82.3) vs 60.4 months (95% CI 45.7-71.5) with and without concurrent temozolomide, respectively (HR=0.97, 99.1% CI 0.73-1.28), p=0.76).r
In patients with IDH1 and IDH2 mutant tumours, median OS was significantly longer with adjuvant temozolomide vs without adjuvant temozolomide (HR=0.48, 95% CI 0.35-0.67, p<0.0001). However, no survival benefit was observed with concurrent temozolomide vs without concurrent temozolomide (HR=0.80, 95% CI 0.58-1.10, p=0.17).r
At the time of planned analyses of the prognostic value of IDH1 and IDH2 mutations and median follow-up of 66·7 months, median OS was 1.7 years (95% CI 1.4-1.9) in IDH1/2 wild type anaplastic astrocytoma group vs 8.2 years (95% CI 7.1-not reached) in IDH1/2 mutated anaplastic astrocytoma group (HR=6.95, 95% CI 5.51-8.78, p< 0.0001). MGMT methylation analysis confirmed prognostic value of DNA methylation for IDH1/2 mutated anaplastic astrocytoma patients.r
OS in the intent to treat populationr
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PFS in the intent to treat populationr
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Kaplan-Meier curves of OS in all patients with (A) Concurrent/no concurrent temozolomide (B) Adjuvant/no adjuvant temozolomider
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Kaplan-Meier curves of OS in IDH1/IDH2 mutant patients with (A) Concurrent/no concurrent temozolomide (B) Adjuvant/no adjuvant temozolomider
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