Patients with newly diagnosed non-co-deleted anaplastic glioma may experience greater survival outcomes with adjuvant temozolomide compared with radiotherapy only, according to results from a phase 3, randomized, open-label study published in the Lancet.
Investigators randomly assigned patients (1:1:1:1) to undergo either radiotherapy alone (n=187), concurrent radiotherapy and temozolomide (n=185), radiotherapy with adjuvant temozolomide (n=185), or concurrent radiotherapy and temozolomide plus adjuvant temozolomide (n=188).
The use of adjuvant temozolomide was associated with a hazard ratio of 0.65 (99.145% CI, 0.45-0.93). In patients without adjuvant temozolomide, the overall 5-year survival was 44.1% (95% CI, 36.3-51.6) vs 55.9% (95% CI, 47.2-63.8) with adjuvant temozolomide. Additionally, adjuvant temozolomide use correlated with an improvement in overall survival in a univariate analysis (HR 0.67; 95% CI, 0.51-0.88).
Progression-free survival also improved in these patients (HR 0.62; 95% CI, 0.50-0.76). Disease progression occurred in 46% (n=344) of subjects. Mortality occurred in approximately 30% (n=221) of both patients receiving adjuvant temozolomide and those not receiving adjuvant temozolomide. Treatment was well tolerated across all groups.
According to the researchers, temozolomide showed a clear beneficial effect despite that the patient population with 1p/19q non-co-deleted anaplastic glioma is less sensitive to chemotherapy than patients with 1p/19q co-deleted tumors.
Despite these findings, the investigators believe that additional research is necessary “to establish the efficacy of concurrent temozolomide chemotherapy and the effects of molecular signatures on outcome.”
van den Bent MJ, Baumert B, Erridge SC, et al. Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study. Lancet. 2017;390(10103):1645-1653.