Adjuvant temozolomide therapy after radiotherapy may significantly improve overall and progression-free survival (OS and PFS, respectively) among patients with newly diagnosed, non-co-deleted anaplastic glioma, according to a study published in The Lancet.1
Evidence from previous studies demonstrated that administering chemotherapy to patients with chemotherapy-sensitive brain malignancies after radiotherapy did not improve OS.
For the CATNON phase 3 trial (ClinicalTrials.gov Identifier: NCT00626990), researchers enrolled 745 patients with anaplastic glioma and randomly assigned them to receive radiotherapy (59.4 Gy in 33 fractions of 1.8 Gy) alone or with adjuvant temozolomide 150 to 200mg/m2 given on days 1 to 5 for 12 4-week cycles, or to receive radiotherapy with concurrent temozolomide 75mg/m2 daily, alone or with adjuvant temozolomide.
At the median follow-up of 27 months, 46% of patients had disease progression and 30% had died. The adjusted hazard ratio (HR) for OS was 0.65 (99-145% CI, 0.45-0.93).
The adjuvant temozolomide group had a 5-year OS of 55.9% (95% CI, 47.2-63.8) vs 44.1% (95% CI, 36.3-51.6) among others.
The adjuvant temozolomide group had a 5-year PFS of 43.1% (95% CI, 35.0-50.9) vs 24.3% (95% CI, 17.7-31.6) among others.
Overall, 54% of patients in the non-adjuvant temozolomide arm had disease progression vs 39% of the adjuvant temozolomide arm.
RELATED: Phase 1 Study of A Dendritic Cell Vaccine for High-grade Glioma and Glioblastoma
The authors concluded that “further follow-up and tissue studies are needed 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, randomized, open-label intergroup study. Lancet. 2017 Aug 8. doi: 10.1016/S0140-6736(17)31442-3 [Epub ahead of print]