CHICAGO–Long-term data do not support a differential efficacy of primary temozolomide monotherapy or PCV (procarbazine, CCNU, and vincristine) polychemotherapy versus radiotherapy in patients with anaplastic glioma, a study presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in has shown.
“NOA-04 aimed at demonstrating superiority of initial chemo over radiotherapy in patients with newly diagnosed anaplastic gliomas after central histology,” said Wolfgang Wick, MD, of Heidelbeg University Hospital in Germany. “The final analysis did not demonstrate a difference in PFS/TTF or OS between initial chemo or radiotherapy.”
For the study, researchers conducted a long-term analysis of the NOA-04 phase III trial, which included 274 patients in the intention-to-treat population. All patients were randomly assigned 2:1:1 to receive radiotherapy to 54-60 Gy, four 6-week cycles of PCV, or eight 4-week cycles of temozolomide.
Results showed that during a median observation period of 11.8 years, the median time-to-treatment-failure was 4.6 years (95% CI: 3.4, 5.1) for radiotherapy compared with 4.4 years (95% CI: 3.3, 5.3) for chemotherapy.
RELATED: Tumor Treating Fields Improve Survival in Newly Diagnosed Glioblastoma
Researchers also found that median progression-free survival (2.5 years [95% CI: 1.4, 3.4] vs. 2.6 years [95% CI: 1.9, 3.2]) and overall survival (8 years [95% CI: 5.5, 10.3] vs. 6.5 years [95% CI: 5.4, 8.3]) did not differ between treatment arms (radiotherapy vs. chemotherapy).
In addition, the study showed that molecular diagnosis is superior to histology and MGMT is predictive in IDH wild-type gliomas..
Dr. Wick concluded, “NOA-04 long-term data do not support a differential efficacy of primary monochemotherapy with TMZ or PCV versus RT in any of the histological or molecular subgroups of anaplastic glioma, although absolute numbers in each of the subgroups compare well with published data from EORTC 26951 and RTOG 9402.”
- Wick W, Roth P, Wiestler B, et al. Long-term analysis of the NOA-04 randomized phase III trial of sequential radiochemotherapy of anaplastic glioma with PCV or temozolomide. J Clin Oncol. 2015;33:(suppl; abstr 2001).