Adding interferon-α to adjuvant temozolomide can prolong overall survival (OS) in patients with high-grade glioma, according to research presented in a poster at the Society for Neuro-Oncology 27th Annual Meeting.
Interferon-α improved OS, but not progression-free survival (PFS), in the entire study cohort, in the subgroup of patients with grade 4 glioma, and in patients with unmethylated MGMT. Interferon-α improved both PFS and OS in patients with grade 3 glioma.
Researchers conducted this phase 3 trial (ClinicalTrials.gov Identifier: NCT01765088) in 199 patients with newly diagnosed, high-grade glioma. All patients underwent surgery and received standard radiotherapy with temozolomide.
After a 4-week break, the researchers randomly assigned 99 patients to receive standard temozolomide (200 mg/m2 for 5 days) and 100 patients to receive temozolomide plus interferon-α (3 mIU subcutaneously on days 1, 3, and 5) every 28 days.
The median follow-up was 66.0 months, and the primary endpoint was OS. The median OS was significantly longer in the interferon-α arm than in the standard arm — 26.67 months and 18.83 months, respectively (hazard ratio [HR], 0.64; 95% CI, 0.47-0.88; P =.005).
PFS was similar between the arms. The median PFS was 14.83 months in the interferon-α arm and 12.90 months in the standard arm (HR, 0.79; 95% CI, 0.59-1.06; P =.114).
Among patients with grade 3 glioma, the median OS and PFS were longer in the interferon-α arm. The median OS was 39.57 months in the interferon-α arm and 29.40 months in the standard arm (HR, 0.61; 95% CI, 0.37-0.99; P =.043). The median PFS was 24.33 and 14.13 months, respectively (HR, 0.63; 95% CI, 0.41-0.99; P =.044).
Among patients with grade 4 glioma, there was a significant difference in OS, but not PFS, between the treatment arms. The median OS was 20.53 months in the interferon-α arm and 17.70 months in the standard arm (HR, 0.67; 95% CI, 0.45-0.99; P =.044). The median PFS was 12.00 months and 12.83 months, respectively (HR, 1.11; 95% CI, 0.76-1.64; P =.582).
Among patients with unmethylated MGMT, the median OS was significantly longer in the interferon-α arm (HR, 0.57; 95% CI, 0.37-0.87; P =.008), but the median PFS was similar between the arms (HR, 0.68; 95% CI, 0.46-1.02; P =.059).
Among patients with methylated MGMT, there was no significant difference in OS (P =.248) or PFS (P =.723) between the treatment arms.
Seizures and influenza-like symptoms were more common in the interferon-α arm. The incidence of neutropenia, thrombocytopenia, anemia, increased transaminase, fatigue, nausea or vomiting, and skin reactions was similar between the arms.
“Compared with the standard regimen, [temozolomide plus interferon-α] combination treatment could prolong the survival time of high-grade patients, especially the MGMT promoter unmethylated patients, and the toxicity remained tolerable,” the researchers concluded.
Disclosures: The study authors did not provide disclosures.
Chen Z, Guo C, Chen J. CSNO2012001 study: A phase III trial on adjuvant temozolomide chemotherapy with or without interferon-alpha in newly diagnosed high-grade gliomas. Presented at SNO 2022; November 16-20, 2022. Abstract CTNI-33.