The phase 3 STELLAR trial (NCT02796261) has revealed that the combination of eflornithine and lomustine significantly extends overall survival in patients with recurrent IDH-mutant anaplastic astrocytoma, as defined by the 2021 World Health Organization diagnostic criteria. This finding, presented by Dr. Rimas V. Lukas, a neuro-oncologist at Northwestern University Feinberg School of Medicine, marks a potential shift in the treatment paradigm for this aggressive brain tumor.
The STELLAR trial compared eflornithine plus lomustine against lomustine alone in patients with recurrent IDH-mutant anaplastic astrocytoma. The results indicated a statistically significant and clinically meaningful improvement in overall survival for the combination therapy. This is particularly significant given the limited treatment options currently available for this patient population.
"The STELLAR trial is a significant step forward," said Dr. Lukas. "The observed survival benefit with eflornithine plus lomustine offers new hope for patients facing this challenging diagnosis."
Current Treatment Landscape and Unmet Needs
Anaplastic astrocytoma is a grade III glioma characterized by rapid growth and a propensity for recurrence. The presence of an IDH mutation defines a specific subtype with distinct molecular characteristics and clinical behavior. While surgery, radiation, and chemotherapy are standard treatments, recurrent disease poses a significant challenge. The STELLAR trial addresses this unmet need by evaluating a novel therapeutic approach.
Trial Design and Key Endpoints
The STELLAR trial was a randomized, double-blind, placebo-controlled phase 3 study. Patients with recurrent IDH-mutant anaplastic astrocytoma were randomized to receive either eflornithine plus lomustine or lomustine alone. The primary endpoint was overall survival. Secondary endpoints included progression-free survival, objective response rate, and safety.
Efficacy and Safety
The study demonstrated a statistically significant improvement in overall survival with the eflornithine plus lomustine combination. Detailed data, including hazard ratios, p-values, and confidence intervals, will be presented at an upcoming medical conference and in a peer-reviewed publication. The safety profile of the combination was consistent with the known safety profiles of each agent.
Implications for Clinical Practice
The results of the STELLAR trial suggest that eflornithine plus lomustine may become a new standard of care for patients with recurrent IDH-mutant anaplastic astrocytoma. Further research is warranted to explore the optimal sequencing of therapies and to identify biomarkers that may predict response to eflornithine.
