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STELLAR: Phase III, Randomized, Open-Label Study of Eflornithine Plus Lomustine Versus Lomustine Alone in Patients
Howard Colman1, Giuseppe Lombardi2, Eric T Wong3
1Huntsman Cancer Institute, Department of Neurosurgery, University of Utah, Salt Lake City, UT.
Summary
Eflornithine plus lomustine improved survival in recurrent IDH-mutant grade 3 astrocytoma patients, doubling progression-free survival. This combination therapy showed significant benefits compared to lomustine monotherapy in a phase III trial.
Area of Science:
- Neuro-oncology
- Clinical Trials
- Cancer Therapeutics
Background:
- Recurrent grade 3 astrocytoma presents a significant therapeutic challenge.
- Previous treatments like radiotherapy and temozolomide (TMZ) have limitations.
- Investigating novel combination therapies is crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy and safety of eflornithine plus lomustine versus lomustine monotherapy in patients with recurrent grade 3 astrocytoma.
- To assess the impact of this combination on overall survival (OS) and progression-free survival (PFS).
Main Methods:
- Phase III, randomized, open-label STELLAR trial (NCT02796261) involving 343 patients.
- Stratified randomization based on IDH mutation, age, resection extent, and geography.
- Treatment arms: eflornithine + lomustine vs. lomustine monotherapy; primary endpoint: OS.
Main Results:
- No significant OS difference in the overall population (23.4 vs. 20.3 months).
- Subset analysis of IDH-mutant, grade 3 astrocytoma (n=196) showed improved median OS (34.9 vs. 23.5 months) and PFS (15.8 vs. 7.2 months) with eflornithine + lomustine.
- Adverse events included myelosuppression and hearing impairment; no new safety signals.
Conclusions:
- Eflornithine plus lomustine demonstrated clinically meaningful improvements in OS and PFS for recurrent IDH-mutant grade 3 astrocytoma.
- The combination therapy doubled PFS in this specific patient subgroup.
- No benefits were observed in patients with CNS grade 4 disease.

