Phase II study of ifosfamide, carboplatin, and etoposide in patients with a first recurrence of glioblastoma multiforme.

Abstract

e12512 Background: The prognosis of recurrent glioblastoma multiforme (GBM) remains unsatisfactory. The authors conducted a phase II study of ifosfamide, carboplatin, and etoposide (ICE) for a first recurrence of GBM to determine whether it prolonged a patient's good quality life. Methods: This trial was an open-label, single-center phase II study. Forty-two patients with a first GBM relapse after surgery followed by standard radiotherapy (60 Gy) and first-line temozolomide- or nimustine-based chemotherapy were eligible to participate. The primary end point was progression-free survival at 6 months after the ICE treatment (PFS-6), and secondary end points were response rate, toxicity, and overall survival. Chemotherapy consisted of ifosfamide (1,000 mg/m2 on Days 1, 2, and 3), carboplatin (110 mg/m2 on Day 1), etoposide (100 mg/m2 on Days 1, 2, and 3), every 6 weeks. Results: Progression-free survival at 6 months after ICE treatment was 35% (95% CI 22%–50%). The median duration of PFS was 17 weeks (95% CI 10–24 weeks). The response rate was 25% (95% CI 9%–34%). Adverse events were generally mild and consisted mainly of alopecia. Conclusions: This regimen was well tolerated and has some activity and could be one of the options for patients with recurrent GBM. No significant financial relationships to disclose.