Long-term stabilization in patients with malignant glioma after treatment with liposomal doxorubicin

BACKGROUND. Resistance to chemotherapeutic agents and poor blood-brain barr ier penetration are major limitations in the treatment of malignant glioma. To improve drug delivery across the blood-brain barrier, the authors used doxorubicin as liposomal encapsulated formulation (Caelyx, Scheringh-Plough , Munich, Germany) in therapy of recurrent malignant glioma. METHODS. Fifteen patients with recurrent high-grade gliomas were included i n the study. Of these, 13 patients could be evaluated, including 6 patients with glioblastoma, 1 patient with gliosarcoma and 6 patients with anaplast ic astrocytoma. The treatment consisted of liposomal doxorubicin (20 mg/m(2 )), applied intravenously every 2 weeks. RESULTS. Stabilization of the disease was observed in 54% (7 of 13) of pati ents. Partial response and complete response (CR) were not observed. Median time-to-progression was 11 weeks. Progression free survival at 12 months w as 15%. Median overall survival (OS) after doxorubicin therapy was 40.0 wee ks, whereas the median OS after diagnosis reached 20.0 months (87.0 weeks). Doxorubicin was well tolerated, with main side effects being palmoplantar erythrodysesthesia occurring in 38% and myelotoxicity (World Health Organiz ation Grade 3-4) in 31% of the patients. CONCLUSIONS. Doxorubicin has been shown to be a safe treatment with moderat e activity that may lead to long-term stabilization in recurrent high-grade glioma patients. Of note, median OS after all and after initiation of recu rrence therapy was prolonged in comparison with the OS in other Phase II st udies, as recently described by Wong et al. (Wong ET, Hess KR, Gleason M1, heckle KA, Kyritsis AP, Prados MD, et al. Outcomes and prognostic factors i n recurrent glioma patients enrolled onto phase II clinical trials. J Clin Oncol 1999;17:2572.). (C) 2001 American Cancer Society.