Yazmin Odia1, Joohee Sul2, Joanna H Shih3, Teri N Kreisl1, John A Butman4, Fabio M Iwamoto1, Howard A Fine5. 1. Neuro-Oncology Division, Neurological Institute of New York, Columbia University College of Physicians & Surgeons, 710 West 168th Street, 9th Floor, New York, NY 10032, USA. 2. US FDA, 10903 New Hampshire Ave, Bldg WO22 Rm 2331, Silver Spring, MD 20993, USA. 3. Biometric Research Branch, Division of Cancer Treatment & Diagnosis, NCI, 9609 Medical Center Drive, Room 5W124, Rockville, MD 20850, USA. 4. Department of Radiology, National Institutes of Health Clinical Center, Building 10, Clinical Center 10 Center Drive, MSC 1074, Bethesda, MD 20892, USA. 5. Division of Neuro-Oncology, Director of the Brain Tumor Center, New York-Presbyterian Hospital/Weill Cornell Medical Center, 1305 York Avenue, 9th Floor, New York, NY 10021, USA.
Abstract
AIM: A Phase II trial of bevacizumab plus tandutinib. METHODS: We enrolled 41 recurrent, bevacizumab-naive glioblastoma patients for a trial of bevacizumab plus tandutinib. Median age was 55 and 71% were male. Treatment consisted of tandutinib 500 mg two-times a day (b.i.d.) and bevacizumab 10 mg/kg every 2 weeks starting day 15. Of 37 (90%) evaluable, nine (24%) had partial response. RESULTS & CONCLUSION: Median overall and progression-free survival was 11 and 4.1 months; progression-free survival at 6 months was 23%. All patients suffered treatment-related toxicities; common grade ≥3 toxicities were hypertension (17.1%), muscle weakness (17.1%), lymphopenia (14.6%) and hypophosphatemia (9.8%). Four of six with grade ≥3 tandutinib-related myasthenic-like muscle weakness had electromyography-proven neuromuscular junction pathology. Tandutinib with bevacizumab was as effective but more toxic than bevacizumab monotherapy.
AIM: A Phase II trial of bevacizumab plus tandutinib. METHODS: We enrolled 41 recurrent, bevacizumab-naive glioblastomapatients for a trial of bevacizumab plus tandutinib. Median age was 55 and 71% were male. Treatment consisted of tandutinib 500 mg two-times a day (b.i.d.) and bevacizumab 10 mg/kg every 2 weeks starting day 15. Of 37 (90%) evaluable, nine (24%) had partial response. RESULTS & CONCLUSION: Median overall and progression-free survival was 11 and 4.1 months; progression-free survival at 6 months was 23%. All patients suffered treatment-related toxicities; common grade ≥3 toxicities were hypertension (17.1%), muscle weakness (17.1%), lymphopenia (14.6%) and hypophosphatemia (9.8%). Four of six with grade ≥3 tandutinib-related myasthenic-like muscle weakness had electromyography-proven neuromuscular junction pathology. Tandutinib with bevacizumab was as effective but more toxic than bevacizumab monotherapy.
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