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• W2338468407 abstract "e12511 Background: Enz, a PKC-β inhibitor, was developed as an antiangiogenic based on its role in VEGF receptor signal transduction. We recently showed that ENZ has direct glioma cytotoxic activity by inhibiting glycogen synthase kinase 3. BV, a monoclonal VEGF antibody, received FDA accelerated approval for recurrent GBM as monotherapy in May 2009. The objective of this phase II trial was to evaluate the efficacy and safety of Enz with BV in patients (pts) with recurrent GBM. Methods: Pts recurrent GBM and KPS ≥ 60 were eligible. Therapy consisted of daily Enz and BV 10 mg/kg on days 1 and 15 of each 4-week cycle. All pts received a loading dose of Enz on Day 1 (1,125 mg), followed by either 500 or 875 mg qd orally depending on use of EIAED. Brain MRI and clinical reassessment were done every cycle. Primary endpoint was efficacy as measured by PFS6. Results: 40 GBM pts (57.5% men) with a median age of 50.7 years (range, 25.4 to 72.7) and a median KPS of 90 were accrued. Median number of prior chemotherapy regimens was 2 (range 1-5). Grade 3/4 toxicities included neutropenia (n = 1), thrombocytopenia (n = 2), AST elevation (n = 2), bowel perforation (n = 2), thrombosis (n = 1), hypertension (n = 2), hypophosphatemia (n = 2), anemia (n = 1), bleeding (n = 1) and infection (n = 1); 5 pts discontinued secondary to treatment-related toxicity. Using Levin's criteria, 27/39 evaluable pts (69%) had an ORR while 14/35 evaluable pts (40%) had an ORR by Macdonald criteria. 21 of 39 (54%) had a PR according to Levin criteria on MRI done within 96 hours of starting treatment while only 1 pt had an early response according to Macdonald criteria. Early MRI response according to Levin's criteria was a predictor for longer PFS (median of 3 months vs. 1.8 months, log-rank P-value = 0.001). 90% of pts died and the median follow-up of survivors is 21.5 months. Median PFS was 2 months (95% CI, 1.8 to 2.7 months) and PFS6 was 23% (95% CI, 11% to 37%). The median OS was 7.2 months (95% CI, 4.9 to 10.8 months) and 6-month OS was 60% (95% CI, 43% to 73%). Conclusions: Enz combined with BV was reasonably well tolerated and is active in recurrent GBM. However, the addition of Enz to BV did not seem to improve outcomes compared to prior studies of single-agent BV for recurrent GBM. No significant financial relationships to disclose." @default.
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• W2338468407 date "2010-05-20" @default.
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• W2338468407 title "Phase II trial of enzastaurin (Enz) with bevacizumab (BV) in adults with recurrent glioblstoma (GBM)." @default.
• W2338468407 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.e12511" @default.
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