Update on survival from the original phase II trial of bevacizumab and irinotecan in recurrent malignant gliomas.

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Abstract No:

2021

Citation:

J Clin Oncol 26: 2008 (May 20 suppl; abstr 2021)

Author(s):

S. A. Wagner, A. Desjardins, D. A. Reardon, J. Marcello, J. E. Herndon, II, J. A. Quinn, J. N. Rich, S. Sathornsumetee, H. S. Friedman, J. J. Vredenburgh

Abstract:

Background: Recurrent grade III-IV malignant gliomas have a dismal prognosis and effective salvage therapies are limited. Methods: From 4/05-2/06, a phase II trial was conducted at Duke University using bevacizumab and irinotecan in patients with recurrent malignant gliomas. 2 cohorts were enrolled that included 33 grade III and 35 grade IV patients. The first cohort received bevacizumab at 10mg/kg plus irinotecan (dose based on patient's anticonvulsant) every two weeks. The second cohort received bevacizumab at 15mg/kg every 21 days and irinotecan on days 1, 8, 22, and 29. Results: Overall response rates for both grade III and IV were 59% (grade III 61%, grade IV 57%). 6 month PFS and OS for grade III were 59% and 79% and for grade IV 43% and 74% respectively. In 12/07, we evaluated all patients enrolled in the trial to determine the 2 yr OS. From the 2 cohorts, 22% (15/68) of the patients are still alive (11 grade III, 4 grade IV). For the grade IV patients, the 2yr OS is 15%. All four of the grade IV patients completed 9 cycles of therapy. Two (2/4) progressed (8mo and 17mo) and both reinitiated bevacizumab and irinotecan with radiographic response. The other two have been progression free since the end of treatment (11mo and 18mo). Surprisingly, both of these patients had only partial resections at the time of diagnosis. For the grade III patients, the 2 yr OS is 33%. All but one patient has progressed; ranging from 1 to 14 months. 4 patients are currently on bevacizumab-based therapy. 1 on carboplatin, 2 on etoposide and 1 on bevacizumab alone for radiation necrosis. The remaining patients are on metronomic temozolomide (2), etoposide (1), and a phase I clinical trial (2). 2 patients are currently being followed off therapy. The one patient who did not progress only received a partial cycle on study and had to discontinue secondary to TTP and has been off treatment for the last 21 months. Conclusions: The combination of bevacizumab and irinotecan provides a clinically meaningful treatment option for patients with recurrent malignant gliomas.

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