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Randomized phase II trial of irinotecan and bevacizumab as neo-adjuvant and adjuvant to temozolomide-based chemoradiation compared to temozolomide-chemoradiation for unresectable glioblastoma. Final results of the TEMAVIR study from ANOCEF.

Al's Comment:

 This trial did not show much benefit for using Avastin and Irinotecan for newly diagnosed unresectable GBMs.  There was no difference in overall survival, however, the patients in the control group were able to cross over when the progressed, and there was about a 2 month advantage in time to progression.


Posted on: 04/13/2014

 2014 Apr 9. [Epub ahead of print]

Randomized phase II trial of irinotecan and bevacizumab as neo-adjuvant and adjuvant to temozolomide-based chemoradiation compared to temozolomide-chemoradiation for unresectable glioblastoma. Final results of the TEMAVIR study from ANOCEF.

Abstract

BACKGROUND:

Prognosis of unresectable glioblastoma remains poor despite temozolomide-based chemoradiation. Activity of bevacizumab (BEV) and irinotecan (IRI) has been reported in recurrent disease. We evaluated BEV and IRI as neo-adjuvant and adjuvant treatment combined with temozolomide-based chemoradiation for unresectable glioblastoma.

PATIENTS AND METHODS:

Patients with unresectable glioblastoma, age 18-70, IK>50 were eligible. The experimental arm (BEV/IRI) consisted of neo-adjuvant intravenous BEV, 10 mg/kg, and IRI, 125 mg/m2, every 2 weeks for 4 cycles before radiotherapy (60 Gy), concomitant oral temozolomide, 75 mg/m2/day, and BEV, 10 mg/kg every 2 weeks. Adjuvant BEV and IRI were given every 2 weeks for 6 months. The control arm consisted of concomitant oral temozolomide, 75 mg/m2/day during radiotherapy, and 150-200 mg/m2 for 5 days every 28 days for 6 months. Use of bevacizumab was allowed at progression in the control arm.

RESULTS:

Patients (120) were included from April 2009 to January 2011. The working hypothesis was that treatment would increase the progression free survival at 6 month (PFS-6 ) from 50 to 66 %. The primary objective was not achieved, and only 30/60 patients were alive without progression at 6 months (50.0% (IC95% [36.8; 63.1]) in the BEV/IRI arm when 37/60 patients were required according to the Fleming decision rules. PFS-6 was 7.1 months in BEV/IRI versus 5.2 months in the control arm. Median overall survival was not different between the two arms (11.1 months). Main toxicities were 3 fatal intracranial bleedings, 3 bile duct or digestive perforations/infections (1 fatal), and 6 thrombotic episodes in BEV/IRI arm, whereas there was 1 intracranial bleeding, 2 bile duct or digestive perforations/infections (1 fatal) and 1 thrombotic episode in the control arm.

CONCLUSION:

Neo-adjuvant and adjuvant BEV/IRI, combined with temozolomide-radiation, is not recommended for further evaluation in first line treatment of unresectable glioblastoma.

CLINICAL TRIAL REGISTERED UNDER EUDRACT:

number 2008-002775-28 (NCT01022918).

KEYWORDS:

bevacizumab, glioblastoma, irinotecan, radiotherapy, temozolomide

 


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