Phase II Study of Single-agent Bevacizumab in Japanese Patients with Recurrent Malignant Glioma†

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Abstract

Objective

This single-arm, open-label, Phase II study evaluated the efficacy and safety of single-agent bevacizumab, a monoclonal antibody against vascular endothelial growth factor, in Japanese patients with recurrent malignant glioma.

Methods

Patients with histologically confirmed, measurable glioblastoma or World Health Organization Grade III glioma, previously treated with temozolomide plus radiotherapy, received 10 mg/kg bevacizumab intravenous infusion every 2 weeks. The primary endpoint was 6-month progression-free survival in the patients with recurrent glioblastoma.

Results

Of the 31 patients enrolled, 29 (93.5%) had glioblastoma and 2 (6.5%) had Grade III glioma. Eleven (35.5%) patients were receiving corticosteroids at baseline; 17 (54.8%) and 14 (45.2%) patients had experienced one or two relapses, respectively. The 6-month progression-free survival rate in the 29 patients with recurrent glioblastoma was 33.9% (90% confidence interval, 19.2–48.5) and the median progression-free survival was 3.3 months. The 1-year survival rate was 34.5% with a median overall survival of 10.5 months. There were eight responders (all partial responses) giving an objective response rate of 27.6%. The disease control rate was 79.3%. Eight of the 11 patients taking corticosteroids at baseline reduced their dose or discontinued corticosteroids during the study. Bevacizumab was well-tolerated and Grade ≥3 adverse events of special interest to bevacizumab were as follows: hypertension [3 (9.7%) patients], congestive heart failure [1 (3.2%) patient] and venous thromboembolism [1 (3.2%) patient]. One asymptomatic Grade 1 cerebral hemorrhage was observed, which resolved without treatment.

Conclusion

Single-agent bevacizumab provides clinical benefit for Japanese patients with recurrent glioblastoma.

Related collections

Most cited references 37

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A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer.

James Yang, Leah A. Haworth, Richard Sherry … (2003)

Mutations in the tumor-suppressor gene VHL cause oversecretion of vascular endothelial growth factor by clear-cell renal carcinomas. We conducted a clinical trial to evaluate bevacizumab, a neutralizing antibody against vascular endothelial growth factor, in patients with metastatic renal-cell carcinoma. A randomized, double-blind, phase 2 trial was conducted comparing placebo with bevacizumab at doses of 3 and 10 mg per kilogram of body weight, given every two weeks; the time to progression of disease and the response rate were primary end points. Crossover from placebo to antibody treatment was allowed, and survival was a secondary end point. Minimal toxic effects were seen, with hypertension and asymptomatic proteinuria predominating. The trial was stopped after the interim analysis met the criteria for early stopping. With 116 patients randomly assigned to treatment groups (40 to placebo, 37 to low-dose antibody, and 39 to high-dose antibody), there was a significant prolongation of the time to progression of disease in the high-dose--antibody group as compared with the placebo group (hazard ratio, 2.55; P 0.20 for all comparisons). Bevacizumab can significantly prolong the time to progression of disease in patients with metastatic renal-cell cancer. Copyright 2003 Massachusetts Medical Society

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Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer.

David Johnson, Louis Fehrenbacher, William F. Novotny … (2004)

To investigate the efficacy and safety of bevacizumab plus carboplatin and paclitaxel in patients with advanced or recurrent non-small-cell lung cancer. In a phase II trial, 99 patients were randomly assigned to bevacizumab 7.5 (n = 32) or 15 mg/kg (n = 35) plus carboplatin (area under the curve = 6) and paclitaxel (200 mg/m(2)) every 3 weeks or carboplatin and paclitaxel alone (n = 32). Primary efficacy end points were time to disease progression and best confirmed response rate. On disease progression, patients in the control arm had the option to receive single-agent bevacizumab 15 mg/kg every 3 weeks. Compared with the control arm, treatment with carboplatin and paclitaxel plus bevacizumab (15 mg/kg) resulted in a higher response rate (31.5% v 18.8%), longer median time to progression (7.4 v 4.2 months) and a modest increase in survival (17.7 v 14.9 months). Of the 19 control patients that crossed over to single-agent bevacizumab, five experienced stable disease, and 1-year survival was 47%. Bleeding was the most prominent adverse event and was manifested in two distinct clinical patterns; minor mucocutaneous hemorrhage and major hemoptysis. Major hemoptysis was associated with squamous cell histology, tumor necrosis and cavitation, and disease location close to major blood vessels. Bevacizumab in combination with carboplatin and paclitaxel improved overall response and time to progression in patients with advanced or recurrent non-small-cell lung cancer. Patients with nonsquamous cell histology appear to be a subpopulation with improved outcome and acceptable safety risks.

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We suggest "new" response criteria for phase II studies of supratentorial malignant glioma and favor rigorous criteria similar to those in medical oncology, with important modifications. Four response categories are proposed: complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). Response in this scheme is based on major changes in tumor size on the enhanced computed tomographic (CT) or magnetic resonance imaging (MRI) scan. Scan changes are interpreted in light of steroid use and neurologic findings. We advocate careful patient selection, emphasize pitfalls in the assessment of response, and suggest guidelines to minimize misinterpretations of response.

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Author and article information

Journal

Journal ID (nlm-ta): Jpn J Clin Oncol

Journal ID (iso-abbrev): Jpn. J. Clin. Oncol

Journal ID (publisher-id): jjco

Journal ID (hwp): jjco

Title: Japanese Journal of Clinical Oncology

Publisher: Oxford University Press

ISSN (Print): 0368-2811

ISSN (Electronic): 1465-3621

Publication date (Print): October 2012

Publication date (Electronic): 27 July 2012

Publication date PMC-release: 27 July 2012

Volume: 42

Issue: 10

Pages: 887-895

Affiliations

[1 ]Department of Neurosurgery, simpleKyorin University Faculty of Medicine , Tokyo

[2 ]Department of Neuro-Oncology/Neurosurgery, International Medical Center, simpleSaitama Medical University , Saitama

[3 ]Department of Neurosurgery and Neuro-Oncology, simpleNational Cancer Center Hospital , Tokyo

[4 ]Department of Neurosurgery, simpleGraduate School of Medicine, Hokkaido University , Hokkaido

[5 ]Department of Neurosurgery, simpleGraduate School of Human Science, University of Tsukuba , Ibaraki

[6 ]Department of Neurosurgery, simpleKomagome Metropolitan Hospital , Tokyo

[7 ]Department of Neurosurgery, simpleKitano Hospital , Osaka

[8 ]Depatment of Neurosurgery, simpleHiroshima University School of Medicine , Hiroshima

[9 ]Department of Neurosurgery, simpleKumamoto University Faculty of Life Sciences , Kumamoto

[10 ]Faculty of Advanced Techno-Surgery Graduate School of Medicine, simpleTokyo Women's Medical University , Tokyo

[11 ]simpleSawamura Neurosurgery Clinic , Hokkaido, Japan

Author notes

[* ]For reprints and all correspondence: Motoo Nagane, Department of Neurosurgery, Kyorin University Faculty of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan. E-mail: nagane-nsu@ 123456umin.ac.jp

[†]

These data were previously presented at the 2011 European Multidisciplinary Cancer Congress, jointly organized by the European CanCer Organisation (ECCO) and European Society for Medical Oncology (ESMO), Stockholm, Sweden, 23–27 September 2011 and the 2011 Society for Neuro-Oncology, CA, USA, 17–20 November 2011.

Article

Publisher ID: hys121

DOI: 10.1093/jjco/hys121

PMC ID: 3448378

PubMed ID: 22844129

SO-VID: b8d5270a-2981-45dd-9b74-d0274368befc

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.