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J Cancer. 2019 Jun 2;10(14):3214-3223. doi: 10.7150/jca.30123. eCollection 2019.

Efficacy and safety of nimotuzumab in addition to radiotherapy and temozolomide for cerebral glioblastoma: a phase II multicenter clinical trial.

Author information

1
Department of Radiation Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, No. 651 Dongfeng Road East, Guangzhou 510060, China.
2
Department of Radiation Oncology, Shenzhen People's Hospital, No. 1017 Dongmen Road North, Luohu District, Shenzhen 518020, China.
3
Department of Radiation Oncology, Guangdong 999 Brain Hospital, No. 578 Shatai Road South, Guangzhou 510510, China.
4
Department of Radiation Oncology, The First Affiliated Hospital of Guangzhou Medical University, No. 151 Yanjiang Road West, Guangzhou 510120, China.
5
Department of Radiation Oncology, The 5th Affiliated Hospital of Sun Yat-sen University, No. 52 Meihua Road East, Zhuhai, 519000, China.
6
Department of Radiation Oncology, The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University, No. 19 Nonglin Xia Road, Guangzhou 510080, China.
7
Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, No. 651 Dongfeng Road East, Guangzhou 510060, China.
8
Center of Molecular Immunology, Avenue 15 and 216 St., Siboney, Playa, La Habana, Cuba. A.P 16040, La Habana 11600, Cuba.
9
Department of Neuro-Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, No. 651 Dongfeng Road East, Guangzhou 510060, China.
10
Department of Anesthesiology, Stony Brook University, School of Medicine, Health Sciences Tower, Level 4, Rm 060, Stony Brook, NY 11794-8480, United States.

Abstract

Background: Nimotuzumab is a humanized anti-epidermal growth factor receptor (EGFR) antibody that has shown preclinical and clinical anticancer activity in cerebral glioblastoma multiforme (GBM). We conducted a phase II, single-arm, multicenter clinical trial to evaluate the benefit of adding nimotuzumab to current standard chemo-radiotherapy for patients with GBM with positive EGFR expression. Methods: Newly diagnosed patients with histologically proven single supratentorial GBM and epidermal growth factor receptor (EGFR) positive expressions were recruited. All patients were treated with nimotuzumab, administered once a week intravenously for 6 weeks in addition to radiotherapy with concomitant and adjuvant temozolomide after surgery. The primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary objectives included objective response rate (ORR) and toxicity. Results: A total of 39 patients were enrolled and 36 patients were evaluated for efficacy. The ORR at the end of RT was 72.2%. Median OS and PFS were 24.5 and 11.9 months. The 1-year OS and PFS rates were 83.3% and 49.3%. The 2-year OS and PFS rates were 51.1% and 29.0%. O (6)-methylquanine DNA methyl-tranferase (MGMT) expression is known to affect the efficacy of chemotherapy and status of its expression is examined. No significant correlation between treatment outcomes and MGMT status was found. Most frequent treatment-related toxicities were mild to moderate and included constipation, anorexia, fatigue, nausea, vomiting, and leucopenia. Conclusions: Our study show that nimotuzumab in addition to standard treatment is well tolerable and has increased survival in newly diagnosed GBM patients with EGFR positive expression.

KEYWORDS:

O (6)-methylquanine DNA methyl-tranferase (MGMT); epidermal growth factor receptor; glioblastoma; nimotuzumab; radiotherapy; temozolomide

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