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Nimotuzumab, a humanized monoclonal antibody specific for the EGFR , in combination with temozolomide and radiation therapy for newly diagnosed glioblastoma multiforme: First results in C hinese patients
Author(s) -
Wang Yang,
Pan Li,
Sheng Xiaofang,
Chen Shu,
Dai Jiazhong
Publication year - 2016
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/ajco.12166
Subject(s) - nimotuzumab , medicine , temozolomide , tolerability , epidermal growth factor receptor , oncology , radiation therapy , concomitant , progression free survival , chemotherapy , adverse effect , cancer
Aim To evaluate the safety and efficacy of nimotuzumab, a humanized monoclonal antibody specific for the epidermal growth factor receptor ( EGFR ), in combination with temozolomide ( TMZ ) and radiation therapy ( RT ) in the treatment of newly diagnosed glioblastoma ( GBM ) in C hinese patients. Methods Twenty‐six patients with newly diagnosed GBM were enrolled. All patients received standard external beam RT after surgery, with a total dose of 60 G y in 30 fractions. During RT , concurrent TMZ was given daily at 75 mg/m 2 for 40–42 days, combined with six weekly infusions of nimotuzumab at a 200 mg dose. After a 4‐week interval upon completion of RT , six cycles of adjuvant TMZ (150 to 200 mg/m 2 for 5 days in each 28‐day cycle) were given. The primary end point was 6‐month progression‐free survival ( PFS ) rate. EGFR expression in tumor tissues was analyzed by immunohistochemistry. Results Treatment was well tolerated and no grade III or higher grade toxicity was observed. Median PFS and overall survival ( OS ) were 10.0 and 15.9 months, respectively, while the 6‐month PFS and OS rates were 69.2% and 88.5%, respectively. No correlation between efficacy and EGFR expression was found. Conclusions Combination of Nimotuzumab with RT plus concomitant and adjuvant TMZ showed favorable safety and tolerability profiles in newly diagnosed GBM in C hinese patients. The survival times were similar to those seen in historical data of standard therapy.