Advani Suresh, Biswas Ghanashyam, Sinha Shubhadeep, B Balareddy, Bandi Vamsi Krishna, Naidu Neetu, Thakur Pankaj, Chary Sreenivasa
Department of Medical Oncology, Jaslok Hospital and Research Centre, Mumbai, Maharashtra.
Sparsh Hospitals and Critical Care Pvt. Ltd., Bhubaneswar, Orissa.
J Assoc Physicians India. 2018 Jun;66(6):55-59.
:To compare efficacy and safety of a biosimilar, Bevacizumab (Hetero) vs reference medicinal product (Bevacizumab, Roche) as first line therapy in patients with metastatic colorectal cancer (mCRC) in combination with chemotherapy.
Patients of aged 18 to 65 with histologically pre-confirmed mCRC and treatment naïve with unresectable metastatic disease or distant metastases were enrolled and randomized to receive either Hetero-Bevacizumab or RMPBevacizumab along with chemotherapy (XELOX or FOLFOX-4) regimen over a period of 24 weeks (up to 8 cycles of Hetero-Bevacizumab/RMP-Bevacizumab+ XELOX regimen (each cycle of 3 weeks) or up to 12 cycles of Hetero-Bevacizumab/ RMP-Bevacizumab + FOLFOX-4 regimen (each cycle of 2 weeks). Bevacizumab was administered at 7.5 mg/kg as an IV infusion over 60-90 minutes on Day 1 of each treatment cycle. The efficacy endpoints were the overall response rate (CR+PR) and disease control rate (DCR) according to RECIST 1.1. The safety endpoints included assessments of treatment emergent adverse events and immunogenicity.
160 patients were screened; 111 patients were randomized in the study. No statistical significant difference in overall response rate between both the treatment groups (HB-MAB vs. RB-MAB: 35.56 % vs. 20%, P=0.28 at Week 6; 37.50 % vs. 30.77 %, P=0.73 at Week 12). Similar trend was observed for disease control rate (HB-MAB vs. RB-MAB: 100% vs. 96%, P=0.36 at Week 6; 95.83 vs. 100%, P=1.00 at Week 12).
Herero's Bevacizumab was found to be comparable to reference medical product, Bevacizumab in terms of efficacy and tolerability for the Indian patients with metastatic colorectal cancer.
比较生物类似药贝伐单抗（Hetero公司生产）与参比药品（罗氏公司生产的贝伐单抗）作为一线治疗药物，与化疗联合用于转移性结直肠癌（mCRC）患者的疗效和安全性。
纳入年龄在18至65岁之间、组织学确诊为mCRC且未接受过治疗的不可切除转移性疾病或远处转移患者，随机分为两组，分别接受Hetero - 贝伐单抗或参比药品贝伐单抗联合化疗（XELOX或FOLFOX - 4）方案，治疗周期为24周（Hetero - 贝伐单抗/参比药品贝伐单抗 + XELOX方案最多8个周期，每个周期3周；或Hetero - 贝伐单抗/参比药品贝伐单抗 + FOLFOX - 4方案最多12个周期，每个周期2周）。在每个治疗周期的第1天，以7.5 mg/kg的剂量静脉输注贝伐单抗，输注时间为60 - 90分钟。疗效终点为根据RECIST 1.1标准评估的总缓解率（CR + PR）和疾病控制率（DCR）。安全性终点包括对治疗期间出现的不良事件和免疫原性的评估。
共筛选了160例患者；111例患者被随机纳入研究。两个治疗组的总缓解率无统计学显著差异（Hetero - 贝伐单抗组与参比药品贝伐单抗组：第6周时分别为35.56%和20%，P = 0.28；第12周时分别为37.50%和30.77%，P = 0.73）。疾病控制率也观察到类似趋势（Hetero - 贝伐单抗组与参比药品贝伐单抗组：第6周时分别为100%和96%，P = 0.36；第12周时分别为95.83%和100%，P = 1.00）。
对于印度转移性结直肠癌患者，Hetero公司的贝伐单抗在疗效和耐受性方面与参比药品贝伐单抗相当。
