Kumar Ashok, Chakravarty Nilotpal, Bhatnagar Sharad, Chowdhary G S
Department of Radiation Oncology, Command Hospital (CC), Lucknow, Uttar Pradesh, India.
Department of Radiation Oncology, Army Hospital (R and R), Delhi Cantt, New Delhi, India.
South Asian J Cancer. 2019 Apr-Jun;8(2):108-111. doi: 10.4103/sajc.sajc_38_18.
Nimotuzumab is an anti-epidermal growth factor receptor monoclonal antibody which can be added to chemoradiotherapy (CRT) to improve efficacy for management of locally advanced squamous cell carcinoma of the head and neck (LASCCHN). We prospectively evaluated the efficacy and safety of nimotuzumab with CRT for LASCCHN and compared with CRT alone.
In this prospective study, 29 LASCCHN (Stage III-IVb) patients received Nimotuzumab plus CRT or CRT alone. Treatment included six cycles of cisplatin (40-50 mg/week) or carboplatin (area under the curve-based), nimotuzumab (200 mg/week), and radiotherapy (60-70 Gy). Tumor response was evaluated as per response evaluation criteria in solid tumors criteria. MoS was estimated using the Kaplan-Meier method. Toxicity and adverse events (AE's) were assessed as per CTCAE v 4.0.
At 24 weeks after completion of treatment, the tumor response rate (complete response, partial response, stable disease) was 53.3% and 35.7% favoring nimotuzumab arm while progression of disease was 40% and 35.7% in Nimotuzumab plus CRT and CRT groups, respectively. However, the objective response rate was 57% and 30% in favor of nimotuzumab arm. At median follow-up of 45.5 months, MoS was 33 months in Nimotuzumab plus CRT and 27 months in CRT group. The 5-year survival rate was 33.3% in Nimotuzumab plus CRT versus 7.1% in CRT group. Nimotuzumab was observed to be safe with no additional AE's such as hypersensitivity, hypomagnesemia, and allergic reaction was reported.
Addition of Nimotuzumab to standard CRT showed improved survival rate in unresectable, LASCCHN patients without producing additional toxicity.
尼妥珠单抗是一种抗表皮生长因子受体单克隆抗体，可添加到放化疗（CRT）中，以提高局部晚期头颈部鳞状细胞癌（LASCCHN）的治疗效果。我们前瞻性评估了尼妥珠单抗联合CRT治疗LASCCHN的疗效和安全性，并与单纯CRT进行比较。
在这项前瞻性研究中，29例LASCCHN（III-IVb期）患者接受了尼妥珠单抗联合CRT或单纯CRT治疗。治疗包括六个周期的顺铂（40-50mg/周）或卡铂（基于曲线下面积）、尼妥珠单抗（200mg/周）和放疗（60-70Gy）。根据实体瘤疗效评价标准评估肿瘤反应。采用Kaplan-Meier方法估计无进展生存期（MoS）。根据CTCAE v 4.0评估毒性和不良事件（AE）。
治疗完成后24周，肿瘤反应率（完全缓解、部分缓解、疾病稳定）在尼妥珠单抗组为53.3%，单纯CRT组为35.7%，而疾病进展率在尼妥珠单抗联合CRT组和单纯CRT组分别为40%和35.7%。然而，客观缓解率在尼妥珠单抗组为57%，单纯CRT组为30%。在中位随访45.5个月时，尼妥珠单抗联合CRT组的MoS为33个月，单纯CRT组为27个月。尼妥珠单抗联合CRT组的5年生存率为33.3%，单纯CRT组为7.1%。观察到尼妥珠单抗是安全的，未报告额外的不良事件，如过敏反应、低镁血症和过敏反应。
在标准CRT中添加尼妥珠单抗可提高不可切除的LASCCHN患者的生存率，且不产生额外毒性。
