尼妥珠单抗联合化疗治疗晚期恶性肿瘤的临床观察

Clinical observation of nimotuzumab combined with chemotherapy on advanced malignant tumor

目的观察尼妥珠单抗联合化疗治疗晚期恶性肿瘤(非头颈部肿瘤)的有效性和安全性。方法选择25例经病理组织学或细胞学检查确诊的Ⅳ期恶性肿瘤患者,包括非小细胞肺癌9例,结肠癌3例,胃癌3例,食管癌2例,神经胶质瘤2例,膀胱癌2例,胆囊癌2例,胆管癌1例,肝癌1例。患者接受尼妥珠单抗联合化疗。尼妥珠单抗200mg静脉滴注,每周1次,共6周,同时联合一线化疗方案或既往未使用过的化疗药物。参照Karnofsky评分变化评价生活质量,按照实体瘤的疗效评价标准(REC IST)评价近期疗效和按照NC I-CTC 3.0标准评价其毒性反应。结果 25例患者中,有23例可以评价药物的客观疗效,25例可以评价药物的安全性。在23例可评价疗效的病例中,治疗2个周期后PR有6例,SD有10例,PD有7例,客观有效率(RR:CR+PR)为26.09%(6/23),疾病控制率(DCR:CR+PR+SD)为69.56%(16/23);在25例可评价药物安全性的病例中,生活质量改善者有12例(48%),稳定者有9例(36%),仅4例(16%)为生活质量下降。G3/4级毒性主要与化疗药物有关,包括白细胞下降,血小板下降和贫血。与尼妥珠单抗相关的皮疹发生率低,且与临床是否获益无关。结论尼妥珠单抗联合化疗药物是有效和安全的,它可以用于多种恶性肿瘤的治疗,改善患者的QoL,与化疗药物具有一定的协同作用,值得临床推广和进一步研究。

Objective To evaluate the efficacy and safety of nimotuzumab combined with chemotherapy on advanced malignant tumor （non-head and neck cancer）. Methods Nimotuzumab combined with chemotherapy were administrated to 25 malignant cases of stage IV, including 9 cases of non-small cell lung cancer, 3 cases of colon cancer, 3 cases of gas-tric cancer, 2 cases of esophageal cancer, 2 cases of glioma, 2 cases of bladder cancer, 2 cases of gallbladder cancer, 1 case of bile duct cancer, and 1 case of hepatic cancer. All the patients were confirmed by histopathology or cytopathology. Nimotuzumab （200mg） was intravenously injected once a week as one cycle, total 6 cycles. The first line chemotherapy a- gents were given simultaneously. The efficacy was evaluated after 2 cycles of treatment according to RECIST standards, Quality of life （QoL） was evaluated according to Karnofsky scores. The safety was evaluated according to NCI-CTC 3. 0 version standards. Results There were 23 cases capable for efficacy evaluation and 25 cases for safety evaluation. A- mong 23 cases of efficacy evaluation, there were 6 cases achieved PR; others were 10 cases of SD and 7 cases of PD. The objective response rate （RR： CR ＋PR） was 26. 09% （6/23） and disease control rate （DCR： CR ＋PR ＋SD） was 69. 56% （16/23）. The QoL was improved on 12 cases （48%）. stabled on 9 cases （36%）, and decreased on 4 cases （16%）. G3/4 toxicities were mainly related with chemotherapy agents instead of nimotuzumab, and included neutropenia, thrombocytopenia and anemia. The occurrence rates of skin rash related to nimotuzumab was very low. Conclusion Nim- otuzumab combined with chemotherapy can be used in many kinds of advanced malignant tumor. There are syncrgctie effects of nmotuzumab with cytotoxic agents. QoL of patients may be improved by is valuable for further clinical evaluation. treatment. It