不可手术或术后残存或复发胃癌的尼妥珠单抗联合卡培他滨同步放化疗前瞻性研究

Concurrent chemoradiotherapy with nimotuzumab and capecitabine for patients with unresectable, postoperative residual, or recurrent gastric cancer：a prospective study

目的探索尼妥珠单抗联合卡培他滨同步放化疗治疗不可手术或术后残存或复发胃癌患者的不良反应和近期疗效。方法对病理确诊的胃癌患者开展前瞻性Ⅱ期试验，入组条件：有可测量病变的不可手术或术后残存或复发胃癌，病变可行放疗，预期生存〉3个月。患者接受IMRT（PGTV54Gy分30次，±淋巴结预防区域45Gy分25次）和同步卡培他滨（每天1600mg／m^2，第1—35天）及尼妥珠单抗（200mg，1次／周）化疗。用CTCAE3．0和RECIST标准评估急性不良反应和近期疗效。结果2010-2013年纳入30例患者。中位年龄57岁（35～66岁）。23例为术后残存或复发，7例为不可手术患者。28例人组前接受化疗且均为疗后稳定或进展。同步放化疗期间5例（17％）3级急性不良反应，主要为血小板下降（10％）。疗后1个月野内客观缓解率和病变稳定率、全身客观缓解率和病变稳定率分别为43％（CR4％、PR39％）和50％、32％和43％。结论对不可手术或术后残存或复发胃癌患者，尼妥珠单抗联合卡培他滨同步放化疗安全，耐受性、近期疗效、放疗野内控制性均好。

Objective To investigate the adverse effects and short-term therapeutic effect of concurrent chemoradiotherapy with nimotuzumab and capecitabine for patients with unresectable, postoperative residual, or recurrent gastric cancer. Methods A prospective phase Ⅱ study was performed in patients with pathologically confirmed gastric cancer. Inclusion criteria were as follows： unresectable, postoperative residual, or recurrent gastric cancer in which lesions could be measured;lesions which could receive radiotherapy;expected survival time〉3 months. All patients received intensity-modulated radiotherapy （54 Gy in 30 fractions for planned gross tumor volume, 45 Gy in 25 fractions for the prophylactic area in lymph nodes） and concurrent capecitabine （1 600 mg/m^2 per day for 35 days） and nimotuzumab （200 mg once a week）. Common Terminology Criteria for Adverse Events, version 3.0 and Response Evaluation Criteria in Solid Tumors were used to evaluate acute adverse effects and short-term therapeutic effect. Results A total of 30 patients were enrolled from 2010 to 2013. The median age was 57 years （range 35-66 years）. There were 23 patients with postoperative residual or recurrent gastric cancer and 7 with unresectable gastric cancer. Twenty-eight patients received chemotherapy before being enrolled in this study and achieved stable disease or progression. During concurrent chemoradiotherapy, 5 patients （ 17% ） experienced grade 3 acute adverse events, mainly thrombocytopenia （10%）. At one month after treatment, the in-field objective response rate and stable disease rate were 43% （complete response 4%, partial response 39%） and 50%, respectively, and the systemic objective response rate and stable disease rate were 32% and 43%, respectively. Conclusions In patients with unresectable, postoperative residual, or recurrent gastric cancer, concurrent chemoradiotherapy with nimotuzumab and capecitabine has good safety, tolerability, short-term therapeutic effect, and in-field control.