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目的:观察西妥昔单抗联合FOLFIRI方案用于一线治疗失败的局部晚期或转移性胃癌患者,观察其疗效和不良反应,并观察其与疗效和预后的相关性。方法:每2疗程评价肿瘤病灶情况,观察不良反应,随访肿瘤进展情况及生存期。按照实体瘤疗效评价标准(Response Evaluatione Criteria in solid Tumors,RECIST)进行肿瘤缓解评估,按照国立癌症研究所常见不良事件评价标准3.0版(NCI一CTCAE3.0)进行不良事件分级。计算肿瘤缓解率、中位至疾病进展时间和中位总生存期。结果:在38例至少完成了2个周期治疗并进行了疗效评价的患者中,观察到1例完全缓解(CR),占0.03%;13例部分缓解(PR),占34.00%;总的缓解率(ORR=CR+PR)为37.00%。疾病稳定(SD)的患者有20例,占53.00%;疾病控制率(Disease Control Rate,DCR=CR+PR+SD)为89.00%;疾病进展(PD)的患者为4例,占11.00%。本研究方案总体安全性良好,未发生一例治疗相关性死亡。其中III/IV度粒细胞减少的发生率为52.5%,粒缺性发热的发生率为13.1%,III/IV度度贫血的发生率为29.5%,III/IV度度血小板下降的发生率为8.2%。III/IV度非血液学毒性包括恶心(8.2%),呕吐(6.6%),口腔炎(1.6%),腹泻(6.6%),感染(4.9%),乏力(4.9%),肠梗阻(6.6%),转氨酶升高(l.6%),过敏反应(l.6%)和皮疹(9.8%)。结论:本研究显示在晚期胃癌患者的二线治疗中西妥昔单抗联合FOLFIRI是一个安全有效的方案,需要进一步的研究寻找有效的生物标记物。
OBJECTIVE: To observe the efficacy and side effects of cetuximab plus FOLFIRI regimen in patients with locally advanced or metastatic gastric cancer who failed in first-line therapy and observe their correlation with efficacy and prognosis. Methods: Tumor lesions were evaluated every 2 cycles. Adverse reactions were observed. Tumor progression and survival were followed up. Tumor remission assessment was performed according to Response Evaluation Criteria in Solid Tumors (RECIST). Adverse events were graded according to the National Cancer Institute Common Criteria for Evaluation of Adverse Events Version 3.0 (NCI-CTCAE 3.0). Tumor remission rates were calculated from median to disease progression and median overall survival. RESULTS: Of the 38 patients who completed at least 2 cycles of treatment and were evaluated for efficacy, a complete response (CR) was observed in 0.03%, 13 partial responses (PR), or 34.00%, and overall response The rate (ORR = CR + PR) was 37.00%. 20 patients (53.00%) had stable disease (SD), 89.00% had disease control rate (DCR = CR + PR + SD), and 4 patients (11.00%) had disease progression (PD). The overall safety of this study was good and no treatment-related death occurred. The incidence of III / IV neutropenia was 52.5%, the incidence of granulocytic fever was 13.1%, the incidence of III / IV degree of anemia was 29.5%, the incidence of III / IV degree of thrombocytopenia was 8.2%. III / IV non-hematological toxicities include nausea (8.2%), vomiting (6.6%), stomatitis (1.6%), diarrhea (6.6%), infection (4.9%), fatigue (4.9% %), Elevated aminotransferases (1.6%), anaphylaxis (1.6%) and rashes (9.8%). CONCLUSIONS: This study shows that cetuximab plus FOLFIRI is a safe and effective regimen in second-line treatment of patients with advanced gastric cancer and requires further studies in search of effective biomarkers.