西妥昔单抗联合改良的FOLFIRI方案二线治疗晚期胃癌的临床研究

Effects of Cetuximab combined with modified FOLFIRI on advanced gastric cancer in second-line treatment

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 effect of Cetuximab combined with modified FOLFIRI on advanced gastric cancer in second-line treatment and evaluate its efficacy and adverse reactions, and to investigate the relationship between its efficacy and prognosis. Method Tumor lesions and adverse reactions were observed every 2 cycles of treatment, and the progress of tumor and survival were followed up. Tumor remission assessment were performed in accordance with Response Evaluation Criteria in solid Tumors, RECIST） and the adverse event were classified according to the Common adverse events evaluation criteria version 3.0 （NCI a CTCAE3.0） by National Cancer Institute. Calculate the tumor remission rate, median time to progression and median overall survival. Results Among the 38 patients who completed at least 2 cycles of treatment and received efficacy evaluation, one case was observed in complete remission （CR）, accounting for 0.03 %; 13 cases were in partial remission （PR）, accounting for 34.00%; the overall remission rate （ORR = CR ＋ PR） was 37.00%.20 cases were in status of stable disease （SD）, accounting for 53.00%; disease control rate （Disease Control Rate, DCR = CR ＋ PR ＋ SD） was 89.00%. Disease progression （PD） was occurred in 4 cases, ~counting for 11.00%. The overall safety is good, for no case of treatment-related death occurred. The HI / IV neutropenia incidence was 52.5%, incidence of febrile due to particle missing 13.1%, incidence of m / IV degree severe anemia 29.5%, incidence of III / IV degree of thromboeytopenia decline 8.2%. III/ IV degree of non-hematologic toxicity included nausea （8.2%）, vomiting （6.6%）, sto- matitis （1.6%）, diarrhea （6.6%）, infection （4.9%）, fatigue （4.9%）, ileus （6.6 %）, elevated aminotransferases （1.6%）, allergic reactions （1.6%） and rash （9.8%）. Conclusion This study showed that Cetuximab combined with modified FOLFIRI is a safe and effective program in second-line treatment of advanced gastric cancer patients. It is required to further research and find its effective biomarkers.