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目的进展期胃癌(advanced gastric cancer,AGC)的一线化疗方案主要以氟尿嘧啶类及顺铂为基础,一旦出现肿瘤进展,二线治疗疗效欠佳。本研究主要观察多西他赛联合顺铂(DP)以及伊立替康联合顺铂(IP)二线治疗AGC的有效性和安全性。方法回顾性分析2011-01-01-2014-01-31入住于皖南医学院弋矶山医院肿瘤内科的94例既往接受以氟尿嘧啶类药物为基础的一线化疗方案治疗失败的AGC患者,分为DP和IP组。DP组51例,多西他赛(docetaxel,TXT)35mg/m2,静脉滴入,d1、d8;顺铂(cisplatin,DDP)20mg/m2,静脉滴入,d1~d4;21d为1个周期。IP组43例,伊立替康(irinotecan,CPT-11)65mg/m2,静脉滴入,d1、d8;DDP 20mg/m2,静脉滴入,d1~d4;21d为1个周期。化疗过程中注意观察不良反应,根据不良反应的程度调整药物用量。每2个周期评价疗效。结果 94例患者均可评价疗效。DP组完全缓解(complete response,CR)1例(1.96%),部分缓解(partial response,PR)13例(25.49%),稳定(stable disease,SD)15例(29.41%),进展(progressive disease,PD)22例(43.14%),客观有效率(objective response rate,ORR)为27.45%,疾病控制率(disease control rate,DCR)为56.86%,中位无进展生存时间(median progression-freesurvival,mPFS)5.1个月,中位总生存时间(median overall survival,mOS)8.4个月。IP组PR 9例(20.93%),SD 13例(30.23%),PD 21例(48.84%),ORR为20.93%,DCR为51.16%,mPFS 4.5个月,mOS 7.6个月。2组间ORR(χ2=0.063,P=0.467)、DCR(χ2=0.305,P=0.581)、mPFS(χ2=0.320,P=0.571)和mOS(χ2=0.436,P=0.509)均差异无统计学意义;2组间临床分期较早者疗效明显优于临床分期较晚者,P=0.009;ECOG评分较好者疗效明显优于ECOG评分较差者,P=0.009。常见的不良反应主要为骨髓抑制、胃肠道反应、口腔黏膜炎和脱发等。DP组的脱发和口腔黏膜炎发病率高于IP组,差异有统计学意义,Z值分别为-7.854和-2.726,P值分别为<0.001和0.006;IP组的腹泻及胆碱能综合征发病率远高于DP组,差异有显著统计学意义,Z值分别为-5.648和-2.741,P值分别为<0.001和0.006;2组血液学毒性类似,多为Ⅰ~Ⅱ度,可耐受,IP组血小板下降发病率高于DP组,但差异无统计学意义,Z=-1.777,P=0.076。结论 DP和IP方案二线治疗以氟尿嘧啶类药物为基础的一线化疗失败的AGC疗效相当,不良反应轻,患者可耐受,不失为较好的挽救方案。
Objectives The first-line chemotherapy regimen of advanced gastric cancer (AGC) is based on fluorouracil and cisplatin. Once the tumor progresses, the second-line therapy is ineffective. This study was designed to investigate the efficacy and safety of docetaxel combined with cisplatin (DP) and irinotecan plus cisplatin (IP) in the second-line treatment of AGC. Methods Retrospective analysis 2011-01-01-2014-01-31 admitted to the Department of Oncology, Wannan Medical College Yijishan Hospital, 94 patients previously treated with first-line chemotherapy based on fluorouracil-based chemotherapy failed AGC patients were divided into DP And IP group. DP group 51 cases, docetaxel (TXT) 35mg / m2, intravenous infusion, d1, d8; cisplatin (DDP) 20mg / m2, intravenous drip, d1 ~ d4; . IP group 43 cases, irinotecan (CPT-11) 65mg / m2, intravenous infusion, d1, d8; DDP 20mg / m2, intravenous infusion, d1 ~ d4; 21d for a cycle. Adverse reactions observed during chemotherapy, according to the degree of adverse reactions to adjust the amount of drugs. Efficacy was evaluated every 2 cycles. Results 94 patients can evaluate the efficacy. One patient (1.96%) with complete response (CR), 13 (25.49%) patients with partial response (PR), 15 patients (29.41%) with stable disease (SD), progressive disease , PD in 22 cases (43.14%), objective response rate (ORR) was 27.45%, disease control rate (DCR) was 56.86%, median progression-freesurvival mPFS) for 5.1 months, median overall survival (mOS) 8.4 months. There were 9 cases (20.93%) in PR group, 13 cases (30.23%) in SD group and 21 cases (48.84%) in PD group. The ORR was 20.93%, the DCR was 51.16%, mPFS was 4.5 months and mOS was 7.6 months. There were no significant differences in ORR (χ2 = 0.063, P = 0.467), DCR (χ2 = 0.305, P = 0.581), mPFS (χ2 = 0.320, P = 0.571) and mOS The mean clinical scores of two groups were significantly better than those with the later clinical stage (P = 0.009). The patients with better ECOG scores were better than those with poor ECOG scores (P = 0.009). Common adverse reactions are mainly myelosuppression, gastrointestinal reactions, oral mucositis and hair loss. The incidence of alopecia and oral mucositis in DP group was higher than that in IP group (Z = -7.854 and -2.726, P <0.001 and 0.006, respectively). Diarrhea and cholinergic syndrome The incidence was much higher than the DP group, the difference was statistically significant, Z values were -5.648 and -2.741, P values were <0.001 and 0.006; 2 hematological toxicity similar, mostly Ⅰ ~ Ⅱ degree, resistant The incidence of thrombocytopenia in IP group was higher than that in DP group, but the difference was not statistically significant (Z = -1.777, P = 0.076). Conclusions The second-line treatment with DP and IP regimens is equivalent to fluorouracil-based first-line chemotherapy in AGC. The adverse reactions are mild and the patients can tolerate, which is a good salvage plan.