评价伊立替康(CPT-11)联合顺铂(DDP)对一线化疗不成功的胃癌进展期复治患者的疗效及安全性。

对本院2012年6月至2014年6月收治的60例进展期胃癌复治患者进行前瞻性随机对照研究，其中男性41例，女性19例；年龄18～65岁[(48.91±5.77)岁]。将60例患者按完全随机分组方法分为两组，每组30例，分别行CPT-11(180 mg/m²)组和CPT-11(180 mg/m²)＋DDP(25 mg/m²)组。两种化疗方案均以3周为1个治疗周期，对至少连续用药2个及2个以上治疗周期的患者进行疗效与安全性评估。对比观察两组患者治疗前后血清肿瘤标志物(CA199、CEA及CA242)水平、近期疗效[短期有效率(RR)、疾病控制率(DCR)]和远期疗效[无进展生存期(PFS)、总生存时间(OS)]，评价CPT-11单药和CPT-11＋DDP联合化疗的疗效差异。分别记录并分析两组患者化疗后的不良反应情况，依据美国NCI-NTC3.0评价标准对发生的不良反应进行分级判定，对比评价两种化疗方案的用药安全性。

与CPT-11组相比，通过CPT-11＋DDP组患者有较长PFS[(8.49±2.43)个月vs (6.21±1.96)个月，P<0.05]，且血清肿瘤标志物CA199[(220.18±59.93) mg/L vs (154.12±23.77) mg/L]、CEA[(31.24±6.15) mg/L vs (15.29±3.84) mg/L]及CA242[(50.17±5.86) mg/L vs (36.46±6.44) mg/L]的表达水平均降低(P均<0.05)。但两组患者RR、DCR及OS差异无统计学意义。CPT-11所涉及化疗方案发生的3～4级不良反应主要为白细胞减少[18.33%(11/60)]、贫血[8.33%(5/60)]和恶心[5%(3/60)]；与CPT-11组相比，CPT-11＋DDP组腹泻[46.67%(14/30) vs 16.67%(5/30)，P<0.05]发生率下降，但恶心[76.67%(29/30) vs 70.00%(21/30)，P<0.05]和乏力[70.00%(21/30)vs 26.67%(8/30)，P<0.05]发生率增加。

在胃癌进展期二线化疗方案中，CPT-11＋DDP联合用药可明显提高患者PFS，降低肿瘤标志物CA199、CEA和CA242的水平，减少腹泻的发生，但将增加恶心和乏力的发生。

To evaluate safety and clinical effects of Irinotecan (CPT-11) plus ciplatin (DPP) on treatments of advanced gastric cancer patients for whom first-line treatment failed.

A total of 60 patients with advanced gastric cancer were enrolled from June 2012 to June 2014 based on the inclusion and exclusion criteria. There were 41 males and 19 females, aged from 18 to 65 years with an average age of (48.91±5.77) years. The patients were randomly divided into two groups including CPT-11(180 mg/m²)treatment group and CPT-11(180 mg/m²)+ DDP(25 mg/m²) group. After CPT-11 and CPT-11+ DPP treatments, clinical evaluation was performed by the detection of tumor markers, recent efficacy and long-term efficacy. Adverse events were also analyzed in this study.

Compared with CPT-11 regimen, CPT-11+ DDP regimen had more effective in progression-free-sur (PFS) and the level of CA199 [(220.18±59.93) mg/L vs (154.12±23.77) mg/L], CEA [(31.24±6.15) mg/L vs (15.29±3.84) mg/L] and CA242 [(50.17±5.86) mg/L vs (36.46±6.44) mg/L] were significantly lower (P<0.05). Butthere were no significantly differences in response rate (RR), disease control rate (DCR) and overall survival (OS). The occurrence rates of the adverse effects grade 3-4 events were leukopenia [18.33%(11/60)], anemia [8.33%(5/60)] and vomiting [5%(3/60)] in all regimens. The incidence rate of diarrhea of CPT-11+ DDP regimen was less than that of CPT-11 [46.67%(14/30) vs 16.67%(5/30), P<0.05]. And, CPT-11+ DPP regimen had more fatigue [76.67%(29/30) vs 70.00%(21/30), P<0.05] and vomiting [70.00%(21/30) vs 26.67%(8/30), P<0.05].

CPT-11+ DPP treatments significantly improve the patient’s PFS and reduce the expression of tumor markers and the incidence of diarrhea, but increase the incidence of vomiting and fatigue.