背景与目的:对进展期及转移性胃癌目前还没有标准化疗方案,迄今为止,仅少数方案如ECF(表柔比星,顺铂,氟尿嘧啶)联合方案疗效被III期试验所验证。但ECF方案中5-FU持续滴注21天,不良反应大且不便。近来,有研究示奥沙利铂在胃癌中疗效优于顺铂,而不良反应较顺铂轻。因此,我们以奥沙利铂取代ECF方案中的顺铂,将5-FU持续滴注21天改为5天,组成EOF5方案,用于晚期胃癌的治疗,以期提高疗效及安全性。本试验目的是评价EOF5方案治疗复发转移或进展期胃癌的疗效与安全性。方法:对符合入组条件的胃癌患者采用表柔比星50 mg/m2静脉推注,d1;奥沙利铂130 mg/m2静脉滴注2h,d1;氟尿嘧啶375~425 mg/m2.d1~5 d静脉持续输注120h,每3周重复,每化疗2疗程评价1次疗效。对该方案的安全性、近期疗效及生活质量(包括症状的改善)进行评估。结果:入组晚期胃癌患者17例,其中进展期胃癌无法手术的6例,术后复发转移的11例,可评价疗效者16例,其中完全有效(CR)2例(2/16,12.5%),部分有效(PR)5例(5/16,31.3%),稳定(SD)8例(50%),进展(PD)1例,其中一线治疗总有效率(ORR)50%(7/14)。主要的毒副作用为骨髓抑制、粘膜炎、肢端麻木及消化道反应。17例患者共接受64周期EOF5方案化疗,其中Ⅲ度以上不良反应周期百分比为:白细胞及中性粒细胞减少各为6.3%,血红蛋白下降1.6%,血小板下降1.6%,恶心呕吐3.2%,口腔粘膜炎1.6%,手足麻木1.6%,静脉炎1.6%。其中除血小板下降外,余不良反应均未达Ⅳ度,所有周期治疗中未出现肝肾功能损害,未有患者出现心功能异常,或新发心律失常。在未采用PICC的12例患者中,Ⅱ度以上静脉炎达50%,5例采用PICC者无1发生静脉炎,所有患者无化疗相关死亡。结论:EOF5方案治疗晚期胃癌疗效较高,不良反应轻而且安全,是安全有效的晚期胃癌治疗方案,可用于一线治疗,但其疗效、TTP、生存期等资料还需扩大样本进一步验证。 BACKGROUND & OBJECTIVE: There is currently no standard chemotherapy regimen for advanced and metastatic gastric cancer. To date, only a few regimens, such as ECF (epirubicin, cisplatin and fluorouracil), have been validated in Phase III trials. However, 5-FU in the ECF regimen continued for 21 days with adverse reactions and inconvenience. Recently, studies have shown that oxaliplatin in gastric cancer is superior to cisplatin, and adverse reactions than cisplatin light. Therefore, we replaced cisplatin with oxaliplatin in ECF regimen, and changed the continuous infusion of 5-FU for 21 days to 5 days to form EOF5 regimen for the treatment of advanced gastric cancer in order to improve efficacy and safety. The purpose of this trial was to evaluate the efficacy and safety of the EOF5 regimen in the treatment of relapsed or advanced gastric cancer. Methods: The gastric cancer patients who met the inclusion criteria were treated with intravenous injection of epirubicin 50 mg / m2, d1; oxaliplatin 130 mg / m2 intravenously for 2h, d1; and fluorouracil 375-425 mg / 5 d continuous infusion of intravenous 120h, repeated every 3 weeks, 2 cycles per chemotherapy evaluation 1 effect. Evaluate the safety, short-term efficacy and quality of life (including improvement of symptoms) of the program. Results: There were 17 cases with advanced gastric cancer, 6 cases with advanced gastric cancer inoperable, 11 cases with recurrent and postoperative metastasis, and 16 cases with evaluable effect. Among them, 2 cases (2/16, 12.5% ), Partial effective (PR) in 5 cases (5/16, 31.3%), stable (SD) in 8 cases (50%) and progression (PD) in 1 case. The first-line treatment total efficiency (ORR) 14). The main side effects of bone marrow suppression, mucositis, numbness and digestive tract acuity. Seventeen patients received a total of 64 cycles of EOF5 regimen. The percentage of adverse reactions with grade Ⅲ or higher was 6.3% for leukopenia and neutropenia, 1.6% for hemoglobin, 1.6% for thrombocytopenia, 3.2% for nausea and vomiting, Inflammation 1.6%, 1.6% numb hands and feet, phlebitis 1.6%. In addition to platelet decline, the adverse reactions were less than grade IV, all cycles of treatment did not appear liver and kidney dysfunction, no patient had cardiac dysfunction, or new arrhythmias. Among 12 patients who did not adopt PICC, phlebitis of grade 2 or more was 50%, and none of 5 patients with PICC developed phlebitis. All patients had no chemotherapy-related death. Conclusion: EOF5 regimen is a safe and effective treatment for advanced gastric cancer with high efficacy and safety. It is a safe and effective treatment for advanced gastric cancer. It can be used for first-line treatment. However, its efficacy, TTP, survival and other data need to be further verified by extended samples.