不同化疗方案一线治疗晚期胃癌的临床分析

发布时间：2018-07-21 18:36

【摘要】：目的:胃癌是消化道最常见的恶性肿瘤之一,严重威胁人类的健康及生存。其分布具有明显的地域差异,主要集中在东亚地区[1]。我国是胃癌大国,其发病率占到全世界的42%左右[2]。在我国,胃癌总的发病率高居全国癌症第二位,每年新发胃癌病例约60万例,占所有新发癌症病例的15.82%[3]。然而,胃癌的治疗手段有限,总体预后差,根治胃癌的唯一手段仍然是手术切除。但由于我国胃癌筛查体系尚不完善且胃癌发病较隐匿,胃癌早诊率低,仅有5%-20%[4],多数患者就诊时已发展为进展期胃癌(Advanced Gastric Cancer),又称晚期胃癌,失去手术机会。此时单纯手术治疗往往无法取得较好的疗效,且术后复发转移率较高。REGATTA[5]研究显示,对于晚期胃癌患者,联合手术不仅不能带来生存优势,对于部分亚型患者,总生存情况甚至比单纯化疗更差。因此,以化疗为主的综合治疗仍是晚期胃癌患者的主要治疗手段,可改善部分患者的预后,提高患者生活质量。但由于胃癌异质性高,迄今为止,关于胃癌的化疗方案仍未达到共识。因此,寻求低毒高效的化疗方案成为临床的迫切需求。随着化疗药物的不断发展,第三代铂类药物奥沙利铂越来越多的应用于临床。本研究重点观察并比较了FOLFOX、SOX、TO三种化疗方案治疗晚期胃癌的临床疗效及不良反应,同时分析影响晚期胃癌生存预后的因素,为胃癌化疗方案的优化提供依据。方法:收集2009年9月1日至2015年12月31日于河北医科大学第四医院消化内科确诊且首次行化疗治疗的112例胃癌IV期患者,进行回顾性分析。根据化疗方案的不同,将患者分为三组,分别为FOLFOX组(n=33)、SOX组(n=48)、TO组(n=31)。收集患者临床资料,包括性别、年龄、肿瘤部位、KPS评分、组织学病理、肿瘤标记物、化疗周期数等14项指标。电话随访患者的生存状态。采用SPSS21版统计软件对数据进行统计处理,不同方案的疗效及毒性比较采用卡方检验,生存分析应用Kaplan-Meier曲线及Log-Rank检验,多因素分析采用Cox比例风险回归模型,计算P值、相对危险度及95%可信区间,以P0.05为差异有统计学意义。结果:1三组方案中均未见CR患者,FOLFOX组PR:6例,SD:18例,PD:9例。总有效率18.2%;临床获益率72.72%。SOX组PR:15例,SD:23例,PD:10例。总有效率31.3%;临床获益率79.16%。TO组PR:8例,SD:15例,PD:8例。总有效率25.8%;临床获益率74.19%。三组有效率及临床获益率之间未见明显差异。2三组方案无进展生存时间分别为7 m vs.9 m vs.7 m,(P=0.527)。总生存时间分别为12 m vs.12 m vs.11 m,(P=0.233)。三组间无进展生存期及总生存期差异无显著统计学意义。3主要不良反应为骨髓抑制、消化道反应及周围神经毒性等,以I、II度为主。三组周围神经毒性发生率分别为9.09%vs.4.2%vs.12.9%(P0.05),骨髓抑制发生率分别为24.2%vs.39.6%vs.29.0%(P0.05)。消化道不良反应发生率分别为54.5%vs.29.2%vs.51.6%(P0.05)。三组的骨髓抑制发生率及周围神经毒性发生率无显著差异,但在消化道不良反应方面,SOX组发生率明显低于FOLFOX组及TO组。4单因素分析表明:KPS评分、化疗前CEA水平、化疗周期数与患者OS存在相关性(P0.05),而年龄、性别、病理类型、肿瘤部位等与总生存期无相关性。经过COX回归多因素分析后,确定影响OS的因素为KPS评分、化疗前CEA水平、化疗周期数。结论:1 FOLFOX、SOX、TO方案都是治疗晚期胃癌比较有效的方法。2 SOX组消化道不良反应较低,患者耐受性更好,生活质量相对较高。3患者的KPS评分、化疗前CEA水平、化疗周期数为影响晚期胃癌患者OS的因素。
[Abstract]:Objective: gastric cancer is one of the most common malignant tumors in the digestive tract, which seriously threatens human health and survival. Its distribution has obvious regional differences, mainly concentrated in [1]. in East Asia, China is a big stomach cancer country, its incidence is about 42% [2]. in the world, the total incidence of gastric cancer ranks second in China, and the new incidence is new year in China. There are about 600 thousand cases of gastric cancer, which account for the 15.82%[3]. of all new cancer cases. However, the treatment of gastric cancer is limited and the overall prognosis is poor. The only means to cure the gastric cancer is still surgical excision. However, because the screening system of gastric cancer is not perfect and the incidence of gastric cancer is hidden, the early diagnosis rate of gastric cancer is low and only 5%-20%[4] is found, most of the patients have been developed. For advanced gastric cancer (Advanced Gastric Cancer), also known as advanced gastric cancer, it is lost the operation opportunity. At this time, simple surgical treatment is often unable to achieve better curative effect, and the high recurrence rate after operation.REGATTA[5] study shows that for advanced gastric cancer patients, combined operation not only can not bring survival advantage, for partial subtype patients, the total survival situation. It is still worse than chemotherapy alone. Therefore, comprehensive chemotherapy based chemotherapy is still the main treatment for patients with advanced gastric cancer, which can improve the prognosis of some patients and improve the quality of life of the patients. However, because of the high heterogeneity of gastric cancer, the chemotherapy regimen for gastric cancer has not reached consensus so far. Therefore, a low toxic and efficient chemotherapy scheme is sought. With the development of chemotherapeutic drugs, the third generation of platinum drugs oxaliplatin is more and more clinical. This study focuses on the observation and comparison of the clinical efficacy and adverse reactions of FOLFOX, SOX, TO chemotherapy in the treatment of advanced gastric cancer, and analyses the factors affecting the survival prognosis of advanced gastric cancer. Methods: a retrospective analysis was made in 112 cases of gastric cancer IV in the digestive department of the fourth hospital of Hebei Medical University from September 1, 2009 to December 31, 2015. The patients were divided into three groups according to the different chemotherapy regimens, group FOLFOX (n=33), group SOX (n=48), TO, respectively. Group (n=31). Collect the patient's clinical data, including sex, age, tumor site, KPS score, histological pathology, tumor markers, chemotherapy cycle number and other 14 indicators. Telephone follow up the patient's survival state. Use the SPSS21 version of statistical software to statistical processing, the efficacy and toxicity of different schemes were compared with chi square test, survival analysis should Using Kaplan-Meier curve and Log-Rank test, multi factor analysis used Cox proportional risk regression model to calculate P value, relative risk degree and 95% confidence interval, and P0.05 was statistically significant. Results: 1 of three groups had no CR patients, FOLFOX group PR:6, SD:18 cases, PD: 9 cases. The total effective rate was 18.2%, 72.72%.SOX group PR:15 cases, clinical benefit rate, 72.72%.SOX group, SD:23 cases, PD:10 cases, the total effective rate was 31.3%, the clinical benefit rate 79.16%.TO group PR:8 cases, SD:15 cases, PD:8 cases, the total effective rate was 25.8%, the clinical benefit rate 74.19%. three had no significant difference between the three groups and the clinical benefit rate, the group.2 three was 7 m vs.9 M vs.7, respectively, and the total survival time was 12 respectively. M, (P=0.233). There was no significant difference in the progression free survival and total survival period between the three groups. The main adverse reactions were bone marrow suppression, digestive tract reaction and peripheral neurotoxicity, such as I and II. The incidence of peripheral neurotoxicity in the three groups was 9.09%vs.4.2%vs.12.9% (P0.05), and the incidence of myelosuppression was 24.2%vs.39.6%vs.29.0%, respectively. (P0.05) the incidence of adverse reactions in the digestive tract was 54.5%vs.29.2%vs.51.6% (P0.05). There was no significant difference in the incidence of myelosuppression and the incidence of peripheral neurotoxicity in the three groups, but in the side effects of the digestive tract, the incidence of the SOX group was significantly lower than the single factor analysis of.4 in the FOLFOX group and the TO group: the KPS score, the level of CEA before chemotherapy, and the number of chemotherapy cycles. There was no correlation with patients' OS (P0.05), but age, sex, pathological type and tumor site were not related to the total survival time. After COX regression analysis, the factors affecting OS were KPS score, CEA level before chemotherapy, and the number of chemotherapy cycles. Conclusion: 1 FOLFOX, SOX, TO scheme are all effective methods for the treatment of advanced gastric cancer,.2 SOX group elimination The adverse reaction was low, the patient was well tolerated, the KPS score of.3 patients with higher quality of life, the CEA level before chemotherapy, and the number of chemotherapy cycles were the factors affecting the OS in the patients with advanced gastric cancer.
【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.2

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