【摘要】：目的:胃癌是消化道最常見的惡性腫瘤之一,嚴重威脅人類的健康及生存。其分布具有明顯的地域差異,主要集中在東亞地區(qū)[1]。我國是胃癌大國,其發(fā)病率占到全世界的42%左右[2]。在我國,胃癌總的發(fā)病率高居全國癌癥第二位,每年新發(fā)胃癌病例約60萬例,占所有新發(fā)癌癥病例的15.82%[3]。然而,胃癌的治療手段有限,總體預后差,根治胃癌的唯一手段仍然是手術切除。但由于我國胃癌篩查體系尚不完善且胃癌發(fā)病較隱匿,胃癌早診率低,僅有5%-20%[4],多數(shù)患者就診時已發(fā)展為進展期胃癌(Advanced Gastric Cancer),又稱晚期胃癌,失去手術機會。此時單純手術治療往往無法取得較好的療效,且術后復發(fā)轉移率較高。REGATTA[5]研究顯示,對于晚期胃癌患者,聯(lián)合手術不僅不能帶來生存優(yōu)勢,對于部分亞型患者,總生存情況甚至比單純化療更差。因此,以化療為主的綜合治療仍是晚期胃癌患者的主要治療手段,可改善部分患者的預后,提高患者生活質量。但由于胃癌異質性高,迄今為止,關于胃癌的化療方案仍未達到共識。因此,尋求低毒高效的化療方案成為臨床的迫切需求。隨著化療藥物的不斷發(fā)展,第三代鉑類藥物奧沙利鉑越來越多的應用于臨床。本研究重點觀察并比較了FOLFOX、SOX、TO三種化療方案治療晚期胃癌的臨床療效及不良反應,同時分析影響晚期胃癌生存預后的因素,為胃癌化療方案的優(yōu)化提供依據。方法:收集2009年9月1日至2015年12月31日于河北醫(yī)科大學第四醫(yī)院消化內科確診且首次行化療治療的112例胃癌IV期患者,進行回顧性分析。根據化療方案的不同,將患者分為三組,分別為FOLFOX組(n=33)、SOX組(n=48)、TO組(n=31)。收集患者臨床資料,包括性別、年齡、腫瘤部位、KPS評分、組織學病理、腫瘤標記物、化療周期數(shù)等14項指標。電話隨訪患者的生存狀態(tài)。采用SPSS21版統(tǒng)計軟件對數(shù)據進行統(tǒng)計處理,不同方案的療效及毒性比較采用卡方檢驗,生存分析應用Kaplan-Meier曲線及Log-Rank檢驗,多因素分析采用Cox比例風險回歸模型,計算P值、相對危險度及95%可信區(qū)間,以P0.05為差異有統(tǒng)計學意義。結果:1三組方案中均未見CR患者,FOLFOX組PR:6例,SD:18例,PD:9例�？傆行�18.2%;臨床獲益率72.72%。SOX組PR:15例,SD:23例,PD:10例�？傆行�31.3%;臨床獲益率79.16%。TO組PR:8例,SD:15例,PD:8例�？傆行�25.8%;臨床獲益率74.19%。三組有效率及臨床獲益率之間未見明顯差異。2三組方案無進展生存時間分別為7 m vs.9 m vs.7 m,(P=0.527)。總生存時間分別為12 m vs.12 m vs.11 m,(P=0.233)。三組間無進展生存期及總生存期差異無顯著統(tǒng)計學意義。3主要不良反應為骨髓抑制、消化道反應及周圍神經毒性等,以I、II度為主。三組周圍神經毒性發(fā)生率分別為9.09%vs.4.2%vs.12.9%(P0.05),骨髓抑制發(fā)生率分別為24.2%vs.39.6%vs.29.0%(P0.05)。消化道不良反應發(fā)生率分別為54.5%vs.29.2%vs.51.6%(P0.05)。三組的骨髓抑制發(fā)生率及周圍神經毒性發(fā)生率無顯著差異,但在消化道不良反應方面,SOX組發(fā)生率明顯低于FOLFOX組及TO組。4單因素分析表明:KPS評分、化療前CEA水平、化療周期數(shù)與患者OS存在相關性(P0.05),而年齡、性別、病理類型、腫瘤部位等與總生存期無相關性。經過COX回歸多因素分析后,確定影響OS的因素為KPS評分、化療前CEA水平、化療周期數(shù)。結論:1 FOLFOX、SOX、TO方案都是治療晚期胃癌比較有效的方法。2 SOX組消化道不良反應較低,患者耐受性更好,生活質量相對較高。3患者的KPS評分、化療前CEA水平、化療周期數(shù)為影響晚期胃癌患者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.
【學位授予單位】：河北醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R735.2

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