【摘要】：背景和目的食道癌是全世界癌癥死亡的第六主要原因,在中國尤其常見[1]。然而,與西方國家和日本相比,我們遠(yuǎn)遠(yuǎn)落后于時代,貢獻(xiàn)最少的A級證據(jù)[2-3]。與其他胃腸道惡性腫瘤相比,食管癌由于早期淋巴結(jié)和遠(yuǎn)處器官轉(zhuǎn)移而呈現(xiàn)出高度惡性。局部晚期或廣泛轉(zhuǎn)移食管癌因其嚴(yán)重侵襲周圍器官、進(jìn)展迅速且患者因進(jìn)食困難造成營養(yǎng)狀況差而難以治療繼而導(dǎo)致預(yù)后差[4-5]。相關(guān)文獻(xiàn)顯示食管癌患者的5年生存率僅為5%-30%[5]。以往,食管切除術(shù)在早期和局部食管癌治療中起著關(guān)鍵作用,但對于老年患者,食管切除術(shù)的應(yīng)用卻日益減少[6-8],這是因為大多數(shù)患者在確診時已屬于晚期,失去了最佳手術(shù)機(jī)會[9]。過去的10到15年中已完成的臨床試驗表明,除了手術(shù)切除之外還存在一些可以提高晚期食管癌患者生存期的治療方案[10-11]。化學(xué)治療,對食管癌患者來說起著十分重要的作用。一般而言,氟尿嘧啶聯(lián)合鉑類被視為晚期食管癌的標(biāo)準(zhǔn)一線化療方案,其反應(yīng)率可達(dá)25%-45%[12-16],但中位生存期卻不到一年[17-19]。然而,大多數(shù)患者在標(biāo)準(zhǔn)一線化療后迅速發(fā)生轉(zhuǎn)移或復(fù)發(fā),隨后進(jìn)行二線化療[20-22],但是研究發(fā)現(xiàn)二線化療療效遠(yuǎn)不如一線化療。怎樣才能延長一線化療后疾病進(jìn)展時間呢?對于那些在化療中獲益的患者的后續(xù)治療,過去曾經(jīng)采取“觀望并等待”的模式。但最近幾年,借鑒血液學(xué)腫瘤的成功治療模式[9],應(yīng)用高效、低毒的單藥作為對實體腫瘤的維持治療已經(jīng)應(yīng)用于晚期卵巢癌、晚期結(jié)直腸癌、晚期非小細(xì)胞肺癌、晚期胃癌、胰腺癌中,結(jié)果表明維持治療可延長疾病無進(jìn)展生存期,甚至可能達(dá)到生存獲益[23-24]。但目前針對食管癌的維持治療卻較少報道。卡培他濱是一種口服氟尿嘧啶類藥物[25-27],相關(guān)試驗表明卡培他濱維持治療可延長晚期食管癌患者的無進(jìn)展生存期和總生存期[28]。替吉奧(S-1)是一種口服復(fù)方氟尿嘧啶衍生物,最早由日本大鵬藥品工業(yè)株式會社研制,S-1是替加氟、吉美嘧啶和奧替拉西鉀的混合物,摩爾比為1:0.4:1[29-31]。替加氟是一種口服5-FU前體藥物;吉美嘧啶是二氫嘧啶脫氫酶抑制劑,可增強(qiáng)5-FU的作用;奧替拉西鉀可以減少5-FU的胃腸毒性。因此,從整個配方結(jié)構(gòu),S-1既可增強(qiáng)抗腫瘤作用,延長作用時間,同時也降低了胃腸道毒性[32-33]。到目前為止,S-1已被廣泛應(yīng)用在各種癌癥中,如頭頸部癌,肺癌和胰腺癌等[34-36]。S-1與順鉑的聯(lián)合化療已被確立為胃癌的標(biāo)準(zhǔn)化療方案[37-39]。S-1用于胰腺癌、胃癌、結(jié)直腸癌等消化道腫瘤的維持治療在中外期刊上也見報道[40-41]。基于上述事實,我們有理由認(rèn)為,對于食管癌患者,S-1是一個很有潛力的維持治療藥物。本研究通過對2012.01到2015.12的66例晚期食管癌患者應(yīng)用S-1維持治療的臨床資料進(jìn)行回顧性分析,探討S-1維持治療的臨床療效、不良反應(yīng)。資料與方法研究對象為2012年1月1日—2015年12月31日鄭州大學(xué)第一附屬醫(yī)院腫瘤內(nèi)科收治的經(jīng)病理學(xué)確診為晚期食管癌的66例患者,既往均接受過順鉑聯(lián)合氟尿嘧啶方案一線化療4~6個周期后,療效評價為完全緩解、部分緩解或疾病穩(wěn)定,其中31例繼續(xù)接受S-1單藥口服維持治療直至疾病進(jìn)展或出現(xiàn)不能耐受的不良反應(yīng)(S-1維持治療組),另35例接受最佳支持治療(對照組)。觀察疾病反應(yīng)率、疾病控制率、無進(jìn)展生存期、總生存期及不良反應(yīng)。統(tǒng)計學(xué)方法所有數(shù)據(jù)均采用SPSS17.0統(tǒng)計學(xué)軟件進(jìn)行分析,分類資料采用χ2檢驗,生存分析采用Kaplan-Meier法。P0.05為差異有統(tǒng)計學(xué)意義。結(jié)果1.S-1維持治療組的客觀反應(yīng)率為22.6%,優(yōu)于對照組的3.9%(P0.05)。2.S-1維持治療組的疾病控制率為38.7%,盡管高于對照組的22.9%,但差異無統(tǒng)計學(xué)意義(P0.05)。3.S-1維持治療組的中位無進(jìn)展生存期為17.0個月,優(yōu)于對照組的10.0個月(P0.05)。4.S-1維持治療組的主要毒副反應(yīng)為惡心、嘔吐、貧血、白細(xì)胞減少和手足綜合征等,經(jīng)對癥治療后均好轉(zhuǎn),無治療相關(guān)性死亡病例出現(xiàn)。結(jié)論一線治療后繼續(xù)替吉奧單藥維持治療晚期食管癌,可提高近期有效率,延長中位無進(jìn)展生存期,不良反應(yīng)可以耐受。
[Abstract]:Background and objective esophagus cancer is the sixth main cause of cancer death in the world. In China, [1]. is especially common, however, compared with the western countries and Japan, we are far behind the times. Compared to the other gastrointestinal malignancies, the least contribution of the A-level evidence, [2-3]., presents a high level of early lymph node and distant organ metastasis. Malignant. Locally advanced or widely metastatic carcinoma of the esophagus, due to its severe invasion of the peripheral organs, is progressing rapidly and the patient is poor in nutritional status due to the difficulty of eating. The poor prognosis of the patients leads to poor prognosis, [4-5]. related literature shows that the 5 year survival rate of esophageal cancer patients is only 5%-30%[5].. Esophagectomy has been used in early and local esophageal cancer treatment. There is a key role, but for elderly patients, the use of esophagectomy is increasingly reduced by [6-8], because most patients are late at the time of diagnosis and lose the best chance of operation, [9]. has completed the past 10 to 15 years of clinical trials showing that there are some patients with advanced esophageal cancer besides surgical excision. [10-11]. chemotherapy is very important for patients with esophageal cancer. Generally speaking, fluorouracil combined with platinum is considered as a standard first-line chemotherapy regimen for advanced esophageal cancer, with a response rate of up to 25%-45%[12-16], but the median survival time is less than one year [17-19]., but most of the patients are in the standard line. There is a rapid metastasis or recurrence after treatment, followed by a second line chemotherapy [20-22], but the study has found that second line chemotherapy is far less effective than first-line chemotherapy. How can we extend the time for disease progression after first-line chemotherapy? For patients who benefit from chemotherapy, follow-up treatment has been "wait-and-see" in the past, but in recent years, Using the successful treatment model [9] for hematological tumors, the application of high efficient, low toxic single drug as a maintenance therapy for solid tumors has been applied to advanced ovarian cancer, advanced colorectal cancer, advanced non-small cell lung cancer, advanced gastric cancer, and pancreatic cancer. The results indicate that maintenance treatment can not survive and even achieve survival benefit. [23-24]. but current treatment for esophageal cancer is less reported. Capecitabine is an oral fluorouracil drug [25-27]. Related trials suggest that capecitabine maintenance therapy prolongs the progression free survival of patients with advanced esophageal cancer and the total survival time [28]. teggio (S-1) is an oral compound fluorouracil derivative, the earliest S-1 is a mixture of tegafon, pyrimidine and oretirase, the mole ratio is 1:0.4:1[29-31]. tegafur, an oral 5-FU precursor drug; gimilacil is a two hydrogen pyrimidine dehydrogenase inhibitor, which can enhance the effect of 5-FU; thus, oretiari potassium can reduce the gastrointestinal toxicity of 5-FU. Therefore, from the whole, from the whole The combination of [34-36].S-1 and cisplatin, such as head and neck cancer, lung cancer and pancreatic cancer, has been widely used in various cancers, such as head and neck cancer, lung cancer and pancreatic cancer, and the combined chemotherapy of [34-36].S-1 and cisplatin, such as head and neck cancer, lung cancer and pancreatic cancer, has been established as the standard chemotherapy for gastric cancer, [37-39].S-1 is used in the pancreas for the use of S-1. The maintenance treatment of digestive tract tumors such as adenocarcinoma, gastric cancer and colorectal cancer is also reported in Chinese and foreign periodicals. [40-41]. is based on the above facts. We have reason to think that S-1 is a potential maintenance therapy for patients with esophageal cancer. This study is based on the application of S-1 maintenance therapy to 66 patients with advanced esophageal cancer in 2012.01 to 2015.12. The clinical efficacy and adverse reactions of S-1 maintenance treatment were analyzed retrospectively. 66 patients with advanced esophageal cancer confirmed by pathology from January 1, 2012 to December 31, 2015 in the First Affiliated Hospital of Zhengzhou University were treated with cisplatin combined with fluorouracil. After line chemotherapy for 4~6 cycles, the curative effect was evaluated as complete remission, partial remission or disease stability, of which 31 cases continued to accept S-1 single drug oral maintenance therapy until disease progression or intolerance (S-1 maintenance treatment group), and the other 35 cases received optimal support treatment (control group). The survival period, the total life period and the adverse reaction. All the statistical methods were analyzed by SPSS17.0 statistics software. The classification data were tested by chi 2, and the survival analysis using the Kaplan-Meier method.P0.05 was statistically significant. Results the objective response rate of the 1.S-1 maintenance group was 22.6%, which was better than the control group of 3.9% (P0.05).2.S-1 maintenance. The rate of disease control in the treatment group was 38.7%, although it was higher than 22.9% in the control group, but the difference was not statistically significant (P0.05) the median progression free survival of the.3.S-1 maintenance group was 17 months, and the major side effects of the 10 months (P0.05) group of the control group were nausea, vomiting, anemia, leukocyte reduction and hand foot syndrome. After treatment, there was no treatment related death cases. Conclusion after first-line treatment, continuing the treatment of advanced esophageal cancer with monotherapy, can improve the short-term efficiency, prolong the median progression free survival and tolerable adverse effects.
【學(xué)位授予單位】：鄭州大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R735.1

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