沙利度胺联合化疗治疗晚期食管鳞癌的临床观察

发布时间：2018-06-07 19:21

本文选题：晚期食管鳞癌 + 沙利度胺　；参考：《郑州大学》2017年硕士论文

【摘要】：背景和目的食管癌是我国极为常见的恶性消化系统肿瘤之一,易侵犯其他组织器官,侵袭性强,恶性程度非常高,预后极差。近些年来食管癌疾病的发生率在不断上升,己逐步成为严重威胁人类健康和生命的主要恶性疾病之一,在我国各种恶性肿瘤中,食管癌的发病率排在第六位,其死亡率居于第四位。食管癌的发病具有明显的区域特征,中国也是食管癌的高发区之一,无论其发病率还是死亡率都居于我国恶性消化系统肿瘤的第三位,仅次于胃癌及肝癌。鳞状细胞癌和腺癌是食管癌主要且有代表性的两大组织学类型,鳞状细胞癌占据我国食管癌的大多数,其发病的主要危险因素是烟草和酒精。当前食管癌的治疗方式主要有手术、化疗、放疗,对其治疗通常采用多模式综合治疗的手段,如果食管肿瘤能手术切除,且在患者可耐受的情况下,手术为其首要治疗方式,因其初期即发生转移和扩散,多半患者在明确诊断时已经处于晚期,错失了外科治疗的最适时间,放化疗就成为其重要治疗手段。当前,顺铂与氟尿嘧啶联合应用被认为是食管癌的标准及常用治疗方案,但其疗效提高并不理想,毒副反应也较重。近些年来,紫杉醇逐渐应用在晚期食管癌的治疗上,它被认为是食管癌治疗方面的有效的药物之一。沙利度胺是一种非巴比妥类镇静剂,最先应用在早孕反应的治疗中,后来由于其可显著导致胎儿畸形而被禁止应用。近些年来多项研究提示,沙利度胺具有抗肿瘤的作用,其作用机制主要是抗肿瘤血管生成、诱导细胞凋亡、免疫调节等。当前,沙利度胺已经应用在晚期食管癌、肝癌、小细胞肺癌、非小细胞肺癌、胶质瘤和恶性黑色素瘤等的辅助治疗中,是一种具有潜力且有前景的抗肿瘤药物。本研究主要是针对我院(郑州大学第一附属医院)肿瘤科2014年4月份至2015年4月份诊断明确的70例晚期食管鳞癌患者的治疗效果进行研究分析,分别接受沙利度联合化疗或单纯化疗,研究的主要观察指标为近期疗效、生存率、中位生存时间、生活质量改善及对药物不良反应的耐受性,从而在食管癌治疗方式的选择方面提供一定的理论依据。方法该研究的对象为2014年4月到2015年4月我院肿瘤科收治且经病理学或细胞学证实的70例晚期食管鳞癌患者;TNM分期全部为Ⅳ期;诊断明确后的初次抗肿瘤治疗;KPS评分≥70分;能进半流质或顺利进流质饮食,未见严重恶病质及心血管系统疾病,且无气管侵犯现象和穿孔X线征象;多于一个能够应用影像学的方法评估治疗效果的病变;预计生存时间3个月。70例患者按1:1比例随机分为2组:对照组采用紫杉醇联合顺铂方案化疗,试验组患者在对照组基础上同步联合使用沙利度胺治疗。治疗前详细告知其可能发生的不良反应和化疗过程中的相关注意事项,若发生无法耐受的药物相关性不良反应时及时终止化疗。结果试验组及对照组患者在完成2周期化疗后,可进行近期疗效评估的患者共70例,其中试验组:完全缓解(CR)1例,部分缓解(PR)14例,稳定(SD)15例,进展(PD)5例,疾病控制率(DCR)为85.7%(30/35);对照组:完全缓解(CR)0例,部分缓解(PR)13例,稳定(SD)16例,进展(PD)6例,疾病控制率(DCR)为82.9%(29/35);比较试验组与对照组患者的疾病控制率,组间差异不具有显著性(P0.05)。在生活质量改善方面,与对照组比较,试验组患者KPS评分、睡眠和体重变化改善情况均具有明显优势,组间具有显著性差异(P0.05)。两组患者不良反应主要表现为血液学毒性(白细胞减少、血小板减少、血红蛋白减少)、胃肠道毒性(恶心、呕吐)等,以Ⅰ~Ⅱ度不良反应为主。试验组病人恶心和呕吐等消化道反应的发生率明显低于对照组,组间差异有统计学意义(χ2=5.757,P=0.0160.05);试验组便秘的发生率高于对照组(χ2=7.124,P=0.0080.05);其它的不良反应,两组间发生率比较无明显差异(P0.05)。治疗过程中试验组与对照组患者发生的毒副反应经临床对症处理后均可控制,并未发生药物相关毒副反应导致治疗停止的情况,也无治疗相关的死亡。截止到随访日期,试验组和对照组的中位生存时间分别为11.0个月(95%置信区间为9.267-12.733)和10.0个月(95%置信区间为8.344-11.656),两组生存曲线比较差异无统计学意义(P0.05)。试验组和对照组的1年生存率分别为40.0%、31.4%,两组比较差异均不具有统计学意义(P0.05)。结论1.沙利度胺联合化疗治疗晚期食管鳞癌可明显改善患者的生活质量,提高对化疗的顺应性。2.沙利度胺联合化疗治疗晚期食管鳞癌可明显降低恶心、呕吐等消化道反应的发生率,不良反应可耐受,沙利度胺用于治疗食管癌值得进一步研究及推广。
[Abstract]:Background and objective esophageal cancer is one of the most common malignant digestive system tumors in China. It is easy to encroaches on other tissues and organs. It has strong invasiveness, high degree of malignancy and poor prognosis. The incidence of esophageal cancer is rising in recent years. It has gradually become one of the major malignant diseases that seriously threaten human health and life. Among the malignant tumors, the incidence of esophageal cancer ranks in the sixth place, with a mortality rate of fourth. The incidence of esophageal cancer has obvious regional characteristics. China is one of the high incidence areas of esophageal cancer. Both the incidence and mortality rate in third of the malignant digestive system tumors in China, second only to gastric cancer and liver cancer. Squamous cell carcinoma and squamous cell carcinoma. Adenocarcinoma is the main and representative two major histological type of esophageal cancer. Squamous cell carcinoma occupies most of the cancer of the esophagus in our country. The main risk factors are tobacco and alcohol. The main treatment methods of esophageal cancer are surgery, chemotherapy and radiotherapy. Surgical excision, and in the case of patient tolerable, operation is the primary treatment. Because of its initial metastasis and diffusion, most patients have been in a late period of definite diagnosis and missed the most suitable time for surgical treatment. Chemotherapy and chemotherapy is an important treatment. Current, cisplatin and fluorouracil are considered to be the esophagus. In recent years, paclitaxel has been used in the treatment of advanced esophageal cancer, which is considered to be one of the effective drugs in the treatment of esophageal cancer. Thalidomide is a non barbiturate sedative, first used in the treatment of early pregnancy. In recent years, a number of studies have suggested that thalidomide has an antitumor effect. Its mechanism is mainly anti-tumor angiogenesis, apoptosis and immunomodulation. At present, thalidomide has been used in advanced esophageal, hepatocellular carcinoma, small cell lung cancer, and non small cell lung. In the adjuvant therapy of cancer, glioma and malignant melanoma, it is a potential and promising antitumor drug. This study is mainly aimed at the analysis of the therapeutic effects of 70 patients with advanced esophageal squamous carcinoma diagnosed from April 2014 to April 2015 of our hospital (the First Affiliated Hospital of Zhengzhou University). The main objective of the study was the short-term efficacy, survival, median survival time, quality of life, and tolerance to adverse drug reactions, which provided a theoretical basis for the selection of esophageal cancer treatment. The object of this study was from April 2014 to April 2015 in our hospital. 70 cases of advanced esophageal squamous cell carcinoma confirmed by pathology or cytology were admitted to the Department of oncology. The TNM staging was all IV stage; the first antitumor treatment after diagnosis; the KPS score was more than 70; it could enter a half fluid or a smooth intake of fluid, no severe cachexia and cardiovascular system diseases, and no tracheal invasion and perforation X ray signs; An imaging method was used to evaluate the effect of treatment. The estimated survival time was 3 months for.70 patients randomly divided into 2 groups according to the proportion of 1:1. The control group was treated with paclitaxel combined with cisplatin regimen, and the experimental group was synchronously combined with thalidomide on the basis of the control group. In the process of good reaction and chemotherapy, the chemotherapy was terminated in time for the adverse drug related adverse reactions. Results in the experimental group and the control group, 70 patients were evaluated after 2 cycles of chemotherapy, including 1 cases of complete remission (CR), 14 cases of partial remission (PR), and stability (SD) 15. For example, 5 cases (PD), disease control rate (DCR) was 85.7% (30/35); control group: complete remission (CR) 0 cases, partial remission (PR) 13 cases, stability (SD) 16 cases, progression (PD) 6 cases, disease control rate (DCR) 82.9% (29/35); comparison between the test group and the control group, the difference between the group was not significant (P0.05). In quality of life improvement, and right Compared with group KPS, the patients in the experimental group had obvious advantages in the improvement of sleep and body weight, and there was a significant difference between the groups (P0.05). The two groups of patients were mainly characterized by hematological toxicity (leukocyte reduction, thrombocytopenia, hemoglobin), gastrointestinal toxicity (nausea, vomiting) and so on. The incidence of nausea and vomiting in the experimental group was significantly lower than that of the control group. The difference between the groups was statistically significant (x 2=5.757, P=0.0160.05); the incidence of constipation in the experimental group was higher than that of the control group (x 2=7.124, P=0.0080.05); the other adverse reactions, the incidence of the two groups were not significantly different (P0.05). The side effects of the patients in the control group were controlled after clinical symptomatic treatment. There was no drug related side effects and no treatment related deaths. The median survival time of the test group and the control group was 11 months (95% confidence interval 9.267-12.733) and 10 months (95 months, respectively). % confidence interval was 8.344-11.656). There was no significant difference between the two groups of survival curves (P0.05). The 1 year survival rates of the experimental group and the control group were 40% and 31.4% respectively. The difference of the two groups was not statistically significant (P0.05). Conclusion 1. thalidomide combined with chemotherapy in the treatment of late esophageal squamous cell carcinoma could significantly improve the quality of life of the patients and improve the quality of the patients. .2. thalidomide combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma can significantly reduce the incidence of nausea, vomiting and other digestive tract reactions, and the adverse reactions can be tolerated. Thalidomide is worth further research and promotion in the treatment of esophageal cancer.
【学位授予单位】：郑州大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.1

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