多西他赛联合顺铂用于局部晚期胃癌患者围手术期治疗完成后复发或转移患者的疗效及安全性分析

发布时间：2018-07-18 14:05

【摘要】：目的:胃癌是世界范围内常见的恶性肿瘤。在我国,发病率更是有逐年上升的趋势。众所周知,胃癌发病时症状不明显,较为隐秘,多数患者就诊时病情已进入晚期失去手术机会。目前为止,对于局部晚期胃癌患者最主要的治疗手段仍手术为主的综合治疗。但是多由于患者就诊时间较晚及胃癌病理的特点,部分患者会在其完成手术及围手术期化疗后1-3年便出现复发或转移的情况,此时多数患者已失去再次手术机会,治疗手段相对单一。对于大多数患者会选择再次行全身化疗。但是,针对完成手术及围手术期化疗后又复发转移的局部晚期胃癌患者的化疗方案、疗程、具体适应症等方面尚未形成一个金标准,其疗效及安全性亦无大宗临床试验得到证实,所以本研究旨在以上这些方面进行研究探讨,进一步证实多西他赛联合顺铂用于局部晚期胃癌患者围手术期治疗完成后复发或转移患者的疗效及安全性,为胃癌患者提供更好的治疗理论及方法。方法:选择河北医科大学第四医院外三科2012年1月1日至2015年5月31日确诊为进展期胃癌患者后经D2根治术及氟尿嘧啶联合奥沙利铂围手术期治疗后复发转移患者60例,分为实验组(治疗组)46例和对照组(支持组)14例。实验组接受多西他赛+注射用顺铂的治疗方案:多西他赛60-75mg/m2+浓度为0.9%的氯化钠溶液250ml静脉滴注,第1天。注射用顺铂60-75mg/m2+浓度为0.9%的氯化钠溶液500ml,第1天。第2天给予水化治疗,目的在于尽可能的减少患者化疗副反应,降低患者不适程度。21天为1个周期。多西他赛给药前D1、D2、D3天晚22点给予地塞米松片(0.75mg/片)20片,口服,早7点给予地塞米松片(0.75mg/片)10片,口服。观察实验组治疗后的近期疗效、远期疗效及不良反应;比较两组ORR和DCR的差别;随访比较两组的短期总生存期(OS)和疾病进展时间(TTP)。具体临床疗效评价指标如下:1实验组患者治疗前后通过对复发转移病灶的CT、MRI结果比较,评价治疗有效率和疾病的控制率。2通过对比患者治疗前后肿瘤标记物变化情况评价治疗效果。3通多观察患者治疗前后症状、主诉来评价疾病变化情况。4通过观察、随访患者在治疗过程中出现的不适对治疗进行不良反应的评价。5通过对比患者在治疗过程中血常规、电解质及生化全项等观察指标来评价化疗方案的安全性。6通过观察、随访比较两组的OS及TTP的差别。结果:1两组病人60例患者均获得随访,实验组46例随访总共247.1个月,人均5.37个月,中位随访时间5.2个月;对照组随访总月份67.1个月,人均4.79个月,中位随访时间4.8个月。实验组46例患者均获疗效评价,其中完全缓解0例,部分缓解8例,病情稳定18例,20例进展。客观缓解率为13.04%(8/46),疾病控制率为56.52%(26/46)。对照组14例患者均获疗效评价,其中完全缓解0例,部分缓解0例,病情稳定2例,12例进展。客观缓解率为0.00%(0/14),疾病控制率为14.29%(2/14)。2实验组与对照组比较,ORR不具有统计学差异,P值为0.179,DCR具有统计学差异,P值为0.006。3中位疾病进展时间为5.2个月(3.8-8.2个月),中位生存时间为8.35个月(5.6-12.8个月)。4实验组与对照组比较,TTP和OS均具有统计学意义。P0.055多西他赛联合顺铂作为局部晚期胃癌患者围手术期治疗完成后复发或转移的再治疗方案,毒副反应小,可耐受。结论:1多西他赛联合顺铂化疗方案用于局部晚期胃癌患者围手术期治疗完成后复发或转移患者一定程度上可以控制疾病的发展。2多西他赛联合顺铂化疗方案毒副反应较小,安全性好。3多西他赛联合顺铂化疗方案用于局部晚期胃癌患者围手术期治疗完成后复发或转移患者有延长疾病进展时间和总生存期的趋势,是晚期胃癌患者安全有效的治疗模式。
[Abstract]:Objective: gastric cancer is a common malignant tumor in the world. In China, the incidence of the disease is increasing year by year. It is well known that the symptoms of gastric cancer are not obvious and are more secretive. Most of the patients have entered the late stage and lose the operation opportunity. So far, the most important treatment for patients with advanced gastric cancer is still operating. However, due to the late diagnosis and pathological features of the gastric cancer, some patients will have a recurrence or metastasis 1-3 years after the operation and perioperative chemotherapy, and most patients have lost the chance of reoperation and the treatment is relatively simple. For most patients, they will choose to do their whole body again. Chemotherapy, however, has not formed a gold standard for the chemotherapy regimen, course of treatment and specific indications for patients with locally advanced gastric cancer after surgery and chemotherapy after perioperative chemotherapy. The efficacy and safety of the patients have not been confirmed by large clinical trials. To confirm the efficacy and safety of docetaxel combined with cisplatin in patients with local advanced gastric cancer after perioperative treatment, and to provide better therapeutic theory and methods for patients with gastric cancer. Methods: selected patients from fourth hospitals in Hebei Medical University from January 1, 2012 to May 31, 2015 were diagnosed as advanced gastric cancer patients. 60 cases of recurrent and metastatic patients after D2 radical resection and fluorouracil combined with oxaliplatin were divided into the experimental group (treatment group) and the control group (14 cases). The experimental group received docetaxel + Cisplatin for Injection treatment regimen: Docetaxel 60-75mg/m2+ concentration of 0.9% Sodium Chloride Solution 250ml intravenous drip, first days. Sodium Chloride Solution 500ml with cisplatin 60-75mg/m2+ concentration of 0.9%, first days and second days to be treated with hydration, the aim was to reduce the side effects of chemotherapy and reduce the patient's discomfort to 1 cycles for.21 days. 20 tablets (0.75mg/) were given at 22 points before D1, D2, D3 days, and 7 points were given to dexamethasone. 10 tablets of 0.75mg/ tablets were taken orally. The short-term effect, the long-term effect and the adverse reaction of the experimental group were observed. The difference between the two groups was compared with that of the DCR. The short-term total survival time (OS) and the disease progression time (TTP) were compared between the two groups. The specific clinical efficacy evaluation indexes were below: 1 in the 1 experimental group, after the treatment of the recurrence and metastasis of CT, M RI comparison, evaluation of therapeutic effectiveness and control rate of disease.2 by comparing the changes of tumor markers before and after the treatment of patients, the treatment effect was evaluated.3 through observation of the symptoms of the patients before and after treatment, the main complaint was to evaluate the change of the disease, and.4 was observed, and the patients were followed up in the treatment process to evaluate the adverse reactions to the treatment. .5 evaluated the safety of chemotherapy by comparing patients' blood routine, electrolyte and biochemical indexes during the treatment process to evaluate the safety of chemotherapy.6 through observation, followed up and compared the difference between the two groups of OS and TTP. Results: 1 two groups of patients were followed up, 46 cases in the experimental group were followed up for a total of 247.1 months, 5.37 months per person, and median follow-up time 5.. 2 months, the control group was followed up for a total of 67.1 months, 4.79 months per person, and median follow-up time of 4.8 months. 46 patients in the experimental group were evaluated, including 0 cases of complete remission, 8 cases of partial remission, 18 cases of stable condition and 20 progress. The objective remission rate was 13.04% (8/46), and the control rate of disease was 56.52% (26/46). All patients in the control group received efficacy evaluation, There were 0 cases of complete remission, 0 cases of partial remission, 2 cases of stable condition and 12 progress. The objective remission rate was 0% (0/14), the rate of disease control was 14.29% (2/14).2 experimental group compared with the control group, ORR did not have statistical difference, P value was 0.179, DCR had statistical difference, P value was 5.2 months (3.8-8.2 months), median of 0.006.3 median disease (3.8-8.2 months), median The survival time was 8.35 months (5.6-12.8 months).4 experimental group compared with the control group, TTP and OS had statistical significance.P0.055 docetaxel combined with cisplatin as a local advanced gastric cancer patients with recurrent or metastatic retreatment after perioperative treatment, the side effects were small and tolerable. Conclusion: 1 docetaxel combined with cisplatin chemotherapy regimen is used. Patients with locally advanced gastric cancer patients with recurrent or metastases after perioperative treatment can control the development of the disease to a certain extent..2 docetaxel combined with cisplatin chemotherapy regimen has less side effects. Safe and good.3 docetaxel combined with cisplatin chemotherapy regimen is used for local advanced gastric cancer patients after perioperative treatment to relapse or metastases. Patients who have prolonged trend of disease progression and overall survival are safe and effective treatment modalities for 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】：2016
【分类号】：R735.2

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