局部晚期鼻咽癌多西他赛对比顺铂同期放化疗疗效与副反应研究
发布时间：2018-08-12 08:36
【摘要】：目的:鼻咽癌(nasopharyngeal carcinoma,NPC)是中国广东及沿海地区最常见的头颈部恶性肿瘤。含顺铂的同期放化疗(CCRT)是局部晚期鼻咽癌(LA-NPC)的标准治疗方法,但顺铂所致恶心呕吐、粘膜等副作用明显,可能导致患者中断治疗,影响疗效。有研究发现新一代化疗药多西他赛作为同期化疗方案,其疗效不劣于顺铂且副作用较小。但这些结果均来自小样本的回顾性研究,目前缺乏前瞻性的研究。放射性口腔粘膜炎是鼻咽癌同期放化疗中最主要的副作用之一。放射性口腔粘膜炎目前尚无有效的治疗方法及药物。近年来中医中药尤其是滋阴清热类中药在减轻放化疗副作用上具有一定的疗效。增液汤是滋阴类方剂的代表之一。有研究显示增液汤可减轻放化疗的口腔粘膜反应,但相关研究较少,在此方基础上加味应用能否减轻放疗过程中口腔黏膜炎仍有待研究证实。基于以上问题,设计了本研究。采用前瞻性随机研究方法,对比多西他赛和顺铂应用于鼻咽癌同期放化疗的近期疗效及副作用,旨在探讨多西他赛能否作为顺铂的替代化疗药物,以期为鼻咽癌患者提供更多高效低毒的化疗方案选择。同时本研究在放疗过程中配合服用加味增液汤方,以期明确加味增液汤在防治鼻咽癌放化疗期间对放射性口腔粘膜炎的作用,为降低放化疗副作用,提高治疗依从性提供有效的中药方剂。方法:筛选2015年3月3日至2017年2月15日广州军区总医院肿瘤科初治的局部晚期鼻咽癌患者81例,所有患者先行3周期诱导化疗,再行同期放化疗。诱导化疗方案为多西他赛(TXT)75 mg/m2、顺铂(DDP)80 mg/m2,每3周一次。放疗采用三维适形放疗(3D-CRT),DT:70Gy/35f。放疗开始后随机分为两组,研究组采用多西他赛同期化疗(方案为75mg/m2/3周),对照组采用顺铂同期化疗(方案为40mg/m2/周×7次或80mg/m2/3周×3次)。放疗期间,两组中分别随机选取患者口服加味增液汤。观察放化疗期间急性放射性口腔黏膜炎等副反应发生情况,治疗结束后3个月评价其疗效。结果:所有患者均完成放化疗。1例患者在治疗过程中病情进展,80例可评价近期疗效。两组近期疗效相当(CR率分别为73.3%vs.72.0%;PR率分别为26.7%vs.28.0%,P0.05)。副作用方面,TXT组放疗过程中1-3级放射性口腔黏膜炎发生率分别为10.0%、56.7%、33.3%;DDP组放疗过程中1-3级放射性口腔黏膜炎发生率分别为2.0%、37.3%、60.8%,两组均无4级放射性口腔粘膜炎发生。TXT组放射性口腔黏膜炎程度较轻,差异有统计学意义(P=0.011)。TXT组和DDP组放射性口腔粘膜炎发生时间分别出现在放疗后11.63±3.68天、9.76±3.57天,TXT组口腔粘膜炎发生时间较晚(t=2.249、P=0.027)。多因素分析显示:同期化疗药物是3度口腔粘膜炎发生的独立影响因素(OR=0.324,P=0.034)。性别、年龄、T分期、N分期、总临床分期、放疗同时是否口服中药均不是3级放射性口腔炎发生的显著影响因素(P0.05)。TXT组1-3级放射性皮炎的发生率分别为56.7%、30.0%、13.30%;DDP组1-3级放射性皮炎的发生概率分别为49.0%、43.1%、7.8%(P=0.723),两组比较差异无统计学意义。DDP组恶心呕吐的发生率高于TXT组(91.2%vs.56.7%,P=0.001)。多因素分析显示:同期化疗药物是2-3级恶心呕吐的影响因素(OR=0.272,P=0.026)。两组在放化疗期间各等级骨髓抑制发生率无统计学差异(户0.05)。多因素分析显示同期化疗药物多西他赛(P=0.016)、男性(P=0.029)是影响贫血发生的独立影响因素。非中药组放射性口腔粘膜炎发生率为1级1.9%、2级38.5%、3级59.6%;中药组放射性口腔粘膜炎发生率为1级10.3%、2级55.2%、3级34.5%,中药组放射性口腔黏膜炎程度低于非中药组,差异有统计学意义(P=0.019)。结论:在局部晚期鼻咽癌同步放化疗中,多西他赛与顺铂单药同期化疗的近期疗效相当。TXT组放射性黏膜炎及胃肠道反应更小,患者耐受性可,有可能成为顺铂同期化疗替代药物之一。放疗期间口服加味增液汤可减轻放射性口腔黏膜炎,提高患者耐受性和治疗依从性。
[Abstract]:Objective: Nasopharyngeal carcinoma (NPC) is the most common head and neck malignancy in Guangdong and coastal areas of China. The concurrent chemoradiotherapy with cisplatin (CCRT) is the standard treatment for locally advanced nasopharyngeal carcinoma (LA-NPC), but the side effects such as nausea, vomiting and mucosa caused by cisplatin are obvious, which may lead to discontinuation of treatment and affect the curative effect. As a concurrent chemotherapy regimen, docetaxel, a new generation of chemotherapeutics, has been found to be no less effective than cisplatin and has fewer side effects. However, these results are based on a small sample of retrospective studies, and there is no prospective study. Radioactive oral mucositis is one of the major side effects of concurrent radiotherapy and chemotherapy for nasopharyngeal carcinoma. In recent years, traditional Chinese medicine, especially Ziyin Qingre herbal medicine, has a certain effect on reducing the side effects of radiotherapy and chemotherapy. Zengye decoction is one of the representatives of Ziyin decoction. Some studies have shown that Zengye decoction can reduce the oral mucosal reaction of radiotherapy and chemotherapy, but there are few related studies. Based on the above questions, a prospective randomized study was designed to compare the short-term efficacy and side effects of docetaxel and cisplatin in concurrent radiotherapy and chemotherapy for nasopharyngeal carcinoma. The purpose of this study is to clarify the effect of Jiawei Zengye Decoction on the prevention and treatment of radioactive oral mucositis during radiotherapy and chemotherapy of nasopharyngeal carcinoma, and to provide effective Chinese medicine for reducing the side effects of radiotherapy and chemotherapy and improving the compliance of treatment. METHODS: 81 patients with locally advanced nasopharyngeal carcinoma were selected from March 3, 2015 to February 15, 2017 in the Department of Oncology, General Hospital of Guangzhou Military Region. All patients received three cycles of induction chemotherapy followed by concurrent radiotherapy and chemotherapy. The induction chemotherapy regimen was docetaxel (TXT) 75 mg/m2, cisplatin (DDP) 80 mg/m2, once every three weeks. D-CRT, DT:70Gy/35f. Patients were randomly divided into two groups at the beginning of radiotherapy. The study group received concurrent chemotherapy with docetaxel (75mg/m2/3 weeks) and the control group received concurrent chemotherapy with cisplatin (40mg/m2/week x 7 or 80mg/m2/3 weeks x 3 times). During radiotherapy, patients in the two groups were randomly selected to take Jiawei Zengye Decoction. Results: All patients completed radiotherapy and chemotherapy. One patient progressed in the course of treatment, and 80 patients could evaluate the short-term efficacy. The short-term efficacy of the two groups was similar (CR rate was 73.3% vs. 72.0%; PR rate was 26.7% vs. 28.0%, P 0.05). The incidence of Grade 1-3 radiation oral mucositis was 10.0%, 56.7% and 33.3% in group DDP and 2.0%, 37.3% and 60.8% in group DDP. There was no grade 4 radiation oral mucositis in both groups. The degree of radiation oral mucositis in group TXT was mild, and the difference was statistically significant (P = 0.011). The onset time of radiation-induced oral mucositis in TXT group and DDP group were 11.63 (+ 3.68) and 9.76 (+ 3.57) days after radiotherapy respectively. The onset time of radiation-induced oral mucositis in TXT group was later (t = 2.249, P = 0.027). Multivariate analysis showed that the concurrent chemotherapy drugs were the independent influencing factors (OR = 0.324, P = 0.034). Sex, age, T stage, N stage, total. The incidence of Grade 1-3 radiodermatitis in TXT group was 56.7%, 30.0% and 13.30% respectively, and that in DDP group was 49.0%, 43.1% and 7.8% (P = 0.723), respectively. The incidence of cardiac vomiting was higher than that of TXT group (91.2% vs. 56.7%, P = 0.001). Multivariate analysis showed that the concurrent chemotherapy drugs were the influencing factors of grade 2-3 nausea and vomiting (OR = 0.272, P = 0.026). There was no significant difference in the incidence of bone marrow suppression between the two groups (household 0.05). Multivariate analysis showed that the concurrent chemotherapy drug docetaxel (P = 0.016), male. The incidence of radiation-induced oral mucositis in non-traditional Chinese medicine group was 1.9%, 38.5% and 59.6% respectively; the incidence of radiation-induced oral mucositis in traditional Chinese medicine group was 10.3%, 55.2% and 34.5% respectively. The degree of radiation-induced oral mucositis in traditional Chinese medicine group was lower than that in non-traditional Chinese medicine group (P = 0.019). Conclusion: Docetaxel and cisplatin have similar short-term effects in concurrent chemoradiotherapy for locally advanced nasopharyngeal carcinoma. Radioactive mucositis and gastrointestinal tract reactions in TXT group are less severe, and patients can tolerate it. It may be one of the substitutes for cisplatin in concurrent chemoradiotherapy. Improve patient tolerance and treatment compliance.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R739.63
，
本文编号：2178521
[Abstract]:Objective: Nasopharyngeal carcinoma (NPC) is the most common head and neck malignancy in Guangdong and coastal areas of China. The concurrent chemoradiotherapy with cisplatin (CCRT) is the standard treatment for locally advanced nasopharyngeal carcinoma (LA-NPC), but the side effects such as nausea, vomiting and mucosa caused by cisplatin are obvious, which may lead to discontinuation of treatment and affect the curative effect. As a concurrent chemotherapy regimen, docetaxel, a new generation of chemotherapeutics, has been found to be no less effective than cisplatin and has fewer side effects. However, these results are based on a small sample of retrospective studies, and there is no prospective study. Radioactive oral mucositis is one of the major side effects of concurrent radiotherapy and chemotherapy for nasopharyngeal carcinoma. In recent years, traditional Chinese medicine, especially Ziyin Qingre herbal medicine, has a certain effect on reducing the side effects of radiotherapy and chemotherapy. Zengye decoction is one of the representatives of Ziyin decoction. Some studies have shown that Zengye decoction can reduce the oral mucosal reaction of radiotherapy and chemotherapy, but there are few related studies. Based on the above questions, a prospective randomized study was designed to compare the short-term efficacy and side effects of docetaxel and cisplatin in concurrent radiotherapy and chemotherapy for nasopharyngeal carcinoma. The purpose of this study is to clarify the effect of Jiawei Zengye Decoction on the prevention and treatment of radioactive oral mucositis during radiotherapy and chemotherapy of nasopharyngeal carcinoma, and to provide effective Chinese medicine for reducing the side effects of radiotherapy and chemotherapy and improving the compliance of treatment. METHODS: 81 patients with locally advanced nasopharyngeal carcinoma were selected from March 3, 2015 to February 15, 2017 in the Department of Oncology, General Hospital of Guangzhou Military Region. All patients received three cycles of induction chemotherapy followed by concurrent radiotherapy and chemotherapy. The induction chemotherapy regimen was docetaxel (TXT) 75 mg/m2, cisplatin (DDP) 80 mg/m2, once every three weeks. D-CRT, DT:70Gy/35f. Patients were randomly divided into two groups at the beginning of radiotherapy. The study group received concurrent chemotherapy with docetaxel (75mg/m2/3 weeks) and the control group received concurrent chemotherapy with cisplatin (40mg/m2/week x 7 or 80mg/m2/3 weeks x 3 times). During radiotherapy, patients in the two groups were randomly selected to take Jiawei Zengye Decoction. Results: All patients completed radiotherapy and chemotherapy. One patient progressed in the course of treatment, and 80 patients could evaluate the short-term efficacy. The short-term efficacy of the two groups was similar (CR rate was 73.3% vs. 72.0%; PR rate was 26.7% vs. 28.0%, P 0.05). The incidence of Grade 1-3 radiation oral mucositis was 10.0%, 56.7% and 33.3% in group DDP and 2.0%, 37.3% and 60.8% in group DDP. There was no grade 4 radiation oral mucositis in both groups. The degree of radiation oral mucositis in group TXT was mild, and the difference was statistically significant (P = 0.011). The onset time of radiation-induced oral mucositis in TXT group and DDP group were 11.63 (+ 3.68) and 9.76 (+ 3.57) days after radiotherapy respectively. The onset time of radiation-induced oral mucositis in TXT group was later (t = 2.249, P = 0.027). Multivariate analysis showed that the concurrent chemotherapy drugs were the independent influencing factors (OR = 0.324, P = 0.034). Sex, age, T stage, N stage, total. The incidence of Grade 1-3 radiodermatitis in TXT group was 56.7%, 30.0% and 13.30% respectively, and that in DDP group was 49.0%, 43.1% and 7.8% (P = 0.723), respectively. The incidence of cardiac vomiting was higher than that of TXT group (91.2% vs. 56.7%, P = 0.001). Multivariate analysis showed that the concurrent chemotherapy drugs were the influencing factors of grade 2-3 nausea and vomiting (OR = 0.272, P = 0.026). There was no significant difference in the incidence of bone marrow suppression between the two groups (household 0.05). Multivariate analysis showed that the concurrent chemotherapy drug docetaxel (P = 0.016), male. The incidence of radiation-induced oral mucositis in non-traditional Chinese medicine group was 1.9%, 38.5% and 59.6% respectively; the incidence of radiation-induced oral mucositis in traditional Chinese medicine group was 10.3%, 55.2% and 34.5% respectively. The degree of radiation-induced oral mucositis in traditional Chinese medicine group was lower than that in non-traditional Chinese medicine group (P = 0.019). Conclusion: Docetaxel and cisplatin have similar short-term effects in concurrent chemoradiotherapy for locally advanced nasopharyngeal carcinoma. Radioactive mucositis and gastrointestinal tract reactions in TXT group are less severe, and patients can tolerate it. It may be one of the substitutes for cisplatin in concurrent chemoradiotherapy. Improve patient tolerance and treatment compliance.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R739.63
，
本文编号：2178521
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