新辅助同步放化疗联合诱导化疗、巩固化疗治疗局部进展期直肠癌的临床研究

发布时间：2018-08-12 16:43

【摘要】：研究目的:初步评估诱导化疗+卡培他滨同步放化疗+巩固化疗“类三明治”新辅助治疗方案治疗局部进展期直肠癌的疗效及安全性,为后期临床试验提供依据。研究方法:该研究为前瞻性单中心单臂临床试验。所有纳入研究的直肠癌患者将先进行1周期XELOX方案诱导化疗,然后进行卡培他滨同步放化疗(采用常规分割放疗,放疗同时口服卡培他滨),再进行1周期XELOX方案巩固化疗,放疗结束后6-8周接受TME手术治疗。收集每位患者的基本信息、治疗前后肿瘤情况、治疗期间不良反应、手术情况、术后病理及术后并发症。采用实体肿瘤的反应评估标准(RECIST,version 1.1)评估新辅助治疗前后肿瘤反应情况。术后病理按照Dworak肿瘤消退分级予以评估。新辅助治疗期间出现的毒副反应根据第4版美国国立癌症研究所不良反应事件评价标准(NCICTCAE,version 4.0)予以分级。该研究的主要研究终点为完全病理缓解(pCR)率,次要研究终点为肿瘤反应、毒副反应、R0切除率及术后并发症。所有数据采用SPSS 19.0软件进行统计分析。研究结果:自2014年10月1日至2016年10月31日共有38例局部进展期直肠癌患者纳入该研究并收集了完整资料。所有患者均按计划完成新辅助治疗并接受手术治疗。在新辅助治疗期间,共发生9例3级不良反应事件,未出现4级不良反应事件;包括1例中性粒细胞减少症,2例白细胞减少症,1例血小板减少症,2例腹泻,1例疲劳,2例放射性皮炎。该研究的pCR率为28.9%(11/38),总有效率(CR+PR)为71.1%(27/38),明显的癌细胞减退率(TRG3+4)为60.5%(23/38);T或者N降期率为84%(32/38),50%(19/38)的患者同时获得了T和N降期。R0切除率为100%(38/38),保肛率为52.6%(20/38)。术后并发症发生率为10.5%(4/38),包括吻合口漏、吻合口出血、肠梗阻、切口感染各1例。研究结论:诱导化疗+卡培他滨同步放化疗+巩固化疗“类三明治”的新辅助治疗方案治疗局部进展期直肠癌具有可行性,该新辅助治疗方案具有较好的疗效和较高的安全性。但是,后续仍需前瞻性随机对照试验进一步予以验证。
[Abstract]:Objective: to evaluate the efficacy and safety of chemotherapeutic "sandwich" neoadjuvant therapy for local advanced rectal cancer, and to provide evidence for later clinical trials. Methods: this study is a prospective single-arm clinical trial. All rectal cancer patients included in the study were treated with 1 cycle of XELOX regimen induced chemotherapy, followed by capecitabine concurrent radiotherapy (conventional fractionated radiotherapy, radiotherapy combined with oral capecitabine), and 1 cycle of XELOX regimen consolidation chemotherapy. TME was performed 6-8 weeks after radiotherapy. Collect the basic information of each patient, tumor status before and after treatment, adverse reactions during treatment, surgical conditions, postoperative pathology and postoperative complications. Tumor response before and after neoadjuvant therapy was evaluated by the solid tumor response assessment criteria (RECIST version 1.1). Postoperative pathology was evaluated according to Dworak grade of tumor regression. Adverse reactions during neoadjuvant therapy were graded according to the National Cancer Institute adverse event Assessment criteria (NCICTCAEversion 4.0). The main endpoints of this study were complete pathological remission (pCR) rate, and the secondary endpoints were tumor response, toxicity, R0 resection rate and postoperative complications. All the data were analyzed by SPSS 19.0 software. Results: from October 1, 2014 to October 31, 2016, 38 patients with locally advanced rectal cancer were included in the study and complete data were collected. All patients completed neo-adjuvant therapy and received surgical treatment as planned. During neo-adjuvant therapy, 9 cases of grade 3 adverse reactions occurred, and no grade 4 adverse events occurred. Including 1 case of neutropenia 2 cases of leukopenia 1 case of thrombocytopenia 2 cases of diarrhea 1 case of fatigue and 2 cases of radiation dermatitis. In this study, the rate of pCR was 28.9% (11 / 38), the total effective rate of (CR PR) was 71.1% (27 / 38), the rate of significant cancer cell decline (TRG3 _ 4) was 60.5% (23 / 38), the rate of T (32 / 38) / 50% (19 / 38) was 84% (32 / 38) / 50% (19 / 38), the resection rate of T and N decreased to 100% (38 / 38), the anal preservation rate was 52.6% (20 / 38). The incidence of postoperative complications was 10.5% (4 / 38), including anastomotic leakage, anastomotic bleeding, intestinal obstruction and incisional infection in 1 case. Conclusion: it is feasible to treat local advanced rectal cancer with the new adjuvant regimen of induction chemotherapy, capecitabine concurrent radiotherapy and chemotherapeutic consolidation "sandwich", and the new adjuvant therapy has better curative effect and higher safety. However, further validation is needed in prospective randomized controlled trials.
【学位授予单位】：第二军医大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.37

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