新輔助同步放化療聯(lián)合誘導化療、鞏固化療治療局部進展期直腸癌的臨床研究
發(fā)布時間：2018-08-12 16:43
【摘要】：研究目的:初步評估誘導化療+卡培他濱同步放化療+鞏固化療“類三明治”新輔助治療方案治療局部進展期直腸癌的療效及安全性,為后期臨床試驗提供依據(jù)。研究方法:該研究為前瞻性單中心單臂臨床試驗。所有納入研究的直腸癌患者將先進行1周期XELOX方案誘導化療,然后進行卡培他濱同步放化療(采用常規(guī)分割放療,放療同時口服卡培他濱),再進行1周期XELOX方案鞏固化療,放療結束后6-8周接受TME手術治療。收集每位患者的基本信息、治療前后腫瘤情況、治療期間不良反應、手術情況、術后病理及術后并發(fā)癥。采用實體腫瘤的反應評估標準(RECIST,version 1.1)評估新輔助治療前后腫瘤反應情況。術后病理按照Dworak腫瘤消退分級予以評估。新輔助治療期間出現(xiàn)的毒副反應根據(jù)第4版美國國立癌癥研究所不良反應事件評價標準(NCICTCAE,version 4.0)予以分級。該研究的主要研究終點為完全病理緩解(pCR)率,次要研究終點為腫瘤反應、毒副反應、R0切除率及術后并發(fā)癥。所有數(shù)據(jù)采用SPSS 19.0軟件進行統(tǒng)計分析。研究結果:自2014年10月1日至2016年10月31日共有38例局部進展期直腸癌患者納入該研究并收集了完整資料。所有患者均按計劃完成新輔助治療并接受手術治療。在新輔助治療期間,共發(fā)生9例3級不良反應事件,未出現(xiàn)4級不良反應事件;包括1例中性粒細胞減少癥,2例白細胞減少癥,1例血小板減少癥,2例腹瀉,1例疲勞,2例放射性皮炎。該研究的pCR率為28.9%(11/38),總有效率(CR+PR)為71.1%(27/38),明顯的癌細胞減退率(TRG3+4)為60.5%(23/38);T或者N降期率為84%(32/38),50%(19/38)的患者同時獲得了T和N降期。R0切除率為100%(38/38),保肛率為52.6%(20/38)。術后并發(fā)癥發(fā)生率為10.5%(4/38),包括吻合口漏、吻合口出血、腸梗阻、切口感染各1例。研究結論:誘導化療+卡培他濱同步放化療+鞏固化療“類三明治”的新輔助治療方案治療局部進展期直腸癌具有可行性,該新輔助治療方案具有較好的療效和較高的安全性。但是,后續(xù)仍需前瞻性隨機對照試驗進一步予以驗證。
[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.
【學位授予單位】：第二軍醫(yī)大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R735.37
本文編號：2179652
[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.
【學位授予單位】：第二軍醫(yī)大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R735.37
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