局部中晚期直肠癌术前新辅助同期加量IMRT联合术前化疗的Ⅱ期临床研究

doi:10.3760/cma.j.issn.1004-4221.2017.03.011

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摘要

目的观察评估局部中晚期直肠癌术前SIB-IMRT联合1周期卡培他滨诱导化疗联合全直肠系膜切除术治疗方案的可行性、安全性及疗效。方法 2015—2016年入组37例局部中晚期直肠癌患者接受术前放疗,直肠病变及阳性淋巴结给予58.75 Gy分25次,盆腔淋巴引流区给予50.00 Gy分25次,同步卡培他滨化疗。同步放化疗结束后休息1周继续行1周期卡培他滨诱导化疗。同步放化疗结束后6~8周接受直肠癌根治术。研究主要终点为pCR,次要终点为TN降期率、保肛手术率、不良反应等。结果 37例患者顺利完成术前同步放化疗,32例行手术治疗,4例因症状缓解拒绝手术,1例患者因肛周水肿手术延迟。pCR率为34%(11/32),TN降期率为91%(29/32),R₀切除率为100%,保肛手术率为75%(24/32)。放化疗期间大部分为1、2级急性不良反应,3、4级不良反应共3例。术后并发症为输尿管损伤(1例)和肠梗阻(1例),围手术期内未见死亡。结论局部中晚期直肠癌行术前SIB-IMRT联合1周期卡培他滨术前化疗及全直肠系膜切除术方案的初步结果表明其近期疗效好、安全可行、急性不良反应轻。

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	刘其腾
	陈静
	贾宝庆
	戴广海
	杜晓辉
	王运来
	温珂
	杨涛
	曾铭玥
	冯林春

关键词 ：直肠肿瘤/调强放射疗法, 调强放射疗法,同期加量, 直肠肿瘤/化学疗法, 卡培他滨

Abstract：

Objective To investigate the feasibility, safety, and short-term efficacy of preoperative capecitabine and simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) followed byone cycle of neoadjuvant capecitabine in patients with locally advanced rectal cancer (LARC). MethodsFrom March 2015 to April 2016, a total of 37 patients with LARC were enrolled in this study. They received capecitabine (825 mg/m² orally twice daily for 5 weeks, days 1-5 weekly) and SIB-IMRT (58.75 Gy in 25 fractions for rectal lesion and positive lymph nodes and 50.00 Gy in 25 fractions for pelvic lymphatic drainage area). After the concurrent chemoradiotherapy, they were allowed to rest for one week. And then they received one cycle of induction chemotherapy with capecitabine (1250 mg/m² orally twice daily for 14 days). And total mesorectal excision (TME) was scheduled at 6-8 weeks after the concurrent chemoradiotherapy. The primary endpoint was pathologic complete response (pCR) rate, and the secondary endpoints included tumor and nodal (TN) downstaging rate, the rate of sphincter-preserving surgery, and adverse events. Results All the 37 patients successfully received the preoperative concurrent chemoradiotherapy. Only 32 patients underwent the surgical resection, 4 patients refused surgery due to symptom relief, and 1 patient delayed surgery due to perianal edema after radiotherapy. The pCR rate was 34%(11/32);the TN downstaging rate was 91%(29/32);the R₀ resection rate was 100%;24 patients (75%) underwent the sphincter-preserving surgery. During the period of chemoradiotherapy, most of the patients experienced grade 1/2 acute adverse events and grade 3/4 adverse events occurred in 3 patients. The postoperative complications included ureteral injury (1 patient) and intestinal obstruction (1 patient), and no death occurred in the perioperative period. Conclusions For patients with LARC, preoperative SIB-IMRT combined with one cycle of capecitabine followed by TME is safe and feasible, and has good short-term efficacy and mild acute adverse events.

Key words： Rectal neoplasms/intensity modulated radiotherapy Intensity modulated radiotherapy,boost Rectal neoplasms/chemotherapy Capecitabine

收稿日期: 2016-09-02

基金资助:

解放军总医院临床科研扶持基金(2013FC-TSYS-1024);科技部国家重点研发计划(2016YFC0105712)

通讯作者: 冯林春,Email:301flc@163.com

引用本文:

刘其腾,陈静,贾宝庆等. 局部中晚期直肠癌术前新辅助同期加量IMRT联合术前化疗的Ⅱ期临床研究[J]. 中华放射肿瘤学杂志, 2017, 26(3): 302-306.

Liu Qiteng,Chen Jing,Jia Baoqing et al. Efficacy of preoperative neoadjuvant simultaneous integrated boost intensity-modulated radiotherapy combined with preoperative chemotherapy for locally advanced rectal cancer:a phase Ⅱ clinical study[J]. Chinese Journal of Radiation Oncology, 2017, 26(3): 302-306.

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http://journal12.magtechjournal.com/Jweb_fszlx/CN/10.3760/cma.j.issn.1004-4221.2017.03.011 或 http://journal12.magtechjournal.com/Jweb_fszlx/CN/Y2017/V26/I3/302

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