| 丁叔波,胡望远,黎萍,杜金林,王建平,张天明,施红旗.局部晚期直肠癌新辅助治疗同期加量调强与三维适形放疗随机对照研究[J].中华放射医学与防护杂志,2016,36(4):283-287 |
| 局部晚期直肠癌新辅助治疗同期加量调强与三维适形放疗随机对照研究 |
| A randomized controlled trial comparing the efficacy and toxicities between neoadjuvant concomitant boost intensity-modulated radiotherapy(IMRT) and 3-dimensional conformal radiotherapy (3-DCRT) for locally advanced rectal cancer |
| 投稿时间：2015-10-27 |
| DOI：10.3760/cma.j.issn.0254-5098.2016.04.010 |
| 中文关键词: 直肠癌 调强放射治疗 三维适形放疗 新辅助放化疗 |
| 英文关键词:Rectal cancer Intensity-modulated radiation therapy 3-dimensional conformal radiotherapy Preoperative chemoradiotherapy |
| 基金项目:国家自然科学基金(30970864) |
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| 中文摘要: |
| 目的 评估局部晚期直肠癌新辅助治疗同期加量调强放疗对比三维适形放疗疗效及安全性。方法 前瞻性研究自2010年5月至2015年5月,临床分期为T3/T4或淋巴结阳性且肿瘤下缘距肛门10 cm以内初治直肠腺癌患者共130例。采用随机数字表法分为调强放疗组和三维适形放疗组,调强放疗组66例,三维适形放疗组64例。调强放疗方案为盆腔放疗剂量45 Gy,1.8 Gy/次,共5周,同步原发病灶及转移淋巴结外放1 cm加量放疗剂量至55 Gy。三维适形放疗为盆腔放疗45 Gy,1.8 Gy/次,共5周,两组于放疗第1~14天及第22~35天接受卡培他滨1 650 mg·m-2·d-1口服化疗。手术于放化疗结束后6~8周进行。结果 两组患者性别、年龄、肿瘤位置、病理分化程度以及临床分期基线指标差异均无统计学意义(P>0.05)。2例患者出现放疗终止情况,分别为调强放疗组1例3级腹泻与三维适形放疗组1例3级乏力。两组血液及非血液不良反应差异均无统计学意义,无4级及以上不良反应出现。手术类型及术后并发症两组差异均无统计学意义。术后4级病理降期(病理完全缓解)率调强放疗组为22.7%,三维适形放疗组为15.6%,两组比较差异无统计学意义(P>0.05),3级与4级病理降期率两组比例分别为42.4%和25.0%,两组比较差异有统计学意义(χ2=4.406, P=0.036)。结论 局部晚期直肠癌新辅助同期加量调强放疗为可行治疗方案,与三维适形放疗相比可进一步提高病理降期。临床试验注册 中国临床试验注册中心,ChiCTR-INR-16008004。 |
| 英文摘要: |
| Objective To compare the efficacy and toxicities between preoperative concomitant boost intensity-modulated radiotherapy (IMRT) and 3-dimensional conformal RT (3-DCRT) for locally advanced rectal cancer. Methods A prospective study from May 2010 to May 2015. A total of 130 patients with histologically confirmed, newly diagnosed, locally advanced rectal adenocarcinoma (cT3-T4 and/or cN+) located within 10 cm from the anal verge were included in this study. The patients were divided into IMRT and 3D-CRT groups by random number table method. Sixty-six patients were treated with IMRT, and the other sixty-four patients were treated with 3-DCRT. In the IMRT group, the prescription dose was 1.8 Gy/fraction to 45 Gy to the pelvis and 2.2 Gy/fraction to 55 Gy to the gross tumor volume simultaneously. The 3D-CRT prescription was 45 Gy in 25 fractions to the pelvis. Capecitabine (1 650 mg·m-2·d-1) was given twice daily from days 1 to 14 and days 22 to 35 during RT in both arms. Total mesorectal excision(TME) was scheduled 6-8 weeks after the completion of chemoradiation. Results There were no significant differences in age, gender, tumor location, pathological differentiation degree and clinical stage between the two groups. Two patients withdrew from the study: one for grade 3 radiation dermatitis in IMRT group and the other for grade 3 fatigue in 3D-CRT. There was no significant difference in hematologic or nonhematologic toxicities between the two groups. No grade 4 or 5 toxicity was observed in either group. Compared with conformal radiotherapy, IMRT did not increase the difficulty of surgery. No significant difference was found in type of surgery or postoperative complications between the two groups. The rate of tumor regression grade (TRG) 4 (pathologic complete response, pCR) was 22.7% for IMRT and 15.6% for 3D-CRT, respectively(P>0.05). The rate of both TRG 4 and 3 was 42.4% for IMRT and 25.0% for 3D-CRT, respectively (χ2=4.406, P=0.036). Conclusions Neoadjuvant concomitant boost IMRT is feasible and has a higher histopathological regression for patients with locally advanced rectal cancer. Trial registration Chinese clinical trial registry, ChiCTR-INR-16008004. |
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