| 李雷蕾,王文玲,董洪敏,王刚,罗妍,胡银祥,王志勇.局部进展期直肠癌术前同步放化疗后联合新辅助化疗的前瞻性Ⅱ期随机对照研究[J].中华放射医学与防护杂志,2017,37(2):107-113 |
| 局部进展期直肠癌术前同步放化疗后联合新辅助化疗的前瞻性Ⅱ期随机对照研究 |
| Prospective phase Ⅱ study of neoadjuvant chemoradiotherapy followed by chemotherapy in locally advanced rectal cancer |
| 投稿时间：2016-09-02 |
| DOI：10.3760/cma.j.issn.0254-5098.2017.02.005 |
| 中文关键词: 直肠癌 同步放化疗 新辅助化疗 病理完全缓解率 总生存率 |
| 英文关键词:Locally advanced rectal Cancer Chemoradiotherapy Neoadjuvant chemotherapy Rate of pathologic complete response Overall survival |
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| 中文摘要: |
| 目的 探索术前同步放化疗加新辅助化疗治疗局部进展期直肠癌的疗效及安全性。方法 收集2012年1月-2015年12月贵州省肿瘤医院腹部肿瘤科收治的中低位局部进展期直肠癌患者80例，采用抽签法随机分为：试验组40例，为同步放化疗加化疗组。盆腔放疗DT：45 Gy/25次 ，5周，直肠肿块同步加量至50 Gy/25次，5周，放疗每周第1~5天同步5-FU持续滴注，随后行4周期FOLFOX4方案化疗，治疗结束后行全直肠系膜切除术（TME手术），术后4周再行4周期FOLFOX4方案辅助化疗。对照组40例，为同步放化疗组。盆腔同步放化疗方案同试验组，治疗结束后6~8周行TME手术，术后4周行8周期FOLFOX4方案辅助化疗。比较两组患者病理完全缓解率、降期率、R0切除率、局部复发率、远处转移率、总生存率、不良反应发生率、手术并发症及观察各组治疗完成情况。结果 试验组、对照组病理完全缓解率（pCR率）分别为20.0%、5.0%（χ2=4.114，P<0.05）；降期率分别为77.4%、55.6%（P>0.05）；R0切除率分别为77.5%和65.0%（P>0.05）。3年局部复发率分别为9.6%及11.5%（P>0.05），3年总生存率、3年远处转移率分别为72.5%和65.5%（P>0.05）、25.0%和37.5%（P>0.05）。两组完成新辅助同步放化疗、根治性切除术及围手术期全身化疗患者共57例，试验组31例，对照组为26例。接受8周期全身化疗完成率试验组与对照组分别为87.1%及61.5%（χ2=4.985，P<0.05）。试验组患者发生1~4级急性反应低于对照组，但差异无统计学意义（P>0.05）；两组术中出血发生率、伤口延期愈合发生率及吻合口瘘发生率差异均无统计学意义（P>0.05）。结论 术前同步放化疗联合新辅助化疗治疗局部进展期直肠癌较标准术前同步放化疗能提高近期疗效（pCR率），不良反应发生率更低，但尚需长时间随访观察及扩大病例数进行进一步临床研究。 |
| 英文摘要: |
| Objective To evaluate the efficacy and safety of adding neoadjuvant chemotherapy following neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer.Methods A total of 80 patients confirmed with locally advanced rectal cancer were enrolled during January 2012 and December 2015 in Guizhou Medical University Affiliated Cancer Hospital and were randomized with the method of lottery into the experimental group and the control group. In the experimental group, 40 patients received 4 cycles of FOLFOX4 after chemoradiotherapy and then had total mesorectal excision (TME). Another 4 cycles of FOLFOX4 were administered after surgery. In the control group, 40 patients had TME surgery 6-8 weeks after chemoradiotherapy and received 8 cycles of FOLFOX4 as adjuvant chemotherapy. Pelvic radiotherapy dose was 50 Gy in 25 fractions, 5 days per week for 5 weeks. 5-Fu continuous infusion was administered throughout radiotherapy. The pCR rate, downstaging rate, R0 resection rate, local recurrence rate, distant metastasis rate, survival rate, incidence of toxicities, surgical complications and completion of treatment were observed. Results The pCR rate was 20.0% in the experimental group and 5.0% in the control group (χ2=4.114, P<0.05).The downstaging rate was 77.4% in the experimental group and 55.6% in the control group(P>0.05). No statistically significant difference was observed in R0 resection rate, 3-year local recurrence rate, 3-year distant metastasis rate and 3-year survival rate between the two groups (P>0.05). Patients in the experimental group had higher completion rate of 8 cycles of systemic chemotherapy (87.1% vs. 61.5%, χ2=4.985,P<0.05). No statistically significant difference was observed in acute toxicities and postoperative complications. Conclusions Adding systemic chemotherapy after neoadjuvant chemoradiotherapy for locally advanced rectal cancer has significantly higher pCR rate and lower toxicities and side events compared with chemoradiotherapy alone. Longer follow-up and larger scale of clinical research are needed. |
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