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全直肠系膜切除术(total mesorectal excision,TME)能够完整切除直肠及其系膜,是中晚期直肠癌重要的治疗手段,但患者术后可能发生局部复发。近年来,有研究者认为,局部晚期直肠癌患者在行TME前接受新辅助化疗和放疗可以诱导肿瘤消退,增加切缘阴性的可能性,降低局部复发的风险[1],其已逐渐成为中晚期肿瘤术前的常用模式。因此,实施术前化疗和放疗是治疗局部晚期直肠癌的有效手段,其可以加强局部控制、降低转移发生率、提高生存率。然而,术前化疗和放疗与严重的不良反应有关。术前常规放疗联合化疗周期较长,但部分患者耐受性较差,因此亟待在临床上改进这种模式。国外相关资料显示,短程放疗联合化疗能缩短术前等待时间,降低盆腔局部的复发率[2]。细胞增殖核抗原Ki-67(简称Ki-67)在直肠癌等多种癌症中高表达,并与肿瘤的恶性生物学行为有关[3]。Runt相关转录因子(Runt related transcription factor,Runx)3是一种抑癌基因,其在直肠癌组织中的表达显著低于正常肠黏膜组织,是直肠癌患者预后的独立危险因素[4]。目前,关于放化疗对Runx3和Ki-67影响的报道较少。本研究分析术前行短程放化疗或常规放化疗对ⅢB期直肠癌患者的手术效果及切除的组织标本中Runx3和Ki-67表达的差异,为临床应用提供客观依据。
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随访2年,观察组无失访病例,对照组有2例失访。由表1可知,2组患者的年龄、性别、体重指数、肿瘤最大径、肿瘤至肛缘长度、病理分型、分化程度、合并疾病、TNM分期的差异均无统计学意义(均P>0.05)。
临床资料 对照组
(n=50)观察组
(n=50)检验值 P值 年龄( ±s,岁)$\bar x $ 59.18±10.01 57.94±10.56 t=0.603 0.548 女性/男性(例) 22/28 26/24 χ2=0.641 0.423 体重指数( ±s,kg/m2)$\bar x $ 22.36±1.45 22.19±0.96 t=0.691 0.491 肿瘤最大径( ±s,cm)$\bar x $ 5.18±1.24 4.98±1.01 t=0.884 0.379 肿瘤至肛缘长度[例(%)] 5~8 cm 23(46) 21(42) χ2=0.162 0.687 <5 cm 27(54) 29(58) 病理分型[例(%)] 腺癌 44(88) 41(82) χ2=0.706 0.401 黏液腺癌 6(12) 9(18) 分化程度[例(%)] 低分化 13(26) 11(22) χ2=0.219 0.896 中分化 19(38) 20(40) 高分化 18(36) 19(38) 合并疾病[例(%)] 高血压 4(8) 7(14) χ2=0.919 0.338 冠心病 3(6) 5(10) χ2=0.136 0.712 糖尿病 11(22) 9(18) χ2=0.250 0.617 高脂血症 6(12) 4(8) χ2=0.444 0.505 TNM分期[例(%)] T1N2bM0 2(4) 2(4) χ2=0.283 0.194 T2N2bM0 4(8) 3(6) χ2=0.638 0.208 T2N2aM0 5(10) 3(6) χ2=0.753 0.239 T3N2aM0 20(40) 18(36) χ2=0.198 0.143 T3N1M0 16(32) 20(40) χ2=0.760 0.492 T4aN1M0 3(6) 4(8) χ2=0.729 0.280 注:TNM为肿瘤、淋巴结、转移 表 1 2组ⅢB期直肠癌患者临床资料的比较
Table 1. Comparison of clinical data between two groups of patients with stage ⅢB rectal cancer
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由表2可知,2组患者的手术时间、术中出血量、术后排气时间、住院时间、手术并发症的差异均无统计学意义(均P>0.05)。
组别 手术时间( ±s,min)$\bar x$ 术中出血量( ±s,mL)$\bar x$ 术后排气时间( ±s,h)$\bar x$ 住院时间( ±s,d)$\bar x$ 手术并发症[例(%)] 吻合口瘘 肠梗阻 感染 观察组(n=50) 165.89±18.73 215.63±56.89 62.28±16.47 13.97±7.11 3(6) 2(4) 2(4) 对照组(n=50) 158.14±23.57 227.84±60.75 59.28±12.04 15.01±5.29 1(2) 0(0) 4(8) 检验值 t=1.820 t=1.037 t=1.040 t=0.854 χ2=0.260 − χ2=0.177 P值 0.072 0.302 0.301 0.395 0.610 0.495 0.674 注:−表示采用Fisher's确切概率法,无检验值 表 2 2组ⅢB期直肠癌患者行放化疗后手术情况的比较
Table 2. Comparison of surgical conditions between two groups of patients with Ⅲ B rectal cancer after radiotherapy
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由表3可知,2组患者周围神经系统毒性、骨髓抑制、消化道反应发生率的差异均无统计学意义(均P>0.05);观察组放射性皮炎的总发生率低于对照组,且差异有统计学意义(P<0.05)。
不良反应 分级(例) 总发生率[例(%)] χ2值 P值 Ⅰ Ⅱ Ⅲ Ⅳ 周围神经系统毒性 0.136 0.712 观察组(n=50) 1 1 1 0 3(6) 对照组(n=50) 4 1 0 0 5(10) 骨髓抑制 0.488 0.485 观察组(n=50) 4 1 1 0 6(12) 对照组(n=50) 2 1 0 0 3(6) 消化道反应 0.567 0.418 观察组(n=50) 15 6 2 0 23(46) 对照组(n=50) 10 9 0 0 19(38) 放射性皮炎 4.883 0.027 观察组(n=50) 4 2 0 0 6(12) 对照组(n=50) 8 7 0 0 15(30) 表 3 2组ⅢB期直肠癌患者术后不良反应的比较
Table 3. Comparison of postoperative adverse reactions between two groups of patients with Ⅲ B rectal cancer
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由表4可知,2组患者术后T分期降期率和pCR率的差异均无统计学意义(均P>0.05)。
组别 术后T分期 T分期降期率 pCR率 T0 T1 T2 T3 T4 观察组(n=50) 2(4) 6(12) 16(32) 23(46) 3(6) 24(48) 2(4) 对照组(n=50) 3(6) 8(16) 15(30) 22(44) 2(4) 26(52) 3(6) χ2值 − − − − − 0.160 0.000 P值 − − − − − 0.689 1.000 注:pCR为病理学完全缓解;−为无此项数据 表 4 2组ⅢB期直肠癌患者术后T分期降期率和pCR率的比较[例(%)]
Table 4. Comparison of postoperative T staging down rate and pCR rate of patients with ⅢB rectal cancer between two groups (cases(%))
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由表5可知,观察组术中切除标本中的Runx3表达评分高于对照组,且差异有统计学意义(P<0.01),Ki-67表达评分低于对照组,且差异有统计学意义(P<0.01)。
组别 Runx3 Ki-67 治疗前 术中切除标本 治疗前 术中切除标本 观察组(n=50) 1.57±0.36 2.56±0.51 4.87±0.63 2.39±1.03 对照组(n=50) 1.62±0.29 1.87±0.72 4.92±0.55 3.94±0.46 t值 0.765 5.530 0.423 9.716 P值 0.446 <0.01 0.673 <0.01 注:Runx3为Runt相关转录因子3;Ki-67为细胞增殖核抗原 表 5 2组ⅢB期直肠癌患者Runx3和Ki-67表达评分的比较 (分,
±s)$\bar x $ Table 5. Comparison of the expression score of Runt related transcription factr and cell proliferating nuclear antigen Ki-67 between two groups of patients with ⅢB rectal cancer (
±s)$\bar x $ -
观察组局部复发1例,复发率为2%(1/50),低于对照组的17%(8/48),且差异有统计学意义(χ2=5.936,P=0.015)。观察组远处转移7例,对照组远处转移8例,远处转移率(14%对17%)的差异无统计学意义(χ2=0.141,P=0.707)。随访期间观察组45例生存,对照组44例生存,生存率(90%对92%)的差异无统计学意义(χ2=0.095,P=0.758)。
术前行短程或常规放化疗的ⅢB期直肠癌患者术后疗效及组织标本中Runx3、Ki-67表达的差异
Effect of preoperative short course or conventional radiotherapy and chemotherapy on patients with stage ⅢB rectal cancer and the difference in the expression of Runx3 and Ki-67 in resected tissue specimens
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摘要:
目的 分析术前行短程放化疗或常规放化疗对ⅢB期直肠癌患者的手术效果及切除的组织标本中Runt相关转录因子3(Runx3)、细胞增殖核抗原Ki-67(简称Ki-67)表达的差异。 方法 前瞻性研究2019年1至12月于河北北方学院附属第一医院确诊的100例ⅢB期直肠癌患者的临床资料,其中男性52例、女性48例,年龄38~79(58.56±9.11)岁。将所有患者按电脑随机数字表法分为对照组和观察组,每组50例。对照组术前接受常规调强适形放疗+化疗,观察组术前接受短程放疗+化疗,分别比较2组患者手术的一般临床资料、术后病理T分期降期率、病理学完全缓解(pCR)率、不良反应发生情况、局部复发率、远处转移率和生存率,对切除的直肠癌组织标本采用免疫组化方法分别计算Runx3和Ki-67表达的评分。2组间计量资料的比较采用独立样本t检验;2组间的计数资料进行比较时,当例数<40或理论频数T≤1时采用Fisher's确切概率法,当例数≥40且理论频数T≥5(未校正)或1<T<5(校正)时采用χ2检验。 结果 观察组与对照组患者的手术时间[(165.89±18.73) min 对(158.14±23.57) min]、术中出血量[(215.63±56.89) mL对(227.84±60.75) mL]、术后排气时间[(62.28±16.47) h 对(59.28±12.04) h]、住院时间[(13.97±7.11) d对(15.01±5.29) d]、吻合口瘘率[6%(3/50)对2%(1/50)]、肠梗阻率[4%(2/50)对0(0/50)]、感染率4%(2/50)对[8%(4/50)]的差异均无统计学意义(t=0.854~1.820,χ2=0.260、0.177,Fisher's确切概率法,均P>0.05)。2组患者术后T分期降期率和pCR率的差异均无统计学意义(χ2=0.160、0.000,均P>0.05)。观察组放射性皮炎总发生率(12%,6/50)低于对照组(30%,15/50),且差异有统计学意义(χ2=4.883,P<0.05)。观察组术中切除标本中Runx3表达的评分为(2.56±0.51)分,高于对照组的(1.87±0.72)分,且差异有统计学意义(t=5.530,P<0.01),Ki-67表达的评分为(2.39±1.03)分,低于对照组的(3.94±0.46)分,且差异有统计学意义(t=9.716,P<0.01);观察组局部复发率(2%,1/50)低于对照组(17%,8/48),且差异有统计学意义(χ2=5.936,P<0.05)。 结论 对ⅢB期直肠癌术前行短程放化疗,不会增加全直肠系膜切除术的难度与风险,可减少不良反应的发生,降低局部复发率。手术切除标本中Runx3和Ki-67的表达存在差异。 -
关键词:
- 直肠肿瘤 /
- 放化疗,辅助 /
- Ki-67抗原 /
- Runt相关转录因子3
Abstract:Objective To analyze the effect of preoperative short course radiotherapy and chemotherapy or conventional radiotherapy and chemotherapy on patients with stage ⅢB rectal cancer and determine the differences in the expression of Runt-related transcription factor 3 (Runx3) and cell proliferating nuclear antigen Ki-67 (short for Ki-67) in the resected tissue specimens. Methods From January 2019 to December 2019, a prospective study was conducted on 100 patients with stage ⅢB rectal cancer in the First Affiliated Hospital of Hebei North University, including 52 males and 48 females, aged 38–79(58.56±9.11) years. All patients were randomly divided into the control group and observation group, with 50 cases in each group. The control group received conventional radiotherapy + chemotherapy before operation, whereas the observation group received short-term radiotherapy + chemotherapy before operation. The operation-related conditions, postoperative pathological T staging reduction rate, pathological complete remission (pCR) rate, occurrence of adverse reactions, local recurrence rate, distant metastasis rate and survival rate were compared between the two groups. Immunohistochemical methods were used to detect the expression score of Runx3 and Ki-67 on the resected rectal cancer tissue samples. The measurement data of the two groups were compared using independent sample t test. When the number of cases was <40 or the theoretical frequency T≤1, Fisher's exact probability method was used. When the number of cases was ≥40 and when the theoretical frequency was T≥5 (uncorrection) or 1<T<5 (correction), the χ2 test was used. Results The operation time ((165.89±18.73) min), intraoperative blood loss ((215.63±56.89) mL), postoperative exhaust time ((62.28±16.47) h), hospitalization time ((13.97±7.11) d), anastomotic leakage rate (6%, 3/50), intestinal obstruction rate (4%, 2/50) and infection rate (4%, 2/50) in the observation group were compared with those in the control group (i.e., (158.14±23.57) min, (227.84±60.75) mL, (59.28±12.04) h, (15.01±5.29) d, 2% (1/50), 0 (0/50) and 8% (4/50), respectively), and the differences were not statistically significant (t=0.854–1.820, χ2=0.260, 0.177, Fisher's exact probability method, all P>0.05). There was no significant difference in the T staging rate and pCR rate between the two groups (χ2=0.160, 0.000; both P>0.05). The total incidence of radiation dermatitis in the observation group (12%, 6/50) was significantly lower than that in the control group (30% (15/50)) (χ2=4.883, P<0.05). The expression score of Runx3 in the specimens resected during operation in the observation group was 2.56±0.51, which was significantly higher than 1.87±0.72 in the control group (t=5.530, P<0.01). The expression score of Ki-67 was 2.39±1.03, which was significantly lower than 3.94±0.46 in the control group (t=9.716, P<0.01). The local recurrence rate (2%,1/50) in the observation group was significantly lower than that (17%, 8/48) in the control group (χ2=5.936, P<0.05). Conclusions Preoperative short course radiotherapy and chemotherapy for stage ⅢB rectal cancer will not increase the difficulty and risk of total mesorectal excision. It can reduce the occurrence of adverse reactions, and decrease the rate of local recurrence. A statistically significant difference was found in the expression of Runx3 and Ki-67 in surgical resection specimens obtained. -
表 1 2组ⅢB期直肠癌患者临床资料的比较
Table 1. Comparison of clinical data between two groups of patients with stage ⅢB rectal cancer
临床资料 对照组
(n=50)观察组
(n=50)检验值 P值 年龄( ±s,岁)$\bar x $ 59.18±10.01 57.94±10.56 t=0.603 0.548 女性/男性(例) 22/28 26/24 χ2=0.641 0.423 体重指数( ±s,kg/m2)$\bar x $ 22.36±1.45 22.19±0.96 t=0.691 0.491 肿瘤最大径( ±s,cm)$\bar x $ 5.18±1.24 4.98±1.01 t=0.884 0.379 肿瘤至肛缘长度[例(%)] 5~8 cm 23(46) 21(42) χ2=0.162 0.687 <5 cm 27(54) 29(58) 病理分型[例(%)] 腺癌 44(88) 41(82) χ2=0.706 0.401 黏液腺癌 6(12) 9(18) 分化程度[例(%)] 低分化 13(26) 11(22) χ2=0.219 0.896 中分化 19(38) 20(40) 高分化 18(36) 19(38) 合并疾病[例(%)] 高血压 4(8) 7(14) χ2=0.919 0.338 冠心病 3(6) 5(10) χ2=0.136 0.712 糖尿病 11(22) 9(18) χ2=0.250 0.617 高脂血症 6(12) 4(8) χ2=0.444 0.505 TNM分期[例(%)] T1N2bM0 2(4) 2(4) χ2=0.283 0.194 T2N2bM0 4(8) 3(6) χ2=0.638 0.208 T2N2aM0 5(10) 3(6) χ2=0.753 0.239 T3N2aM0 20(40) 18(36) χ2=0.198 0.143 T3N1M0 16(32) 20(40) χ2=0.760 0.492 T4aN1M0 3(6) 4(8) χ2=0.729 0.280 注:TNM为肿瘤、淋巴结、转移 表 2 2组ⅢB期直肠癌患者行放化疗后手术情况的比较
Table 2. Comparison of surgical conditions between two groups of patients with Ⅲ B rectal cancer after radiotherapy
组别 手术时间( ±s,min)$\bar x$ 术中出血量( ±s,mL)$\bar x$ 术后排气时间( ±s,h)$\bar x$ 住院时间( ±s,d)$\bar x$ 手术并发症[例(%)] 吻合口瘘 肠梗阻 感染 观察组(n=50) 165.89±18.73 215.63±56.89 62.28±16.47 13.97±7.11 3(6) 2(4) 2(4) 对照组(n=50) 158.14±23.57 227.84±60.75 59.28±12.04 15.01±5.29 1(2) 0(0) 4(8) 检验值 t=1.820 t=1.037 t=1.040 t=0.854 χ2=0.260 − χ2=0.177 P值 0.072 0.302 0.301 0.395 0.610 0.495 0.674 注:−表示采用Fisher's确切概率法,无检验值 表 3 2组ⅢB期直肠癌患者术后不良反应的比较
Table 3. Comparison of postoperative adverse reactions between two groups of patients with Ⅲ B rectal cancer
不良反应 分级(例) 总发生率[例(%)] χ2值 P值 Ⅰ Ⅱ Ⅲ Ⅳ 周围神经系统毒性 0.136 0.712 观察组(n=50) 1 1 1 0 3(6) 对照组(n=50) 4 1 0 0 5(10) 骨髓抑制 0.488 0.485 观察组(n=50) 4 1 1 0 6(12) 对照组(n=50) 2 1 0 0 3(6) 消化道反应 0.567 0.418 观察组(n=50) 15 6 2 0 23(46) 对照组(n=50) 10 9 0 0 19(38) 放射性皮炎 4.883 0.027 观察组(n=50) 4 2 0 0 6(12) 对照组(n=50) 8 7 0 0 15(30) 表 4 2组ⅢB期直肠癌患者术后T分期降期率和pCR率的比较[例(%)]
Table 4. Comparison of postoperative T staging down rate and pCR rate of patients with ⅢB rectal cancer between two groups (cases(%))
组别 术后T分期 T分期降期率 pCR率 T0 T1 T2 T3 T4 观察组(n=50) 2(4) 6(12) 16(32) 23(46) 3(6) 24(48) 2(4) 对照组(n=50) 3(6) 8(16) 15(30) 22(44) 2(4) 26(52) 3(6) χ2值 − − − − − 0.160 0.000 P值 − − − − − 0.689 1.000 注:pCR为病理学完全缓解;−为无此项数据 表 5 2组ⅢB期直肠癌患者Runx3和Ki-67表达评分的比较 (分,
±s)$\bar x $ Table 5. Comparison of the expression score of Runt related transcription factr and cell proliferating nuclear antigen Ki-67 between two groups of patients with ⅢB rectal cancer (
±s)$\bar x $ 组别 Runx3 Ki-67 治疗前 术中切除标本 治疗前 术中切除标本 观察组(n=50) 1.57±0.36 2.56±0.51 4.87±0.63 2.39±1.03 对照组(n=50) 1.62±0.29 1.87±0.72 4.92±0.55 3.94±0.46 t值 0.765 5.530 0.423 9.716 P值 0.446 <0.01 0.673 <0.01 注:Runx3为Runt相关转录因子3;Ki-67为细胞增殖核抗原 -
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