新辅助同步放化疗与新辅助化疗治疗局部进展期食管鳞癌的疗效分析

Effect analysis of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy in the treatment of locally advanced esophageal squamous cell carcinoma

  • 摘要: 目的:比较新辅助同步放化疗与新辅助化疗治疗局部进展期食管鳞癌的临床疗效
    方法:
    采用回顾性队列研究方法。收集2010年1月1日至2015年12月31日复旦大学附属中山医院收治的 156例局部进展期食管鳞癌患者的临床病理资料。156例患者中,59例行新辅助同步放化疗设为新辅助放化疗组,97例行新辅助化疗设为新辅助化疗组。新辅助放化疗组采用紫杉醇+顺铂方案化疗2个周期+放疗40 Gy(2 Gy/d);新辅助化疗组采用紫杉醇+顺铂方案化疗2个周期。两组患者新辅助治疗结束6周后再次行影像学检查评估,行胸腔镜右胸腹左颈三切口食管癌手术。观察指标:(1)治疗情况。(2)术后病理学检查情况。(3)随访和生存情况。采用门诊和电话方式进行随访,第1~2年每3个月随访1次,第3年开始每半年随访1次。随访内容为肿瘤标志物水平(CEA、鳞状细胞癌相关抗原),胸腹部CT检查,颈部及腹部超声检查,必要时行胃镜或PET/CT检查;了解患者生存情况。随访时间截至2017年1月。正态分布的计量资料以±s表示,组间比较采用t检验;偏态分布的计量资料以M(范围)表示,组间比较采用非参数检验。计数资料比较采用x2检验或Fisher确切概率法。等级资料比较采用非参数检验。采用寿命表法计算生存率,Logrank检验比较患者生存情况。
    结果:
    (1)治疗情况:两组患者均能耐受新辅助治疗+胸腔镜食管癌切除术。新辅助放化疗组和新辅助化疗组患者中分别有6例和15例中转开胸手术,手术时间分别为(201±25)min、(195±20)min,术中出血量分别为(137±66)mL、(133±58)mL,术后再次入住ICU患者分别为5、8例,术后发生并发症患者分别为24例(肺部并发症10例、吻合口漏8例、声音嘶哑3例、心血管并发症2例、乳糜胸1例)和30例(吻合口漏11例、肺部并发症10例、声音嘶哑4例、心血管并发症2例、术后出血1例、胃排空障碍1例、乳糜胸1例),围术期死亡例数分别为0、1例,术后住院时间分别为12 d(9~93 d)、11 d(9~78 d)。两组上述指标比较,差异均无统计学意义(x2=0.883,t=0.102,0.692, x2=0.048,1.541,Z=0.225, P>0.05)。(2)术后病理学检查情况:新辅助放化疗组和新辅助化疗组患者R0切除率分别为96.6%、93.8%,两组比较,差异无统计学意义(x2=0.589,P>0.05)。术后病理学检查结果显示:新辅助放化疗组患者肿瘤消退分级G0、G1、G2、G3级分别为18、16、7、18例,新辅助化疗组分别为4、5、4、84例,两组比较,差异有统计学意义(Z=-7.151,P<0.05)。新辅助放化疗组患者肿瘤术后ypTNM分期0、Ⅰ、Ⅱ、ⅢA、ⅢB、ⅣA分别为16、9、23、4、6、1例,新辅助化疗组分别为4、9、37、6、34、7例,两组比较,差异有统计学意义(Z=-4.890,P<0.05)。新辅助放化疗组和新辅助化疗组发生降期例数分别为48、50例,两组比较,差异有统计学意义(x2=13.957,P<0.05)。(3)随访和生存情况:156例患者中,153例获得术后随访,随访时间为12~82个月,中位随访时间为36个月。新辅助放化疗组患者术后1、3、5年总体生存率分别为88.1%、61.4%、34.9%,新辅助化疗组患者分别为81.4%、43.8%、23.1%,两组生存情况比较,差异有统计学意义(x2=4.336,P<0.05)。
    结论:新辅助同步放化疗与新辅助化疗比较,前者治疗进展期食管鳞癌不增加围术期并发症发生率,且能提高术后病理学反应率和降期率,以及患者总体生存率。

     

    Abstract: Objective:To compare the clinical effect of neoadjuvant chemoradiotherapy (nCRT) and neoadjuvant chemotherapy (nCT) in the treatment of locally advanced esophageal squamous cell carcinoma.
    Methods:The retrospective cohort study was conducted. The clinicopathological data of 156 patients with local advanced esophageal squamous cell carcinoma who were admitted to the Zhongshan Hospital of Fudan University from January 1, 2010 to December 31, 2015 were collected. Among 156 patients, 59 undergoing nCRT were allocated into the nCRT group and 97 undergoing nCT were allocated into the nCT group. Patients in the nCRT group and nCT group respectively received 2 cycles chemotherapy by the TP regimen+40 Gy radiotherapy (2 Gy/d) and 2 cycles chemotherapy by the TP regimen. Patients were evaluated by imaging examinations after 6 weeks neoadjuvant therapy completion, and then underwent abdominal and right chestleft cervico threeincision thoracoscopic surgery. Observation indicators: (1) treatment situations; (2) postoperative pathological examination; (3) followup and survival situations. Followup using outpatient examination and telephone interview was performed once every 3 months within 2 years and once every 6 months after 3 years up to January 2017. Followup included levels of tumor markers [carcinoembryonic antigen (CEA) and SCCAg], thoracic or abdominal computed tomography (CT), neck and abdominal ultrasonography and gastroscopy or PET/CT examination if necessary. Measurement data with normal distribution were represented as ±s and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were described as M (range) and comparison between groups was analyzed using the nonparametric test. Count data were analyzed using the chisquare test or Fisher exact probability. Comparison of ordinal data was done by the nonparametric test. The survival rate was calculated using the life table method and survival was analyzed by the Logrank test.
    Results:(1) Treatment situations: all the patients in the 2 groups were able to burden neoadjuvant therapy and thoracic esophagectomy. Six patients in the nCRT group and 15 in the nCT group had conversion to open surgery. Operation time, volume of intraoperative blood loss, cases with postoperative readmission of ICU, cases with complications, cases with perioperative death and duration of hospital stay were (201±25)minutes, (137± 66)mL, 5, 24 (10 with pulmonary complications,8 with anastomotic leakage, 3 with hoarseness, 2 with cardiovascular complications and 1 with chylopleura), 0, 12 days (range, 9-93 days) in the nCRT group and (195±20)minutes, (133±58)mL, 8, 30 (11 with anastomotic leakage,10 with pulmonary complications, 4 with hoarseness, 2 with cardiovascular complications, 1 with postoperative hemorrhage, 1 with delayed gastric emptying and 1 with chylopleura), 1, 11 days (range, 9-78 days) in the nCT group, respectively, with no statistically significant difference between the 2 groups (x2=0.883, t=0.102, 0.692, x2=0.048, 1.541, Z=0.225, P>0.05). (2) Postoperative pathological examination: R0 resection rate was 96.6% in the nCRT group and 93.8% in the nCT group, with no statistically significant difference between the 2 groups (x2=0.589, P>0.05). Results of postoperative pathological examination showed that G0, G1, G2 and G3 of tumor regression grade were respectively detected in 18, 16, 7, 18 patients in the nCRT group and 4, 5, 4, 84 patients in the nCT group, with a statistically significant difference between the 2 groups (Z=-7.151, P<0.05). Stage 0, Ⅰ, Ⅱ, ⅢA, ⅢB and ⅣA of postoperative ypTNM stage were respectively detected in 16, 9, 23, 4, 6, 1 patients in the nCRT group and 4, 9, 37, 6, 34, 7 in the nCT group, with a statistically significant difference between the 2 groups (Z=-4.890, P<0.05). The downstaging was detected in 48 patients of the nCRT group and 50 patients of the nCT group, with a statistically significant difference between the 2 groups (x2=13.957, P<0.05). (3) Followup and survival situations: of 156 patients, 153 were followed up for 12-82 months, with a median time of 36 months. The 1, 3, 5year overall survival rates were 88.1%, 61.4%, 34.9% in the nCRT group and 81.4%, 43.8%, 23.1% in the nCT group, with a statistically significant difference between the 2 groups (x2=4.336, P<0.05).
    Conclusion:The nCRT in the treatment of locally advanced esophageal squamous cell carcinoma can enhance postoperative pathological response rate, downstaging rate and overall survival rate compared with nCT, without increasing incidence of perioperative complications.

     

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