新辅助放化疗联合手术治疗直肠黏液腺癌的疗效分析
Efficacy of neoadjuvant chemoradiotherapy combined with surgery for rectal mucinous adenocarcinoma
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摘要:
目的:探讨新辅助放化疗联合手术治疗直肠黏液腺癌的临床疗效。
方法:采用回顾性队列研究方法。收集2008年1月至2013年12月福建医科大学附属协和医院收治的313例行新辅助放化疗联合手术治疗局部进展期直肠癌患者的临床资料。 其中32例黏液腺癌患者设为黏液腺癌组，281例非黏液腺癌患者设为非黏液腺癌组。放疗照射范围包括直肠原发病灶及盆腔内淋巴引流区域，上界于第5腰椎下缘。两侧超出真骨盆缘1.5 cm，下界达肛缘。化疗采用氟尿嘧啶类化疗方案或氟尿嘧啶类联用奥沙利铂化疗方案。末次放疗结束6～8周接受外科手术治疗。手术方式按照全直肠系膜切除(TME)操作规范进行。术后化疗均采用与术前相同的化疗方案，化疗共维持6个月。观察指标：(1)两组患者新辅助放化疗敏感性比较［ypTNM分期、T降期、N降期、病理完全缓解、直肠癌消退分级(RCRG)］。(2)两组患者新辅助放化疗后远期疗效比较。采用电话、信件、门诊复查相结合的方式进行随访。术后2年内每3个月随访1次，术后第3年每半年随访1次，术后第4年后每年随访1次。随访内容包括体格检查、血CEA和CA19-9检查、胸部X线、肝脏B超及肠镜等检查。复查结果异常时进一步行肺部CT、腹部MRI及骨ECT检查，必要时行PET/CT检查。随访终点为发现肿瘤复发转移证据或患者死亡。随访时间截至2015年 6月30日。正态分布的计量资料用
±s表示，两组间比较采用独立样本的t检验。偏态分布采用M(范围)表示。等级资料采用非参数MannWhitney U检验。计数资料的比较用χ2检验。采用KaplanMeier法绘制生存曲线和计算生存率，生存分析比较采用Logrank检验。
结果:(1)两组患者新辅助放化疗敏感性比较：黏液腺癌组与非黏液腺癌组ypTNM 0、Ⅰ、Ⅱ、Ⅲ期患者例数分别为2、5、12、13例和56、65、77、83例，两组比较，差异有统计学意义(Z=4.845，P<0.05)；黏液腺癌组与非黏液腺癌组T降期患者例数分别为 10例和135例，N降期患者例数分别为19例和198例，病理完全缓解患者例数分别为2例和56例，RCRG 1、2、3级患者数分别为11、16、5例和145、96、40例，两组患者上述指标比较，差异均无统计学意义(χ2=3.258，1.661，3.561，Z=2.629，P>0.05)。(2)两组患者新辅助放化疗后远期疗效比较：259例患者获得随访，中位随访时间为39个月(6～90个月)。54例患者死亡，72例患者复发转移。黏液腺癌组与非黏液腺癌组患者的3年总体生存率分别为82.3%和84.4%，3年无瘤生存率分别为73.8%和78.0%，两组患者上述指标比较，差异均无统计学意义(χ2=0.399，0.359，P>0.05)。
结论:新辅助放化疗联合手术治疗能使直肠黏液腺癌患者受益，并可获得与非黏液腺癌患者相当的总体生存时间。Abstract:Objective:To explore the efficacy of neoadjuvant chemoradiotherapy (NACRT) combined with surgery for rectal mucinous adenocarcinoma.
Methods:The retrospective cohort study was conducted. The clinical data of 313 patients with locally advanced rectal carcinoma who underwent NACRT combined with surgery at the Fujian Medical University Union Hospital between January 2008 and December 2013 were collected. Among the 313 patients, 32 and 281 patients were respectively allocated into the mucinous adenocarcinoma (MA) group and nonmucinous adenocarcinoma (NMA) group. Irradiation range included primary rectal lesion and pelvic lymph drainage, the upper bound is the fifth lumbar vertebra lower edge, both sides beyond true pelvic brim 1.5 cm, and the lower bound is the anus verge. Chemotherapy regimens included fluorouracil capecitabine and capecitabine combined with oxaliplatin. Operation was carried out after 6-8 weeks at the end of radiation according to the standard of total mesorectal excision (TME). Postoperative chemotherapy was conducted using the same preoperative regimen for 6 months. Observation indicators: (1) the sensitivity comparison of NACRT between the 2 groups ［ypTNM stage, T downstaging, N downstaging, pathological complete response (PCR), rectal cancer regression grade (RCRG)］ ; (2) longterm outcomes comparison after neoadjuvant chemoradiotherapy between the 2 groups. Followup using telephone interview, correspondence and outpatient examination was conducted once every 3 months within postoperative 2 years, once every 6 months at postoperative 3 years and once every year at postoperative 4 years up to June 30, 2015 and the end of followup (tumor recurrence and metastasis or death). Followup included physical examination, carcinoembryonic antigen (CEA) and CA19-9 test, chest Xray and hepatic ultrasound and colonoscopy. Chest computed tomography (CT) and abdominal magnetic resonance imaging (MRI) or bone emission computed tomography (ECT) were conducted and PET/CT was conducted when necessary. Measurement data with normal distribution were represented as
±s, and comparison between groups was analyzed using an independent sample t test. Measurement data with skewed distribution were represented as M (range). Ordinal data were analyzed by the MannWhitney U test. Comparisons of count data were done using chisquare test. The KaplanMeier method was used to draw the survival curve and assess survival rate. The Logrank test was used to compare survival.
Results:(1) The sensitivity comparison of NACRT between MA and NMA groups: number of patients in stage ypTNM 0, Ⅰ, Ⅱ and Ⅲ was 2, 5, 12, 13 in the MA group and 56, 65, 77, 83 in the NMA group, respectively, with a statistically significant difference between the 2 groups (Z=4.845, P<0.05). Numbers of patients in T downstaging, N downstaging, PCR and stage 1, 2 and 3 of RCRG were 10, 19, 2, 11, 16, 5 in the MA group and 135, 198, 56, 145, 96, 40 in the NMA group, respectively, showing no statistically significant difference in above indexes between the 2 groups (χ2=3.258, 1.661, 3.561, Z=2.629, P>0.05). (2) The longterm outcomes comparison after neoadjuvant chemoradiotherapy between the 2 groups: 259 patients were followed up for a median time of 39 months (range, 6-90 months), 54 were dead and 72 had tumor recurrence or metastasis. The 3year overall survival rate and 3year tumorfree survival rate were 82.3%, 73.8% in the MA group and 84.4%, 78.0% in the NMA group, respectively, with no statistically significant difference between the 2 groups (χ2=0.399, 0.359, P>0.05).
Conclusion:The NACRT combined with surgery for rectal cancer has also benefited mucinous rectal carcinoma, and it is equivalent in the overall survival of patients with nonmucinous adenocarcinoma. -
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