初始化疗、初始手术治疗或者手术治疗联合术后放疗对于宫颈癌ⅠB期及ⅡA期患者疗效的Meta分析
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摘要
背景：Meta分析是指用统计学方法对收集的多个研究资料进行分析和概括。在解决如何从大量的针对同一疾病的类似的临床研究中获得适宜的治疗方案的问题上，Meta分析日益受到人们的欢迎。如果将这些研究分开来看，单独任一研究都可能因为样本量过少或研究范围过于局限而很难得到关于疗效的一个明确的或者具有一般性的结论。通过整合这些临床研究的结果，针对某一种治疗的疗效，我们可以获得强有力的证据，以此得出最佳的治疗方案。宫颈癌是全世界女性第二大常见的肿瘤，是威胁撒哈拉以南、非洲、中美洲、中南亚等地区女性最主要的肿瘤。通过一段时间的对宫颈癌的筛查，在北美、欧洲部分地区、澳大利亚以及新西兰等地区的宫颈癌的发病率及死亡率已显著下降。子宫颈上皮由鳞状上皮和柱状上皮组成。二者的交界区是宫颈癌的好发部位。宫颈癌发生的最主要原因是人乳头瘤病毒（HPV）的感染。HPV主要通过性行为进行传播。性行为增加了感染HPV的机会，也增加了女性患宫颈癌的风险。临床上主要是根据宫颈癌患者的临床分期及肿瘤的体积对其进行诊治。目前，针对宫颈癌患者的治疗方案的选择存在以下争议：对于宫颈癌ⅠB期及ⅡA期患者是应先行手术治疗，术后辅以放射治疗，还是应先行化疗，再行手术治疗。因此，我们通过Meta分析对宫颈癌ⅠB期及ⅡA期患者接受新辅助化疗、手术治疗或者行手术治疗后辅以放射治疗这三种治疗方案后的不良反应及生存期进行评价，以得出上述宫颈癌患者的最佳治疗方案。
方法：对1974-2012年已经公开发表的关于宫颈癌ⅠB期及ⅡA期患者的研究进行Meta分析。检索以下数据库：Pub Med,the Lancet, Elsevier Gynecological Oncology,Elsevier Ejso, Gynecological Radiology, Med Line, Cross Ref Med Line, Oncology grouppublications and cancer literature。筛选检索到的全部研究，并将其中有足够样本量并对患者进行充分随访的14项研究纳入Meta分析。研究对象包括宫颈癌患者的治疗后的不良反应、随访、复发率以及总生存期。并且获取所有研究的完整文献进行进一步的评价。排除不符合纳入标准的文件，从符合纳入标准的研究中获取信息，计算相对风险度（OR）和95％置信区间（CI）进行Meta分析。
结果：通读上述14项研究、试验及已公开发表的文章，将其中10项符合标准的研究纳入meta分析。其平均样本量为190例患者（单个样本量介于45-611例患者之间）。研究对象包括不良反应、总生存期（OS）、并发症及复发率。随访时间从2个月到249个月。这些研究都已在1974-2012年公开发表，并且，其中9项为回顾性研究，1项为随机研究。在这10项研究中，有3项是在泰国进行，2项在意大利及美国，1项在中国及韩国。7项研究报道了不同治疗方案所产生的不良反应，包括有症状的淋巴囊肿、淋巴水肿、出血性放射性膀胱炎、胃肠道毒性、恶心、呕吐、肠梗阻、膀胱炎、直肠炎、胆结石及盆腔脓肿。治疗方案的不同——新辅助化疗联合手术治疗或者手术治疗联合术后放疗，导致其并发症的发生率亦不相同。在研究中主要涉及白细胞计数降低、中性粒细胞计数降低及淋巴水肿。有7项试验对淋巴结为阳性还是阴性的结果也进行了记录。用Kaplan-Meier法计算各项研究中的总生存期，并利用以上数据计算其风险比（HR）及95%置信区间（CI）。在这10项研究中，有9项研究的研究对象为宫颈癌IB-IIA期的患者，1项研究的研究对象为宫颈癌IA2-IIA期的患者。有8项研究报道了5年总生存期，1项研究报道了2年总生存期，1项研究报道了3年及5年总生存期。由于其治疗程序不同，导致其5年无瘤生存率也各不相同。最短随访中位数是19个月，最长为84个月。研究中的随访部分还体现了笔者关于并发症的出现以及是否会复发的一些想法。并且，存在单纯手术治疗组与手术治疗联合术后放疗组存活的患者数的问题。在随访调查中对接受治疗的患者是死于疾病的复发还是其它疾病进行一一列举。10项试验结果显示患者的复发率在3.3%-42%之间，并且在手术组、放疗组及化疗组的患者的复发率存在差异。通过对纳入Meta分析的所有研究的结果进行统计学分析，Meta分析证实，综合考虑患者的并发症、复发率及5年总生存率，根治性的子宫切除术、淋巴结切除术联合术后放疗对于宫颈癌ⅠB期及ⅡA期患者而言，是最佳的治疗方案。Meta分析显示，在这10项研究中，有5项研究在统计学上有显著性的疗效。在根治性子宫切除术联合术后放疗组中，疗效较满意的患者的5%相对危险度（P<0.05）分别为：0.097（95%置信区间：0.055-0.1771）(Monk et al.,1994),1.71(95%置信区间：1.254–0.2.347)(Landoni et al.,1997),以及3.5(95%置信区间：1.707–7.197))(Siriwaranya et al.,2003)。这些研究的置信区间的宽度较小，表明其结果的估计更加精准。另一方面，在根治性子宫切除术联合术后同期放化疗组中，疗效较满意的患者的5%相对危险度（P<0.05）分别为3.973(95%置信区间,1.934–8.16)(Kim et al.,2008),以及2.327(95%置信区间,1.637–3.306)(Sittidilokratna et al.,2010)。然而，这些研究的CI的宽度显示出其对其结果的评估的不甚精确。
结论：通过对纳入Meta分析的所有调查结果进行统计学分析，证实，综合考虑患者的并发症、复发率及5年总生存率，根治性的子宫切除术、淋巴结切除术联合术后放疗对于宫颈癌ⅠB期及ⅡA期患者而言，是最佳的治疗方案。与此同时，根治性的子宫切除术、淋巴结切除术联合术后放疗在降低患者发病率方面也得到了满意的结果。并且，手术治疗联合放疗既提高了患者的生存率，又降低了患者的盆腔复发率。在改善高危患者的生存期的方面，新辅助化疗也有显著效果。根据我们的研究结果，对于宫颈癌ⅠB期及ⅡA期患者，如有局部淋巴结转移，应行术后放射治疗。然而，当肿瘤在宫旁与盆腔淋巴结均有转移时，则需考虑其它的替代疗法。
Background: Meta-analysis is defined as the statistical analysis of a collection of analyticalresults for the purpose of integrating the findings. Such analyses are becoming increasinglypopular in medical research, where information on efficacy of a treatment is available froma number of clinical studies with similar treatment protocols. If these studies are consideredseparately, each study is either too small or too limited in scope to come to unequivocal orgeneralized conclusions about the effect of treatment. Combining the findings across suchstudies represents an attractive alternative to strengthen the evidence about the treatmentefficacy.
Cervical cancer is the second most common cancer among women worldwide and themain cancer that affects women in the Sub-Sahara and Africa, Central America and South–Central Asia. A significant decline in incidence and mortality have been seen in NorthAmerica, parts of Europe, Australia and New Zealand where screening programs have beenimplemented for some time.
There are two cell types present (squamous and glandular) and cervical cancers tend tooccur where the two cell types meet. The main cause of cervical cancer is a virus called HPV(human papillomavirus). HPV is sexually transmitted and sexual activity increases the riskfor infection with HPV and for cervical cancer. The standard management of cervical cancerdepends on clinical stage and tumor volume. Controversies are the selection of NeoadjuvantChemotherapy (NC) to pelvic radiation did improve survival for high-risk patients, orSurgery Followed by Radiotherapy for patient of cervical Stage IB and IIA. Thus, we usedmeta-analysis to evaluate the adverse effects to the treatment and survival outcome of cervical cancer stage IB and IIA treatment with (1) NC first (2) or surgery first or (3) surgeryfollowed by radiotherapy to determine the best option for cervical cancer treatment.
Methods: A systematic review of literature and published studies between1974and2012incervical treatment stage IB and IIA was performed and a meta-analysis of identified studieswas carried out. We searched the following databases: Pub Med, the Lancet, ElsevierGynecological Oncology, Elsevier EJSO, Gynecological Radiology, Med Line, Cross RefMed Line, Oncology group publications and Cancer literature. All eligible studies wereevaluated and there were14studies among them to count on because of the number ofpatients and sufficient follow up was conducted with patients. The outcomes of interest wereadverse effects to the treatment, follow up, recurrence rate and overall survival (OS) forcervical cancer patients. All full article texts were obtained for further evaluation. After thereview of the researches, exclude the studies that not up to the standard. Meta-analysis wasperformed and the summary information from eligible studies was estimated to calculateOdd ratio (OR) and95%confidence interval (CI).
Results:After reviewing the researches, trials and published articles, we chose fourteenstudies. Of the14, we used10of the studies, which were eligible for meta-analysis and fitthe criteria. The average sample size was190patients (from45to611patients). Theoutcomes of interest were adverse effects to the treatment and the overall survival (OS),complications and recurrence. The follow-up time was from two months to two hundred andforty nine months. The studies were published between1974-2012and included nineretrospective studies, andone randomized study. Of ten included trials, three trials wereconducted in Thailand, two in Italy and the United States of America, and one in China andKorea. Seven studies reported the adverse effects to the treatment of the different treatmentof this study including symptomatic lymphocyst, lymphedema, radiation hemorrhagiccystitis,gastro-intestinal toxicity, vomiting, nausea, bowel obstruction or cystitis and proctitis, gallstone and pelvic abscess.Complication rate differs due to the treatment applied: surgeryplus NC or surgery plus radiotherapy. Also leukopenia or neutropenia were included in thestudy together with lymphaedema. Presence of (+) lymph nodes and (-) lymph nodes are alsorecorded in seven trials. Studies showed the data of the overall survival calculated by theKaplan-Meier Method to calculate Hazard ratio (HR) and95%confidence interval (CI).Nine studies had treated patients in stage IB-IIA, and one had treated patients in stage IA2-IIA. Eight studies reported the5-year overall survival (OS), one study reported2-yearoverall survival (OS), and one study reported3and5-year survival. The5-year disease-freesurvival rate were different from one trial to another due to the changes in treatmentprocedures. The shortest median follow up reported was19months, while the longestreported was84months. The follow up shown in the study gave idea about the presence ofcomplication and recurrence or without recurrence. The number of patients alive was despiteproblems from surgery or combined therapy. The follow up of treated patients also showed ifpatients died from other diseases or due to recurrence. Results of10trials indicated thatpatients developed recurrence were between3.3%and42%and this was also changed in thesurgery group than in radiotherapy treatment and NC. Meta analysis and systematic reviewproved that for cervical cancer stage IB and IIA the best option of treatment after reviewingthe complications, recurrence and overall survival rate for5years is radical hysterectomywith lymph nodes removal followed by radiotherapy. Of the ten studies, five studies havestatistically significant treatment effects (Kim et al.,2008; Siriwaranya et al.,2003;Sittidilokratna et al.,2010; Monk et al.,1998; Landoni etal.,1997). The significant oddratios (OR) at the5%level (P<0.05) of having a favorable outcome among the studies usingradiotherapy after radical hysterectomy were0.097(95%CI,0.055–0.1771)(Monk et al.,1994),1.71(95%CI,1.254–0.2.347)(Landoni et al.,1997), and3.5(95%CI,1.707–7.197)(Siriwaranya et al.,2003).In other hand, the significant odds ratios (ORs) at the5%level (P<0.05) of having a favorable outcome among the studies using NC plus radiotherapy afterradical hysterectomy were3.973(95%CI,1.934–8.16)(Kim et al.,2008), and2.327(95%CI,1.637–3.306)(Sittidilokratna et al.,2010). However, the width of CI for Kim study mayindicate that lessprecise estimates for their results.
Conclusions:After using systematic review and Meta analysis, we indicated that the bestoption of treatment cervical cancer stage IB and IIA after reviewing the complications,recurrence and overall survival rate for5years is radical hysterectomy with lymph nodesremoval followed by radiotherapy. While, radical hysterectomy and radiotherapy pluslymphadectomy produce favorable results with low morbidity. In addition, surgery plusradiotherapy increase the survival rate and decrease the pelvic recurrence, whereas NC didimprove survival for high-risk patients. Based on our result, we recommend thatpostoperative radiation be considered in the management of patients with stage IB-IIAcervical carcinomas found to have regional lymph node metastases; however, alternate formsof therapy deserve consideration when the tumor extends to both the parametrium and pelviclymph nodes.
方法：对1974-2012年已经公开发表的关于宫颈癌ⅠB期及ⅡA期患者的研究进行Meta分析。检索以下数据库：Pub Med,the Lancet, Elsevier Gynecological Oncology,Elsevier Ejso, Gynecological Radiology, Med Line, Cross Ref Med Line, Oncology grouppublications and cancer literature。筛选检索到的全部研究，并将其中有足够样本量并对患者进行充分随访的14项研究纳入Meta分析。研究对象包括宫颈癌患者的治疗后的不良反应、随访、复发率以及总生存期。并且获取所有研究的完整文献进行进一步的评价。排除不符合纳入标准的文件，从符合纳入标准的研究中获取信息，计算相对风险度（OR）和95％置信区间（CI）进行Meta分析。
结果：通读上述14项研究、试验及已公开发表的文章，将其中10项符合标准的研究纳入meta分析。其平均样本量为190例患者（单个样本量介于45-611例患者之间）。研究对象包括不良反应、总生存期（OS）、并发症及复发率。随访时间从2个月到249个月。这些研究都已在1974-2012年公开发表，并且，其中9项为回顾性研究，1项为随机研究。在这10项研究中，有3项是在泰国进行，2项在意大利及美国，1项在中国及韩国。7项研究报道了不同治疗方案所产生的不良反应，包括有症状的淋巴囊肿、淋巴水肿、出血性放射性膀胱炎、胃肠道毒性、恶心、呕吐、肠梗阻、膀胱炎、直肠炎、胆结石及盆腔脓肿。治疗方案的不同——新辅助化疗联合手术治疗或者手术治疗联合术后放疗，导致其并发症的发生率亦不相同。在研究中主要涉及白细胞计数降低、中性粒细胞计数降低及淋巴水肿。有7项试验对淋巴结为阳性还是阴性的结果也进行了记录。用Kaplan-Meier法计算各项研究中的总生存期，并利用以上数据计算其风险比（HR）及95%置信区间（CI）。在这10项研究中，有9项研究的研究对象为宫颈癌IB-IIA期的患者，1项研究的研究对象为宫颈癌IA2-IIA期的患者。有8项研究报道了5年总生存期，1项研究报道了2年总生存期，1项研究报道了3年及5年总生存期。由于其治疗程序不同，导致其5年无瘤生存率也各不相同。最短随访中位数是19个月，最长为84个月。研究中的随访部分还体现了笔者关于并发症的出现以及是否会复发的一些想法。并且，存在单纯手术治疗组与手术治疗联合术后放疗组存活的患者数的问题。在随访调查中对接受治疗的患者是死于疾病的复发还是其它疾病进行一一列举。10项试验结果显示患者的复发率在3.3%-42%之间，并且在手术组、放疗组及化疗组的患者的复发率存在差异。通过对纳入Meta分析的所有研究的结果进行统计学分析，Meta分析证实，综合考虑患者的并发症、复发率及5年总生存率，根治性的子宫切除术、淋巴结切除术联合术后放疗对于宫颈癌ⅠB期及ⅡA期患者而言，是最佳的治疗方案。Meta分析显示，在这10项研究中，有5项研究在统计学上有显著性的疗效。在根治性子宫切除术联合术后放疗组中，疗效较满意的患者的5%相对危险度（P<0.05）分别为：0.097（95%置信区间：0.055-0.1771）(Monk et al.,1994),1.71(95%置信区间：1.254–0.2.347)(Landoni et al.,1997),以及3.5(95%置信区间：1.707–7.197))(Siriwaranya et al.,2003)。这些研究的置信区间的宽度较小，表明其结果的估计更加精准。另一方面，在根治性子宫切除术联合术后同期放化疗组中，疗效较满意的患者的5%相对危险度（P<0.05）分别为3.973(95%置信区间,1.934–8.16)(Kim et al.,2008),以及2.327(95%置信区间,1.637–3.306)(Sittidilokratna et al.,2010)。然而，这些研究的CI的宽度显示出其对其结果的评估的不甚精确。
结论：通过对纳入Meta分析的所有调查结果进行统计学分析，证实，综合考虑患者的并发症、复发率及5年总生存率，根治性的子宫切除术、淋巴结切除术联合术后放疗对于宫颈癌ⅠB期及ⅡA期患者而言，是最佳的治疗方案。与此同时，根治性的子宫切除术、淋巴结切除术联合术后放疗在降低患者发病率方面也得到了满意的结果。并且，手术治疗联合放疗既提高了患者的生存率，又降低了患者的盆腔复发率。在改善高危患者的生存期的方面，新辅助化疗也有显著效果。根据我们的研究结果，对于宫颈癌ⅠB期及ⅡA期患者，如有局部淋巴结转移，应行术后放射治疗。然而，当肿瘤在宫旁与盆腔淋巴结均有转移时，则需考虑其它的替代疗法。
Background: Meta-analysis is defined as the statistical analysis of a collection of analyticalresults for the purpose of integrating the findings. Such analyses are becoming increasinglypopular in medical research, where information on efficacy of a treatment is available froma number of clinical studies with similar treatment protocols. If these studies are consideredseparately, each study is either too small or too limited in scope to come to unequivocal orgeneralized conclusions about the effect of treatment. Combining the findings across suchstudies represents an attractive alternative to strengthen the evidence about the treatmentefficacy.
Cervical cancer is the second most common cancer among women worldwide and themain cancer that affects women in the Sub-Sahara and Africa, Central America and South–Central Asia. A significant decline in incidence and mortality have been seen in NorthAmerica, parts of Europe, Australia and New Zealand where screening programs have beenimplemented for some time.
There are two cell types present (squamous and glandular) and cervical cancers tend tooccur where the two cell types meet. The main cause of cervical cancer is a virus called HPV(human papillomavirus). HPV is sexually transmitted and sexual activity increases the riskfor infection with HPV and for cervical cancer. The standard management of cervical cancerdepends on clinical stage and tumor volume. Controversies are the selection of NeoadjuvantChemotherapy (NC) to pelvic radiation did improve survival for high-risk patients, orSurgery Followed by Radiotherapy for patient of cervical Stage IB and IIA. Thus, we usedmeta-analysis to evaluate the adverse effects to the treatment and survival outcome of cervical cancer stage IB and IIA treatment with (1) NC first (2) or surgery first or (3) surgeryfollowed by radiotherapy to determine the best option for cervical cancer treatment.
Methods: A systematic review of literature and published studies between1974and2012incervical treatment stage IB and IIA was performed and a meta-analysis of identified studieswas carried out. We searched the following databases: Pub Med, the Lancet, ElsevierGynecological Oncology, Elsevier EJSO, Gynecological Radiology, Med Line, Cross RefMed Line, Oncology group publications and Cancer literature. All eligible studies wereevaluated and there were14studies among them to count on because of the number ofpatients and sufficient follow up was conducted with patients. The outcomes of interest wereadverse effects to the treatment, follow up, recurrence rate and overall survival (OS) forcervical cancer patients. All full article texts were obtained for further evaluation. After thereview of the researches, exclude the studies that not up to the standard. Meta-analysis wasperformed and the summary information from eligible studies was estimated to calculateOdd ratio (OR) and95%confidence interval (CI).
Results:After reviewing the researches, trials and published articles, we chose fourteenstudies. Of the14, we used10of the studies, which were eligible for meta-analysis and fitthe criteria. The average sample size was190patients (from45to611patients). Theoutcomes of interest were adverse effects to the treatment and the overall survival (OS),complications and recurrence. The follow-up time was from two months to two hundred andforty nine months. The studies were published between1974-2012and included nineretrospective studies, andone randomized study. Of ten included trials, three trials wereconducted in Thailand, two in Italy and the United States of America, and one in China andKorea. Seven studies reported the adverse effects to the treatment of the different treatmentof this study including symptomatic lymphocyst, lymphedema, radiation hemorrhagiccystitis,gastro-intestinal toxicity, vomiting, nausea, bowel obstruction or cystitis and proctitis, gallstone and pelvic abscess.Complication rate differs due to the treatment applied: surgeryplus NC or surgery plus radiotherapy. Also leukopenia or neutropenia were included in thestudy together with lymphaedema. Presence of (+) lymph nodes and (-) lymph nodes are alsorecorded in seven trials. Studies showed the data of the overall survival calculated by theKaplan-Meier Method to calculate Hazard ratio (HR) and95%confidence interval (CI).Nine studies had treated patients in stage IB-IIA, and one had treated patients in stage IA2-IIA. Eight studies reported the5-year overall survival (OS), one study reported2-yearoverall survival (OS), and one study reported3and5-year survival. The5-year disease-freesurvival rate were different from one trial to another due to the changes in treatmentprocedures. The shortest median follow up reported was19months, while the longestreported was84months. The follow up shown in the study gave idea about the presence ofcomplication and recurrence or without recurrence. The number of patients alive was despiteproblems from surgery or combined therapy. The follow up of treated patients also showed ifpatients died from other diseases or due to recurrence. Results of10trials indicated thatpatients developed recurrence were between3.3%and42%and this was also changed in thesurgery group than in radiotherapy treatment and NC. Meta analysis and systematic reviewproved that for cervical cancer stage IB and IIA the best option of treatment after reviewingthe complications, recurrence and overall survival rate for5years is radical hysterectomywith lymph nodes removal followed by radiotherapy. Of the ten studies, five studies havestatistically significant treatment effects (Kim et al.,2008; Siriwaranya et al.,2003;Sittidilokratna et al.,2010; Monk et al.,1998; Landoni etal.,1997). The significant oddratios (OR) at the5%level (P<0.05) of having a favorable outcome among the studies usingradiotherapy after radical hysterectomy were0.097(95%CI,0.055–0.1771)(Monk et al.,1994),1.71(95%CI,1.254–0.2.347)(Landoni et al.,1997), and3.5(95%CI,1.707–7.197)(Siriwaranya et al.,2003).In other hand, the significant odds ratios (ORs) at the5%level (P<0.05) of having a favorable outcome among the studies using NC plus radiotherapy afterradical hysterectomy were3.973(95%CI,1.934–8.16)(Kim et al.,2008), and2.327(95%CI,1.637–3.306)(Sittidilokratna et al.,2010). However, the width of CI for Kim study mayindicate that lessprecise estimates for their results.
Conclusions:After using systematic review and Meta analysis, we indicated that the bestoption of treatment cervical cancer stage IB and IIA after reviewing the complications,recurrence and overall survival rate for5years is radical hysterectomy with lymph nodesremoval followed by radiotherapy. While, radical hysterectomy and radiotherapy pluslymphadectomy produce favorable results with low morbidity. In addition, surgery plusradiotherapy increase the survival rate and decrease the pelvic recurrence, whereas NC didimprove survival for high-risk patients. Based on our result, we recommend thatpostoperative radiation be considered in the management of patients with stage IB-IIAcervical carcinomas found to have regional lymph node metastases; however, alternate formsof therapy deserve consideration when the tumor extends to both the parametrium and pelviclymph nodes.
引文
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