Research Progress on Relation Between SII and Prognosis of Non-small Cell Lung Cancer Patients
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摘要:
肺癌是世界上常见的恶性肿瘤,其中非小细胞肺癌(NSCLC)占肺癌的大多数。虽然在手术、化学药物治疗、放射治疗、靶向治疗、免疫治疗中NSCLC患者的总体生存率在不断改善,但部分患者预后仍较差。炎性反应在肿瘤的发生、进展和转移中均起着重要作用。因此,与炎性反应相关的全血细胞计数将会是预测NSCLC预后的有效指标。由中性粒细胞、淋巴细胞、血小板系统组成的系统免疫炎症指数(SII)能全面反映宿主全身炎症及免疫状态,与其他炎症指标如C反应蛋白/白蛋白值(CAR)、晚期肺癌炎症指数(ALI)、预后营养指数(PNI)等的联合检测,可以增加对NSCLC患者预后的预测效能。此外,SII检测成本低廉、操作简单、获取方便,易于在临床中运用。本文就SII与NSCLC预后关系的研究进展综述如下。
Abstract:Lung cancer is a common malignant tumor in the world and NSCLC accounts for the majority. Although the overall survival rate of patients with NSCLC is improving through surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy, the prognosis of some patients is still poor. Inflammatory response plays an important role in the occurrence, progress and metastasis of tumors. Therefore, the whole blood cell count associated with inflammatory response will be an effective index to predict the prognosis of NSCLC. The systemic immune-inflammatory index (SII), composed of neutrophils, lymphocytes and platelet systems, can fully reflect the systemic inflammation and immune status of the host, and can be combined with other inflammatory indexes such as C-reactive protein/albumin value (CAR), advanced lung cancer inflammatory index (ALI) and prognostic nutritional index (PNI). It can increase the predictive efficacy of NSCLC patieats' prognosis. In addition, SII has the advantages of low cost, simple operation and convenient acquisition, and is easy to be used in clinic. This paper reviews the research progress of the relation between SII and the prognosis of NSCLC.
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0 引言
鼻咽癌又称“广东瘤”,在我国南方发病率较高,其中男性发病率超过20/10万,女性超过10/10万。在东南亚、北非、中东和北极地区,以及亚洲和太平洋岛屿上的移民人口中,发病率略低于我国南方,而在世界其他地区,这一比率普遍低于1/10万[1]。随着调强放射治疗技术及同步化疗的应用,鼻咽癌的预后得到明显提高。目前Ⅰ期鼻咽癌患者5年总生存率高达96%,但局部晚期鼻咽癌患者5年总生存率仍不理想,远处转移是治疗失败的主要模式,相较T分期,N分期是影响远处转移的主要因素[2-5]。Xu等[4]报道181例经同步放化疗的局部晚期鼻咽癌患者预后,全组分3亚组T3~4N0~1M0、T1~2N2~3M0、T3~4N2~3M0 ,三组3年无远处转移率分别为89.6%、75.7%和76.3%(P=0.028),笔者认为在目前调强技术和铂类同期化疗的背景下,鼻咽肿瘤局部晚期(T3~4期)预后明显优于局部区域晚期(N2~3期),基于N分期的分层治疗较为合适。因此如何进一步提高N2~3期局部晚期鼻咽癌患者的总生存率,降低远处转移率是目前临床研究热点。本研究回顾性分析我院收治的N2~3期局部晚期鼻咽癌患者临床资料,探讨患者预后影响因素,比较不同新辅助化疗疗程预后差异。
1 资料与方法
1.1 临床资料
2012年1月—2013年12月广州医科大学附属肿瘤医院收治的18~70岁、病理证实、临床资料完整、临床分期为T1~4N2~3M0(UICC/AJCC第6版分期)的局部晚期鼻咽癌,剔除同时合并其他恶性肿瘤、存在严重的内科合并症、重要脏器(心、肺、肝、肾)功能不全的病例,共270例患者纳入本次研究。全部患者均有2~3种影像学检查以诊断鼻咽病灶及区域淋巴结的分期并排除远处转移(如肝转移、肺转移或骨转移等),包括鼻咽+颈部MRI、胸片、CT、PET-CT以及核素骨扫描。270例患者中,男200例、女70例,中位年龄46岁。局部病变分期手段:235例行鼻咽+颈部MRI、27例行鼻咽+颈部CT、8例行PET-CT分期。全组病理类型分为:鼻咽未分化型非角化性癌155例(57.4%)、鼻咽低分化型非角化性癌100例(37.0%),鼻咽角化性鳞癌15例(5.6%)。临床分期T1、T2、T3、T4分别为17例(6.3%)、93例(34.4%)、114例(42.2%)及46例(17.0%)。临床N2、N3分别为235例(87.0%)、35例(13.0%)。
1.2 治疗方案
新辅助化疗方案:化疗方案为DP(多西他赛75 mg/m2第1天+顺铂或奈达铂75 mg/m2第1天)、PLF(顺铂或奈达铂75 mg/m2+氟尿嘧啶300~500 mg/m2第1~5天+亚叶酸钙200 mg/m2第1~5天)、TP(紫杉醇175 mg/m2第1天+顺铂或奈达铂75 mg/m2第1天)及TPF(多西他赛60 mg/m2第1天+顺铂或奈达铂60 mg/m2第1天+5-Fu 500 mg/m2第1~5天),每3周重复。本研究将顺铂与奈达铂合计一组统计。全组依据NCT化疗疗程数分为:NCT≥3程(84例)、NCT=1~2程(106例)、NCT=0程(80例)患者分别为84例、106例和80例。
根治性放疗:采用调强放射(IMRT)技术,放疗剂量:原发病灶(GTVnx)70~72 Gy/30~32次,颈部淋巴结(GTVnd)64~70 Gy/30~32次,高危预防区(CTV1)60 Gy/30~32次,低危预防区(CTV2)50~54 Gy/30~32次;依据肿瘤消退情况,部分患者经放化疗后鼻咽残留病灶或转移淋巴结残留病灶局部加量8~10 Gy/4~5次,或行1次γ刀5 Gy/次。靶区勾画及正常组织的保护参照RTOG标准。同步化疗方案:顺铂或奈达铂每周(40 mg/m2第1天,共6~7程)或三周方案(75 mg/m2第1天,共2~3程),多西他赛+铂类(多西他赛75 mg/m2第1天+顺铂或奈达铂75 mg/m2第1天,3周方案,共2~3程)。放疗同期进行。本研究将放疗前7天内、或放疗结束后7天内化疗均定义为同期化疗。
1.3 统计学方法
统计分析采用SPSS19.0软件。定量资料比较采用Wilcoxon rank秩和检验,定性资料比较采用卡方及Fisher精确检验,采用Kaplan-Meier生存函数比较生存率、绘制生存曲线,各组生存率比较应用Log rank检验,Cox回归进行单、多因素分析。以P < 0.05为差异有统计学意义。
2 结果
2.1 化疗疗程资料
全组行5、4、3、2、1程新辅助化疗分别为1(0.4%)、2(0.7%)、81(30%)、101(37.4%)及5(1.9%)例,行单纯同期放化疗为80(29.6%)例。因本研究行5、4、1程新辅助化疗病例较少,故将行新辅助化疗3、4、5程合并一组,行新辅助化疗1、2程新辅助化疗者合并一组。不同新辅助化疗疗程临床资料比较,见表 1。
表 1 N2~3期局部晚期鼻咽癌患者不同新辅助化疗疗程临床资料比较n(%)Table 1 Comparison of cllinical data of stage N2-3 locally advanced nasopharyngeal carcinoma patients among three groups n(%)2.2 全组预后
总生存期(OS)、无病生存期(DFS)、无局部复发生存(LRFS)、无远处转移生存(DMFS)均定义为从明确诊断日期开始到任一事件发生日期或末次随访日期。末次随访日期为2018年4月30日。全组中位随访时间63月(6~75月)。全组死亡57例(21.1%)。全组单纯局部复发6例(2.2%),2例颈部淋巴结复发,4例鼻咽原发灶复发,单纯远处转移54例(20%),同时出现局部复发和远处转移(鼻咽病灶复发+肺肝转移)1例(0.4%)。全组5年OS、DFS、LRFS和DMFS分别为78.4%、77.8%、97.7%和79.5%。
2.3 鼻咽癌患者不同疗程新辅助化疗的预后
鼻咽癌患者不同疗程新辅助化疗5年OS、DFS、DMFS差异有统计学意义,NCT≥3程新辅助化疗的预后明显优于另外两组疗程,LRFS差异无统计学意义,见表 2。
表 2 N2~3期鼻咽癌患者不同新辅助化疗疗程5年预后比较Table 2 Comparison of 5-year prognosis of N2-3 nasopharyngeal carcinoma patients among three groups2.4 影响无远处转移率的单因素、多因素分析
单因素分析显示新辅助化疗疗程、N分期和年龄是影响无远处转移生存率的主要因素,见表 3。将单因素分析中有意义的临床因素进行多因素分析,结果提示新辅助化疗疗程、N分期、年龄均是治疗后有无转移的独立预后因素,见表 4。
表 3 影响N2~3期局部晚期鼻咽癌无远处转移率的单因素分析Table 3 Univariate logistic analysis of clinical factors for DMFS in N2-3 locally advanced nasopharyngeal patients表 4 N2~3期局部晚期鼻咽癌无远处转移生存率影响因素多因素分析Table 4 Univariate logistic analysis of clinical factors for DMFS in N2-3 locally advanced nasopharyngeal patients2.5 不良反应
全组均顺利完成治疗。其中NCT≥3程3~4度骨髓抑制者21例(25%)、NCT=1~2程28例(26.4%),NCT=0程23例(28.8%),差异无统计学意义(P=0.165)。
3 讨论
本研究结果显示NCT≥3程新辅助化疗的N2~3期局部晚期鼻咽癌患者的5年总生存、无瘤生存、无远处转移均优于行2程或单纯同期放化疗的患者,且可顺利完成治疗。
目前NCCN对局部晚期鼻咽癌的治疗推荐并无分层治疗,其建议对局部晚期鼻咽癌即临床分期为Ⅱ~ⅣB期即T1、N1~3M0或T2~T4、N0~3M0的患者治疗以同期放化疗为主,新辅助化疗+同期放化疗为2A类证据[6]。其2A类证据源于3项临床研究及一项Meta分析[7-10]。但三项对新辅助化疗在局部晚期鼻咽癌患者预后影响的临床研究中均对局部晚期鼻咽癌入组分期提出要求。Sun等[7]入组标准为Ⅲ~ⅣB期,除外T3~4N0M0患者,Cao等[8]入组标准则为Ⅲ~ⅣB期,除外T3N0~1M0期。Lee等[9]入组标准为Ⅲ~ⅣB期。三组研究均同时去除了Ⅱ期即T2N0-1M0、T1N1M0低危转移患者。Chen等[11]Meta分析纳入9项研究共1 988例鼻咽癌患者,结果提示新辅助化疗+同期放化疗相比单纯同期放化疗可降低远处转移率(P=0.03)。笔者认为基于鼻咽癌复发转移模式的不同,即局部晚期T分期(T3~4)早N分期(N0~1)组患者更倾向局部治疗失败,而晚N分期(N2~3)早T分期(T1~2)患者更倾向出现远处转移,基于新辅助化疗对远处转移的控制,笔者认为新辅助化疗更适用于高危转移即晚N分期(N2~3)早T分期(T1~2)患者。
研究发现T、N分期对患者预后影响并不相同,相较T分期,N分期是影响远处转移、总生存的主要因素[4-5, 12-14]。Setakornnukul等[12]266例局部晚期鼻咽癌行NCT-CCRT及同期放化疗+辅助化疗的回顾分析发现N3患者在NCT中明显获益,远处转移危险系数较辅助化疗者为0.48。Chen等[15] 556例T3~4N0~3鼻咽癌患者,经单纯放疗,结果发现N0、N1、N2、N3的5年OS分别为73.98%、65.96%、57.58%、29.39%(P=0.0009),T、N分期均是影响总生存、远处转移的独立预后因素,但N分期是主要预后指标,T分期为次要相关因素。在目前IMRT放射治疗背景下,鼻咽癌局控率得到明显提高,本组仅复发7例,5年无局部复发率为97.7%,因此对局部晚期鼻咽癌依据N分期进行分层治疗较为合适。例如对高危转移的N2~3期患者行高强度诱导化疗+同期放化疗,低危患者行同期放化疗或2程诱导后同期放化疗等。
单纯对N2~3期局部晚期鼻咽癌的研究较少。Yin等[16]比较了不同同期化疗强度的128例N2~3期鼻咽癌患者预后,结果提示N2~3期鼻咽癌患者在同期放化疗中提高化疗强度可提高总生存率,降低远处转移率。Kawahira等[17]小样本回顾分析N2~3期局部晚期鼻咽癌,12例行TPF3程诱导化疗,16例行同期放化疗+辅助治疗,结果显示TPF诱导化疗组明显提高患者总生存、降低远处转移率,两组3年OS分别为94%、75%,两组3年远处转移率分别为0、26%。魏嘉旺等[18]认为N2~3期局部晚期鼻咽癌为系统性疾病,在就诊前已有相当部分病例存在微转移灶,高强度的新辅助化疗可杀灭微转移灶,提高该部分患者的总生存、降低远处转移率,该研究按照1:2:1比例以年龄、N分期、病理类型、NCT方案配对后,NCT≥3程、NCT=2程、NCT=0程分别有179例、358例、179例N2~3期局部晚期鼻咽癌纳入研究,中位随访58月后,三组5年OS分别为89.4%、81.6%、73.7%(P=0.000),5年DFS分别为83.2%、69.8%、64.2%(P=0.001),5年DMFS分别为86.6%、76.0%、68.3%(P=0.000)。本研究结果同上述两项研究,均提示对N2~3期局部晚期鼻咽癌患者提高新辅助化疗药物强度或剂量强度可明显降低该部分患者远处转移率,提高总生存率。
本研究局部复发率较低,5年无局部复发率高达97.7%。大部分文献报道鼻咽癌放疗剂量GTV为68~72 Gy/30~32次[7, 19]。分析本组数据,有61例(22.6%)行75~80 Gy的剂量,提示较高的放疗剂量可进一步提高局部控制率,但伴随高剂量放疗,放疗后遗症如放射线脑病、放射线中耳炎、放射线脊髓炎、激素分泌水平下降等可能进一步升高而严重影响患者生活质量。对高剂量放疗研究值得进一步探讨。
本研究提示年龄 < 50岁患者较易发生远处转移(P=0.009)。原因可能为:鼻咽癌为成人常见肿瘤,发病高峰年龄40~59岁,故在 < 50岁患者中发病可能预示肿瘤侵袭性较强,出现远处转移概率较高。有研究结果提示 > 50岁患者更易出现远处转移[3](P=0.025),但该研究仅行2程新辅助化疗,是否对总生存造成影响进一步影响年龄因素并不确定。
因本文为回顾分析,存在较多局限性:(1)样本量较少,全组仅270例,N3病例仅35例(13%);(2)病例存在一定程度选择偏倚。临床行3程及以上诱导化疗者多身体状态较好,医师评估可耐受化疗的患者;(3)本研究新辅助化疗方案多样,文献报道奈达铂在同期化疗中与顺铂同效果,但在诱导化疗中疗效是否相同并无文献报道[19]。本研究诱导化疗中将奈达铂与顺铂合并一组统计,可能对结果造成一定影响。
综上,N2~3期局部晚期鼻咽癌患者行NCT≥3程诱导化疗+同步放化疗可明显提高总生存、降低远处转移率。对局部晚期鼻咽癌分层治疗的前瞻性临床研究亟待探索。
Competing interests: The authors declare that they have no competing interests.作者贡献:陈晓博:论文构思、撰写及修改王倩:参与文献收集及整理李庆霞:论文构思、写作指导及审阅 -
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