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Article(id=1198602000804970859, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1198601997155922872, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.0963.2024.0104, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1689523200000, receivedDateStr=2023-07-17, revisedDate=null, revisedDateStr=null, acceptedDate=1698768000000, acceptedDateStr=2023-11-01, onlineDate=1763698585940, onlineDateStr=2025-11-21, pubDate=1719504000000, pubDateStr=2024-06-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763698585940, onlineIssueDateStr=2025-11-21, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1763698585940, creator=13701087609, updateTime=1763698585940, updator=13701087609, issue=Issue{id=1198601997155922872, tenantId=1146029695717560320, journalId=1189873630562394117, year='2024', volume='49', issue='6', pageStart='611', pageEnd='732', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1763698585070, creator=13701087609, updateTime=1763698770557, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1198602775211901122, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1198601997155922872, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1198602775211901123, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1198601997155922872, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=623, endPage=628, ext={EN=ArticleExt(id=1198602001111155053, articleId=1198602000804970859, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Short-term efficacy of chemotherapy induced by nimotuzumab combined with TP regimen and sequential concurrent chemoradiotherapy in patients with EGFR-positive locally advanced nasopharyngeal carcinoma, columnId=1190310109000602400, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Clinical Research, runingTitle=null, highlight=null, articleAbstract=

Objective To investigate the short-term efficacy and safety of chemotherapy induced by nimotuzumab (NTZ) combined with TP regimen and sequential concurrent chemoradiotherapy in patients with epidermal growth factor receptor positive(EGFR-positive) locally advanced nasopharyngeal carcinoma. Methods A total of 48 patients with stage Ⅲ to IV A nasopharyngeal carcinoma in Guizhou Provincial People's Hospital from January 2020 to December 2022 were prospectively enrolled, and were randomized into two groups: NTP (NTZ+docetaxel/albumin-paclitaxel+cisplatin) group and TP (Docetaxel/albumin-paclitaxel+cisplatin) group(24 cases per group) by random number table method. After 2 or 3 cycles of induction chemotherapy in NTP group, NTZ was sequentially used in combination with cisplatin for concurrent chemoradiotherapy. Immunohistochemistry was used to detect the EGFR expression level, exploring EGFR expression intensity and the therapeutic effect of NTZ in NTP group patients. Meanwhile, short-term efficacy, withdrawal rate and toxic side effects were compared between the two groups after induction chemotherapy. Results In NTP group, the positive expression rate of EGFR was 100%, and EGFR expression intensity significantly correlated with the efficacy of NTZ-combined induction therapy (P<0.05). After induction chemotherapy, the objective response rate (ORR) of cervical lymph nodes in NTP group was significantly higher than that in TP group (75% vs. 45.8%, P=0.039). The primary lesion ORR and overall (primary lesion and cervical lymph node) ORR showed no significant difference between the two groups (P>0.05). Comparison of adverse reactions between the two groups during induction therapy: leukopenia and gastrointestinal reaction in NTP group were lower than those in TP group (P<0.05), but rash was higher than those in TP group (P<0.05). There was no significant difference in liver function, hemoglobin and thrombocytopenia between two groups (P>0.05). Conclusions EGFR expression intensity varies in nasopharyngeal carcinoma tissues, with higher levels indicating greater clinical benefit of combined induction therapy with NTZ. NTZ combined with TP induction regimen demonstrates good short-term efficacy and safety for cervical lymph nodes in patients with locally advanced nasopharyngeal carcinoma.

, correspAuthors=Hai-Zhen Zhu, authorNote=null, correspAuthorsNote=
E-mail:
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目的 探讨尼妥珠单抗(NTZ)联合TP方案诱导化疗对表皮生长因子受体(EGFR)阳性局部晚期鼻咽癌的近期疗效及其安全性。方法 前瞻性选取贵州省人民医院2020年1月-2022年12月收治的Ⅲ-ⅣA期鼻咽癌患者48例，采用随机数表法分为NTZ+多西他赛/白蛋白紫杉醇+顺铂(NTP)组(n=24)与多西他赛/白蛋白紫杉醇+顺铂(TP)组(n=24)。NTP组2或3个周期诱导治疗后序贯NTZ配合顺铂同步放化疗，采用免疫组化检测肿瘤组织EGFR表达水平，探究NTP组患者EGFR表达强度和尼妥珠单抗的治疗效果；比较两组诱导治疗结束后的近期疗效、肿瘤退缩率及不良反应发生情况。结果 NTP组EGFR阳性表达率为100%，EGFR表达强度与联合NTZ的诱导治疗疗效相关(P<0.05)；诱导治疗结束后的两组疗效比较，NTP组颈部淋巴结的客观缓解率(ORR)明显高于TP组(75.0% vs. 45.8%，P=0.039)，两组肿瘤原发病灶及总体(肿瘤原发病灶和颈部淋巴结)ORR比较差异无统计学意义(P>0.05)；不良反应方面，NTP组白细胞减少、胃肠道反应发生率低于TP组(P<0.05)，皮疹发生率高于TP组(P<0.05)，两组肝功能异常、血红蛋白及血小板减少比较差异无统计学意义(P>0.05)。结论 鼻咽癌组织中存在不同强度的EGFR表达，EGFR表达强度较高时，联合NTZ诱导治疗临床获益更明显；NTZ联合TP诱导方案治疗对于局部晚期鼻咽癌颈部淋巴结的近期疗效和安全性较好。

, correspAuthors=朱海振, authorNote=null, correspAuthorsNote=
朱海振，E⁃mail：
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宋娟，硕士研究生，主要从事肿瘤临床治疗方面的研究

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宋娟，硕士研究生，主要从事肿瘤临床治疗方面的研究

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宋娟，硕士研究生，主要从事肿瘤临床治疗方面的研究

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articleId=1198602000804970859, language=CN, label=图1, caption=免疫组化检测局部晚期鼻咽癌患者肿瘤细胞的EGFR表达强度(DAB ×400), figureFileSmall=E2WrIM9KNY38dK7picqUGg==, figureFileBig=8azpMRw33Fig/HdO/tk/oA==, tableContent=null), ArticleFig(id=1198602008279220826, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1198602000804970859, language=EN, label=Fig.2, caption=Correlation between EGFR expression and therapeutic effect in NTP group of patients with locally advanced nasopharyngeal carcinoma, figureFileSmall=Pw9RHGNHC8C8/NLQg0qx3A==, figureFileBig=nk2cp8hy5uNKUjLJNmQvzw==, tableContent=null), ArticleFig(id=1198602008371495521, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1198602000804970859, language=CN, label=图2, caption=EGFR表达强度与NTP组局部晚期鼻咽癌疗效相关性分析

NTP. 尼妥珠单抗+多西他赛/白蛋白紫杉醇+顺铂；A. EGFR表达强度与NTP组肿瘤原发灶和转移淋巴结平均退缩率；B. EGFR表达强度与NTP组肿瘤原发灶、转移淋巴结及总体(肿瘤原发灶+转移淋巴结)客观缓解率

, figureFileSmall=Pw9RHGNHC8C8/NLQg0qx3A==, figureFileBig=nk2cp8hy5uNKUjLJNmQvzw==, tableContent=null), ArticleFig(id=1198602008451187302, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1198602000804970859, language=EN, label=Tab.1, caption=

Comparison of clinical data between two groups of patients with locally advanced nasopharyngeal carcinoma [n(%)]

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临床特征TP组(n=24)NTP组(n=24)χ2P
年龄0.0001.000
≤60岁21(87.5)20(83.3)
>60岁3(12.5)4(16.7)
性别0.1180.731
男18(75.0)19(79.2)
女6(25.0)5(20.8)
T分期0.5050.477
T1+T24(16.7)6(25.0)
T3+T420(83.3)18(75.0)
N分期0.2730.602
N0+N13(12.5)1(4.2)
N2+N321(87.5)23(95.8)
临床分期0.1500.699
Ⅲ期5(20.8)3(12.5)
Ⅳ期19(79.2)21(87.5)
诱导周期0.8000.371
2周期17(70.8)13(54.2)
3周期7(29.2)11(45.8)
化疗方案0.3560.551
白蛋白紫杉醇+顺铂14(58.3)16(66.7)
多西他赛+顺铂10(41.7)8(33.3)
), ArticleFig(id=1198602008577016431, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1198602000804970859, language=CN, label=表1, caption=

两组局部晚期鼻咽癌患者临床资料比较 [例(%)]

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临床特征TP组(n=24)NTP组(n=24)χ2P
年龄0.0001.000
≤60岁21(87.5)20(83.3)
>60岁3(12.5)4(16.7)
性别0.1180.731
男18(75.0)19(79.2)
女6(25.0)5(20.8)
T分期0.5050.477
T1+T24(16.7)6(25.0)
T3+T420(83.3)18(75.0)
N分期0.2730.602
N0+N13(12.5)1(4.2)
N2+N321(87.5)23(95.8)
临床分期0.1500.699
Ⅲ期5(20.8)3(12.5)
Ⅳ期19(79.2)21(87.5)
诱导周期0.8000.371
2周期17(70.8)13(54.2)
3周期7(29.2)11(45.8)
化疗方案0.3560.551
白蛋白紫杉醇+顺铂14(58.3)16(66.7)
多西他赛+顺铂10(41.7)8(33.3)
), ArticleFig(id=1198602008669291124, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1198602000804970859, language=EN, label=Tab.2, caption=

Comparison of short-term efficacy after induction chemotherapy between two groups of patients with locally advanced nasopharyngeal carcinoma [n(%), n=24]

, figureFileSmall=null, figureFileBig=null, tableContent=
疗效原发灶颈部淋巴结原发灶+颈部淋巴结
TP组NTP组TP组NTP组TP组NTP组
CR1(4.2)2(8.3)01(4.2)01(4.2)
PR12(50.0)14(58.4)11(45.8)17(70.8)13(54.2)15(62.5)
SD11(45.8)8(33.3)12(50.0)6(25.0)10(41.6)8(33.3)
PD001(4.2)01(4.2)0
ORR13(54.2)16(66.7)11(45.8)18(75.0)13(45.2)16(66.7)
χ20.7844.2690.784
P0.3760.0390.376
), ArticleFig(id=1198602008757371512, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1198602000804970859, language=CN, label=表2, caption=

两组局部晚期鼻咽癌IC后近期疗效比较 [例(%), n=24]

, figureFileSmall=null, figureFileBig=null, tableContent=
疗效原发灶颈部淋巴结原发灶+颈部淋巴结
TP组NTP组TP组NTP组TP组NTP组
CR1(4.2)2(8.3)01(4.2)01(4.2)
PR12(50.0)14(58.4)11(45.8)17(70.8)13(54.2)15(62.5)
SD11(45.8)8(33.3)12(50.0)6(25.0)10(41.6)8(33.3)
PD001(4.2)01(4.2)0
ORR13(54.2)16(66.7)11(45.8)18(75.0)13(45.2)16(66.7)
χ20.7844.2690.784
P0.3760.0390.376
), ArticleFig(id=1198602008837063295, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1198602000804970859, language=EN, label=Tab.3, caption=

Comparison of adverse reactions during induction therapy between the two groups of patients with locally advanced nasopharyngeal carcinoma [n(%), n=24]

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应TP组NTP组ZP
白细胞减少-2.3280.020
0级14(58.3)21(87.5)
1-2级4(16.7)2(8.3)
3-4级6(25.0)1(4.2)
贫血-1.4600.144
0级17(70.8)12(50.0)
1-2级7(29.2)12(50.0)
3-4级00
血小板减少-0.3660.714
0级20(83.3)19(79.2)
1-2级4(16.7)5(20.8)
3-4级00
消化道反应-2.0230.043
0级1(4.2)6(25.0)
1-2级23(95.8)18(75.0)
3-4级00
肝功能异常-1.2570.209
0级19(79.2)15(62.5)
1-2级5(20.8)9(37.5)
3-4级00
皮疹-2.1100.035
0级22(91.7)16(66.7)
1-2级2(8.3)8(33.3)
3-4级00
), ArticleFig(id=1198602008941920902, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1198602000804970859, language=CN, label=表3, caption=

两组局部晚期鼻咽癌诱导治疗阶段不良反应比较 [例(%), n=24]

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应TP组NTP组ZP
白细胞减少-2.3280.020
0级14(58.3)21(87.5)
1-2级4(16.7)2(8.3)
3-4级6(25.0)1(4.2)
贫血-1.4600.144
0级17(70.8)12(50.0)
1-2级7(29.2)12(50.0)
3-4级00
血小板减少-0.3660.714
0级20(83.3)19(79.2)
1-2级4(16.7)5(20.8)
3-4级00
消化道反应-2.0230.043
0级1(4.2)6(25.0)
1-2级23(95.8)18(75.0)
3-4级00
肝功能异常-1.2570.209
0级19(79.2)15(62.5)
1-2级5(20.8)9(37.5)
3-4级00
皮疹-2.1100.035
0级22(91.7)16(66.7)
1-2级2(8.3)8(33.3)
3-4级00
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尼妥珠单抗联合TP方案诱导化疗对EGFR阳性局部晚期鼻咽癌的近期疗效及其安全性
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宋娟 1 , 孙轶 2 , 廖加群 2 , 何馨云 2 , 黄立敏 2 , 雷竹 2 , 李源丽 1 , 朱海振 2, *
解放军医学杂志 | 临床研究 2024,49(6): 623-628
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解放军医学杂志 | 临床研究 2024, 49(6): 623-628
尼妥珠单抗联合TP方案诱导化疗对EGFR阳性局部晚期鼻咽癌的近期疗效及其安全性
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宋娟1, 孙轶2, 廖加群2, 何馨云2, 黄立敏2, 雷竹2, 李源丽1, 朱海振2, *
作者信息
  • 1贵州中医药大学第二临床医学院，贵州贵阳 550000
  • 2贵州省人民医院肿瘤科，贵州贵阳 550000

    • 宋娟，硕士研究生，主要从事肿瘤临床治疗方面的研究

通讯作者:

朱海振，E⁃mail：
Short-term efficacy of chemotherapy induced by nimotuzumab combined with TP regimen and sequential concurrent chemoradiotherapy in patients with EGFR-positive locally advanced nasopharyngeal carcinoma
Juan Song1, Yi Sun2, Jia-Qun Liao2, Xin-Yun He2, Li-Min Huang2, Zhu Lei2, Yuan-Li Li1, Hai-Zhen Zhu2, *
Affiliations
  • 1The Second Clinical Medical College, Guizhou University of Traditional Chinese Medicine, Guiyang, Guizhou 550000, China
  • 2Department of Oncology, Guizhou Provincial People's Hospital, Guiyang, Guizhou 550000, China
出版时间: 2024-06-28 doi: 10.11855/j.issn.0577-7402.0963.2024.0104
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摘要
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目的 探讨尼妥珠单抗(NTZ)联合TP方案诱导化疗对表皮生长因子受体(EGFR)阳性局部晚期鼻咽癌的近期疗效及其安全性。方法 前瞻性选取贵州省人民医院2020年1月-2022年12月收治的Ⅲ-ⅣA期鼻咽癌患者48例，采用随机数表法分为NTZ+多西他赛/白蛋白紫杉醇+顺铂(NTP)组(n=24)与多西他赛/白蛋白紫杉醇+顺铂(TP)组(n=24)。NTP组2或3个周期诱导治疗后序贯NTZ配合顺铂同步放化疗，采用免疫组化检测肿瘤组织EGFR表达水平，探究NTP组患者EGFR表达强度和尼妥珠单抗的治疗效果；比较两组诱导治疗结束后的近期疗效、肿瘤退缩率及不良反应发生情况。结果 NTP组EGFR阳性表达率为100%，EGFR表达强度与联合NTZ的诱导治疗疗效相关(P<0.05)；诱导治疗结束后的两组疗效比较，NTP组颈部淋巴结的客观缓解率(ORR)明显高于TP组(75.0% vs. 45.8%，P=0.039)，两组肿瘤原发病灶及总体(肿瘤原发病灶和颈部淋巴结)ORR比较差异无统计学意义(P>0.05)；不良反应方面，NTP组白细胞减少、胃肠道反应发生率低于TP组(P<0.05)，皮疹发生率高于TP组(P<0.05)，两组肝功能异常、血红蛋白及血小板减少比较差异无统计学意义(P>0.05)。结论 鼻咽癌组织中存在不同强度的EGFR表达，EGFR表达强度较高时，联合NTZ诱导治疗临床获益更明显；NTZ联合TP诱导方案治疗对于局部晚期鼻咽癌颈部淋巴结的近期疗效和安全性较好。

鼻咽癌  /  诱导化疗  /  表皮生长因子受体  /  尼妥珠单抗  /  不良反应

Objective To investigate the short-term efficacy and safety of chemotherapy induced by nimotuzumab (NTZ) combined with TP regimen and sequential concurrent chemoradiotherapy in patients with epidermal growth factor receptor positive(EGFR-positive) locally advanced nasopharyngeal carcinoma. Methods A total of 48 patients with stage Ⅲ to IV A nasopharyngeal carcinoma in Guizhou Provincial People's Hospital from January 2020 to December 2022 were prospectively enrolled, and were randomized into two groups: NTP (NTZ+docetaxel/albumin-paclitaxel+cisplatin) group and TP (Docetaxel/albumin-paclitaxel+cisplatin) group(24 cases per group) by random number table method. After 2 or 3 cycles of induction chemotherapy in NTP group, NTZ was sequentially used in combination with cisplatin for concurrent chemoradiotherapy. Immunohistochemistry was used to detect the EGFR expression level, exploring EGFR expression intensity and the therapeutic effect of NTZ in NTP group patients. Meanwhile, short-term efficacy, withdrawal rate and toxic side effects were compared between the two groups after induction chemotherapy. Results In NTP group, the positive expression rate of EGFR was 100%, and EGFR expression intensity significantly correlated with the efficacy of NTZ-combined induction therapy (P<0.05). After induction chemotherapy, the objective response rate (ORR) of cervical lymph nodes in NTP group was significantly higher than that in TP group (75% vs. 45.8%, P=0.039). The primary lesion ORR and overall (primary lesion and cervical lymph node) ORR showed no significant difference between the two groups (P>0.05). Comparison of adverse reactions between the two groups during induction therapy: leukopenia and gastrointestinal reaction in NTP group were lower than those in TP group (P<0.05), but rash was higher than those in TP group (P<0.05). There was no significant difference in liver function, hemoglobin and thrombocytopenia between two groups (P>0.05). Conclusions EGFR expression intensity varies in nasopharyngeal carcinoma tissues, with higher levels indicating greater clinical benefit of combined induction therapy with NTZ. NTZ combined with TP induction regimen demonstrates good short-term efficacy and safety for cervical lymph nodes in patients with locally advanced nasopharyngeal carcinoma.

nasopharyngeal carcinoma  /  induction chemotherapy  /  EGFR  /  nimotuzumab  /  adverse reactions
宋娟, 孙轶, 廖加群, 何馨云, 黄立敏, 雷竹, 李源丽, 朱海振. 尼妥珠单抗联合TP方案诱导化疗对EGFR阳性局部晚期鼻咽癌的近期疗效及其安全性. 解放军医学杂志, 2024 , 49 (6) : 623 -628 . DOI: 10.11855/j.issn.0577-7402.0963.2024.0104
Juan Song, Yi Sun, Jia-Qun Liao, Xin-Yun He, Li-Min Huang, Zhu Lei, Yuan-Li Li, Hai-Zhen Zhu. Short-term efficacy of chemotherapy induced by nimotuzumab combined with TP regimen and sequential concurrent chemoradiotherapy in patients with EGFR-positive locally advanced nasopharyngeal carcinoma[J]. Medical Journal of Chinese People’s Liberation Army, 2024 , 49 (6) : 623 -628 . DOI: 10.11855/j.issn.0577-7402.0963.2024.0104
正文
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鼻咽癌(nasopharyngeal carcinoma，NPC)是华南地区常见的恶性肿瘤，多数患者确诊时已处于局部中晚期。目前诱导化疗(induction chemotherapy，IC)联合同步放化疗(concurrent chemoradiotherapy，CCRT)被认为是局部晚期鼻咽癌的标准治疗方式[1]。一项研究显示，IC序贯CCRT可降低局部晚期鼻咽癌的远处转移率而提高生存获益，但也可能增加不良反应[2]。因此，迫切需要找到一种效率更高、不良反应较少的治疗方式，以进一步改善鼻咽癌患者的预后。多项研究显示，NPC患者对含紫杉类药物的IC方案的耐受性优于不含紫杉类的IC方案，且前者可延长总生存时间[3-5]。有研究显示，表皮生长因子受体(epidermal growth factor receptor，EGFR)在鼻咽恶性肿瘤细胞中高表达，EGFR阳性患者的生存率明显低于阴性患者[6]。尼妥珠单抗(nimotuzumab，NTZ)是一种人源化程度95%的EGFR抗体，可通过阻断信号通路介导细胞毒效应，从而达到抗肿瘤目的。然而，白蛋白紫杉醇/多西他赛+顺铂(TP)联合NTZ方案(NTP)用于局部晚期鼻咽癌治疗的研究报道较少。本研究通过与TP方案比较，探讨NTZ联合紫杉类药物方案在局部晚期鼻咽癌诱导治疗中的近期疗效及安全性，旨在为NPC的治疗提供参考。
1 资料与方法
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1.1 研究对象
前瞻性纳入2020年1月-2022年12月在贵州省人民医院就诊的初治鼻咽癌患者48例。入选标准：(1)年龄18~70岁；(2)病灶活检病理诊断为鼻咽癌；(3)鼻咽癌分期Ⅲ期或ⅣA期[美国癌症联合会(AJCC)癌症分期第八版][7]；(4)KPS评分≥60分，预计生存期≥3个月；(5)血常规、肝肾功能正常；(6)签署知情同意书。排除标准：(1)有严重的过敏史或特异性体质；(2)存在放射治疗、化疗禁忌证；(3)曾患其他恶性肿瘤；(4)曾接受表皮生长因子靶向治疗；(5)妊娠或哺乳期妇女。本研究方案获贵州省人民医院伦理委员会审批[伦审(科研)2020-61号]。
1.2 治疗方法
48例鼻咽癌患者采用随机数字表法分为TP组与NTP组(n=24)。TP组接受白蛋白紫杉醇(石药集团欧意药业有限公司，国药准字H20183044)260 mg/m2或多西他赛(江苏恒瑞医药股份有限公司，国药准字H20020543)75 mg/m2，d 1静脉滴注；顺铂(齐鲁制药海南公司，国药准字H20073652)75 mg/m2，d 1-d 3静脉滴注。NTP组接受NTZ(百泰生物药业有限公司，国药准字S20080001，200 mg/次)联合TP方案。每3周1次。肿瘤退缩好的患者化疗2个周期，退缩差的患者化疗3个周期；2或3个周期后，采用NTZ 100 mg/(次.周)静脉滴注，配合顺铂 [30 mg/(m2.周)或80 mg/m2，d 1-d 3静脉滴注，每3周1次]和同期的调强适形放射治疗(intensity modulated radiation therapy，IMRT)。所有患者IMRT治疗前行增强CT及MRI扫描，各计划靶区处方剂量分别为：95%肿瘤原发灶靶区的照射剂量为6996~7194 cGy/33 f，95%颈部淋巴结靶区为6600~6996 cGy/33 f，95%病灶+双侧颈部淋巴引流区为5096~6006 cGy/33 f，每周5次。根据放射治疗协作组(RTOG) 0615 RTOG 0225的要求进行危及器官限制剂量和计划评估，采用6 MV-X射线调强放疗技术，逆向调强计划设计，并优化放疗方案。当患者白细胞计数<1.0×109/L时，后续治疗予以预防性升白处理，若白细胞仍偏低，可根据化疗药物减量原则调整诱导治疗方案。所有化疗周期均配合止吐治疗，同时根据恶心、呕吐等情况及时调整当前及后续周期止吐方案。
1.3 评价指标
诱导治疗结束1个月后，复查鼻咽部+颈部增强MRI，治疗期间定期进行血常规、生化等实验室检查，比较两组患者近期客观缓解率(objective response rate，ORR)、肿瘤退缩率及不良反应发生情况。按实体瘤疗效评价标准(RECIST 1.1版)进行疗效评价，(1)完全缓解(CR)：所有目标病灶消失，至少持续4周；(2)部分缓解(PR)：基线病灶最大径之和减少≥30%，至少持续4周；(3)病变稳定(SD)：基线病灶最大径之和减少<30%或增加<20%；(4)病变进展(PD)：基线病灶最大径之和增加≥20%或出现新病灶。OPR=CR+PR。参照常见药物不良反应分级标准(NCI-CTC AE4.0)进行化疗相关不良反应评价。肿瘤原发灶及转移淋巴结退缩率(%)=(1-化疗后轴位最大径/化疗前轴位最大径)×100%。
1.4 免疫组化检测肿瘤细胞EGFR表达水平
采用免疫组化检测肿瘤细胞中EGFR表达水平，并根据染色强度进行分组，结果由两位病理科医师进行判读。操作方法：(1)制成的石蜡包埋肿瘤组织切片放入70 ℃烤箱烘烤1 h；(2)脱蜡、洗涤、高压锅热修复；(3)加入H2O2溶液去除内源性过氧化物酶；(4)滴加一抗(北京中杉金桥公司)，４ ℃冰箱内过夜后，PBS缓冲液中清洗3 min×3次，滴加二抗，室温孵育20~25 min；(5)二氨基联苯胺(DAB)显色10 min，苏木精复染细胞核后脱水封片。于显微镜下观察，EGFR表达阳性为包膜或胞质呈棕黄色。按细胞染色强度分组：弱阳性(+)、中度阳性(++)、强阳性(+++)、强强阳性(++++)。
1.5 统计学处理
采用SPSS 26.0软件统计进行分析。符合正态分布的计量资料以$\bar{x}±s$表示，组间比较采用t检验；不符合正态分布的以M(Q1，Q3)表示，组间比较采用非参数检验。计数资料以例(%)表示，组间比较采用χ2检验；当期望值为1~5时，行校正χ2检验。P<0.05为差异有统计学意义。
2 结果
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2.1 两组一般资料比较
两组局部晚期鼻咽癌患者的年龄、性别、T分期、N分期、临床分期、诱导周期及化疗方案的各临床特征比较，差异均无统计学意义(P>0.05，表1)。
2.2 EGFR表达与诱导治疗疗效的相关性
免疫组化检测结果显示，NTP组患者肿瘤组织EGFR阳性表达率为100%，其中83.3%为中高度表达[表达强度为(++)-(++++)，图1]。EGFR强阳性及强强阳性患者的肿瘤原发灶退缩率均明显高于EGFR弱阳性患者(95%CI 0.355~2.920，P=0.022；95%CI 0.780~3.225，P=0.007)；EGFR强强阳性患者的转移淋巴结退缩率明显高于EGFR弱阳性(95%CI 22.895~64.333，P<0.001)、中度阳性(95%CI 8.578~47.040，P=0.007)、强阳性(95%CI 1.700~38.044，P=0.034)患者，EGFR表达强阳性患者的转移淋巴结退缩率明显高于EGFR弱阳性患者(95%CI 1.486~45.998，P=0.038)(图2A)。EGFR表达强度较高的患者肿瘤原发灶、转移淋巴结及总体(肿瘤原发灶+转移淋巴结)ORR也更高(图2B)。
2.3 两组近期疗效比较
2.3.1 诱导治疗后原发灶、淋巴结及总体疗效
诱导治疗后，NTP组颈部淋巴结的ORR明显高于TP组(75.0% vs. 45.8%，P=0.039)；而两组肿瘤原发病灶及总体(肿瘤原发病灶+颈部淋巴结)的ORR比较，差异无统计学意义(P>0.05，表2)。
2.3.2 诱导治疗后肿瘤退缩率比较
诱导治疗后，NTP组肿瘤原发灶退缩率[50.0%(40.1%, 64.9%) vs. 47.1%(31.3%, 76.1%)，Z=-3.911，P<0.001]和颈部淋巴结退缩率(50.8%±22.4% vs. 35.0%±28.2%，t=-2.142，P=0.038)均明显高于TP组。
2.4 两组不良反应发生率比较
与TP组比较，NTP组的白细胞减少、胃肠道反应明显减少(12.5% vs. 41.7%、75.0% vs. 95.8%，P<0.05)；皮疹发生率高于TP组(33.3% vs. 8.3%，P<0.05)，予对症治疗后明显缓解。两组贫血、血小板减少及肝功能不全等比较，差异无统计学意义(P>0.05，表3)。两组患者均无因不良反应而调整治疗方案者。
3 讨论
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鼻咽癌病变部位隐蔽，且缺乏特异性症状，临床确诊时多为中晚期，首选治疗方法为放化疗。2009年我国一项Ⅱ期临床试验报道在同步放化疗前进行IC可将鼻咽癌患者的3年总生存率从68%提高到94%[8]。此后多项研究显示，IC可破坏微转移灶，降低肿瘤负荷，使局部复发及远处转移的风险明显降低，生存获益明显[9-10]。2021年中国临床肿瘤学会(CSCO)和美国临床肿瘤学会(ASCO)的指南均肯定了IC在局部晚期鼻咽癌治疗中的地位。最新的2023年指南推荐的常用IC方案为TPF(多西他赛、顺铂、5-氟尿嘧啶)、GP(吉西他滨、顺铂)和TPC(紫杉醇、顺铂、卡培他滨)；而TP方案(紫杉醇/多西他赛+顺铂)一直存在争议。多项大型Ⅲ期随机对照试验分别评估了TPF方案和GP方案在局部晚期鼻咽癌患者中的疗效[11-13]。TPF方案在各种药物剂量降低20%的情况下，Ⅲ-Ⅵ度不良反应如中性粒细胞减少、白细胞减少和腹泻等的发生率仍较高；GP方案中，患者的3年总生存率、无进展生存率和无远处转移生存率均得到提高，患者耐受性相对较好，但GP方案需要8 d时间，住院时间长、花费较高，患者及家属经济负担较重。另一项多中心、开放的Ⅲ期随机试验评估了TPC诱导方案与PF(5-氟尿嘧啶、顺铂)诱导方案组的疗效，结果显示，TPC组3年无复发生存率和无远处转移率分别为93.8%、91.4%，均明显高于PF组，但TPC组对早期总生存率的影响不明显[14]；该项研究仅与PF方案比较，并未与TFP、GP等其他诱导方案比较。由此可见，诱导化疗方案的选择可能会影响患者的耐受性、依从性，选择低毒、高效的诱导方案仍需要进一步探索。
一项包含了8214例患者共28项研究、基于个体病例数据的网状Meta分析结果显示，在总生存率方面，含紫杉类的IC方案优于不含紫杉类的IC方案[4]。He等[3]分析了TPF与TP(多西紫杉醇和顺铂)这两种IC方案的疗效和不良反应发生情况，结果显示，TPF和TP方案成为最佳诱导方案的概率相近，但TPF方案Ⅲ度以上黏膜反应发生率较高；因此，该项研究推荐采用减毒、高效的含紫杉醇类的诱导方案。
近年来，随着分子生物学机制研究的推进，越来越多的靶向药物开始作为鼻咽癌的治疗手段之一，其中抗EGFR靶向药物较为突出。NTZ是一种高度人源化的EGFR抗体，与同类型的西妥昔单抗相比，具有中等亲和力的特质，与人体正常细胞结合不稳定，不良反应发生率较低。陆颖等[15]发现，EGFR高表达水平患者接受联合NTZ的诱导治疗有更好的治疗反应。本研究中，NTP组24例EGFR表达均阳性，仅4例为低表达；随着EGFR表达强度由低到高，患者肿瘤原发灶平均退缩率逐渐递增，分别为8.8%、22.0%、42.2%、63.3%；转移淋巴结平均退缩率随着EGFR表达增高也逐渐增高，分别为25.2%、41.0%、48.9%、68.8%；此外，患者接受NTZ诱导治疗后，EGFR表达水平越高，ORR也越高，与陆颖等[15]的报道相近；提示联合NTZ诱导治疗EGFR阳性的局部晚期鼻咽癌患者可能提高临床疗效。
对于局部晚期鼻咽癌患者，采用NTZ联合IC序贯CCRT是可行的，且已有少量临床研究报道。Peng等[16]报道抗EGFR治疗(NTZ/CTX)联合IC，其中IC可选取TP、PF或TPF三种方案，结果显示，抗EGFR抗体早期介入可提高无疾病生存率(84.3% vs. 74.3%)；两组不良反应发生率相近；因此，抗EGFR联合诱导化疗是可行的，但其IC方案有TPF、TP及PF，并未统一，抗EGFR抗体有NTZ及CTX，也未统一。陆颖等[17]的多中心前瞻性研究显示，NTZ联合PF方案诱导化疗，在降低诱导化疗强度的情况下颈部淋巴结转移者仍可明显获益(81% vs. 60%)，且不良反应未见增多。此项研究中NPF组较TPF组降低了化疗强度，而目前降低化疗强度后NPF组能否获益尚不清楚。因此，本研究在不降低化疗强度的前提下，采用NTZ联合低毒、高效的含紫杉醇类的诱导治疗方案，结果显示，NTP组诱导治疗结束后颈部淋巴结ORR为75.0%，明显高于TP组的45.8%；在两组肿瘤原发灶及总体(肿瘤原发病灶和转移淋巴结)ORR相近的情况下，NTP组肿瘤原发灶及转移淋巴结退缩率均明显优于TP组；不良反应方面，NTP组仅8例患者发生1-2级皮疹(稍高于TP组)，予以对症治疗后可明显缓解；且白细胞减少、胃肠道反应等发生率较TP组更低，贫血、血小板减少及肝功能不全发生率相近。上述结果与吕科友等[18]报道的NTZ联合TP(多西他赛+顺铂)诱导治疗序贯CCRT研究相似。
综上，本研究结果显示，在Ⅲ-ⅣA期鼻咽癌患者中，EGFR表达强度与加入NTZ治疗的效果相关，对于EGFR表达高的患者，加入NTZ后临床获益更明显，且肿瘤原发灶及颈部淋巴结退缩率更高。因此，肿瘤退缩率可能作为预测鼻咽癌疗效的重要指标之一。但本研究仍存在不足之处，如入组患者相对较少，随访时间较短等。因此，对于鼻咽癌临床获益的影响，后续仍需通过增加样本量、延长随访时间来进行验证。
基金
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  • 国家自然科学基金(82260357)
  • 贵州省科技计划项目(黔科合基础[2020]1Y428)
  • 贵州省科技计划项目(黔科合支撑[2021]一般093)
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参考文献 引证文献
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2024年第49卷第6期
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文章信息
doi: 10.11855/j.issn.0577-7402.0963.2024.0104
  • 接收时间：2023-07-17
  • 首发时间：2025-11-21
  • 出版时间：2024-06-28
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  • 收稿日期：2023-07-17
  • 录用日期：2023-11-01
基金
National Natural Science Foundation of China(82260357)
国家自然科学基金(82260357)
Guizhou Provincial Science and Technology Plan Project(Qian-basic(2020)1Y428)
贵州省科技计划项目(黔科合基础[2020]1Y428)
Guizhou Provincial Science and Technology Plan Project(Qian-support(2021)General093)
贵州省科技计划项目(黔科合支撑[2021]一般093)
作者信息
    1贵州中医药大学第二临床医学院，贵州贵阳 550000
    2贵州省人民医院肿瘤科，贵州贵阳 550000

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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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