Ⅲ期恶性黑色素瘤患者术后辅助抗PD-1 <italic style="font-style: italic">vs</italic> 靶向治疗：中国多中心真实世界数据分析

李婷; 徐宇; 贾东东; 廖智超; 孙伟; 吴海啸; 任志午; 赵军; 邢汝维; 滕胜; 杨蕴; 陈勇; 李涛; 杨吉龙

doi:10.19401/j.cnki.1007-3639.2022.12.002

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Ⅲ期恶性黑色素瘤患者术后辅助抗PD-1 vs 靶向治疗：中国多中心真实世界数据分析

专题论著 | 更新时间：2025-12-31

- Ⅲ期恶性黑色素瘤患者术后辅助抗PD-1 vs 靶向治疗：中国多中心真实世界数据分析
- Adjuvant therapy with anti-PD-1 antibody vs targeted therapy for patients with resected stage Ⅲ malignant melanoma: a real-world data analysis from China centers
- 中国癌症杂志 2022年32卷第12期页码：1147-1157
- 作者机构：
  
  1. 天津医科大学肿瘤医院骨与软组织肿瘤科，国家恶性肿瘤临床医学研究中心，天津 300060
  2. 天津市恶性肿瘤临床医学研究中心，天津市肿瘤防治重点实验室，天津市肿瘤分子流行病重点实验室，天津 300060
  3. 复旦大学附属肿瘤医院骨与软组织外科，复旦大学上海医学院肿瘤学系，上海 200032
  4. 中国科学院大学附属肿瘤医院（浙江省肿瘤医院）骨与软组织肿瘤科，浙江杭州 310022
- 作者简介：
  
  [ "李婷（ORCID: 0000-0001-8186-5783）；" ]
  [ "徐宇（ORCID：0000-0002-0894-5311）；" ]
  [ "贾东东（ORCID：0000-0002-6804-4988）；" ]
  陈勇（ORCID: 0000-0002-7188-4566）；
  李涛（ORCID：0000-0002-5924-0522）；
  [ "杨吉龙，主任医师，教授，博士研究生导师，现任天津医科大学肿瘤医院骨与软组织肿瘤科行政副主任。兼任中国抗癌协会黑色素瘤专业委员会候任主任委员、中国抗癌协会青年理事会常务理事、中国抗癌协会肉瘤专业委员会常务委员、中国抗癌协会肉瘤专业委员会基础及转化研究学组副组长、中国抗癌协会皮肤肿瘤专业委员会常务委员、天津市抗癌协会恶性黑色素瘤专业委员会主任委员、中国临床肿瘤学会恶性黑色素瘤专家委员会委员等。获天津市“131创新型人才”、天津市高校“中青年骨干创新人才”、 “全国卫生系统青年岗位能手”等称号。主要从事骨与软组织肉瘤以手术治疗为主的综合治疗，能熟练进行常见骨与软组织肿瘤的外科手术治疗及综合治疗，开展多项肉瘤靶向治疗的临床研究。精通恶性黑色素瘤的综合治疗。科研工作专注于肉瘤、恶性黑色素瘤的基因组学、转化医学及精准治疗研究，探讨肉瘤的发病机制并筛选生物标志物，寻找肉瘤特异性治疗的靶点，在骨肉瘤、平滑肌肉瘤、恶性周围神经鞘瘤等方面处于国内领先和国际先进地位。主持或参与省部级以上课题10项，主编或参编专著13部，获省部级以上科技奖励4项。培养多名博士及硕士研究生，培养的研究生曾多人次获国家奖学金、天津医科大学优秀研究生、天津医科大学优秀毕业研究生等荣誉。" ]
- 基金信息：
  
  天津市教委科研计划项目(2021KJ199);天津市卫生健康科研项目(TIWJ2022QN014);天津市医学重点学科（专科）建设项目(TJYXZDXK-009A)
- DOI：10.19401/j.cnki.1007-3639.2022.12.002
  中图分类号： R739.5
- 收稿：2022-09-26，
  
  修回：2022-11-29，
  
  纸质出版：2022-12-30
- 稿件说明：
移动端阅览
李婷, 徐宇, 贾东东, 等. Ⅲ期恶性黑色素瘤患者术后辅助抗PD-1 vs 靶向治疗：中国多中心真实世界数据分析[J]. 中国癌症杂志, 2022,32(12):1147-1157.

Ting LI, Yu XU, Dongdong JIA, et al. Adjuvant therapy with anti-PD-1 antibody vs targeted therapy for patients with resected stage Ⅲ malignant melanoma: a real-world data analysis from China centers[J]. China Oncology, 2022, 32(12): 1147-1157.
李婷, 徐宇, 贾东东, 等. Ⅲ期恶性黑色素瘤患者术后辅助抗PD-1 vs 靶向治疗：中国多中心真实世界数据分析[J]. 中国癌症杂志, 2022,32(12):1147-1157. DOI： 10.19401/j.cnki.1007-3639.2022.12.002.

Ting LI, Yu XU, Dongdong JIA, et al. Adjuvant therapy with anti-PD-1 antibody vs targeted therapy for patients with resected stage Ⅲ malignant melanoma: a real-world data analysis from China centers[J]. China Oncology, 2022, 32(12): 1147-1157. DOI： 10.19401/j.cnki.1007-3639.2022.12.002.

摘要

背景与目的：

众多的临床试验结果表明，抗程序性死亡[蛋白

]

-1（programmed death-1，PD-1）治疗及靶向治疗均可显著延长Ⅲ期恶性黑色素瘤患者术后的无复发生存时间（recurrence-free survival，RFS）。然而，抗PD-1辅助治疗在中国真实世界中的治疗效果尚未见文献报道。本研究旨在总结分析中国Ⅲ期恶性黑色素瘤患者术后接受抗PD-1辅助治疗的RFS，并与

BRAF

V600

抑制剂vemurafenib进行初步对比分析。

方法：

回顾性分析2018年8月30日—2020年8月30日来自中国3所癌症中心的120例已经切除的Ⅲ期恶性黑色素瘤患者的临床信息。这些患者都接受了术后辅助性的pembrolizumab/toripalimab或vemurafenib治疗。采用Kaplan-Meier曲线评估RFS，采用log-r

ank检验来判断差异是否有统计学意义。

结果：

在接受辅助性抗PD-1治疗的90例Ⅲ期恶性黑色素瘤患者中，中位RFS（median-RFS，mRFS）为16个月（95% CI：14~18个月）；12个月RFS率为69.5%（95% CI：64.6%~74.4%），24个月RFS率为45.8%（95% CI：40.5%~51.1%）。30例接受vemurafenib治疗的Ⅲ期恶性黑色素瘤患者中，mRFS为18个月（95% CI：10~21个月），12个月RFS率为62.8%（95% CI：54.0%~71.6%），24个月RFS率为35.9%（95% CI：27.1%~44.7%）。分层分析初步结果显示，抗PD-1治疗组和vemurafenib组的RFS没有明显差异。其次，

BRAF

V600E

是否突变可能不影响抗PD-1治疗的RFS。另外，在本研究中，对于

BRAF

V600E

突变的患者，术后接受抗PD-1治疗或vemurafenib，其RFS差异无统计学意义。最后，虽然皮肤型恶性黑色素瘤患者的RFS优于肢端型患者，来源不明患者的RFS最差，但在中国真实世界中，抗PD-1辅助治疗的治疗效果仍较差。

结论：

作为中国Ⅲ期恶性黑色素瘤患者辅助抗PD-1治疗的真实世界数据，在本研究中，辅助性抗PD-1治疗与辅助vemurafenib治疗效果的差异并无统计学意义，提示对于中国Ⅲ期恶性黑色素瘤患者，我们可能仍然需要探索更多的联合治疗来改善其辅助治疗的效果。

Abstract

Background and purpose:

Anti-programmed death-1 (anti-PD-1) adjuvant therapy and targeted therapy have resulted in longer recurrence-free survival (RFS) for malignant melanoma patients in clinical trials. However

the efficacy of adjuvant anti-PD-1 therapy in Chinese melanoma patients has not been previously reported. The purpose of this study was to retrospectively analyze the RFS in Chinese resected stage Ⅲ malignant melanoma patients treated with adjuvant anti-PD-1 therapy and to preliminarily compare it with

BRAF

V600

inhibitor vemurafenib.

Methods:

This study retrospectively collected the information of 120 patients with resected stage Ⅲ malignant melanoma from three major cancer centers in China from August 30

2018 to August 30

2020. These patients received adjuvant pembrolizumab/toripalimab or vemurafenib. RFS rates were assessed by Kaplan-Meier curves and log-rank tests were used to examined differences.

Results:

Among the 90 patients with stage Ⅲ malignant melanoma receiving adjuvant anti-PD-1 therapy

the median-RFS (mRFS) was 16 months (95% CI: 14-18 months); the 12-month RFS rate was 69.5% (95% CI: 64.6%-74.4%) and the 24-month RFS rate was 45.8% (95% CI

: 40.5%-51.1%). The mRFS for 30 patients who received vemurafenib was 18 months (95% CI: 10-21 months)

the 12-month RFS rate was 62.8% (95% CI: 54.0%-71.6%)

and the 24-month RFS rate was 32.9% (95% CI: 27.1%-44.7%). In the stratified analysis

firstly

there was no difference in RFS between anti-PD-1 therapy group and vemurafenib group. Secondly

the

BRAF

V600E

mutation status may did not affect the RFS of anti-PD-1 therapy. In addition

in this study

for the patients with

BRAF

V600E

mutation

the RFS showed no difference between these patients received anti-PD-1 therapy or vemurafenib. Finally

although the RFS was better in patients with cutaneous melanoma than in patients with acral and worst in patients of unknown origin

the data for adjuvant therapy in China were still poor.

Conclusion:

These are the real-world data from adjuvant anti-PD-1 therapy in patients with resected stage Ⅲ cutaneous and acral melanoma patients in China. In our study

adjuvant anti-PD-1 therapy is indistinguishable from vemurafenib indicates more combination therapies are needed to improve outcome in China.

关键词

Keywords

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Adjuvant therapy with anti-PD-1 antibody vs targeted therapy for patients with resected stage Ⅲ malignant melanoma: a real-world data analysis from China centers

DOI：10.19401/j.cnki.1007-3639.2022.12.002

摘要

Abstract

关键词

Keywords

references