Retrospective analysis of adjuvant therapy with dabrafenib and trametinib for 24 patients with malignant melanoma

Dongdong JIA; Tao LI

doi:10.19401/j.cnki.1007-3639.2022.12.005

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Retrospective analysis of adjuvant therapy with dabrafenib and trametinib for 24 patients with malignant melanoma

Specialists' Article | 更新时间：2025-12-31

- Retrospective analysis of adjuvant therapy with dabrafenib and trametinib for 24 patients with malignant melanoma
- China Oncology Vol. 32, Issue 12, Pages: 1178-1183(2022)
- 作者机构：
  
  中国科学院大学附属肿瘤医院（浙江省肿瘤医院）骨与软组织肿瘤外科，中国科学院基础医学与肿瘤研究所，浙江杭州 310005
- 作者简介：
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2022.12.005
  CLC： R739.5
- Received：09 November 2022，
  
  Revised：2022-12-01，
  
  Published：30 December 2022
- 稿件说明：
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Dongdong JIA, Tao LI. Retrospective analysis of adjuvant therapy with dabrafenib and trametinib for 24 patients with malignant melanoma[J]. China Oncology, 2022, 32(12): 1178-1183.
DOI：

Dongdong JIA, Tao LI. Retrospective analysis of adjuvant therapy with dabrafenib and trametinib for 24 patients with malignant melanoma[J]. China Oncology, 2022, 32(12): 1178-1183. DOI： 10.19401/j.cnki.1007-3639.2022.12.005.

摘要

背景与目的：

恶性黑色素瘤是最致命的皮肤恶性肿瘤。Ⅲ期黑色素瘤术后复发的风险相对较高，本文回顾性分析了达拉非尼联合曲美替尼作为辅助治疗对携带有

BRAF

突变的中国Ⅲ期恶性黑色素瘤患者的疗效及安全性。

方法：

回顾性分析2019年8月—2022年4月在浙江省肿瘤医院收治的24例接受曲美替尼联合达拉非尼辅助治疗的Ⅲ期皮肤及肢端恶性黑色素瘤的患者。

结果：

在24例患者中，7例为黑色素瘤ⅢB期，11例为ⅢC期，3例为ⅢD期，3例为Ⅲ期（具体分期不明）。截至2022年10月1日，有12例（50.0%）患者完成了1年的辅助治疗。全部24例患者中有5例（20.8%）报告肿瘤复发。1年无复发生存（relapse-free survival，RFS）率为76.2%（95% CI：65.2% ~ 87.2%）。在皮肤黑色素瘤亚组中，1年RFS率为81.6%（95% CI：71.6% ~ 91.6%）。2例在辅助治疗期间复发，3例患者在完成治疗方案后复发。20例患者（83.3%）报告了至少一次不良事件，其中7例患者（29.2%）发生了3级或4级的严重不良反应。最常见的不良反应是发热、疲劳和恶心。有4例患者发生了脂膜炎，主要累及大腿及上肢。1例患者（4.2%）因不良事件导致永久停药，2例患者（8.3%）因不良事件导致剂量调整，7例患者（29.2%）因不良事件导致用药中断。

结论：

本研究结果显示，达拉非尼联合曲美替尼辅助治疗可使

BRAF

V600

突变的Ⅲ期黑色素瘤患者短期获益，耐受性良好。

Abstract

Background and purpose:

Melanoma is the most lethal cutaneous malignant tumor. Patients with resected stage Ⅲ melanomas have a high risk of recurrence after surgery. This study retrospectively analyzed the efficacy and safety of dabrafenib combined with trametinib in the adjuvant setting for stage Ⅲ melanoma patients with BRAF mutation in China.

Methods:

A retrospective analysis was performed on 24 patients with stage Ⅲ cutaneous and acral malignant melanoma who received adjuvant treatment with trametinib and dabrafenib in Zhejiang Cancer Hospital from August 2019 to April 2022.

Results:

Of the 24 patients

7 were stage Ⅲ B

11 were stage Ⅲ C

3 were stage Ⅲ D

and 3 were stage Ⅲ (the specific stage was unknown). As of October 1

2022

12 patients (50.0%) had completed the protocol for one year. Of the 24 patients

5 (20.8%) patients relapsed. The The 1-year recurrence-free survival (RFS) rate was 76.2% (95% CI: 65.2%-87.2%). In the cutaneous melanoma subgroup

the 1-year RFS rate was 81.6% (95% CI: 71.6%-91.6%). Two patients relapsed during adjuvant therapy

and three patients relapsed after completing the

protocol. Twenty patients (83.3%) reported at least one adverse event

of which 7 patients (29.2%) had grade 3 or grade 4 serious adverse reactions. The most common adverse reactions were fever

fatigue and nausea. Panniculitis occurred in 4 patients

mainly involving thighs and upper limbs. One patient (4.2%) permanently stopped taking the drug due to adverse events

the dose was adjusted in 2 patients (8.3%) due to adverse events

and drug treatment was interrupted in 7 patients (29.2%) due to adverse events.

Conclusion:

This study confirmed the short-term benefit and good tolerance of the adjuvant therapy with dabrafenib combined with trametinib in Chinese patients with stage Ⅲ melanoma with

BRAF

V600

mutation.

关键词

Keywords

references

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