Real-World Efficacy and Safety of Anti-PD-1 Antibody Plus Apatinib and Temozolomide for Advanced Acral Melanoma.

IF 2.5 4区 医学 Q3 ONCOLOGY
Cancer Management and Research Pub Date : 2025-05-01 eCollection Date: 2025-01-01 DOI:10.2147/CMAR.S520937
Jiaran Zhang, Huichun Tian, Lili Mao, Caili Li, Xiaoting Wei, Junjie Gu, Xuan Wang, Li Zhou, Bin Lian, Bixia Tang, Xieqiao Yan, Siming Li, Chuanliang Cui, Zhihong Chi, Xinan Sheng, Jun Guo, Lu Si
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引用次数: 0

Abstract

Purpose: The combination of programmed cell death-1 (PD-1) blockade camrelizumab plus apatinib (an antiangiogenic agent) and temozolomide has displayed promising therapeutic effects in patients with advanced acral melanoma (AM) in a non-randomized Phase II clinical trial (NCT04397770). The aim of this retrospective study was to evaluate the efficacy and safety of the triplet regimen for advanced AM in the real-world setting.

Methods: The data of patients with advanced AM who received anti-PD-1 antibody plus apatinib and temozolomide at Peking University Cancer Hospital and Institute between September 2019 and December 2023 were analyzed. The primary endpoint was the overall response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and treatment-related adverse events (TRAEs).

Results: Overall, 250 patients were eligible for the analysis. The ORR was 38.1% and the DCR was 92.2%. The median PFS, OS, and DOR were 8.5, 18.0, and 13.2 months, respectively. When used as first-line treatment, the ORR was 48.1%, the median PFS was 12.0 months, and the median OS was 24.8 months. The number of lines of therapy (≥2 lines), elevated lactate dehydrogenase, and presence of brain or liver metastasis were negative predictors of survival. Overall, 92.4% and 45.2% of the patients experienced any-grade and grade 3-4 TRAEs, respectively.

Conclusion: This study provides real-world evidence that support the effectiveness and safety of combined anti-PD-1 antibody, apatinib and temozolomide for treating advanced AM, demonstrating a considerable ORR and prolonged survival, as well as acceptable tolerability.

抗pd -1抗体联合阿帕替尼和替莫唑胺治疗晚期肢端黑色素瘤的实际疗效和安全性。
目的:在一项非随机II期临床试验(NCT04397770)中,程序性细胞死亡-1 (PD-1)抑制剂camrelizumab联合阿帕替尼(一种抗血管生成药物)和替莫唑胺在晚期肢端黑色素瘤(AM)患者中显示出有希望的治疗效果。本回顾性研究的目的是评估在现实世界中三联疗法治疗晚期AM的有效性和安全性。方法:分析2019年9月至2023年12月在北京大学肿瘤医院及研究所接受抗pd -1抗体联合阿帕替尼和替莫唑胺治疗的晚期AM患者的资料。主要终点是总缓解率(ORR)。次要终点包括无进展生存期(PFS)、总生存期(OS)、疾病控制率(DCR)、反应持续时间(DOR)和治疗相关不良事件(TRAEs)。结果:总共有250例患者符合分析条件。ORR为38.1%,DCR为92.2%。中位PFS、OS和DOR分别为8.5、18.0和13.2个月。作为一线治疗时,ORR为48.1%,中位PFS为12.0个月,中位OS为24.8个月。治疗线数(≥2线)、乳酸脱氢酶升高、脑或肝转移的存在是生存的负面预测因素。总体而言,92.4%和45.2%的患者分别经历了任何级别和3-4级trae。结论:本研究提供了真实世界的证据,支持抗pd -1抗体、阿帕替尼和替莫唑胺联合治疗晚期AM的有效性和安全性,显示出可观的ORR和延长的生存期,以及可接受的耐受性。
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来源期刊
Cancer Management and Research
Cancer Management and Research Medicine-Oncology
CiteScore
7.40
自引率
0.00%
发文量
448
审稿时长
16 weeks
期刊介绍: Cancer Management and Research is an international, peer reviewed, open access journal focusing on cancer research and the optimal use of preventative and integrated treatment interventions to achieve improved outcomes, enhanced survival, and quality of life for cancer patients. Specific topics covered in the journal include: ◦Epidemiology, detection and screening ◦Cellular research and biomarkers ◦Identification of biotargets and agents with novel mechanisms of action ◦Optimal clinical use of existing anticancer agents, including combination therapies ◦Radiation and surgery ◦Palliative care ◦Patient adherence, quality of life, satisfaction The journal welcomes submitted papers covering original research, basic science, clinical & epidemiological studies, reviews & evaluations, guidelines, expert opinion and commentary, and case series that shed novel insights on a disease or disease subtype.
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