Department of Clinical Oncology, Clinical Oncology Clinic, Maria Sklodowska-Curie National Research Institute of Oncology, Cracow Branch, Garncarska 11, 31-115, Cracow, Poland.
Department of Clinical Oncology, Wroclaw Comprehensive Cancer Center, Wroclaw, Poland.
Target Oncol. 2023 Mar;18(2):235-245. doi: 10.1007/s11523-023-00954-w. Epub 2023 Mar 11.
Combined treatment with BRAFi and/or MEK inhibitors (MEKi) improves outcomes in advanced melanoma patients in comparison with monotherapy.
We aim to report real-world treatment efficacy and safety of vemurafenib (V) and vemurafenib + cobimetinib (V + C) from 10 years of practice.
A total of 275 consecutive patients with unresectable or metastatic BRAF mutated melanoma started first-line V or V + C treatment between 1 October 2013 and 31 December 2020. Survival analyses were performed using the Kaplan-Meier method, and Log-rank and Chi-square tests were used for comparison between groups.
The estimated median overall survival (mOS) was 10.3 months in the V group, and 12.3 months in the V + C group (p = 0.0005; HR = 1.58, 95% CI 1.2-2.1), although the latter group of patients had lactate dehydrogenase elevated numerically more often. Estimated median progression-free survival (mPFS) was 5.5 months in the V group, and 8.3 months in the V + C group (p = 0.0002; HR = 1.62, 95% CI 1.3-2.1). Complete response, partial response, stable disease, and progressive disease as best responses were recorded in the V/V + C groups in 7%/10%, 52%/46%, 26%/28%, and 15%/16% of patients, respectively. The numbers of patients with any grade of adverse effects were similar in both groups.
We confirmed significant improvement in the mOS and mPFS of unresectable and/or metastatic BRAF mutated-melanoma patients treated outside clinical trials with V + C as compared with V, with no major increase in toxicity for the combination.
与单药治疗相比，联合 BRAFi 和/或 MEKi 治疗可改善晚期黑色素瘤患者的预后。
我们旨在报告从 10 年实践中获得的 vemurafenib（V）和 vemurafenib+ cobimetinib（V+C）的真实世界治疗疗效和安全性。
2013 年 10 月 1 日至 2020 年 12 月 31 日期间，共 275 例不可切除或转移性 BRAF 突变黑色素瘤患者连续入组，接受一线 V 或 V+C 治疗。采用 Kaplan-Meier 法进行生存分析，组间比较采用 Log-rank 和 Chi-square 检验。
V 组的估计中位总生存期（mOS）为 10.3 个月，V+C 组为 12.3 个月（p=0.0005；HR=1.58，95%CI 1.2-2.1），尽管后者组患者的乳酸脱氢酶升高的比例更高。V 组的估计中位无进展生存期（mPFS）为 5.5 个月，V+C 组为 8.3 个月（p=0.0002；HR=1.62，95%CI 1.3-2.1）。V/V+C 组患者的最佳反应分别为完全缓解、部分缓解、稳定疾病和进展性疾病，比例分别为 7%/10%、52%/46%、26%/28%和 15%/16%。两组患者发生任何级别不良反应的人数相似。
与 V 相比，V+C 可显著改善不可切除和/或转移性 BRAF 突变黑色素瘤患者的 mOS 和 mPFS，且联合用药毒性无明显增加。
