Fukushima Satoshi, Miyashita Azusa, Kimura Toshihiro, Kuriyama Haruka, Mizuhashi Satoru, Ichigozaki Yuki, Masuguchi Shinichi
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
J Dermatol. 2024 Mar;51(3):335-342. doi: 10.1111/1346-8138.17093. Epub 2024 Jan 11.
Numerous clinical trials have demonstrated a significant improvement in recurrence-free survival among melanoma patients receiving high-dose interferon-α, immune checkpoint inhibitors (pembrolizumab, nivolumab), and BRAF/MEK inhibitors (dabrafenib-trametinib). This study aimed to investigate whether these findings hold true in real-world conditions for patients with stage III and IV melanoma. In particular, the study explores the efficacy and side effects of adjuvant therapies, focusing on anti-PD-1 antibodies and BRAF/MEK inhibitors. While clinical trials have shown comparable efficacy, differences in side-effect profiles, especially the persistence of immune-related adverse events with anti-PD-1 antibodies, highlight the need for careful consideration in adjuvant settings. In the absence of established biomarkers for guiding adjuvant therapy decisions, it becomes imperative to transparently communicate the advantages and disadvantages of drug administration to patients. The study also delved into the impact of melanoma subtype and BRAF mutation status on the effectiveness of adjuvant therapy, emphasizing the need for further investigation.
大量临床试验表明，接受高剂量干扰素-α、免疫检查点抑制剂（帕博利珠单抗、纳武利尤单抗）以及BRAF/MEK抑制剂（达拉非尼-曲美替尼）治疗的黑色素瘤患者，其无复发生存期有显著改善。本研究旨在调查这些结果在III期和IV期黑色素瘤患者的实际临床情况中是否成立。具体而言，该研究探讨了辅助治疗的疗效和副作用，重点关注抗PD-1抗体和BRAF/MEK抑制剂。虽然临床试验显示了相当的疗效，但副作用特征的差异，尤其是抗PD-1抗体导致的免疫相关不良事件的持续性，凸显了在辅助治疗中需谨慎考虑的必要性。在缺乏指导辅助治疗决策的既定生物标志物的情况下，向患者透明地传达药物治疗的优缺点变得至关重要。该研究还深入探讨了黑色素瘤亚型和BRAF突变状态对辅助治疗效果的影响，强调了进一步研究的必要性。
