Polkowska Marta, Ekk-Cierniakowski Paweł, Czepielewska Edyta, Wysoczański Wojciech, Matusewicz Wojciech, Kozłowska-Wojciechowska Małgorzata
Department of Clinical Pharmacy and Pharmaceutical Care, Faculty of Pharmacy, Medical University of Warsaw, Banacha St. 1, 02-097, Warsaw, Poland.
Agency for Health Technology Assessment and Tariff Systems, Warsaw, Poland.
J Cancer Res Clin Oncol. 2017 Oct;143(10):2087-2094. doi: 10.1007/s00432-017-2453-z. Epub 2017 Jun 12.
Recently, several new drugs have been licensed for advanced melanoma therapy, significantly changing the therapeutic landscape. Ipilimumab and vemurafenib were the first drugs that demonstrated a survival benefit over the long-standing standard therapy with dacarbazine. However, the comparative efficacy of these novel drugs has not been properly assessed yet.
We conducted a retrospective analysis of all the Polish population treated between January 2012 and October 2016 with one of the following agents: ipilimumab (IPI), vemurafenib (VEM), dabrafenib (DAB), and classic chemotherapy (CTH). The main objective was to assess the overall survival of melanoma patients treated in real-world conditions, taking into account sequences of treatment.
We identified 3397 patients with malignant melanoma treated for the first line and the second line. Patients receiving CTH were significantly older than those treated with the novel drugs. At the same time, the population treated with immunotherapy and targeted therapy was well balanced. Overall survival was significantly better for the novel drugs compared to classic chemotherapy in both lines (for the first line, VEM vs CTH HR = 0.72, 95% CI 0.65-0.81; p < .01, and for the second line, VEM vs CTH HR = 0.78, 95% CI 0.62-0.98; p = .03; IPI vs CTH HR = 0.72, 95% CI 0.62-0.86; p < .01). There was no statistically significant difference for IPI vs VEM; however, subgroup analysis revealed superior results in the case of the CTH-IPI over BRAFi-IPI sequence.
Novel drugs for melanoma provide a significant advantage in survival over classic chemotherapy. Comparative assessment of IPI and VEM indicated no difference, but only immunotherapy-treated patients achieved long-lasting results. Our data on sequential treatment indicate that immunotherapy might be a better option for the first line rather than targeted therapy, but that conclusion requires further studies of the best way to manage the treatment of melanoma patients.
最近，几种新药已被批准用于晚期黑色素瘤治疗，显著改变了治疗格局。伊匹单抗和维莫非尼是首批显示出比长期使用的达卡巴嗪标准疗法更具生存获益的药物。然而，这些新药的相对疗效尚未得到恰当评估。
我们对2012年1月至2016年10月期间接受以下药物之一治疗的所有波兰患者进行了回顾性分析：伊匹单抗（IPI）、维莫非尼（VEM）、达拉非尼（DAB）和经典化疗（CTH）。主要目的是在考虑治疗顺序的情况下，评估在现实世界中接受治疗的黑色素瘤患者的总生存期。
我们确定了3397例接受一线和二线治疗的恶性黑色素瘤患者。接受CTH治疗的患者比接受新药治疗的患者年龄显著更大。同时，接受免疫治疗和靶向治疗的人群分布均衡。在两条治疗线中，新药治疗的患者总生存期均显著优于经典化疗（一线治疗中，VEM与CTH相比，HR = 0.72，95% CI 0.65 - 0.81；p <.01；二线治疗中，VEM与CTH相比，HR = 0.78，95% CI 0.62 - 0.98；p =.03；IPI与CTH相比，HR = 0.72，95% CI 0.62 - 0.86；p <.01）。IPI与VEM之间无统计学显著差异；然而，亚组分析显示CTH - IPI序列的结果优于BRAFi - IPI序列。
黑色素瘤新药在生存方面比经典化疗具有显著优势。IPI和VEM的比较评估表明无差异，但只有接受免疫治疗的患者获得了持久疗效。我们关于序贯治疗的数据表明，免疫治疗可能是一线治疗比靶向治疗更好的选择，但这一结论需要对黑色素瘤患者治疗的最佳管理方式进行进一步研究。
