Mengoni Miriam, Gaffal Evelyn, Braun Andreas Dominik
Klinik für Dermatologie, Allergologie und Venerologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Deutschland.
Universitätshautklinik Magdeburg, Universitätsklinikum Magdeburg A. ö. R., Leipziger Straße 44, 39120, Magdeburg, Deutschland.
Dermatologie (Heidelb). 2025 Jun;76(6):345-353. doi: 10.1007/s00105-025-05507-y. Epub 2025 May 22.
The introduction of adjuvant treatment with immune checkpoint inhibitors (ICI) and BRAF/MEK inhibitors has significantly improved recurrence-free (RFS) and distant metastasis-free survival (DMFS) for melanoma patients. However, a significant improvement in overall survival (OS) has currently not been demonstrated in phase III clinical trials. Furthermore, not all patients benefit from adjuvant systemic therapy. For these patients, perioperative and neoadjuvant systemic therapy represent a promising new therapeutic approach.
In this review, we explore the origins of neoadjuvant and perioperative therapy for melanoma therapy and describe the current state of clinical trials. We also address the opportunities and hurdles for the integration of these novel therapy concepts into routine clinical practice.
Current studies have shown an improved RFS and DMFS for patients with melanoma ≥ stage IIIB treated with neoadjuvant and perioperative systemic therapies compared to adjuvant systemic therapy. Pathologic response is proving to be an excellent prognostic marker for the success of neoadjuvant therapy. ICI appears to be superior to treatment with BRAF/MEK inhibitors in the neoadjuvant setting and therefore constitutes the current preferred neoadjuvant treatment strategy.
The efficacy of perioperative and neoadjuvant systemic therapies in melanoma patients suggests that these therapy concepts should be integrated into routine patient care. However, neoadjuvant and perioperative therapies are only available for patients with resectable metastases, and the current lack of approval represents an obstacle to the use of neoadjuvant systemic therapies in routine care in Germany.
免疫检查点抑制剂(ICI)和BRAF/MEK抑制剂辅助治疗的引入显著改善了黑色素瘤患者的无复发生存期(RFS)和无远处转移生存期(DMFS)。然而,目前III期临床试验尚未证明总生存期(OS)有显著改善。此外,并非所有患者都能从辅助全身治疗中获益。对于这些患者,围手术期和新辅助全身治疗是一种有前景的新治疗方法。
在本综述中,我们探讨黑色素瘤治疗中新辅助和围手术期治疗的起源,并描述当前的临床试验状况。我们还讨论了将这些新治疗概念整合到常规临床实践中的机会和障碍。
目前的研究表明,与辅助全身治疗相比,接受新辅助和围手术期全身治疗的≥IIIB期黑色素瘤患者的RFS和DMFS有所改善。病理反应被证明是新辅助治疗成功的优秀预后标志物。在新辅助治疗中,ICI似乎优于BRAF/MEK抑制剂治疗,因此构成了当前首选的新辅助治疗策略。
围手术期和新辅助全身治疗对黑色素瘤患者的疗效表明,这些治疗概念应整合到常规患者护理中。然而,新辅助和围手术期治疗仅适用于有可切除转移灶的患者,目前缺乏批准是德国在常规护理中使用新辅助全身治疗的障碍。