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Neoadjuvant Immune Checkpoint Inhibitor Therapy in Melanoma: Efficacy, Safety and Timing.
BioDrugs ( IF 5.4 ) Pub Date : 2022-04-09 , DOI: 10.1007/s40259-022-00525-x
Alexander C J van Akkooi 1, 2, 3 , Lisanne P Zijlker 4 , Michel W J M Wouters 4, 5
Affiliation  

The introduction of effective systemic therapies has significantly changed the treatment of stage III and IV melanoma. Both immune checkpoint inhibitors and targeted therapies have improved recurrence-free survival in the adjuvant setting. Recent interest has sparked for neoadjuvant systemic therapy with immune checkpoint inhibitors. The intended benefit of pre-operative treatment with immunotherapy is amongst others to enable tailoring of the surgery and adjuvant systemic therapy according to the treatment response. Most importantly, recurrence-free survival might be improved by neoadjuvant systemic therapy over the current standard of care of surgery followed by adjuvant systemic therapy. The first phase I and II trials investigating anti-PD1 inhibitors, both as a single agent and in combination with anti-CTLA-4 inhibitors or other therapeutic agents, have shown promising results. Pathological complete response on neoadjuvant systemic therapy seems a valid surrogate endpoint for relapse-free and overall survival. Pathological complete response rates in these trials vary between 30 and 70%. The optimal dose with respect to efficacy and toxicity and the interval between systemic and surgical treatment remain important issues to address. Accumulating follow-up data and ongoing phase III studies must prove if neoadjuvant systemic therapy is superior to surgery followed by standard-of-care adjuvant therapy.

中文翻译:


黑色素瘤的新辅助免疫检查点抑制剂治疗:功效、安全性和时机。



有效的全身疗法的引入显着改变了 III 期和 IV 期黑色素瘤的治疗。免疫检查点抑制剂和靶向治疗都改善了辅助治疗中的无复发生存率。最近人们对免疫检查点抑制剂的新辅助全身治疗产生了兴趣。术前免疫疗法治疗的预期好处之一是能够根据治疗反应调整手术和辅助全身治疗。最重要的是,与目前手术后辅助全身治疗的护理标准相比,新辅助全身治疗可能会改善无复发生存率。第一个 I 期和 II 期试验研究了抗 PD1 抑制剂,无论是作为单一药物还是与抗 CTLA-4 抑制剂或其他治疗药物联合使用,都显示出有希望的结果。新辅助全身治疗的病理学完全缓解似乎是无复发生存和总生存的有效替代终点。这些试验中的病理完全缓解率在 30% 至 70% 之间。就疗效和毒性而言的最佳剂量以及全身治疗和手术治疗之间的间隔仍然是需要解决的重要问题。不断积累的随访数据和正在进行的 III 期研究必须证明新辅助全身治疗是否优于手术后标准护理辅助治疗。
更新日期:2022-04-09
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