Department of Surgery, Duke University Medical Center, Durham, NC.
Department of Medicine, UVA, Charlottesville, VA.
Ann Surg. 2023 Jun 1;277(6):e1306-e1312. doi: 10.1097/SLA.0000000000005459. Epub 2022 Jul 7.
To determine the feasibility and impact of neoadjuvant therapy (NT) in patients who present with advanced melanoma amenable to surgical resection.
Given current effective systemic therapy for melanoma, the use of NT is being explored in patients with advanced melanoma with disease amenable to surgical resection.
Prospective data from 3 institutions was obtained in patients with clinically evident Stage III/IV melanoma who underwent NT. The primary objective was to compare recurrence-free survival between patients who had pathologic complete response (pCR) to those with persistent disease.
NT was offered to 45 patients, with 43 patients initiating various NT regimens including PD-1 antagonist (PD-1) therapy (N = 16), PD-1 plus ipilimumab (N = 10), BRAF/MEK inhibitor therapy (N = 14), a combination of those three (N = 1), and talimogene laherparepvec (TVEC) (N = 2). Thirty-two (74.1%) patients underwent surgery whereas 11 patients did not undergo surgery for these reasons: clinical CR (N = 7), progressive disease not amenable to resection (N = 3), and ongoing therapy (N = 1). 12 of 32 patients (37.5%) had pCR with these therapies: PD-1 (N = 4), PD-1 plus ipilimumab (N = 2), BRAF/MEK (N = 4), combination (N = 1), and TVEC (N = 1). At median follow-up of 16.4 months there was only 1 recurrence in the pCR group and patients with a pCR had significantly improved recurrence-free survival compared to patients without pCR (p = 0.004).
Despite variability in NT regimens across institutions, NT for melanoma is feasible and associated with improved prognosis in patients who achieve a pCR. Maximizing rates of pCR could improve prognosis for patients with advanced melanoma.
确定新辅助治疗(NT)在可手术切除的晚期黑色素瘤患者中的可行性和影响。
鉴于目前黑色素瘤有效的全身治疗方法,正在探索将 NT 应用于可手术切除的晚期黑色素瘤患者。
从 3 家机构获得了接受 NT 的临床明显 III/IV 期黑色素瘤患者的前瞻性数据。主要目的是比较病理完全缓解(pCR)患者与持续疾病患者的无复发生存率。
为 45 名患者提供了 NT,其中 43 名患者开始接受各种 NT 方案,包括 PD-1 拮抗剂(PD-1)治疗(N=16)、PD-1 加伊匹单抗(N=10)、BRAF/MEK 抑制剂治疗(N=14)、三者联合(N=1)和替莫唑胺拉滨(TVEC)(N=2)。32 名(74.1%)患者接受了手术,而 11 名患者因以下原因未接受手术:临床完全缓解(CR)(N=7)、不可切除的进展性疾病(N=3)和持续治疗(N=1)。12 名(37.5%)患者接受这些治疗后获得 pCR:PD-1(N=4)、PD-1 加伊匹单抗(N=2)、BRAF/MEK(N=4)、联合(N=1)和 TVEC(N=1)。在中位随访 16.4 个月时,pCR 组仅 1 例复发,与无 pCR 患者相比,pCR 患者的无复发生存率显著提高(p=0.004)。
尽管各机构的 NT 方案存在差异,但黑色素瘤的 NT 是可行的,并且与 pCR 患者的预后改善相关。最大限度地提高 pCR 率可以改善晚期黑色素瘤患者的预后。