Department of Surgical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, the Netherlands; Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.
Department of Surgical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, the Netherlands.
Eur J Cancer. 2023 May;185:131-138. doi: 10.1016/j.ejca.2023.03.003. Epub 2023 Mar 7.
Neoadjuvant systemic therapy has shown promising results in the treatment of high-risk stage III melanoma; however, the effects on surgery are currently unknown. This study aims to compare the surgical outcomes, in terms of postoperative complications, postoperative morbidity, duration of surgery and textbook outcomes, of patients with high-risk stage III melanoma who received neoadjuvant systemic therapy followed by lymph node dissection with patients who received an upfront lymph node dissection.
In this retrospective cohort study, patients with high-risk stage III melanoma treated with neoadjuvant anti-PD1 and anti-CTLA4 in the OpACIN (NCT02437279) and OpACIN-neo (NCT02977052) trial between October 2014 and August 2018 were included and compared to patients who received upfront surgery in the same time period.
A total of 120 patients were included in this study, of whom 44 received neoadjuvant systemic therapy and 76 underwent upfront surgery. There was no significant difference in the overall rate of postoperative complications between the neoadjuvant group and the upfront surgery group (31.8% versus 36.8%, p = 0.578) and neither in rate of postoperative morbidity (seroma 56.8% versus 57.9%, p = 0.908) (lymphedema 22.7% versus 13.2%, p = 0.175). There was a non-significant difference towards a slightly longer duration of surgery after neoadjuvant immunotherapy (105 versus 90 min, p = 0.077). There were no differences in textbook outcomes (50% versus 49%, p = 0.889).
This study shows that the surgical outcomes for patients who underwent a lymph node dissection after neoadjuvant systemic immunotherapy or underwent upfront lymph node dissection for high-risk stage III melanoma are comparable.
新辅助全身治疗在治疗高危 III 期黑色素瘤方面显示出良好的效果;然而,其对手术的影响目前尚不清楚。本研究旨在比较接受新辅助全身治疗后行淋巴结清扫术和直接行淋巴结清扫术的高危 III 期黑色素瘤患者的手术结果,包括术后并发症、术后发病率、手术持续时间和手术结果。
这是一项回顾性队列研究,纳入了 2014 年 10 月至 2018 年 8 月期间接受 OpACIN(NCT02437279)和 OpACIN-neo(NCT02977052)试验新辅助抗 PD-1 和抗 CTLA-4 治疗的高危 III 期黑色素瘤患者,并与同期直接手术的患者进行比较。
本研究共纳入 120 例患者,其中 44 例接受新辅助全身治疗,76 例直接手术。新辅助组和直接手术组的总体术后并发症发生率无显著差异(31.8% vs. 36.8%,p=0.578),术后发病率也无显著差异(血清肿 56.8% vs. 57.9%,p=0.908;淋巴水肿 22.7% vs. 13.2%,p=0.175)。新辅助免疫治疗后手术时间略长,但无统计学意义(105 分钟 vs. 90 分钟,p=0.077)。两组手术结果(完全切除率 50% vs. 49%,p=0.889)无差异。
本研究表明,接受新辅助全身免疫治疗后行淋巴结清扫术或直接行淋巴结清扫术的高危 III 期黑色素瘤患者的手术结果相当。