Department of Cutaneous Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Department of Surgery, Royal Adelaide Hospital, University of Adelaide, Adelaide, SA, Australia.
Ann Surg Oncol. 2019 Aug;26(8):2486-2494. doi: 10.1245/s10434-019-07288-w. Epub 2019 Mar 25.
Isolated limb infusion (ILI) is a minimally invasive procedure for delivering high-dose regional chemotherapy to patients with locally advanced or in-transit melanoma located on a limb. The current international multicenter study evaluated the perioperative and long-term oncologic outcomes for patients who underwent ILI for stage 3B or 3C melanoma.
Patients undergoing a first-time ILI for stage 3B or 3C melanoma (American Joint Committee on Cancer [AJCC] 7th ed) between 1992 and 2018 at five Australian and four United States of America (USA) tertiary referral centers were identified. The primary outcome measures included treatment response, in-field (IPFS) and distant progression-free survival (DPFS), and overall survival (OS).
A total of 687 first-time ILIs were performed (stage 3B: n = 383, 56%; stage 3C; n = 304, 44%). Significant limb toxicity (Wieberdink grade 4) developed in 27 patients (3.9%). No amputations (grade 5) were performed. The overall response rate was 64.1% (complete response [CR], 28.9%; partial response [PR], 35.2%). Stable disease (SD) occurred in 14.5% and progressive disease (PD) in 19.8% of the patients. The median follow-up period was 47 months, with a median OS of 38.2 months. When stratified by response, the patients with a CR or PR had a significantly longer median IPFS (21.9 vs 3.0 months; p < 0.0001), DPFS (53.6 vs 12.7 months; p < 0.0001), and OS (46.5 vs 24.4 months; p < 0.0001) than the nonresponders (SD + PD).
This study is the largest to date reporting long-term outcomes of ILI for locoregionally metastatic melanoma. The findings demonstrate that ILI is effective and safe for patients with stage 3B or 3C melanoma confined to a limb. A favorable response to ILI is associated with significantly longer IFPS, DPFS, and OS.
孤立肢体灌注（ILI）是一种将高剂量区域化疗递送至位于肢体上的局部晚期或转移期黑色素瘤患者的微创程序。目前这项国际多中心研究评估了 1992 年至 2018 年期间在五个澳大利亚和四个美国的三个转诊中心接受 ILI 治疗的 IIIB 或 IIIC 期黑色素瘤患者的围手术期和长期肿瘤学结果。
确定了在五个澳大利亚和四个美国的三个转诊中心接受首次 IIIB 或 IIIC 期（美国癌症联合委员会[AJCC]第 7 版）黑色素瘤 ILI 治疗的患者。主要终点包括治疗反应、局部无进展生存期（IPFS）和远处无进展生存期（DPFS）和总生存期（OS）。
共进行了 687 次首次 ILI（III B 期：n=383，56%；III C 期：n=304，44%）。27 名患者出现明显的肢体毒性（Wieberdink 分级 4）（3.9%）。没有进行截肢（分级 5）。总缓解率为 64.1%（完全缓解[CR]，28.9%；部分缓解[PR]，35.2%）。14.5%的患者疾病稳定（SD），19.8%的患者疾病进展（PD）。中位随访时间为 47 个月，中位 OS 为 38.2 个月。根据反应分层，CR 或 PR 的患者中位 IPFS（21.9 与 3.0 个月；p<0.0001）、DPFS（53.6 与 12.7 个月；p<0.0001）和 OS（46.5 与 24.4 个月；p<0.0001）明显长于非缓解者（SD+PD）。
本研究是迄今为止报告的最大规模的局部转移性黑色素瘤 ILI 长期结果的研究。结果表明，ILI 对局限于肢体的 IIIB 或 III C 期黑色素瘤患者有效且安全。ILI 的良好反应与明显更长的 IFPS、DPFS 和 OS 相关。
