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孤立肢体灌注或输注作为一线与二线治疗方案用于治疗移行性转移性黑色素瘤

Isolated Limb Infusion or Perfusion as First-Line Versus Second-Line Therapy for In-Transit Metastatic Melanoma.

作者信息

Dugan Michelle M, Boby Aleena, Ghali Helana, Aflatooni Shaliz, DePalo Danielle K, Huibers Anne, Fan Wenyi, Olofsson Bagge Roger, Zager Jonathan S

机构信息

Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, FL, USA.

University of South Florida Morsani College of Medicine, Tampa, FL, USA.

出版信息

Ann Surg Oncol. 2025 May 10. doi: 10.1245/s10434-025-17403-9.

Abstract

BACKGROUND

In-transit metastases (ITM) develops in 10% of patients with high-risk melanoma. Isolated limb infusion and perfusion (ILI/ILP) are well-established therapies for ITM, but the ideal line of therapy has not been defined. This study compared ILI/ILP as first- versus second-line therapy.

METHODS

An international multi-institution retrospective study reviewed patients with unresectable ITM who underwent ILI/ILP from 2006 to 2023.

RESULTS

The study was comprised of 364 patients (55% female) with a median age of 71 years. Of the 364 patients, 329 (90%) were treated with ILI/ILP as first-line therapy, and 35 (10%) were treated with ILI/ILP as second-line therapy. The median follow-up period was 3 years. Lower-extremity disease was present in 85% (n = 310) of the patients. The best response for ILI/ILP as any line of therapy was 54% complete response (CR), 29 % partial response (PR), 8.2% stable disease (SD), and 9.1% progressive disease (PD). The CR/PR/SD/PD rates for first- versus second-line therapy were respectively 55%/ 29%/ 7.5%/ 8.2% versus 41%/ 26%/ 15%/ 18% (P = 0.09). As first-line therapy, ILI/ILP was associated with a significantly higher overall response rate (ORR) of 84% versus 68% (odds ratio [OR], 2.9; 95% confidence interval [CI], 1.2-6.9; P = 0.02). The comparison showed no statistical difference in median in-field progression-free survival (PFS) (10.8 vs. 8.1 months; P = 0.2), out-of-field PFS (13.5 vs. 15.3 months; P = 0.4), or overall survival (OS) (4.1 vs. 4.5 years; P = 0.7).

CONCLUSION

For patients with unresectable melanoma ITM, ILI/ILP either as first- or second-line therapy provides high overall response rates. Although first-line therapy had a higher ORR, this did not translate to a difference in in-field PFS, indicating that ILI/ILP is indeed an effective salvage therapy also as second-line therapy.

摘要

背景

10%的高危黑色素瘤患者会发生途中转移(ITM)。孤立肢体灌注和输注(ILI/ILP)是治疗ITM的成熟疗法,但理想的治疗方案尚未明确。本研究比较了ILI/ILP作为一线与二线治疗的效果。

方法

一项国际多机构回顾性研究,对2006年至2023年接受ILI/ILP治疗的不可切除ITM患者进行了分析。

结果

该研究纳入了364例患者(55%为女性),中位年龄71岁。364例患者中,329例(90%)接受ILI/ILP作为一线治疗,35例(10%)接受ILI/ILP作为二线治疗。中位随访期为3年。85%(n = 310)的患者存在下肢疾病。ILI/ILP作为任何一线治疗的最佳缓解率为54%完全缓解(CR)、29%部分缓解(PR)、8.2%疾病稳定(SD)和9.1%疾病进展(PD)。一线与二线治疗的CR/PR/SD/PD率分别为55%/29%/7.5%/8.2%和41%/26%/15%/18%(P = 0.09)。作为一线治疗,ILI/ILP的总缓解率(ORR)显著更高,为84%,而二线治疗为68%(优势比[OR],2.9;95%置信区间[CI],1.2 - 6.9;P = 0.02)。比较显示,中位瘤内无进展生存期(PFS)(10.8个月对8.1个月;P = 0.2)、瘤外PFS(13.5个月对15.3个月;P = 0.4)或总生存期(OS)(4.1年对4.5年;P = 0.7)无统计学差异。

结论

对于不可切除的黑色素瘤ITM患者,ILI/ILP作为一线或二线治疗均能提供较高的总缓解率。虽然一线治疗的ORR更高,但这并未转化为瘤内PFS的差异,表明ILI/ILP作为二线治疗确实也是一种有效的挽救治疗方法。

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