Regional Therapy for Recurrent Metastatic Melanoma Confined to the Extremity: Hyperthermic Isolated Limb Perfusion vs. Isolated Limb Infusion

Reintgen, Michael; Reintgen, Christian; Nobo, Christopher; Giuliano, Rosemary; Shivers, Steven C.; Reintgen, Douglas S.

doi:10.3390/cancers20100043

Cited by 10 publications

(8 citation statements)

References 11 publications

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“…29 However, we have demonstrated that Esmarch tourniquets can be utilized very effectively in ILI as an alternative to a pneumatic tourniquet to achieve a higher level of isolation. 23 In addition, we have safely performed nodal dissections in conjunction with an ILI after completing the regional treatment and correcting the patient’s coagulation status by reversing the heparinization with protamine.…”

Section: Discussionmentioning

confidence: 90%

Current Trends in Regional Therapy for Melanoma: Lessons Learned from 225 Regional Chemotherapy Treatments between 1995 and 2010 at a Single Institution

Raymond

Beasley

Broadwater

et al. 2011

Journal of the American College of Surgeons

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Background Hyperthermic isolated limb perfusion (HILP) and isolated limb infusion (ILI) are utilized to manage advanced extremity melanoma but no consensus exists as to which treatment is preferable and how to monitor patients post-treatment. Study Design Using a prospectively-maintained database, we reviewed our experience with melphalan based HILP (that included 62 first time and 10 second time) and ILI (that included 126 first time and 18 second time) procedures performed in 188 patients. PET/CT was obtained 3 months post regional treatment for one year and then every 6 months thereafter. Results The overall response rate (complete response (CR) + partial response (PR)) of HILP was 81% (80% CI: 73-87%) while the overall response rate from ILI was 43% (80% CI: 37-49%) for first time procedures only. HILP had a CR rate of 55% with a median duration of 32 months, while ILI had a CR rate of 30% with median duration of 24 months. Patients who experienced a regional recurrence after initial regional treatment were more likely to achieve a CR following repeat HILP (50%, n = 10) compared to repeat ILI (28%, n = 18). Although the spectrum of toxicity was similar for ILI and HILP, the likelihood of rare catastrophic complication of limb loss was greater with HILP (2/62) than ILI (0/122). PET/CT was effective for surveillance after regional therapy to identify regional nodal and pulmonary disease that was not clinically evident, but often amenable to surgical resection (25/49, 51% of cases). In contrast, PET/CT was not effective at predicting complete response to treatment with an accuracy of only 50%. Conclusions In the largest single institution regional therapy series reported to date, we found that while ILI is effective, and well-tolerated, HILP is a more definitive way to control advanced disease.

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Section: Discussionmentioning

confidence: 90%

Current Trends in Regional Therapy for Melanoma: Lessons Learned from 225 Regional Chemotherapy Treatments between 1995 and 2010 at a Single Institution

Raymond

Beasley

Broadwater

et al. 2011

Journal of the American College of Surgeons

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“…168,169 ILI is associated with lower rates of toxicity and morbidity compared with ILP, but retrospective comparisons of response and survival with ILP versus ILI have shown varying results. 168,[170][171][172][173][174] An analysis of 7 studies involving 576 patients, primarily with stage III disease and treated with melphalan/actinomycin D combination via ILI, showed an overall response rate of 73%, with complete response in 33% (range, 26%-44% across studies), partial response in 40% (33%-53%), and stable disease in 14%. 167 A smaller pooled analysis of 2 additional studies (N=58), one a noncomparative phase II study (ClinicalTrials.gov identifier: NCT00004250), showed similar overall response rates for stage IIIB versus stage IIIC disease (48% vs 40%), and similar 5-year survival rates (38% vs 52%).…”

Section: Regional Therapy: Isolated Limb Perfusion and Infusionmentioning

confidence: 99%

Melanoma, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology

Coit¹,

Thompson²,

Algazi³

et al. 2016

J Natl Compr Canc Netw

218

167

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OverviewIn 2016, an estimated 76,380 patients will be diagnosed with and approximately 10,130 patients will die of melanoma in the United States.1 However, these figures for new cases may represent a substantial underestimate, as many superficial and in situ melanomas treated in the outpatient setting are not reported. The incidence of melanoma continues to increase dramatically, at an overall rate of 33% for men and 23% women from 2002 to 2006.2 Melanoma is increasing in men more rapidly than any other malignancy, and in women more rapidly than any other malignancy except lung cancer. AbstractThis selection from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Melanoma focuses on adjuvant therapy and treatment of in-transit disease, because substantial changes were made to the recommendations for the 2016 update. Depending on the stage of the disease, options for adjuvant therapy now include biochemotherapy and highdose ipilimumab. Treatment options for in-transit disease now include intralesional injection with talimogene laherparepvec (T-VEC), a new immunotherapy. These additions prompted reassessment of the data supporting older recommended treatment options for adjuvant therapy and in-transit disease, resulting in extensive revisions to the supporting discussion sections. J Natl Compr Canc Netw 2016;14(4):450-473 NCCN Categories of Evidence and ConsensusCategory 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate. Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.All recommendations are category 2A unless otherwise noted.Clinical trials: NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Please NoteThe NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) are a statement of consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult the NCCN Guidelines ® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network ® (NCCN ® ) makes no representation or warranties of any kind regarding their content, use, or application and disclaims any responsibility for their applications or use in any way. The full NCCN Guidelines for Melanoma are not printed in this issue of JNCCN but can be accessed online at NCCN.org.© National Comprehensive Cancer Network, Inc. 2016, All rights reserved. The NCCN Guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. Disclosures for the NCCN Melanoma ...

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“…This therapy is technically challenging, requiring general anesthesia and an oxygenated extracorporeal cardiopulmonary bypass system. HILP has an ORR of 77% and is associated with moderate rates of postprocedure complications . A large phase III multicenter randomized study comparing adjuvant HILP in patients with resected high‐risk primary melanoma demonstrated a trend towards improved disease‐free survival although no significant benefit in OS corroborated in other studies .…”

Section: Discussionmentioning

confidence: 94%

“…Table summarizes the key data for each modality and presents the pooled results including the weighted ORR and meta‐analysis data. Assessed studies included: randomized controlled trials, nonrandomized phase I and II comparative and noncomparative studies, and prospective or retrospective case series (NHMRC levels II–IV evidence; Tables S2‐S9) . Only two therapies: amputation and topical imiquimod, were suitable for formal meta‐analysis ( I 2 value ≤ 40%).…”

Section: Resultsmentioning

confidence: 99%

“…HILP has an ORR of 77% and is associated with moderate rates of postprocedure complications. 35,77,78 A large phase III multicenter randomized study comparing adjuvant HILP in patients with resected high-risk primary melanoma demonstrated a trend towards improved disease-free survival although no significant benefit in OS corroborated in other studies. 40,79,80 Furthermore, a recent study also demonstrated that positive histopathological margins after the surgical excision of ITM metastases did not significantly affect the progression-free or OS of patients.…”

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confidence: 82%

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A systematic review and meta‐analysis of locoregional treatments for in‐transit melanoma

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Lonne

Sparks

et al. 2019

Journal of Surgical Oncology

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Background and Objectives In‐transit melanoma (ITM) metastases present a therapeutic challenge and management decisions can be difficult. There are multiple treatments available, with differing efficacy, and supported by different levels of evidence. The primary objective was to perform a systematic review and where suitable, a meta‐analysis of the literature reporting on the use of locoregional treatments for the management of ITM. Methods An independent review was conducted including a comprehensive search of the National Library of Medicine using PubMed, MEDLINE, Embase, and Cochrane Library databases. Key data were tabulated, synthesized and pooled to calculate relevant weighted effect sizes for each therapy using random‐effect models. The statistical heterogeneity was calculated using the Higgins' method. Results Of the initial 32 612 articles identified, 57 original articles satisfied eligibility criteria. Eight treatment modalities were identified comprising: amputation (7); hyperthermic isolated limb perfusion (15); isolated limb infusion (8); carbon dioxide laser (9); PV‐10 intralesional therapy (5); IL‐2 intralesional therapy (8); imiquimod (7); diphenylcyclopropenone (3). Only amputation and topical imiquimod were suitable for formal meta‐analysis. Conclusions All of the assessed therapies have significant selection bias. Variable levels of evidence support the ongoing use of locoregional treatments and these may significantly improve disease‐free survival.

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Regional Therapy for Recurrent Metastatic Melanoma Confined to the Extremity: Hyperthermic Isolated Limb Perfusion vs. Isolated Limb Infusion

Cited by 10 publications

References 11 publications

Current Trends in Regional Therapy for Melanoma: Lessons Learned from 225 Regional Chemotherapy Treatments between 1995 and 2010 at a Single Institution

Current Trends in Regional Therapy for Melanoma: Lessons Learned from 225 Regional Chemotherapy Treatments between 1995 and 2010 at a Single Institution

Melanoma, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology

A systematic review and meta‐analysis of locoregional treatments for in‐transit melanoma

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