A phase II trial of isolated limb infusion with melphalan and dactinomycin for regional melanoma and soft tissue sarcoma of the extremity Journal Article


Authors: Brady, M. S.; Brown, K.; Patel, A.; Fisher, C.; Marx, W.
Article Title: A phase II trial of isolated limb infusion with melphalan and dactinomycin for regional melanoma and soft tissue sarcoma of the extremity
Abstract: Background: Isolated limb infusion (ILI) is a minimally invasive technique of delivering regional chemotherapy in patients with advanced melanoma or soft tissue sarcoma of the limb. Reports from Australia of efficacy similar to that of isolated limb perfusion prompted us to conduct a phase II trial to evaluate the efficacy and safety of ILI. Methods: Eligible patients had American Joint Committee on Cancer stage IIIB or IIIC melanoma or unresectable soft tissue sarcoma of the limb. Angiographic catheters were positioned just above the knee or elbow of the extremity. General anesthesia was performed, a proximal tourniquet was inflated, and a normothermic, low-flow, hypoxic infusion of melphalan and dactinomycin was circulated through the involved limb for 20 minutes. The tumor response was assessed by using standard criteria at 3 months. Morbidity was determined in the hospital and at 2, 6, and 12 weeks. Results: Twenty-five patients were accrued to the trial, and 32 ILIs were performed (8 patients had 2 ILIs); 1 patient was not treated. Of the 22 assessable patients, 11 (50%) had a significant response at 3 months: 23% of patients had a complete response, and 27% of patients had a partial response. The median duration of complete response was 1 year (range, 6-32 months). Morbidity was acceptable. Peak morbidity occurred at 2 weeks and was considered moderate in most patients. Limb edema and erythema were common. No patient developed compartment syndrome or required amputation. Conclusions: ILI is well tolerated. Half of the patients experienced a complete or partial response. Published by Springer Science+Business Media, Inc. © 2006 The Society of Surgical Oncology, Inc.
Keywords: adult; clinical article; controlled study; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; clinical trial; dose response; drug efficacy; drug safety; treatment duration; cancer staging; melanoma; controlled clinical trial; phase 2 clinical trial; neoplasm recurrence, local; skin neoplasms; morbidity; melphalan; sarcoma; limb; peripheral edema; dactinomycin; compartment syndrome; drug infusion; elbow; erythema; general anesthesia; isolated limb infusion; knee; limb tumor; soft tissue sarcoma; chemotherapy, cancer, regional perfusion; extremities; regional chemotherapy; angiography; drug delivery system; limb amputation; limb perfusion
Journal Title: Annals of Surgical Oncology
Volume: 13
Issue: 8
ISSN: 1068-9265
Publisher: Springer  
Date Published: 2006-08-01
Start Page: 1123
End Page: 1129
Language: English
DOI: 10.1245/aso.2006.05.003
PUBMED: 16791448
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 43" - "Export Date: 4 June 2012" - "CODEN: ASONF" - "Source: Scopus"
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MSK Authors
  1. Karen T Brown
    172 Brown
  2. Mary Sue Brady
    184 Brady
  3. William L Marx
    15 Marx
  4. Ami Patel
    24 Patel
  5. Charles H Fisher
    6 Fisher