2006
DOI: 10.1200/jco.2005.05.5152
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Randomized Multicenter Trial of Hyperthermic Isolated Limb Perfusion With Melphalan Alone Compared With Melphalan Plus Tumor Necrosis Factor: American College of Surgeons Oncology Group Trial Z0020

Abstract: In locally advanced extremity melanoma treated with HILP, the addition of TNF-alpha to melphalan did not demonstrate a significant enhancement of short-term response rates over melphalan alone by the 3-month follow-up, and TNF-alpha plus melphalan was associated with a higher complication rate.

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Cited by 204 publications
(115 citation statements)
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“…19,20 The more aggressive therapy, HILP, which requires the surgical isolation of the vessels to be cannulated with higher doses of chemotherapy circulated throughout the extremity, results in complete response rates between 40% and 80%. 8,[21][22][23][24][25][26] The complete response rates in our cohort are similar to these other single-center studies, with complete responses in 30% of patients undergoing an ILI and in 44% of patients receiving an HILP. However, in our study, the rate of progressive disease, defined by the modified Response Evaluation Criteria in Solid Tumors 6 as an increase in size of a preexisting lesion by 20% or the appearance of a new lesion within 12 weeks of regional therapy, was 32% for the ILI cohort and 11% for HILP cohort.…”
Section: Commentsupporting
confidence: 72%
“…19,20 The more aggressive therapy, HILP, which requires the surgical isolation of the vessels to be cannulated with higher doses of chemotherapy circulated throughout the extremity, results in complete response rates between 40% and 80%. 8,[21][22][23][24][25][26] The complete response rates in our cohort are similar to these other single-center studies, with complete responses in 30% of patients undergoing an ILI and in 44% of patients receiving an HILP. However, in our study, the rate of progressive disease, defined by the modified Response Evaluation Criteria in Solid Tumors 6 as an increase in size of a preexisting lesion by 20% or the appearance of a new lesion within 12 weeks of regional therapy, was 32% for the ILI cohort and 11% for HILP cohort.…”
Section: Commentsupporting
confidence: 72%
“…Response rates for ILP with melphalan alone was lower than for melphalan and rhTNF alpha combined (46 % vs. 69 %). In a randomized trial comparing ILP with melphalan alone to ILP with melphalan and rhTNF alpha [439], no significant benefit was detected for combination therapy. However, the trial was aborted at the behest of the DSMB.…”
Section: Clinical Aspects With Regard To Indicationmentioning
confidence: 99%
“…For example, a prospective randomized clinical trial directly comparing hyperthermic ILP with single-agent melphalan to combination melphalan and TNF-alfa did not show a significant difference in response rate. 162 TNF-alfa is currently unavailable for use in the United States.…”
Section: Regional Therapy: Isolated Limb Perfusion and Infusionmentioning
confidence: 99%