title: Analysis of factors influencing outcome in patients with in-transit malignant melanoma undergoing isolated limb perfusion using modern treatment parameters.
abstract: PURPOSE In-transit disease afflicts approximately 10% of patients with extremity melanoma; no single treatment approach has been uniformly accepted as the most effective. We report long-term outcomes in patients with in-transit extremity melanoma who underwent isolated limb perfusion (ILP) in an era of increasingly accurate staging, uniform operative and treatment conditions, and regular long-term follow-up. PATIENTS AND METHODS Between May 1992 and February 2005, 91 patients (median age, 57 years; 50 women, 41 men) underwent a 90-minute hyperthermic ILP (melphalan, 10 to 13 mg/L limb volume, tumor necrosis factor [TNF; n = 44], or interferon [n = 38]) using uniform operative technique and intraoperative leak monitoring. Patients were prospectively followed for response, in-field progression-free survival (PFS), and overall survival (OS). Parameters associated with in-field PFS and OS were analyzed by standard statistical methods. Results There was one operative death (1.1%). There were 62 complete responses (69%) and 23 partial responses (26%) in 90 assessable patients. At a median potential follow-up of 11 years, median in-field PFS was 12.4 months and median OS was 47.4 months; 5 and 10-year actuarial OS probabilities were 43% and 34%, respectively. Female sex and low tumor burden (< or = 20 lesions) were associated with prolonged in-field PFS (male:female hazard ratio [HR], 2.07; 95% CI, 1.27 to 3.38; 21+ v < or = 20 tumors HR, 2.29; 95% CI, 1.21 to 4.34; P < .011 for both). Female sex was associated with improved OS (P = .027; male:female HR, 1.82; 95% CI, 1.07 to 3.09). CONCLUSION In appropriately selected patients, ILP has clinical benefit. The use of TNF was not associated with improved in-field PFS, while female sex was associated with better survival.
authors.affiliation: Department of Surgery, University of Maryland School of Medicine, 22 South Greene St S4B05A, Baltimore, MD 21201, USA. HRAlexander@smail.umaryland.edu
authors.forename: H Richard
authors.initials: HR
authors.lastname: Alexander
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Fraker
authors.forename: David L
authors.initials: DL
authors.lastname: Bartlett
authors.forename: Steven K
authors.initials: SK
authors.lastname: Libutti
authors.forename: Seth M
authors.initials: SM
authors.lastname: Steinberg
authors.forename: Perry
authors.initials: P
authors.lastname: Soriano
authors.forename: Tatiana
authors.initials: T
authors.lastname: Beresnev
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D011446:Prospective Studies