title: Toxicity and morbility after isolated lower limb perfusion in 242 chemo-hyperthermal treatments for cutaneous melanoma: the experience of the Tuscan Reference Centre.
abstract: BACKGROUND
  The aim of this retrospective study was to assess the results concerning the regional and systemic toxicity and complications in 242 chemo-hyperthermal treatments (HILPs) for lower limb melanoma.
  
  
  METHODS
  60 HILPs (G-A) were performed with mild HT plus L-PAM (10 mg/lt) +/- D-actimomycin; 74 HILPs (G-B) with true HT (40-41.8 degrees C) plus L-PAM (10 mg/lt) +/- D-act; 108 HILPs (G-C) with true HT plus L-PAM (10 mg/lt) +/- D-act plus L-PAM (5 mg/lt) additional bolus.
  
  
  RESULTS
  Limb toxicity was very low in G-A and in G-B; increasing toxicity (grade III = 37%) in G-C; no grade IV statistical difference was registered in all three groups, with percentage values among 1.6% and 2.7%. Systemic toxicity showed itself only in the haemopoietic parameters. No differences were registered in G-B vs G-A group. In G-C vs G-B a significative increase of systemic toxicity was seen in grade 3 (p < 0.05). Postoperative complications were acceptable. Local and systemic side-effects were transient; no permanent neurological limb deficit was registered. The postoperative mortality was recorded in 3/182 HILPs (1.6%) of the G-B and G-C groups.
  
  
  CONCLUSIONS
  These data suggested that the technical implementations reduced the occurrence and the severity of the side effects and complications. The essential requirement for HILP is the quality assurance of the procedures. Although higher regional and systemic toxicity were observed in the G-C group caused by L-PAM additional bolus, the safeness of the procedures under the true hyperthermal regimen and the time increase of the high L-PAM concentration have assured the treatment reliability along with the increased clinical efficacy expectations of the treatments.
authors.affiliation: Dept, of Medical and Surgical Critical Care, University of Florence, Regional Reference Centre of Tuscany for Locoregional Perfusional Therapies in Oncology, Florence, Italy. marcello.pace@unifi.it
authors.forename: Marcello
authors.initials: M
authors.lastname: Pace
authors.forename: Riccardo
authors.initials: R
authors.lastname: Gattai
authors.forename: Maria
authors.initials: M
authors.lastname: Matteini
authors.forename: Erminia Macera
authors.initials: EM
authors.lastname: Mascitelli
authors.forename: Paolo
authors.initials: P
authors.lastname: Bechi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000009:adverse effects*; D005260:Female; D006801:Humans; D035002:Lower Extremity; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D012189:Retrospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D055815:Young Adult