title: Quality of life after isolated limb infusion for in-transit melanoma of the extremity.
abstract: BACKGROUND
  Isolated limb infusion (ILI) has been associated with persistent edema, numbness, pain, and functional impairment of the treated limb. However, health-related quality of life (HRQOL) has not yet been assessed using a validated questionnaire.
  
  
  METHODS
  Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires were collected from subjects enrolled a phase I ILI trial with temozolomide at baseline and 2, 6 weeks, and 3 months post-ILI. Of 28 enrolled patients, 19 patients received maximum tolerated dose of temozolomide and are included in the HRQOL analysis. Clinical and operative variables and treatment response data also were collected.
  
  
  RESULTS
  HRQOL scores showed a trend of improvement from baseline through 3-months post-ILI as measured by FACT-M and the melanoma surgery scores. There were no differences in HRQOL when patients were stratified by disease burden, clinical toxicity level, and 3-month disease response. Additionally, fewer patients complained of pain, numbness, and swelling of the affected limb at 3 months post-ILI compared to baseline, and also these symptoms were improved at the immediate postoperative visit compared with baseline.
  
  
  CONCLUSIONS
  Despite the known morbidity of ILI, we have demonstrated with a validated HRQOL questionnaire that HRQOL is not adversely impacted at therapeutic doses of temozolomide delivered intra-arterially from baseline through 3 months posttreatment. Patient centered-outcomes should be evaluated as a standard part of all future regional therapy trials using standardized melanoma-specific HRQOL questionnaires to more completely evaluate the utility of this type of treatment strategy.
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, NC, USA.
authors.forename: Betty S
authors.initials: BS
authors.lastname: Jiang
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Speicher
authors.forename: Samantha
authors.initials: S
authors.lastname: Thomas
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Mosca
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Tyler
mesh_terms: D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage*; D010478:Chemotherapy, Cancer, Regional Perfusion; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005121:Extremities; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007261:Infusions, Intra-Arterial; D008297:Male; D020714:Maximum Tolerated Dose; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D011788:Quality of Life; D000077204:Temozolomide
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide