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Clinical Trial
. 2015 May;22(5):1694-700.
doi: 10.1245/s10434-014-3979-9. Epub 2014 Aug 14.

Quality of life after isolated limb infusion for in-transit melanoma of the extremity

Betty S Jiang  1 , Paul J Speicher, Samantha Thomas, Paul J Mosca, Amy P Abernethy, Douglas S Tyler
Affiliations
Clinical Trial

Quality of life after isolated limb infusion for in-transit melanoma of the extremity

Betty S Jiang et al. Ann Surg Oncol. 2015 May.

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.

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Figures

FIGURE 1
FIGURE 1
HRQOL scores over time, with number of surveys available at each time point (a FACT-M score over time; b Trial outcome index score over time). Mean of the score and 95 % confidence interval are presented for each time point.
FIGURE 2
FIGURE 2
FACT-M score over time by clinical characteristics (a by disease burden; b by greatest clinical toxicity level; c by 3-month final response). Mean of the score and 95 % confidence interval are presented for each time point.
FIGURE 3
FIGURE 3
Percentage of patients reporting pain (a), numbness (b), or swelling (c) over time.
See this image and copyright information in PMC

References

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