Economic Evaluation of Inguinal Versus Ilio-inguinal Lymphadenectomy for Patients with Stage III Metastatic Melanoma to Groin Lymph Nodes: Evidence from the EAGLE FM Randomized Trial.

PURPOSE

We compared health outcomes and costs of inguinal lymphadenectomy (IL) versus ilio-inguinal lymphadenectomy (I-IL) for removal of metastatic melanoma to lymph nodes of the groin in adults with stage III melanoma.

METHODS

A within-trial cost-utility analysis was performed alongside an international randomized trial (EAGLE-FM) with 36 months follow-up from a health system perspective. Healthcare costs were measured by using trial records, and effectiveness measured in quality-adjusted life years (QALYs). Deterministic sensitivity analyses assessed the impact of changes in costs or quality of life on overall results. Statistical bootstrapping was employed to estimate confidence intervals around the cost-utility ratio.

RESULTS

Among 98 trial participants (IL n = 50, I-IL n = 48), with no pelvic or distant disease clinically or on PET/CT imaging, the mean life years saved for those randomized to IL showed a small but nonsignificant increase of 0.05 years compared with those in the I-IL group (2.56 vs. 2.51 years, 95% confidence interval [CI] -0.78 to 0.87). The mean difference in QALYs gained showed a small but nonsignificant increase of 0.04 QALYs (1.95 vs. 1.91, 95% CI -0.49 to 0.57). The mean hospital stay among IL patients was 6.16 days, 1.24 days shorter than I-IL patients (7.40 days) at 36 months follow-up. Mean per-patient healthcare costs of IL surgery were AU$6938 lower than for I-IL surgery ($26,555 vs. $33,493, 95% CI -$24,360 to $10,484). Inguinal lymphadenectomy was slightly more effective and slightly less expensive) over I-IL; a finding supported by 81% of bootstrapped estimates and upheld across sensitivity analyses.

CONCLUSIONS

Our study indicates that less extensive IL surgery might be the preferred surgical strategy for metastatic melanoma to the groin when PET/CT imaging shows no pelvic disease. This surgery is likely to improve quality-adjusted survival and may reduce healthcare costs; however, the differences noted in EAGLE-FM were limited by a small sample size and were not statistically significant.

TRIAL REGISTRATION

Clinicaltrials.gov NCT02166788; anzctr.org.au ACTRN12614000721606.