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.
Rashidul Alam Mahumud, Chi Kin Law, Daniel Ariza Ospino, Johannes H W de Wilt, Barbara L van Leeuwen, Chris Allan, Vinicius de Lima Vazquez, Rowan Pritchard Jones, Julie Howle, Barbara Peric, Andrew J Spillane, Rachael Lisa Morton
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Abstract
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.
目的：我们比较了腹股沟淋巴结切除术（IL）与髂-腹股沟淋巴结切除术（I-IL）对III期成年黑色素瘤患者腹股沟淋巴结转移性黑色素瘤的健康结果和成本。方法：从卫生系统的角度对一项国际随机试验（EAGLE-FM）进行了为期36个月的随访，并进行了试验内成本-效用分析。通过使用试验记录来衡量医疗成本，并以质量调整生命年（QALYs）来衡量有效性。确定性敏感性分析评估了成本或生活质量变化对总体结果的影响。采用统计自举法估计成本-效用比周围的置信区间。结果：98名试验参与者（IL n = 50, I-IL n = 48），临床或PET/CT成像均无盆腔或远处疾病，与I-IL组相比，随机分配到IL组的平均寿命年增加了0.05年（2.56 vs. 2.51年，95%可信区间[CI] -0.78 ~ 0.87）。获得的QALYs的平均差异显示了0.04个QALYs （1.95 vs. 1.91, 95% CI -0.49 ~ 0.57）的小幅但不显著的增加。随访36个月，IL患者平均住院时间为6.16天，比I-IL患者（7.40天）短1.24天。IL手术的平均每位患者医疗费用比I-IL手术低6938澳元（26,555美元对33,493美元，95% CI - 24,360美元到10,484美元）。腹股沟淋巴结切除术比I-IL更有效，更便宜；这一发现得到了81%的自举估计的支持，并在整个敏感性分析中得到了支持。结论：我们的研究表明，当PET/CT成像未显示盆腔疾病时，较小范围的IL手术可能是治疗转移性黑色素瘤至腹股沟的首选手术策略。这种手术可能提高经质量调整的生存率，并可能降低医疗费用；然而，EAGLE-FM中发现的差异受到小样本量的限制，没有统计学意义。试验注册：Clinicaltrials.gov NCT02166788；anzctr.org.au ACTRN12614000721606。
期刊介绍：
The Annals of Surgical Oncology is the official journal of The Society of Surgical Oncology and is published for the Society by Springer. The Annals publishes original and educational manuscripts about oncology for surgeons from all specialities in academic and community settings.
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