Mahumud Rashidul Alam, Law Chi Kin, Ospino Daniel Ariza, de Wilt Johannes H W, van Leeuwen Barbara L, Allan Chris, de Lima Vazquez Vinicius, Jones Rowan Pritchard, Howle Julie, Peric Barbara, Spillane Andrew J, Morton Rachael Lisa
NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia.
Melanoma and Skin Cancer Trials Limited, Melbourne, VIC, Australia.
Ann Surg Oncol. 2025 Jun;32(6):4211-4222. doi: 10.1245/s10434-025-17040-2. Epub 2025 Feb 27.
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.
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.
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.
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.
Clinicaltrials.gov NCT02166788; anzctr.org.au ACTRN12614000721606.
我们比较了腹股沟淋巴结清扫术（IL）与髂腹股沟淋巴结清扫术（I-IL）在清除Ⅲ期黑色素瘤成年患者腹股沟淋巴结转移灶方面的健康结局和成本。
从卫生系统角度进行了一项试验内成本效用分析，并与一项国际随机试验（EAGLE-FM）同时进行，随访36个月。通过试验记录测量医疗保健成本，以质量调整生命年（QALYs）衡量有效性。确定性敏感性分析评估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的置信区间。
在98名试验参与者中（IL组n = 50，I-IL组n = 48），临床或PET/CT成像均未发现盆腔或远处疾病，随机分配至IL组的患者平均挽救生命年数比I-IL组略有增加，但无统计学意义，增加了0.05年（2.56年对2.51年，95%置信区间[CI] -0.78至0.87）。获得的QALYs平均差异略有增加，但无统计学意义，增加了0.04个QALYs（1.95对1.91，95% CI -0.49至0.57）。在36个月的随访中，IL组患者的平均住院时间为6.16天，比I-IL组患者（7.40天）短1.24天。IL手术的平均每位患者医疗保健成本比I-IL手术低6938澳元（26,555澳元对33,493澳元，95% CI -24,360澳元至10,484澳元）。与I-IL相比，腹股沟淋巴结清扫术的有效性略高且成本略低；81%的自举估计支持这一发现，并且在敏感性分析中均成立。
我们的研究表明，当PET/CT成像显示无盆腔疾病时，范围较小的IL手术可能是腹股沟转移性黑色素瘤的首选手术策略。这种手术可能会改善质量调整后的生存率，并可能降低医疗保健成本；然而，EAGLE-FM中指出的差异受样本量小的限制，且无统计学意义。
Clinicaltrials.gov NCT02166788；anzctr.org.au ACTRN12614000721606。
