Department of Plastic & Reconstructive Surgery, Norfolk & Norwich University Hospital, Norwich, UK.
Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Ann Surg. 2022 Oct 1;276(4):e208-e216. doi: 10.1097/SLA.0000000000005621. Epub 2022 Jul 22.
The MELFO (MELanoma FOllow-up) study is an international phase III randomized controlled trial comparing an experimental low-intensity schedule against current national guidelines.
Evidence-based guidelines for the follow-up of sentinel node-negative melanoma patients are lacking.
Overall, 388 adult patients diagnosed with sentinel node-negative primary melanoma patients were randomized in cancer centers in the Netherlands and United Kingdom between 2006 and 2016. The conventional schedule group (control: n=196) was reviewed as per current national guidelines. The experimental schedule group (n=192) was reviewed in a reduced-frequency schedule. Quality of life was the primary outcome measurement. Detection rates and survival outcomes were recorded. Patient satisfaction rates and compliance with allocated schedules were compared.
At 5 years, both arms expressed high satisfaction with their regimens (>97%). This study found no significant group effect on any patient-reported outcome measure scores between the follow-up protocols. In total, 75/388 (19.4%) patients recurred, with no difference in incidence found between the 2 arms (hazard ratio=0.87, 95% confidence interval: 0.54-1.39, P =0.57). Self-examination was the method of detection for 25 experimental patients and 32 control patients (75.8% vs. 76.2%; P =0.41). This study found no difference in any survival outcomes between the 2 study arms (disease-free survival: hazard ratio=1.00, 95% confidence interval: 0.49-2.07, P =0.99).
A reduced-intensity, American Joint Committee on Cancer (AJCC) stage-adjusted follow-up schedule for sentinel node-negative melanoma patients is a safe strategy, and patient self-examination is effective for recurrence detection with no evidence of diagnostic delay. Patients' acceptance is very high.
MELFO（黑色素瘤随访）研究是一项国际 III 期随机对照试验，比较了一种实验性低强度方案与当前国家指南。
缺乏基于证据的前哨淋巴结阴性黑色素瘤患者随访指南。
2006 年至 2016 年期间，在荷兰和英国的癌症中心共纳入 388 例诊断为前哨淋巴结阴性原发性黑色素瘤患者进行随机分组。常规方案组（对照组：n=196）按照当前国家指南进行复查。实验组（n=192）采用低强度、降低频率的复查方案。主要终点为生活质量。记录检出率和生存结果。比较患者满意度和对分配方案的依从性。
5 年时，两组对其治疗方案的满意度均很高（>97%）。本研究未发现两种随访方案在任何患者报告结局测量评分上存在显著的组间差异。共 75/388（19.4%）例患者复发，两组间发病率无差异（风险比=0.87，95%置信区间：0.54-1.39，P=0.57）。25 例实验组和 32 例对照组患者通过自我检查发现复发（75.8% vs. 76.2%；P=0.41）。两种研究方案在任何生存结果上均无差异（无病生存率：风险比=1.00，95%置信区间：0.49-2.07，P=0.99）。
对于前哨淋巴结阴性黑色素瘤患者，采用低强度、美国癌症联合委员会（AJCC）分期调整后的随访方案是一种安全的策略，患者自我检查对于复发检测是有效的，且没有证据表明存在诊断延迟。患者接受度非常高。
