Objectives and Design: 

The MELFO (MELanoma FOllow-up) study is an international phase III randomized controlled trial comparing an experimental low-intensity schedule against current national guidelines.

Background: 

Evidence-based guidelines for the follow-up of sentinel node–negative melanoma patients are lacking.

Methods: 

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.

Results: 

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).

Conclusions: 

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.

中文翻译：

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前哨淋巴结阴性皮肤黑色素瘤患者的随访时间表（MELFO 研究）：一项国际 III 期随机临床试验

 目标和设计：

MELFO (MELanoma FOll-up) 研究是一项国际 III 期随机对照试验，将实验性低强度计划与现行国家指南进行比较。

 背景：

缺乏针对前哨淋巴结阴性黑色素瘤患者随访的循证指南。

 方法：

总体而言，2006 年至 2016 年间，388 名被诊断为前哨淋巴结阴性原发性黑色素瘤的成年患者被随机分配到荷兰和英国的癌症中心。传统方案组（对照：n=196）根据现行国家指南进行了审查。实验计划组（n = 192）以减少频率的计划进行审查。生活质量是主要的结果衡量标准。记录检出率和生存结果。比较了患者满意度和对分配时间表的遵守情况。

 结果：

5 年时，两组患者均对其治疗方案表示高度满意（>97%）。这项研究发现，后续方案之间的任何患者报告的结果测量分数均没有显着的群体效应。总共有 75/388 (19.4%) 例患者复发，两组之间的发病率没有差异（风险比 = 0.87，95% 置信区间：0.54–1.39， P = 0.57）。 25名实验患者和32名对照患者的检测方法为自查（75.8% vs. 76.2%； P =0.41）。本研究发现两个研究组之间的任何生存结果没有差异（无病生存：风险比 = 1.00，95% 置信区间：0.49–2.07， P = 0.99）。

 结论：

对于前哨淋巴结阴性黑色素瘤患者，降低强度、美国癌症联合委员会 (AJCC) 阶段调整的随访计划是一种安全的策略，患者自我检查对于复发检测是有效的，没有诊断延迟的证据。患者的接受度非常高。