The MelFo Study UK: Effects of a Reduced-Frequency, Stage-Adjusted Follow-Up Schedule for Cutaneous Melanoma 1B to 2C Patients After 3-Years

Abstract

Background Evidence-based guidelines for follow-up treatment of American Joint Committee on Cancer (AJCC) stages 1B to 2C melanoma patients are lacking. The MELanoma FOllow-up study is an international phase 3 randomized trial, and the 3-year interim data were recently reported from the Netherlands. The study was undertaken concurrently with a British cohort for comparison and validation of the Dutch study. Methods The study enrolled and stratified 207 patients by AJCC stage. The conventional schedule group (CSG; n = 103) cohort was reviewed as per UK guidelines. The experimental schedule group (ESG; n = 104) cohort was reviewed in a reduced-frequency nurse-led, consultant-supervised clinic. Quality of life (QoL) was measured at baseline (T1), a 1 year (T2), and at 3 years (T3) using the State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS) of the RAND-36. Results Of the 207 QoL questionnaires, 170 (82.1%) were completed at T3. Both cohorts expressed high satisfaction (> 93%) with their regimens. At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols. Recurrence had developed in 33 patients Conventional follow-up (CFU), 16 [15.5%]; Experimental follow-up (EFU), 17 [16.3%]. Self-examination was the method of detection for 12 ESG patients (70.6%) and 11 CSG patients (68.8%). The melanoma-specific survival was identical. Conclusion The UK 3-year data were consistent with the previous Dutch report. The reduced follow-up strategy was shown to be safe, with significant resource usage benefits for national cancer services. Patient anxiety levels were not increased by a less-intensive follow-up regimen, and acceptance was high. The study data indicate that patient self-examination is very effective for recurrence detection.

Follow-up Schedule for Patients With Sentinel Node–negative Cutaneous Melanoma (The MELFO Study)

“…Detailed methods of this multicentre, nonblinded, randomized clinical trial (ClinicalTrials.gov registration number: NCT01018004), initiated by the Department of Surgical Oncology at the University Medical Centre of Groningen (UMCG), have been described previously. [14][15][16] In summary, however, participants were randomized, in a 1:1 fashion, into 2 groups: one following the conventional schedule recommended in the current UK NICE or Dutch National melanoma guidelines, 17,18 and one whose follow-up was an AJCC stageadjusted reduced schedule (Table 1). Patients were stratified by country and AJCC stage (seventh edition), 19 in 2 random permuted blocks of 4 patients, generated by a validated system (Intrialgrator) with the use of a pseudorandom number generator and a supplied seed number.…”

“…Previously published results of the interim analysis of both studies at 3 years demonstrated the highly correlated data between the 2 countries. 14,15 After 5 years of follow-up, 240 (61.9%) completed and returned the PROMs questionnaires. The overwhelming majority ( > 97%) of patients remained satisfied with their follow-up schedule, regardless of the frequency of clinic visits.…”

“…The study was undertaken concurrently in the United Kingdom and the Netherlands, and the 3-year interim analyses concluded that the primary endpoints were not statistically different. 14,15 This final analysis addresses not only the primary endpoint at 5 years but also the predetermined intention of ultimately combining the international dataset to assess the secondary endpoints of detection rates and rate of recurrence in addition to survival outcomes (patient safety). The primary trial null hypothesis is that there is no difference in PROMs with a reduced-intensity AJCC stage-adjusted follow-up regimen when compared with the UK or Dutch national standard recommended follow-up regimen for AJCC pT1b-pT4bN0 melanoma patients staged with SNB.…”

Can Patient-Led Surveillance Detect Subsequent New Primary or Recurrent Melanomas and Reduce the Need for Routinely Scheduled Follow Up? A Protocol for the MEL-SELF Randomised Controlled Trial.

“…Patients also incur travel and parking expenses, which may be especially burdensome for those who do not live close to the treatment centre. Fewer routinely scheduled clinic visits may have little impact on the detection of subsequent new primary or recurrent melanomas [12] and could result in substantial cost savings [13][14][15].…”

In Sentinel Node-Positive Melanoma Patients, Does Omission of Completion Lymph Node Dissection Make More Intensive Follow-Up Necessary, and Does Adjuvant Systemic Therapy Permit Less Intensive Follow-Up?

“…Optimal follow-up surveillance strategies for patients who have been treated for primary melanoma by wide excision with or without SN biopsy have not been determined and are somewhat controversial, 9 but there are ongoing attempts to assemble evidence indicating the costeffectiveness of various follow-up schedules, notably the MELFO studies. 10,11 Although longer follow-up of these studies is required, results to date have shown that a less intensive follow-up schedule, with fewer clinic visits and less frequent routine imaging tests, did not adversely affect outcomes and substantially reduced costs for both patients and healthcare systems. Until now, there has been no information about the efficacy and cost of various followup surveillance strategies for melanoma patients who have had a positive SN but not a CLND, as in the experimental arms of both the MSLT-II and DeCOG-SLT studies.…”