Importance
Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma.
Objective
To determine whether patient-led surveillance in patients with prior localized primary cutaneous melanoma is as safe, feasible, and acceptable as clinician-led surveillance.
Design, Setting, and Participants
This was a pilot for a randomized clinical trial at 2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia. The participants were 100 patients who had been treated for localized melanoma, owned a smartphone, had a partner to assist with skin self-examination (SSE), and had been routinely attending scheduled follow-up visits. The study was conducted from November 1, 2018, to January 17, 2020, with analysis performed from September 1, 2020, to November 15, 2020.
Intervention
Participants were randomized (1:1) to 6 months of patient-led surveillance (the intervention comprised usual care plus reminders to perform SSE, patient-performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (the control was usual care).
Main Outcomes and Measures
The primary outcome was the proportion of eligible and contacted patients who were randomized. Secondary outcomes included patient-reported outcomes (eg, SSE knowledge, attitudes, and practices, psychological outcomes, other health care use) and clinical outcomes (eg, clinic visits, skin surgeries, subsequent new primary or recurrent melanoma).
Results
Of 326 patients who were eligible and contacted, 100 (31%) patients (mean [SD] age, 58.7 [12.0] years; 53 [53%] men) were randomized to patient-led (n = 49) or clinician-led (n = 51) surveillance. Data were available on patient-reported outcomes for 66 participants and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance was associated with increased SSE frequency (odds ratio [OR], 3.5; 95% CI, 0.9 to 14.0) and thoroughness (OR, 2.2; 95% CI, 0.8 to 5.7), had no detectable adverse effect on psychological outcomes (fear of cancer recurrence subscale score; mean difference, -1.3; 95% CI, -3.1 to 0.5), and increased clinic visits (risk ratio [RR], 1.5; 95% CI, 1.1 to 2.1), skin lesion excisions (RR, 1.1; 95% CI, 0.6 to 2.0), and subsequent melanoma diagnoses and subsequent melanoma diagnoses (risk difference, 10%; 95% CI, -2% to 23%). New primary melanomas and 1 local recurrence were diagnosed in 8 (16%) of the participants in the intervention group, including 5 (10%) ahead of routinely scheduled visits; and in 3 (6%) of the participants in the control group, with none (0%) ahead of routinely scheduled visits (risk difference, 10%; 95% CI, 2% to 19%).
Conclusions and Relevance
This pilot of a randomized clinical trial found that patient-led surveillance after treatment of localized melanoma appears to be safe, feasible, and acceptable. Experiences from this pilot study have prompted improvements to the trial processes for the larger trial of the same intervention.
Trial Registration
http://anzctr.org.au Identifier: ACTRN12616001716459.
Behcet's disease (BD) is a rare condition (overall prevalence of 1 to 2 per million) characterized by relapsing oral and genital aphthous-type ulcers, ocular inflammation, arthritis, pustular skin eruptions, and pyoderma gangrenosum as well as neurologic, pulmonary, and renal disease. It is more common in the so-called Silk Road descendants, with a prevalence of 2 per 10,000 in the Mediterranean countries and 4 per 1000 in China. It is a clinical diagnosis with major and minor diagnostic criteria, but aphthous ulcers are almost universally seen in BD patients. Treatments for BD run the gamut of tools from our autoimmune disease toolbox and beyond. Oral and genital ulcers are treated with topical steroids, topical tacrolimus, topical pimecrolimus, colchicine, pentoxifylline, and dapsone, and apremilast has been recently approved by the FDA as the first medication with a BD indication. Other agents that have had case series or clinical trials published include azathioprine, methotrexate, chlorambucil, mycophenolate mofetil, leflunomide, cyclophosphamide, cyclosporin, tacrolimus, interferon alpha, thalidomide, zinc sulfate, and levamisole, along with numerous biologic agents, including inhibitors of CD20, TNF alpha, TNF alpha receptor, IL-1α, IL-1β, IL-1R, IL-2R, IL-6R, and IL-17.1
In the article by London et al, the authors present results of a phase II trial of ustekinumab (inhibitor of IL-12/IL-23) for oral ulcers that have not responded to colchicine in BD patients. They report results from 15 participants in this open-label trial of 90 mg ustekinumab at standard dosing schedule as used in psoriasis of weeks 0 and 4 and then every 12 weeks. At the primary endpoint of week 24, they found 9 complete responders, 2 partial responders and 3 non-responders; 1 patient was lost to follow-up. However, the graphic representations of results show rapid improvement in these ulcers by week 4 (ie, after one dose of ustekinumab). This is very encouraging, as we would hope that inhibition of the TH17 pathway would impact this painful condition much as it is showing promise in other autoimmune and auto-inflammatory conditions like psoriasis, pyoderma gangrenosum, rheumatoid arthritis, and inflammatory bowel diseases. Larger studies are needed, and placebo controls or standard-of-care populations are needed to better clarify these preliminary findings. It remains to be shown but is expected that other biologic therapies targeting IL-23 will have similar efficacy.
Treatment of BD can be as challenging as it is sometimes to diagnose. Targeted immune modulation through anti-cytokine therapies is proving to be a safer, more effective approach in many autoimmune/auto-inflammatory disease.
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