Most patients with sentinel lymph node (SLN)-positive early melanoma accepted active surveillance when offered, but more than a third subsequently were lost to follow-up (LTFU), according to a small study of "real-world" implementation of active surveillance.
All but 10 of 63 patients accepted active surveillance, but 17 of the 53 were lost during follow-up for as long as 40 months. Additionally, almost 40% of the patients did not have ultrasound evaluations included in the active surveillance protocol.
In contrast, 6% of patients were lost to follow-up in the (MSLT-II).
The high LTFU rate illustrates the challenges of translating clinical trial results with active surveillance into real-world implementation of protocols, reported Joshua Herb, MD, of the University of North Carolina at Chapel Hill, and co-authors in .
"Active surveillance strategies hold great potential for advancing cancer care through decreased morbidity, but to realize their full potential, much more work is needed to define best practices for these approaches," the authors concluded.
Management of different types of cancer has increasingly incorporated active surveillance as a means to help patients avoid potential morbidity associated with treatment. Inherently, active surveillance strategies involve tradeoffs, such as an increased risk of disease recurrence and progression versus the potential for early detection with closer follow-up, the authors noted.
To achieve the balance between risk and benefit, surveillance protocols incorporate frequent visits and testing, which may pose time and cost burdens that create a barrier to active surveillance. Herb and colleagues investigated LTFU among patients who opted for active surveillance for SLN-positive melanoma. They hypothesized that both adherence and LTFU would be high and that travel distance and insurance would be associated with compliance.
The MSLT-II and the similarly designed showed no significant differences in oncologic outcomes with active surveillance versus complete lymph node dissection among patients with SLN-positive melanoma. Following publication of the studies, Herb and colleagues implemented an active surveillance protocol that included clinical exams and ultrasound every 3 months.
Investigators retrospectively analyzed records for all patients with surgically resected SLN-positive melanoma at a single center from July 2017 through December 2020. The primary outcomes were the proportion of patients who chose active surveillance, the proportion of completed ultrasound evaluations, any follow-up events that led to discontinuation of active surveillance, and the LTFU rate among patients in active surveillance.
Of 87 patients identified by chart review, 63 were offered active surveillance and 53 accepted. The patients had a mean age of 57, and women accounted for 52% of the study population, which was 100% white. Four patients treated with immunotherapy were excluded because they did not have a planned ultrasound schedule, leaving 49 patients in the active surveillance cohort.
The 49 patients completed 62% of scheduled ultrasound evaluations. No clinical or demographic factors had significant associations with the proportion of completed ultrasound studies. Follow-up ranged from 1 to 40 months, and 35% of the patients were LTFU. Investigators did not identify any factors associated with LTFU. Six (12%) patients who entered active surveillance with ultrasound had disease recurrences: two local, three regional (nodal basin), and one distant.
The "real-world" results are consistent with those observed by Daniel Wang, MD, and colleagues at the Dan L. Duncan Cancer Center at Baylor College of Medicine in Houston.
"The lower adherence rate could partly be due to a more rigorous schedule of exams/ultrasounds every 3 months described in the study," Wang told ֱ via email. "A schedule mirroring the one used in MSLT-II, which included exams/ultrasounds completed every 4 months for the first 2 years and then every 6 months from year 3 to 5, may be easier for patients to follow. The authors also showed that other factors such as insurance and travel distance did not play a significant role in adherence, although these are often barriers for follow-up in our practice."
Melanoma surgeons at his center routinely discuss active surveillance with patients who have SLN-positive melanoma, emphasizing the MSLT-II and DeCOG-SLT data showing no difference in overall survival and less morbidity with surveillance. Their protocol follows the one used in the MSLT-II trial, and most patients choose active surveillance.
"One important thought to consider is the increasing use of adjuvant therapy such as immunotherapy and targeted therapy, which uses frequent cross-sectional imaging during treatment, in some of our stage III SLN-positive melanoma patients," Wang added.
"The use of these therapies with active surveillance of the nodal basin may alter the practice patterns of imaging (cross-sectional imaging/ultrasound) for the treatment team, and further research into the optimal strategy should be explored to balance clinical benefit with burden of costs/adherence," he said.
Disclosures
Herb reported having no relevant relationships with industry.
Primary Source
Annals of Surgical Oncology
Herb J, et al "The difficult reality of active surveillance and the urgent need for ongoing research" Ann Surg Oncol 2022; DOI: 10.1245/s10434-021-10305-6.