TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow-up after radical surgery of stage IIB-C and III cutaneous malignant Melanoma

Naeser, Ylva; Helgadóttir, Hildur; Brandberg, Yvonne; Hansson, Johan; Bagge, Roger Olofsson; Elander, Nils; Ingvar, Christian; Isaksson, Karolin; Flygare, Petra; Nilsson, Cecilia; Jakobsson, Frida; Munoz, Olga del Val; Valachis, Antonis; Jansson, Malin; Sparring, Charlotte; Ohlsson, Lars; Dyrke, Ulf; Papantoniou, Dimitrios; Sundín, Anders; Ullenhag, Gustav

doi:10.1186/s12885-020-07632-4

Cited by 8 publications

(4 citation statements)

References 24 publications

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“…Another study from 2 major Danish centers found that routine FDG PET-CT scans detected occult distant recurrence in 13.8% of patients within the first 17.7 months . However, randomized studies of the survival effect of routine imaging are needed, and results from the ongoing Swedish TRIM trial (Trial to Assess the Role of Imaging During Follow-up After Radical Surgery of Stage IIB-C and III Cutaneous Malignant Melanoma) are awaited …”

Section: Discussionmentioning

confidence: 99%

Stage-Specific Risk of Recurrence and Death From Melanoma in Denmark, 2008-2021

Helvind,

Brinch-Møller Weitemeyer,

Chakera

et al. 2023

JAMA Dermatol

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ImportanceTo ensure optimal treatment and surveillance of patients with melanoma, knowledge of the clinical stage-specific risk of recurrence, mortality, and recurrence patterns across the American Joint Committee on Cancer Eighth Edition (AJCC8) substages is needed.ObjectiveTo estimate stage-specific recurrence and melanoma-specific mortality rates, assess absolute stage-specific risks of recurrence and mortality, and describe stage-specific recurrence patterns, including conditional rates.DesignRetrospective cohort study of prospectively collected nationwide population-based registry data.SettingNationwide, population-based cohort study.ParticipantsThe 25 720 Danish patients, 18 years or older, diagnosed with first-time stage IA to IV cutaneous melanoma between January 1, 2008, and December 31, 2019, were included and followed up from time of primary treatment until December 31, 2021.ExposuresFirst diagnosis of stage IA to IV cutaneous melanoma.Main OutcomesStage-specific cumulative incidence of recurrence and melanoma-specific mortality, melanoma-specific recurrence-free survival, and assessed absolute stage-specific risks of recurrence and melanoma-specific mortality. Secondary outcomes were stage-specific recurrence patterns, including conditional rates, and melanoma-specific survival.ResultsWe followed up 25 720 patients for a median of 5.9 years (95% CI, 58.9-59.3 years). Mean age was 59.1 years (95% CI, 58.9-59.3 years). Patients with stage IIB to IIC melanoma were older, had more comorbidities at diagnosis, and had the lowest rate of pathologic staging by sentinel node biopsy (81.6%-87.4%). A total of 10.6% of patients developed recurrence; first recurrence included distant recurrence, alone or with synchronous locoregional recurrence, in 56.6% of patients. We found a comparable risk of recurrence in stages IIIA and IIB (29.7% vs 33.2%) and in stages IIIB and IIC (35.9% vs 36.8%), respectively. Melanoma-specific mortality was comparable between stages IIIA and IIA (13.0% vs 13.6%) and between stages IIIB and IIB (18.4% vs 22.0%), respectively. These risk patterns persisted in cause-specific hazards models.Conclusions and RelevanceThis nationwide, population-based cohort study found that the increasing stages of the current AJCC8 staging system do not accurately reflect an increasing risk of recurrence and mortality in melanoma. The high proportion of distant recurrences suggests that hematogenous spread is a more common metastatic pathway than previously assumed, and surveillance with routine functional/cross-sectional imaging should be considered for stages IIB to IV. Future efforts should be put toward developing new tools for risk stratification and determining the survival effect of routine imaging in surveillance.

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Section: Discussionmentioning

confidence: 99%

Stage-Specific Risk of Recurrence and Death From Melanoma in Denmark, 2008-2021

Helvind,

Brinch-Møller Weitemeyer,

Chakera

et al. 2023

JAMA Dermatol

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“…The study protocol for the TRIM study has previously been described in detail [ 14 ]. The main inclusion criterion is radical surgery for stage IIB-C or stage III cutaneous melanoma.…”

Section: Methodsmentioning

confidence: 99%

Quality of Life in the First Year of Follow-Up in a Randomized Multicenter Trial Assessing the Role of Imaging after Radical Surgery of Stage IIB-C and III Cutaneous Melanoma (TRIM Study)

Naeser

Helgadóttir

Hansson

et al. 2022

Cancers

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The benefit of imaging in the follow-up setting for high-risk melanoma patients is uncertain, and even less is known about the impact of intensive follow-up on the patient´s quality of life. In 2017, a Swedish prospective randomized multicenter study started, in which high-risk melanoma patients are randomly assigned 1:1 to follow-up by physical examinations +/− whole-body imaging. The first-year examinations are scheduled at 0, 6 and 12 months. The aim of this study was to investigate whether the patients´ health-related quality of life (HRQoL) and levels of anxiety and depression were affected at 1 year by imaging. Anxiety/depression and HRQoL were assessed at 0 and 12 months by the questionnaires Hospital Anxiety and Depression (HAD) scale and EORTC QLQ-C30 version 3. Expected baseline QLQ-C30 values for the patients were calculated using data from the general population. In total, 204 patients were analyzed. Mean differences in subscale scores at 1 year were not statistically significant either for HRQoL or for anxiety/depression. Baseline HRQoL did not differ from expected values in the general Swedish population. In conclusion, the patients in general coped well with the situation, and adding whole-body imaging to physical examinations did not affect the melanoma patients’ HRQoL or levels of anxiety or depression.

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“…Though the risk of selection bias is minimal when all patients are enrolled in a uniform surveillance protocol such as ours, and lead-time and length bias can be addressed statistically 33 , the effect of surveillance with routine imaging on survival should be investigated in a randomized controlled setting. The results of the ongoing Swedish TRIM-trial 34 are awaited.…”

Section: The Effect Of Routine Imaging On Survivalmentioning

confidence: 99%

Earlier Recurrence Detection Using Routine FDG PET-CT Scans in Surveillance of Stage IIB to IIID Melanoma: A National Cohort Study of 1480 Patients

et al. 2023

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The effect of routine imaging in melanoma surveillance is unknown. In 2016, Denmark was the first country in the world to implement routine imaging with positron emission tomography-computed tomography with fluorodeoxyglucose (FDG PET-CT) in a nationwide, population-based surveillance program.The aim of this study was to determine the impact of surveillance with routine FDG PET-CT on hazard, cumulative incidence, and absolute risk of overall, locoregional, and distant recurrence detection in stage IIB-IIID cutaneous melanoma patients. MethodsThis retrospective, population-based, nationwide cohort study used prospectively collected data from five national health registries to compare hazard, cumulative incidence, and absolute risk of recurrence in patients diagnosed in 2008-2010 (cohort 1, followed with clinical examinations) and patients diagnosed in 2016-2017 (cohort 2, followed with clinical examinations and routine FDG PET-CT at 6, 12, 24, and 36 months). Results1,480 stage IIB-IIID patients were included. Cumulative incidences of recurrence and distant recurrence were higher in cohort 2 with a peak difference around three years (32.3% vs. 27.5% and 25.8% vs. 18.5%, respectively). Hazard of recurrence was higher in cohort 2 for the first two years, with hazard rates of overall and distant recurrence of 1.16 4 (95% CI: 0.93 -1.44) and 1.51 (95% CI: 1.16 -1.96). Patterns persisted in absolute risk estimates. ConclusionsStage IIB-IIID melanoma patients followed with routine FDG PET-CT had a 51% increased hazard of distant recurrence detection within the first two years of surveillance. Future studies must determine whether this earlier recurrence detection will translate into improved survival.

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TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow-up after radical surgery of stage IIB-C and III cutaneous malignant Melanoma

Cited by 8 publications

References 24 publications

Stage-Specific Risk of Recurrence and Death From Melanoma in Denmark, 2008-2021

Stage-Specific Risk of Recurrence and Death From Melanoma in Denmark, 2008-2021

Quality of Life in the First Year of Follow-Up in a Randomized Multicenter Trial Assessing the Role of Imaging after Radical Surgery of Stage IIB-C and III Cutaneous Melanoma (TRIM Study)

Earlier Recurrence Detection Using Routine FDG PET-CT Scans in Surveillance of Stage IIB to IIID Melanoma: A National Cohort Study of 1480 Patients

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