The Danish metastatic melanoma database (DAMMED): A nation-wide platform for quality assurance and research in real-world data on medical therapy in Danish melanoma patients

Ellebæk, Eva; Svane, Inge Marie; Haslund, Charlotte Aaquist; Donia, Marco; Hoejberg, Lise; Ruhlmann, Christina H; Guldbrandt, Louise Mahncke; Køhler, Ulrich Heide; Bastholt, Lars

doi:10.1016/j.canep.2021.101943

Cited by 24 publications

(35 citation statements)

References 39 publications

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“…The real-world setting of our analyses adds new insight to this clinical challenge. The group of patients from DAMMED are more inhomogeneous than the group of patients included in the clinical study by Schadendorf et al [ 20 , 26 ]. The DAMMED database includes patients with ocular and mucosal melanoma, CNS metastases, and performance status >1.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Fink

Vittrup

Bastholt

et al. 2021

Cancers

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Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.

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Section: Discussionmentioning

confidence: 99%

“…We extracted data from the Danish Metastatic Melanoma Database (DAMMED), a Danish nationwide database registering all patients with melanoma receiving medical oncological therapy in Denmark [ 26 ].…”

Section: Methodsmentioning

confidence: 99%

Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Fink

Vittrup

Bastholt

et al. 2021

Cancers

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“…To our knowledge, the Danish Metastatic Melanoma Database (DAMMED) is the only other nationwide registry of adjuvant treated melanoma [35]. To facilitate the comparison of treatment patterns and outcomes from registries across Europe, the authors believe that there should be a consensus on data collection in European countries.…”

Section: Benchmarking and Comparison With Other Nationwide Registriesmentioning

confidence: 99%

Adjuvant treatment for melanoma in clinical practice – Trial versus reality

Meza

Ismail

Rauwerdink

et al. 2021

European Journal of Cancer

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Background: Little is known about outcomes of adjuvant-treated melanoma patients beyond the clinical trial setting. Since 2019, adjuvant-treated melanoma patients have been registered in the DMTR, a population-based registry to monitor the quality and safety of melanoma care in the Netherlands. This study aims to describe treatment patterns, relapse, and toxicity rates of adjuvant-treated melanoma patients beyond the clinical trial setting. Methods: Analyses were performed on adjuvant-treated melanoma patients included in the DMTR. Descriptive statistics were used to analyse patient-, and treatment characteristics. A baseline registration completeness analysis was performed, and an analysis on trial eligibility in clinical practice patients. Recurrence-free survival (RFS) at 12-months was estimated with the KaplaneMeier method. Results: A total of 641 patients were treated with adjuvant anti-PD-1 therapy. RFS at 12months was 70.6% (95% CI, 66.9e74.6) with a median follow-up of 12.8 months. Sex, stage of disease and Breslow thickness were associated with a higher hazard for RFS. Eighteen per cent of the anti-PD-1-treated patients developed grade 3 toxicity. Sixty-one per cent of patients prematurely discontinued anti-PD-1 therapy. Conclusion: Adjuvant anti-PD-1 treatment of resected stage III/IV melanoma in daily practice showed slightly higher toxicity rates and more frequent premature discontinuation but similar RFS rates compared to trials.

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“…We conducted a register-based, retrospective, longitudinal, diagnostic accuracy study including patients with highrisk MM who received adjuvant immunotherapy at Odense University Hospital in the Region of Southern Denmark between November 2018 and February 2021. Patients were monitored with FDG-PET/CT scans according to the Danish follow-up program and were identified from the Danish Metastatic Melanoma Database (DAMMED) [15], which contains data on stage III and IV MM patients in Denmark. Data was collected from DAMMED on the 8 th of February 2021.…”

Section: Methodsmentioning

confidence: 99%

“…The patients enrolled have given written consent to participate in research relevant for MM upon being registered in DAMMED. Of patients eligible for inclusion in DAMMED, around 95% were included [15].…”

Section: Ethicsmentioning

confidence: 99%

The diagnostic accuracy and clinical impact of FDG-PET/CT follow-up for patients on adjuvant immunotherapy for high-risk malignant melanoma

Andersen

Spatzek

Vilstrup

et al. 2022

Eur J Nucl Med Mol Imaging

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Objective The benefit of FDG-PET/CT in follow-up of patients treated with adjuvant immunotherapy after resection of highrisk malignant melanoma (MM) is debated. This study evaluated the diagnostic accuracy and clinical impact of FDG-PET/ CT for diagnosing MM recurrence during the first year after surgery. Methods We retrospectively included 124 patients with resected high-risk MM, who received adjuvant immunotherapy and follow-up FDG-PET/CT. Clinical information and AJCC-8 stage was obtained from patients' medical records. Recurrence was verified by biopsy/progression on a subsequent scan leading to change of treatment. Non-recurrence was assumed when no metastases were observed until the subsequent follow-up scan. Incidence of recurrence, sensitivity, specificity, positive and negative predictive values (PPV and NPV) were outcome measures. Results Incidence rate of MM recurrence was 0.27 [95% CI 0.17-0.37] per person-year during the first-year. Recurrence was detected in 13 patients (10%) at 3-month FDG-PET/CT, in 10 patients (8.1%) at 6 months, 1 patient (0.8%) at 9 months, 3 patients (2.4%) at 12 months. The overall sensitivity, specificity, PPV, and NPV were 97% [86-99], 82% [78][79][80][81][82][83][84][85][86], 39% , and 99% [98-99], respectively. The PPV trended towards higher values as disease stage increased. At the 3-month scan, the majority of actions derived from positive findings were surgery or earlier expedition of the subsequent follow-up scan. ConclusionThe high rate of recurrence in patients with high-risk MM treated with adjuvant immunotherapy emphasizes the need for follow-up. The potential harm by a moderately low specificity reflecting a high number of false-positive results must be weighed against the benefit of early detection of recurrence.

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The Danish metastatic melanoma database (DAMMED): A nation-wide platform for quality assurance and research in real-world data on medical therapy in Danish melanoma patients

Cited by 24 publications

References 39 publications

Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Adjuvant treatment for melanoma in clinical practice – Trial versus reality

The diagnostic accuracy and clinical impact of FDG-PET/CT follow-up for patients on adjuvant immunotherapy for high-risk malignant melanoma

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