Adjuvant treatment and outcome of stage III melanoma patients: Results of a multicenter real-world German Dermatologic Cooperative Oncology Group (DeCOG) study

Lodde, Georg; Hassel, Jessica C.; Wulfken, Lena M.; Meier, Friedegund; Mohr, Peter; Kähler, Katharina C.; Hauschild, Axel; Schilling, Bastian; Loquai, Carmen; Berking, Carola; Hüning, Svea; Eckardt, Julia; Gutzmer, Ralf; Reinhardt, Lydia; Glutsch, Valerie; Nikfarjam, Ulrike; Erdmann, Michael; Beckmann, Catharina Lena; Stang, Andreas; Kowall, Bernd; Galetzka, Wolfgang; Roesch, Alexander; Ugurel, Selma; Zimmer, Lisa; Schadendorf, Dirk; Forschner, Andrea; Livingstone, Elisabeth

doi:10.1016/j.ejca.2023.112957

Cited by 9 publications

(6 citation statements)

References 30 publications

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“…The FHIR queries served as the basis for embedding the patient’s EHR into the simulation. For parameters in the data dump where FHIR queries revealed incomplete data, manual re-editing was performed using data from the multicenter study [ 26 ]. Once data completeness was ensured, the simulation proceeded.…”

Section: Resultsmentioning

confidence: 99%

“…To obtain accurate real-world FHIR data from patients with adjuvant-treated malignant melanoma, we identified melanoma patients who were treated at the Skin Cancer Center Essen, Germany, from a previously conducted multicenter study [ 26 ], with corresponding data partly available in SHIP. Our study includes the adjuvant treatment and outcome of patients with stage III melanoma under real-world conditions, as well as patients with melanoma of unknown primary (MUP).…”

Section: Methodsmentioning

confidence: 99%

“…First, all identified FHIR resources and their fields were validated by a computer scientist of the SHIP team, a dermatooncologist, and a tumor records technician for correct semantics and usage. Second, the completeness of the anonymized patient data was validated using real-world patient data from [ 26 ]. An anonymized data dump from SHIP was acquired for manual adjustments resulting from deviations due to unstructured data.…”

Section: Methodsmentioning

confidence: 99%

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Use of Real-World FHIR Data Combined with Context-Sensitive Decision Modeling to Guide Sentinel Biopsy in Melanoma

Beckmann,

Lodde,

Swoboda

et al. 2024

JCM

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Background: To support clinical decision-making at the point of care, the “best next step” based on Standard Operating Procedures (SOPs) and actual accurate patient data must be provided. To do this, textual SOPs have to be transformed into operable clinical algorithms and linked to the data of the patient being treated. For this linkage, we need to know exactly which data are needed by clinicians at a certain decision point and whether these data are available. These data might be identical to the data used within the SOP or might integrate a broader view. To address these concerns, we examined if the data used by the SOP is also complete from the point of view of physicians for contextual decision-making. Methods: We selected a cohort of 67 patients with stage III melanoma who had undergone adjuvant treatment and mainly had an indication for a sentinel biopsy. First, we performed a step-by-step simulation of the patient treatment along our clinical algorithm, which is based on a hospital-specific SOP, to validate the algorithm with the given Fast Healthcare Interoperability Resources (FHIR)-based data of our cohort. Second, we presented three different decision situations within our algorithm to 10 dermatooncologists, focusing on the concrete patient data used at this decision point. The results were conducted, analyzed, and compared with those of the pure algorithmic simulation. Results: The treatment paths of patients with melanoma could be retrospectively simulated along the clinical algorithm using data from the patients’ electronic health records. The subsequent evaluation by dermatooncologists showed that the data used at the three decision points had a completeness between 84.6% and 100.0% compared with the data used by the SOP. At one decision point, data on “patient age (at primary diagnosis)” and “date of first diagnosis” were missing. Conclusions: The data needed for our decision points are available in the FHIR-based dataset. Furthermore, the data used at decision points by the SOP and hence the clinical algorithm are nearly complete compared with the data required by physicians in clinical practice. This is an important precondition for further research focusing on presenting decision points within a treatment process integrated with the patient data needed.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Use of Real-World FHIR Data Combined with Context-Sensitive Decision Modeling to Guide Sentinel Biopsy in Melanoma

Beckmann,

Lodde,

Swoboda

et al. 2024

JCM

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“…report real‐world German data from a DeCOG study with a median observation period of 25.7 months. They assert that BRAF/MEK inhibitors are better in terms of early recurrence and efficacy 28 . RFS, OS, and melanoma‐specific survival (MSS), and response to subsequent treatment in 589 stage III patients (232 BRAF‐mutated) receiving adjuvant PD‐1 antibodies ( n = 479) or targeted therapy ( n = 110) have been reported.…”

Section: Real World Evidence Relapse‐free Survival and Overall Survivalmentioning

confidence: 99%

“…They assert that BRAF/MEK inhibitors are better in terms of early recurrence and efficacy. 28 RFS, OS, and melanoma-specific survival (MSS), and response to subsequent treatment in 589 stage III patients (232 BRAFmutated) receiving adjuvant PD-1 antibodies (n = 479) or targeted therapy (n = 110) have been reported. The main reasons for premature discontinuation of adjuvant therapy were disease progression in PD-1 antibodies (28.8%, n = 138/479) and adverse events in patients treated with BRAF/MEK inhibitors (28.2%, n = 31/110).…”

Section: Lodde Et Al Report Real-world German Data From a Decog Studymentioning

confidence: 99%

Deciphering the role of adjuvant therapy in melanoma and its actual benefits

Fukushima,

Miyashita,

Kimura

et al. 2024

The Journal of Dermatology

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Numerous clinical trials have demonstrated a significant improvement in recurrence‐free survival among melanoma patients receiving high‐dose interferon‐α, immune checkpoint inhibitors (pembrolizumab, nivolumab), and BRAF/MEK inhibitors (dabrafenib‐trametinib). This study aimed to investigate whether these findings hold true in real‐world conditions for patients with stage III and IV melanoma. In particular, the study explores the efficacy and side effects of adjuvant therapies, focusing on anti‐PD‐1 antibodies and BRAF/MEK inhibitors. While clinical trials have shown comparable efficacy, differences in side‐effect profiles, especially the persistence of immune‐related adverse events with anti‐PD‐1 antibodies, highlight the need for careful consideration in adjuvant settings. In the absence of established biomarkers for guiding adjuvant therapy decisions, it becomes imperative to transparently communicate the advantages and disadvantages of drug administration to patients. The study also delved into the impact of melanoma subtype and BRAF mutation status on the effectiveness of adjuvant therapy, emphasizing the need for further investigation.

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Influence of adjuvant therapies on organ‐specific recurrence of cutaneous melanoma: A multicenter study on 1383 patients of the prospective DeCOG registry ADOReg

Wohlfeil,

Kranzmann,

Weiß

et al. 2024

Intl Journal of Cancer

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This study investigated whether adjuvant treatments in stage III cutaneous melanoma (CM) influenced patterns of recurrence. Patients with primary (n = 1033) or relapsed CM (n = 350) who received adjuvant therapies with Nivolumab (N), Pembrolizumab (P), or Dabrafenib and Trametinib (D + T) were extracted from the prospective multicenter real‐world skin cancer registry ADOReg. Endpoints were progression‐free survival (PFS), distant metastasis‐free survival (DMFS), organ‐specific DMFS, and overall survival (OS). For primary cases, D + T indicated an improved PFS (1‐ and 2‐year PFS: 90.9%; 82.7%) as compared to P (81.0%, 73.9%; p = .0208), or N (83.8%, 75.2%; p = .0539). BRAF‐mutated(mut) CM demonstrated significantly lower PFS (p = .0022) and decreased DMFS (p = .0580) when treated with immune checkpoint inhibitor (ICI) instead of D + T. Besides, NRAS‐mut CM tended to perform worse than wt CM upon ICI (PFS: p = .1349; DMFS: p = .0540). OS was similar between the groups. Relapsed cases showed decreased PFS, DMFS, and OS in comparison to primary (all: p < .001), without significant differences between the subgroups. Organ‐specific DMFS was significantly altered for primary cases with bone (p = .0367) or brain metastases (p = .0202). In relapsed CM, the frequency of liver (D + T: 1.5%; P: 12%; N: 9%) and LN metastases (D + T: 1.5%; P: 12%; N: 10.2%) was significantly lower with adjuvant D + T than ICI. NRAS‐mut CM showed increased recurrence in primary and relapsed cases. These data show that adjuvant D + T is superior to ICI in primary BRAF‐mut CM.

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Adjuvant treatment and outcome of stage III melanoma patients: Results of a multicenter real-world German Dermatologic Cooperative Oncology Group (DeCOG) study

Cited by 9 publications

References 30 publications

Use of Real-World FHIR Data Combined with Context-Sensitive Decision Modeling to Guide Sentinel Biopsy in Melanoma

Use of Real-World FHIR Data Combined with Context-Sensitive Decision Modeling to Guide Sentinel Biopsy in Melanoma

Deciphering the role of adjuvant therapy in melanoma and its actual benefits

Influence of adjuvant therapies on organ‐specific recurrence of cutaneous melanoma: A multicenter study on 1383 patients of the prospective DeCOG registry ADOReg

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