Dutch Melanoma Treatment Registry: Quality assurance in the care of patients with metastatic melanoma in the Netherlands

Jochems, Anouk; Schouwenburg, Maartje G.; Leeneman, B; Franken, M; Eertwegh, Alfons J.M. van den; Haanen, John B.A.G.; Gelderblom, Hans; Groot, Carin A. Uyl–de; Aarts, Maureen J.B.; Berkmortel, Franchette W P J van den; Blokx, Willeke A.M.; Cardous-Ubbink, Mathilde C.; Groenewegen, Gerard; Groot, Jan Willem B. de; Hospers, Geke A.P.; Kapiteijn, Ellen; Koornstra, Rutger H.T.; Kruit, Wim; Louwman, Marieke W. J.; Piersma, Djura; Rijn, Rozemarijn S. van; Tije, Albert J. ten; Vreugdenhil, Gerard; Wouters, Michel W. J. M.; Hoeven, J.J.M. van der

doi:10.1016/j.ejca.2016.11.021

Cited by 91 publications

(94 citation statements)

References 21 publications

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“…Furthermore, observational studies are more susceptible to registration bias. To ensure high-quality data, data managers were extensively trained and supervised by oncologists [21]. Another limitation is the small number of patients in the subgroup analyses.…”

Section: Discussionmentioning

confidence: 99%

“…The DMTR contains information on baseline patient and tumor characteristics, local and systemic treatment modalities, treatment-related adverse events (grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 4), and clinical outcomes of all patients with unresectable stage IIIC or IV melanoma. A detailed description of the DMTR was published previously [21].…”

Section: Data: the Dutch Melanoma Treatment Registry (Dmtr)mentioning

confidence: 99%

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Switching to Immune Checkpoint Inhibitors upon Response to Targeted Therapy; The Road to Long-Term Survival in Advanced Melanoma Patients with Highly Elevated Serum LDH?

Schouwenburg

Suijkerbuijk

Koornstra

et al. 2019

Cancers

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The prognosis of patients with advanced melanoma has improved dramatically. However, the clinical outcomes of patients with highly elevated serum lactate dehydrogenase (LDH) remain very poor. The aim of this study was to explore whether patients with normalized LDH after targeted therapy could benefit from subsequent treatment with immune checkpoint inhibitors (ICI). Data from all patients with BRAF-mutant metastatic melanoma with a highly elevated serum LDH at baseline (≥2× upper limit of normal) receiving first-line targeted therapy between 2012 and 2019 in the Netherlands were collected. Patients were stratified according to response status to targeted therapy and change in LDH at start of subsequent treatment with ICI. Differences in overall survival (OS) between the subgroups were compared using log-rank tests. After a median follow-up of 35.1 months, median OS of the total study population (n = 360) was 4.9 months (95% CI 4.4–5.4). Of all patients receiving subsequent treatment with ICI (n = 113), survival from start of subsequent treatment was significantly longer in patients who had normalized LDH and were still responding to targeted therapy compared to those with LDH that remained elevated (median OS 24.7 vs. 1.1 months). Our study suggests that introducing ICI upon response to targeted therapy with normalization of LDH could be an effective strategy in obtaining long-term survival in advanced melanoma patients with initial highly elevated serum LDH.

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Section: Discussionmentioning

confidence: 99%

Section: Data: the Dutch Melanoma Treatment Registry (Dmtr)mentioning

confidence: 99%

Switching to Immune Checkpoint Inhibitors upon Response to Targeted Therapy; The Road to Long-Term Survival in Advanced Melanoma Patients with Highly Elevated Serum LDH?

Schouwenburg

Suijkerbuijk

Koornstra

et al. 2019

Cancers

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“…In this nationwide prospective database, all Dutch patients undergoing treatment for unresectable stage IIIC and IV melanoma are included. This registry was set up to monitor the safety and the outcomes of the novel treatments [26]. Registration in the DMTR is a prerequisite for reimbursement, assuring nationwide coverage.…”

Section: Methodsmentioning

confidence: 99%

Surgery for Unresectable Stage IIIC and IV Melanoma in the Era of New Systemic Therapy

Blankenstein

Aarts

Berkmortel

et al. 2020

Cancers

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Opportunities for surgical treatment in metastatic melanoma patients have re-emerged due to the development of novel systemic therapeutics over the past decade. The aim of this study is to present data on outcomes of surgery in patients with unresectable stage IIIC and IV melanoma, who have previously been treated with immunotherapy or targeted therapy. Data was extracted from the Dutch Melanoma Treatment Registry (DMTR) on 154 patients obtaining disease control to systemic therapy and undergoing subsequent surgery. Disease control was defined as a complete response (CR), which was seen in 3.2% of patients; a partial response (PR), seen in 46.1% of patients; or stable disease (SD), seen in 44.2% of patients. At a median follow-up of 10.0 months (interquartile range 4–22) after surgery, the median overall survival (OS) had not been reached in our cohort and median progression-free survival (PFS) was 9.0 months (95% CI 6.3–11.7). A CR or PR at first follow-up after surgery was associated with both a better OS and PFS compared to stable or progressive disease (p < 0.001). We conclude that selected patients can benefit from surgery after achieving disease control with systemic therapy.

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“…The DMTR has nationwide coverage and includes patients without treatment as well. 7 Results from our study can be used to inform patients on probable prognosis to make well-informed shared-decision and set realistic treatment goals. In patients with (multiple) unfavorable prognostic factors refraining from systemic treatment should be seriously considered.…”

Section: Strengthsmentioning

confidence: 97%

Real-world outcomes of advanced melanoma patients not represented in phase III trials.

Ismail

Zeijl

Wreede

et al. 2020

JCO

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10042 Background: A large proportion of patients with advanced melanoma is not represented in phase III clinical trials, due to ineligibility. Real-world efficacy evidence of immune- and targeted therapies in these patients is lacking. We aimed to provide insight in survival outcomes of systemically treated patients who were not represented in the phase III trials in order to support clinical decision-making. Methods: Systemically treated ineligible patients with advanced melanoma diagnosed between 2014-2017 were analyzed. Prognostic importance of factors associated with overall survival (OS) was assessed by Kaplan Meier method, Cox regression models, predicted OS probabilities of prognostic subgroups and a conditional inference survival (decision) tree. Results: Of 2,536 systemically treated patients with advanced melanoma, 1,004 (40%) patients were ineligible for phase IIII trials. Ineligible patients had a poorer median OS (mOS) compared to eligible patients (8.8 vs 23 months). Eligibility criteria most strongly correlated with survival in ineligible systemically treated patients with ECOG Performance Score (PS) ≥2 vs PS 0-1 (HR 1.95 (95%CI: 1.52-2.5)), symptomatic brain metastases (BM) vs absent BM (HR 1.71 (95%CI: 1.34-2.18)) and LDH > 500 U/l vs normal (HR 1.89 (95%CI: 1.49-2.41)). All other factors for ineligibility were not associated with OS. By combining ECOG PS, BM and LDH, 18 subgroups were created. The 3-year survival probability of patients with ECOG PS ≤1, asymptomatic BM and normal LDH was 35.1%. Patients with ECOG PS of ≥2 with or without symptomatic BM had a mOS of 6.5 and 11.3 months and a 3-year survival probability of 9.3% and 23.6% respectively. In the decision tree, the covariate with the strongest predictive distinctive character for survival was LDH, followed by ECOG PS. Prognosis of LDH of > 500 U/L is infaust, although still long-term survival is possible (3-year survival probability of 15.3%). The decision tree showed the prognosis of patients with symptomatic BM can be good if ECOG PS is 0 and patients are aged ≤55 years (mOS of 22.3 months). Conclusions: Patients with advanced melanoma not represented in phase III trials treated with systemic therapy can achieve long term survival. LDH was the strongest predictive factor associated with survival, followed by ECOG PS and symptomatic BM. Other factors for ineligibility were not associated with OS. These results, together with the decision tree, can be used to provide insight in outcomes to facilitate the shared decision-making process when comparative studies are not available.

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Dutch Melanoma Treatment Registry: Quality assurance in the care of patients with metastatic melanoma in the Netherlands

Cited by 91 publications

References 21 publications

Switching to Immune Checkpoint Inhibitors upon Response to Targeted Therapy; The Road to Long-Term Survival in Advanced Melanoma Patients with Highly Elevated Serum LDH?

Switching to Immune Checkpoint Inhibitors upon Response to Targeted Therapy; The Road to Long-Term Survival in Advanced Melanoma Patients with Highly Elevated Serum LDH?

Surgery for Unresectable Stage IIIC and IV Melanoma in the Era of New Systemic Therapy

Real-world outcomes of advanced melanoma patients not represented in phase III trials.

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