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1. Seasonal variation of anti-PD-1 outcome in melanoma—Results from a Dutch patient cohort

Author

Borgers, J. S.W., Burgers, F. H., Schina, A., Van Not, O. J., van den Eertwegh, A. J.M., Blank, C. U., Aarts, M. J.B., van den Berkmortel, F. W.P.J., de Groot, J. W.B., Hospers, G. A.P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Boer, A. M.Stevense den, van der Veldt, A. A.M., Vreugdenhil, G., Boers-Sonderen, M. J., Wouters, M. W.J.M., Suijkerbuijk, K. P.M., van Thienen, J. V., Haanen, J. B.A.G., Borgers, J. S.W., Burgers, F. H., Schina, A., Van Not, O. J., van den Eertwegh, A. J.M., Blank, C. U., Aarts, M. J.B., van den Berkmortel, F. W.P.J., de Groot, J. W.B., Hospers, G. A.P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Boer, A. M.Stevense den, van der Veldt, A. A.M., Vreugdenhil, G., Boers-Sonderen, M. J., Wouters, M. W.J.M., Suijkerbuijk, K. P.M., van Thienen, J. V., and Haanen, J. B.A.G.

Abstract

Despite the improved survival rates of patients with advanced stage melanoma since the introduction of ICIs, many patients do not have (long-term) benefit from these treatments. There is evidence that the exposome, an accumulation of host-extrinsic factors including environmental influences, could impact ICI response. Recently, a survival benefit was observed in patients with BRAF wild-type melanoma living in Denmark who initiated immunotherapy in summer as compared to winter. As the Netherlands lies in close geographical proximity to Denmark and has comparable seasonal differences, a Dutch validation cohort was established using data from our nationwide melanoma registry. In this study, we did not observe a similar seasonal difference in overall survival and are therefore unable to confirm the Danish findings. Validation of either the Dutch or Danish findings in (combined) patient cohorts from other countries would be necessary to determine whether this host-extrinsic factor influences the response to ICI-treatment.

Published
2024

2. Treatment-specific risk of subsequent malignant neoplasms in five-year survivors of diffuse large B-cell lymphoma

Author

MS Radiotherapie, Cancer, Verpleegkundig specialisten & PA's, Geurts, Y M, Neppelenbroek, S I M, Aleman, B M P, Janus, C P M, Krol, A D G, van Spronsen, D J, Plattel, W J, Roesink, J M, Verschueren, K M S, Zijlstra, J M, Koene, H R, Nijziel, M R, Schimmel, E C, de Jongh, E, Ong, F, Te Boome, L C J, van Rijn, R S, Böhmer, L H, Ta, B D P, Visser, H P J, Posthuma, E F M, Bilgin, Y M, Muller, K, van Kampen, D, So-Osman, C, Vermaat, J S P, de Weijer, R J, Kersten, M J, van Leeuwen, F E, Schaapveld, M, MS Radiotherapie, Cancer, Verpleegkundig specialisten & PA's, Geurts, Y M, Neppelenbroek, S I M, Aleman, B M P, Janus, C P M, Krol, A D G, van Spronsen, D J, Plattel, W J, Roesink, J M, Verschueren, K M S, Zijlstra, J M, Koene, H R, Nijziel, M R, Schimmel, E C, de Jongh, E, Ong, F, Te Boome, L C J, van Rijn, R S, Böhmer, L H, Ta, B D P, Visser, H P J, Posthuma, E F M, Bilgin, Y M, Muller, K, van Kampen, D, So-Osman, C, Vermaat, J S P, de Weijer, R J, Kersten, M J, van Leeuwen, F E, and Schaapveld, M

Published
2024

3. R-miniCHOP versus R-CHOP in elderly patients with diffuse large B-cell lymphoma: A propensity matched population-based study

Author

MS Hematologie, Cancer, Infection & Immunity, Al-Sarayfi, D., Brink, M., Chamuleau, M. E.D., Brouwer, R., van Rijn, R. S., Issa, D., Deenik, W., Huls, G., Mous, R., Vermaat, J. S.P., Diepstra, A., Zijlstra, J. M., van Meerten, T., Nijland, M., MS Hematologie, Cancer, Infection & Immunity, Al-Sarayfi, D., Brink, M., Chamuleau, M. E.D., Brouwer, R., van Rijn, R. S., Issa, D., Deenik, W., Huls, G., Mous, R., Vermaat, J. S.P., Diepstra, A., Zijlstra, J. M., van Meerten, T., and Nijland, M.

Published
2024

4. Seasonal variation of anti-PD-1 outcome in melanoma-Results from a Dutch patient cohort

Author

Cancer, MS Medische Oncologie, Infection & Immunity, Borgers, J S W, Burgers, F H, Schina, A, Van Not, O J, van den Eertwegh, A J M, Blank, C U, Aarts, M J B, van den Berkmortel, F W P J, de Groot, J W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Boer, A M Stevense-den, van der Veldt, A A M, Vreugdenhil, G, Boers-Sonderen, M J, Wouters, M W J M, Suijkerbuijk, K P M, van Thienen, J V, Haanen, J B A G, Cancer, MS Medische Oncologie, Infection & Immunity, Borgers, J S W, Burgers, F H, Schina, A, Van Not, O J, van den Eertwegh, A J M, Blank, C U, Aarts, M J B, van den Berkmortel, F W P J, de Groot, J W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Boer, A M Stevense-den, van der Veldt, A A M, Vreugdenhil, G, Boers-Sonderen, M J, Wouters, M W J M, Suijkerbuijk, K P M, van Thienen, J V, and Haanen, J B A G

Published
2024

5. Treatment-specific risk of subsequent malignant neoplasms in five-year survivors of diffuse large B-cell lymphoma

Author

Geurts, Y. M., Neppelenbroek, S. I.M., Aleman, B. M.P., Janus, C. P.M., Krol, A. D.G., van Spronsen, D. J., Plattel, W. J., Roesink, J. M., Verschueren, K. M.S., Zijlstra, J. M., Koene, H. R., Nijziel, M. R., Schimmel, E. C., de Jongh, E., Ong, F., te Boome, L. C.J., van Rijn, R. S., Böhmer, L. H., Ta, B. D.P., Visser, H. P.J., Posthuma, E. F.M., Bilgin, Y. M., Muller, K., van Kampen, D., So-Osman, C., Vermaat, J. S.P., de Weijer, R. J., Kersten, M. J., van Leeuwen, F. E., Schaapveld, M., Geurts, Y. M., Neppelenbroek, S. I.M., Aleman, B. M.P., Janus, C. P.M., Krol, A. D.G., van Spronsen, D. J., Plattel, W. J., Roesink, J. M., Verschueren, K. M.S., Zijlstra, J. M., Koene, H. R., Nijziel, M. R., Schimmel, E. C., de Jongh, E., Ong, F., te Boome, L. C.J., van Rijn, R. S., Böhmer, L. H., Ta, B. D.P., Visser, H. P.J., Posthuma, E. F.M., Bilgin, Y. M., Muller, K., van Kampen, D., So-Osman, C., Vermaat, J. S.P., de Weijer, R. J., Kersten, M. J., van Leeuwen, F. E., and Schaapveld, M.

Abstract

Background: The introduction of rituximab significantly improved the prognosis of diffuse large B-cell lymphoma (DLBCL), emphasizing the importance of evaluating the long-term consequences of exposure to radiotherapy, alkylating agents and anthracycline-containing (immuno)chemotherapy among DLBCL survivors. Methods: Long-term risk of subsequent malignant neoplasms (SMNs) was examined in a multicenter cohort comprising 2373 5-year DLBCL survivors treated at ages 15-61 years in 1989-2012. Observed SMN numbers were compared with expected cancer incidence to estimate standardized incidence ratios (SIRs) and absolute excess risks (AERs/10 000 person-years). Treatment-specific risks were assessed using multivariable Cox regression. Results: After a median follow-up of 13.8 years, 321 survivors developed one or more SMNs (SIR 1.5, 95% CI 1.3-1.8, AER 51.8). SIRs remained increased for at least 20 years after first-line treatment (SIR ≥20-year follow-up 1.5, 95% CI 1.0-2.2, AER 81.8) and were highest among patients ≤40 years at first DLBCL treatment (SIR 2.7, 95% CI 2.0-3.5). Lung (SIR 2.0, 95% CI 1.5-2.7, AER 13.4) and gastrointestinal cancers (SIR 1.5, 95% CI 1.2-2.0, AER 11.8) accounted for the largest excess risks. Treatment with >4500 mg/m2 cyclophosphamide/>300 mg/m2 doxorubicin versus ≤2250 mg/m2/≤150 mg/m2, respectively, was associated with increased solid SMN risk (hazard ratio 1.5, 95% CI 1.0-2.2). Survivors who received rituximab had a lower risk of subdiaphragmatic solid SMNs (hazard ratio 0.5, 95% CI 0.3-1.0) compared with survivors who did not receive rituximab. Conclusion: Five-year DLBCL survivors have an increased risk of SMNs. Risks were higher for survivors ≤40 years at first treatment and survivors treated with >4500 mg/m2 cyclophosphamide/>300 mg/m2 doxorubicin, and may be lower for survivors treated in the rituximab era, emphasizing the need for studies with longer follow

Published
2024

6. R‐miniCHOP versus R‐CHOP in elderly patients with diffuse large B‐cell lymphoma: A propensity matched population‐based study

Author

Al‐Sarayfi, D., primary, Brink, M., additional, Chamuleau, M. E. D., additional, Brouwer, R., additional, van Rijn, R. S., additional, Issa, D., additional, Deenik, W., additional, Huls, G., additional, Mous, R., additional, Vermaat, J. S. P., additional, Diepstra, A., additional, Zijlstra, J. M., additional, van Meerten, T., additional, and Nijland, M., additional

Published
2023
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7. Early discontinuation of PD-1 blockade upon achieving a complete or partial response in patients with advanced melanoma: the multicentre prospective Safe Stop trial

Author

Mulder, E. E. A. P., de Joode, K., Litière, S., ten Tije, A. J., Suijkerbuijk, K. P. M., Boers-Sonderen, M. J., Hospers, G. A. P., de Groot, J. W. B., van den Eertwegh, A. J. M., Aarts, M. J. B., Piersma, D., van Rijn, R. S., Kapiteijn, E., Vreugdenhil, G., van den Berkmortel, F. W. P. J., Hoop, E. Oomen-de, Franken, M. G., Ryll, B., Rutkowski, P., Sleijfer, S., Haanen, J. B. A. G., and van der Veldt, A. A. M.

Published
2021
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9. Survival of stage IV melanoma in Belgium and the Netherlands

Author

MS Medische Oncologie, Infection & Immunity, Cancer, Anatomie, MS MOD, MS KNO, Suijkerbuijk, K. P.M., Haanen, J. B.A.G., Boers-Sonderen, M. J., Hospers, G. A.P., Blank, C. U., van den Berkmortel, F. W.P.J., de Groot, J. W.B., Piersma, D., Aarts, M. J.B., van Rijn, R. S., Vreugdenhil, G., Westgeest, H. M., Kapiteijn, E., van der Veldt, A. A.M., van den Eertwegh, A. J.M., MS Medische Oncologie, Infection & Immunity, Cancer, Anatomie, MS MOD, MS KNO, Suijkerbuijk, K. P.M., Haanen, J. B.A.G., Boers-Sonderen, M. J., Hospers, G. A.P., Blank, C. U., van den Berkmortel, F. W.P.J., de Groot, J. W.B., Piersma, D., Aarts, M. J.B., van Rijn, R. S., Vreugdenhil, G., Westgeest, H. M., Kapiteijn, E., van der Veldt, A. A.M., and van den Eertwegh, A. J.M.

Published
2022

10. The development of a flexible and easy to tailor disease model to estimate the outcomes of treatment sequences in advanced melanoma by combining trial and real-world data

Author

de Groot, S., Blommestein, H. M., Leeneman, B., Uyl-De Groot, C. A., Haanen, J. B. A. G., Suijkerbuijk, K. P. M., Aarts, M. J. B., van den Berkmortel, F. W. P. J., Blank, C. U., Boers-Sonderen, M. J., van den Eertwegh, A. J. M., de Groot, J. W. B., Hospers, G. A. P., Kapiteijn, E., de Meza, M. M., Piersma, D., van Rijn, R. S., Stevense-den Boer, M. A. M., van der Veldt, A. A. M., Vreugdenhil, G., Wouters, M. W. J. M., Franken, M., van Baal, P. H. M., and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Published
2022

11. Health state utilities of advanced melanoma patients treated in clinical practice in the era of novel immuno- and targeted therapies

Author

Franken, M., de Groot, S., van Dongen, A., Leeneman, B., Groot, Uyl-De C. A., Aarts, M. J. B., Berkmortel, van den F. W. P. J., Blank, C. U., Boers-Sonderen, M. J., Van den Eertwegh, A. J. M., De Groot, J. W. B., Haanen, J. B. A. G., Hospers, G. A. P., Kapiteijn, E., van Not, O. J., Piersma, D., van Rijn, R. S., Boer, Stevense-den M. A. M., Suijkerbuijk, K. P. M., van der Veldt, A. A. M., Vreugdenhil, G., Wouters, M. W. J. M., Versteegh, M., Blommestein, H. M., Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Clinical Neuropsychology

Published
2022

12. Quality of life in advanced melanoma patients in the era of novel immuno- and targeted therapies

Author

Franken, M., Leeneman, B., Aarts, M. J. B., van den Berkmortel, F. W. P. J., Blank, C. U., Boers-Sonderen, M. J., van den Eertwegh, A. J. M., de Groot, J. W. B., Haanen, J. B. A. G., Hospers, G. A. P., Kapiteijn, E., van Not, O. J., Piersma, D., van Rijn, R. S., Stevense-den Boer, M. A. M., Suijkerbuijk, K. P. M., van der Veldt, A. A. M., Vreugdenhil, G., Wouters, M. W. J. M., van Dongen, A., Uyl-De Groot, C. A., and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Published
2022

13. Validity of the eq-5d-3l and eq-5d-5l in advanced melanoma

Author

Franken, M., van Dongen, A., Leeneman, B., Groot, Uyl-De C. A., Aarts, M. J. B., van den Berkmortel, F. W. P. J., Blank, C. U., Boers-Sonderen, M. J., van den Eertwegh, A. J. M., de Groot, J. W. B., Haanen, J. B. A. G., Hospers, G. A. P., Kapiteijn, E., de Meza, M. M., Piersma, D., van Rijn, R. S., Boer, Stevense-den M. A. M., Suijkerbuijk, K. P. M., van der Veldt, A. A. M., Vreugdenhil, G., Wouters, M. W. J. M., Blommestein, H. M., Versteegh, M., and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Published
2022

14. Trends in survival and costs in metastatic melanoma in the era of novel targeted and immunotherapeutic drugs

Author

Franken, M. G., Leeneman, B., Aarts, M. J.B., van Akkooi, A. C.J., van den Berkmortel, F. W.P.J., Boers-Sonderen, M. J., van den Eertwegh, A. J.M., de Groot, J. W.B., Hospers, G. A.P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P.M., van der Veldt, A. A.M., Westgeest, H. M., Wouters, M. W.J.M., Haanen, J. B.A.G., Uyl-de Groot, C. A., Franken, M. G., Leeneman, B., Aarts, M. J.B., van Akkooi, A. C.J., van den Berkmortel, F. W.P.J., Boers-Sonderen, M. J., van den Eertwegh, A. J.M., de Groot, J. W.B., Hospers, G. A.P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P.M., van der Veldt, A. A.M., Westgeest, H. M., Wouters, M. W.J.M., Haanen, J. B.A.G., and Uyl-de Groot, C. A.

Abstract

BACKGROUND: The objective of this study was to evaluate trends in survival and health care costs in metastatic melanoma in the era of targeted and immunotherapeutic drugs.MATERIALS AND METHODS: Data on survival and health care resource use were retrieved from the Dutch Melanoma Treatment Registry. The Kaplan-Meier method was used to estimate overall survival. Health care costs and budget impact were computed by applying unit costs to individual patient resource use. All outcomes were stratified by year of diagnosis.RESULTS: Baseline characteristics were balanced across cohort years. The percentage of patients receiving systemic treatment increased from 73% in 2013 to 90% in 2018. Patients received on average 1.85 [standard deviation (SD): 1.14] lines of treatment and 41% of patients received at least two lines of treatment. Median survival increased from 11.8 months in 2013 [95% confidence interval (CI): 10.7-13.7 months] to 21.1 months in 2018 (95% CI: 18.2 months-not reached). Total mean costs were €100 330 (SD: €103 699); systemic treatments accounted for 84% of the total costs. Costs for patients who received systemic treatment [€118 905 (SD: €104 166)] remained reasonably stable over the years even after the introduction of additional (combination of) novel drugs. From mid-2013 to 2018, the total budget impact for all patients was €452.79 million.CONCLUSION: Our study shows a gain in survival in the era of novel targeted and immunotherapeutic drugs. These novel drugs came, however, along with substantial health care costs. Further insights into the cost-effectiveness of the novel drugs are crucial for ensuring value for money in the treatment of patients with metastatic melanoma.

Published
2021

15. Trends in survival and costs in metastatic melanoma in the era of novel targeted and immunotherapeutic drugs

Author

MS Medische Oncologie, Divisie Beeld & Oncologie, Infection & Immunity, Cancer, Franken, M. G., Leeneman, B., Aarts, M. J.B., van Akkooi, A. C.J., van den Berkmortel, F. W.P.J., Boers-Sonderen, M. J., van den Eertwegh, A. J.M., de Groot, J. W.B., Hospers, G. A.P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P.M., van der Veldt, A. A.M., Westgeest, H. M., Wouters, M. W.J.M., Haanen, J. B.A.G., Uyl-de Groot, C. A., MS Medische Oncologie, Divisie Beeld & Oncologie, Infection & Immunity, Cancer, Franken, M. G., Leeneman, B., Aarts, M. J.B., van Akkooi, A. C.J., van den Berkmortel, F. W.P.J., Boers-Sonderen, M. J., van den Eertwegh, A. J.M., de Groot, J. W.B., Hospers, G. A.P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P.M., van der Veldt, A. A.M., Westgeest, H. M., Wouters, M. W.J.M., Haanen, J. B.A.G., and Uyl-de Groot, C. A.

Published
2021

16. Early discontinuation of PD-1 blockade upon achieving a complete or partial response in patients with advanced melanoma: the multicentre prospective Safe Stop trial

Author

MS Medische Oncologie, Infection & Immunity, Cancer, Mulder, E E A P, de Joode, K, Litière, S, Ten Tije, A J, Suijkerbuijk, K P M, Boers-Sonderen, M J, Hospers, G A P, de Groot, J W B, van den Eertwegh, A J M, Aarts, M J B, Piersma, D, van Rijn, R S, Kapiteijn, E, Vreugdenhil, G, van den Berkmortel, F W P J, Hoop, E Oomen-de, Franken, M G, Ryll, B, Rutkowski, P, Sleijfer, S, Haanen, J B A G, van der Veldt, A A M, MS Medische Oncologie, Infection & Immunity, Cancer, Mulder, E E A P, de Joode, K, Litière, S, Ten Tije, A J, Suijkerbuijk, K P M, Boers-Sonderen, M J, Hospers, G A P, de Groot, J W B, van den Eertwegh, A J M, Aarts, M J B, Piersma, D, van Rijn, R S, Kapiteijn, E, Vreugdenhil, G, van den Berkmortel, F W P J, Hoop, E Oomen-de, Franken, M G, Ryll, B, Rutkowski, P, Sleijfer, S, Haanen, J B A G, and van der Veldt, A A M

Published
2021

17. Survival outcomes of patients with advanced melanoma from 2013 to 2017: Results of a nationwide population-based registry

Author

MS Medische Oncologie, Infection & Immunity, Cancer, van Zeijl, M. C.T., de Wreede, L. C., van den Eertwegh, A. J.M., Wouters, M. W.J.M., Jochems, A., Schouwenburg, M. G., Aarts, M. J.B., van Akkooi, A. C.J., van den Berkmortel, F. W.P.J., de Groot, J. W.B., Hospers, G. A.P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P.M., ten Tije, A. J., van der Veldt, A. A.M., Vreugdenhil, G., van der Hoeven, J. J.M., Haanen, J. B.A.G., MS Medische Oncologie, Infection & Immunity, Cancer, van Zeijl, M. C.T., de Wreede, L. C., van den Eertwegh, A. J.M., Wouters, M. W.J.M., Jochems, A., Schouwenburg, M. G., Aarts, M. J.B., van Akkooi, A. C.J., van den Berkmortel, F. W.P.J., de Groot, J. W.B., Hospers, G. A.P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P.M., ten Tije, A. J., van der Veldt, A. A.M., Vreugdenhil, G., van der Hoeven, J. J.M., and Haanen, J. B.A.G.

Published
2021

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

Author

van Zeijl, M C T, Ismail, R K, de Wreede, L C, van den Eertwegh, A J M, de Boer, A, van Dartel, M, Hilarius, D L, Aarts, M J B, van den Berkmortel, F W P J, Boers-Sonderen, M J, de Groot, J W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Suijkerbuijk, K P M, Ten Tije, A J, van der Veldt, A A M, Vreugdenhil, G, Haanen, J B A G, Wouters, M W J M, Sub Algemeen Math. Inst, Afd Pharmacoepi & Clinical Pharmacology, extern UU GWS, Pharmacoepidemiology and Clinical Pharmacology, Sub Algemeen Math. Inst, Afd Pharmacoepi & Clinical Pharmacology, extern UU GWS, Pharmacoepidemiology and Clinical Pharmacology, CCA - Cancer Treatment and quality of life, AII - Cancer immunology, Medical oncology, Medical Oncology, Radiology & Nuclear Medicine, Surgery, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
Male, Oncology, advanced melanoma, Cancer Research, Phase iii trials, medicine.medical_treatment, ineligibility, THERAPIES, Targeted therapy, chemistry.chemical_compound, MAGNITUDE, Antineoplastic Agents, Immunological, 0302 clinical medicine, METASTATIC MELANOMA, Medicine, BENEFIT, Molecular Targeted Therapy, Prospective Studies, Cancer Therapy and Prevention, AMERICAN SOCIETY, Melanoma, Netherlands, Aged, 80 and over, education.field_of_study, Middle Aged, Prognosis, real-world outcomes, Treatment Outcome, 030220 oncology & carcinogenesis, Female, medicine.drug, Adult, medicine.medical_specialty, Clinical Decision-Making, Population, Ipilimumab, survival, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18], Young Adult, 03 medical and health sciences, Lactate dehydrogenase, Internal medicine, decision tree, CLINICAL ONCOLOGY, Humans, IMMUNOTHERAPY, education, real‐world outcomes, Aged, Neoplasm Staging, Proportional Hazards Models, Advanced melanoma, business.industry, Proportional hazards model, IPILIMUMAB, Patient Selection, Immunotherapy, Survival Analysis, COMBINED NIVOLUMAB, Clinical Trials, Phase III as Topic, chemistry, business
Abstract

The aim was to provide evidence on systemically treated patients with advanced melanoma not represented in phase III trials to support clinical decision‐making. Analysis were performed on advanced melanoma patients diagnosed between 2014 and 2017 in the Netherlands, treated with immune‐ or targeted therapy, who met ≥1 trial exclusion criteria. These criteria were derived from the KEYNOTE‐006 and CHECKMATE‐067/‐066 phase III trials. Prognostic importance of factors associated with overall survival (OS) was assessed with the Kaplan‐Meier method, Cox models, predicted OS probabilities of prognostic subgroups and a conditional inference survival tree (CIST). A nationwide population‐based registry was used as data source. Of 2536 systemically treated patients with advanced melanoma, 1004 (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 strongly associated with OS in systemically treated ineligible patients were Eastern Cooperative Oncology Group Performance Score (ECOG PS) ≥2, brain metastases (BM) and lactate dehydrogenase (LDH) of >500 U/L. Patients with ECOG PS of ≥2 with or without symptomatic BM had a predicted mOS of 6.5 and 11.3 months and a 3‐year survival probability of 9.3% and 23.6%, respectively. The CIST showed the strongest prognostic covariate for survival was LDH, followed by ECOG PS. The prognosis of patients with LDH of >500 U/L is poor, but long‐term survival is possible. The prognosis of ineligible patients with advanced melanoma in real‐world was very heterogeneous and highly dependent on LDH value, ECOG PS and symptomatic BM., What's new? By necessity, randomized controlled trials (RCTs) exclude many patients. However, these ineligible patients are often still treated with new systemic therapies on an individual basis. In this study, the authors examined how various subgroups of ineligible patients fared following treatment for advanced melanoma. They found that several criteria were strongly associated with prognosis in these patients, including lactate dehydrogenase (LDH) levels. These results should provide clinicians with a decision tree of prognostic factors to help guide treatment decisions.

Published
2020

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

Author

Sub Algemeen Math. Inst, Afd Pharmacoepi & Clinical Pharmacology, extern UU GWS, Pharmacoepidemiology and Clinical Pharmacology, van Zeijl, M C T, Ismail, R K, de Wreede, L C, van den Eertwegh, A J M, de Boer, A, van Dartel, M, Hilarius, D L, Aarts, M J B, van den Berkmortel, F W P J, Boers-Sonderen, M J, de Groot, J W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Suijkerbuijk, K P M, Ten Tije, A J, van der Veldt, A A M, Vreugdenhil, G, Haanen, J B A G, Wouters, M W J M, Sub Algemeen Math. Inst, Afd Pharmacoepi & Clinical Pharmacology, extern UU GWS, Pharmacoepidemiology and Clinical Pharmacology, van Zeijl, M C T, Ismail, R K, de Wreede, L C, van den Eertwegh, A J M, de Boer, A, van Dartel, M, Hilarius, D L, Aarts, M J B, van den Berkmortel, F W P J, Boers-Sonderen, M J, de Groot, J W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Suijkerbuijk, K P M, Ten Tije, A J, van der Veldt, A A M, Vreugdenhil, G, Haanen, J B A G, and Wouters, M W J M

Published
2020

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

Author

Researchgr. Cardiovasculaire Radiologie, Cancer, MS Medische Oncologie, Infection & Immunity, van Zeijl, M C T, Ismail, R K, de Wreede, L C, van den Eertwegh, A J M, de Boer, A, van Dartel, M, Hilarius, D L, Aarts, M J B, van den Berkmortel, F W P J, Boers-Sonderen, M J, de Groot, J W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Suijkerbuijk, K P M, Ten Tije, A J, van der Veldt, A A M, Vreugdenhil, G, Haanen, J B A G, Wouters, M W J M, Researchgr. Cardiovasculaire Radiologie, Cancer, MS Medische Oncologie, Infection & Immunity, van Zeijl, M C T, Ismail, R K, de Wreede, L C, van den Eertwegh, A J M, de Boer, A, van Dartel, M, Hilarius, D L, Aarts, M J B, van den Berkmortel, F W P J, Boers-Sonderen, M J, de Groot, J W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Suijkerbuijk, K P M, Ten Tije, A J, van der Veldt, A A M, Vreugdenhil, G, Haanen, J B A G, and Wouters, M W J M

Published
2020

21. A NATIONWIDE COST OF ILLNESS STUDY OF METASTATIC CUTANEOUS MELANOMA IN THE NETHERLANDS

Author

Leeneman, B., Franken, M. G., Aarts, M. J. B., van Akkooi, A. C. J., van den Berkmortel, F. W. P. J., van den Eertwegh, A. J. M., de Groot, J. W. B., Herbschleb, K. H., van der Hoeven, J. J. M., Hospers, G. A. P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P. M., ten Tije, A. J., van der Veldt, A. A. M., Vreugdenhil, G., Wouters, M. W. J. M., Haanen, J. B. A. G., and Uyl-de Groot, C.

Published
2019

22. VALUE FOR MONEY IN METASTATIC CUTANEOUS MELANOMA: DO BENEFITS OUTWEIGH THE COSTS OF NOVEL DRUGS?

Author

Franken, M. G., Leeneman, B., Van, Zeijl M., Aarts, M. J. B., van Akkooi, A. C. J., van den Berkmortel, F. W. P. J., van den Eertwegh, A. J. M., de Groot, J. W. B., Herbschleb, K. H., van der Hoeven, J. J. M., Hospers, G. A. P., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P. M., ten Tije, A. J., van der Veldt, A. A. M., Vreugdenhil, G., Wouters, M. W. J. M., Haanen, J. B. A. G., and Uyl-de Groot, C.

Published
2019

23. END-OF-LIFE CARE IN PATIENTS WITH METASTATIC CUTANEOUS MELANOMA IN THE NETHERLANDS

Author

Leeneman, B., Franken, M., Aarts, M. J., van Akkooi, A. C., van den Berkmortel, F. W., van den Eertwegh, A. J., de Groot, J. W., Herbschleb, K. H., van der Hoeven, K. J., Hospers, G. A., Kapiteijn, E., Piersma, D., van Rijn, R. S., Suijkerbuijk, K. P., ten Tije, A. J., van der Veldt, A. A., Vreugdenhil, G., Wouters, M. W., van Zeijl, M. C., Haanen, J. B., Uyl-de Groot, C. A., and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Published
2018

24. Treatment-specific risk of subsequent malignant neoplasms in five-year survivors of diffuse large B-cell lymphoma.

Author

Geurts YM, Neppelenbroek SIM, Aleman BMP, Janus CPM, Krol ADG, van Spronsen DJ, Plattel WJ, Roesink JM, Verschueren KMS, Zijlstra JM, Koene HR, Nijziel MR, Schimmel EC, de Jongh E, Ong F, Te Boome LCJ, van Rijn RS, Böhmer LH, Ta BDP, Visser HPJ, Posthuma EFM, Bilgin YM, Muller K, van Kampen D, So-Osman C, Vermaat JSP, de Weijer RJ, Kersten MJ, van Leeuwen FE, and Schaapveld M

Subjects
Humans, Rituximab adverse effects, Survivors, Cyclophosphamide, Doxorubicin, Neoplasms, Second Primary epidemiology, Neoplasms, Second Primary etiology, Lymphoma, Large B-Cell, Diffuse epidemiology
Abstract

Background: The introduction of rituximab significantly improved the prognosis of diffuse large B-cell lymphoma (DLBCL), emphasizing the importance of evaluating the long-term consequences of exposure to radiotherapy, alkylating agents and anthracycline-containing (immuno)chemotherapy among DLBCL survivors., Methods: Long-term risk of subsequent malignant neoplasms (SMNs) was examined in a multicenter cohort comprising 2373 5-year DLBCL survivors treated at ages 15-61 years in 1989-2012. Observed SMN numbers were compared with expected cancer incidence to estimate standardized incidence ratios (SIRs) and absolute excess risks (AERs/10 000 person-years). Treatment-specific risks were assessed using multivariable Cox regression., Results: After a median follow-up of 13.8 years, 321 survivors developed one or more SMNs (SIR 1.5, 95% CI 1.3-1.8, AER 51.8). SIRs remained increased for at least 20 years after first-line treatment (SIR ≥20-year follow-up 1.5, 95% CI 1.0-2.2, AER 81.8) and were highest among patients ≤40 years at first DLBCL treatment (SIR 2.7, 95% CI 2.0-3.5). Lung (SIR 2.0, 95% CI 1.5-2.7, AER 13.4) and gastrointestinal cancers (SIR 1.5, 95% CI 1.2-2.0, AER 11.8) accounted for the largest excess risks. Treatment with >4500 mg/m 2 cyclophosphamide/>300 mg/m 2 doxorubicin versus ≤2250 mg/m 2 /≤150 mg/m 2 , respectively, was associated with increased solid SMN risk (hazard ratio 1.5, 95% CI 1.0-2.2). Survivors who received rituximab had a lower risk of subdiaphragmatic solid SMNs (hazard ratio 0.5, 95% CI 0.3-1.0) compared with survivors who did not receive rituximab., Conclusion: Five-year DLBCL survivors have an increased risk of SMNs. Risks were higher for survivors ≤40 years at first treatment and survivors treated with >4500 mg/m 2 cyclophosphamide/>300 mg/m 2 doxorubicin, and may be lower for survivors treated in the rituximab era, emphasizing the need for studies with longer follow-up for rituximab-treated patients., Competing Interests: Disclosure MJK has received research support from Kite/Gilead and financial compensation for attending advisory boards and/or presentations from Roche, Kite/Gilead, Novartis, BMS/Celgene, Miltenyi Biotec, Takeda and Adicet Bio. All other authors have declared no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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25. Trends in survival and costs in metastatic melanoma in the era of novel targeted and immunotherapeutic drugs.

Author

Franken MG, Leeneman B, Aarts MJB, van Akkooi ACJ, van den Berkmortel FWPJ, Boers-Sonderen MJ, van den Eertwegh AJM, de Groot JWB, Hospers GAP, Kapiteijn E, Piersma D, van Rijn RS, Suijkerbuijk KPM, van der Veldt AAM, Westgeest HM, Wouters MWJM, Haanen JBAG, and Uyl-de Groot CA

Subjects
Cohort Studies, Cost-Benefit Analysis, Health Care Costs, Humans, Immunotherapy methods, Melanoma drug therapy
Abstract

Background: The objective of this study was to evaluate trends in survival and health care costs in metastatic melanoma in the era of targeted and immunotherapeutic drugs., Materials and Methods: Data on survival and health care resource use were retrieved from the Dutch Melanoma Treatment Registry. The Kaplan-Meier method was used to estimate overall survival. Health care costs and budget impact were computed by applying unit costs to individual patient resource use. All outcomes were stratified by year of diagnosis., Results: Baseline characteristics were balanced across cohort years. The percentage of patients receiving systemic treatment increased from 73% in 2013 to 90% in 2018. Patients received on average 1.85 [standard deviation (SD): 1.14] lines of treatment and 41% of patients received at least two lines of treatment. Median survival increased from 11.8 months in 2013 [95% confidence interval (CI): 10.7-13.7 months] to 21.1 months in 2018 (95% CI: 18.2 months-not reached). Total mean costs were €100 330 (SD: €103 699); systemic treatments accounted for 84% of the total costs. Costs for patients who received systemic treatment [€118 905 (SD: €104 166)] remained reasonably stable over the years even after the introduction of additional (combination of) novel drugs. From mid-2013 to 2018, the total budget impact for all patients was €452.79 million., Conclusion: Our study shows a gain in survival in the era of novel targeted and immunotherapeutic drugs. These novel drugs came, however, along with substantial health care costs. Further insights into the cost-effectiveness of the novel drugs are crucial for ensuring value for money in the treatment of patients with metastatic melanoma., Competing Interests: Disclosure ACJvA reports grants and personal fees from Amgen and Merck-Pfizer; and personal fees from Bristol-Myers Squibb, Novartis, MSD-Merck, Pierre Fabre, Sanofi, and 4SC, outside the submitted work. AJMvdE reports personal fees from BMS, MSD, Merck, Sanofi, Roche, Novartis, Eisai, Ipsen, Pfizer, and Pierre Fabre; and grants from Grant for clinical studies, outside the submitted work. MGF reports grants from Roche Nederland B.V., Daiichi Sankyo, Abbvie, Gilead Sciences Netherlands BV, and Astellas Pharma BV, outside the submitted work. JWBdG reports personal fees from BMS, MSD, Pierre Fabre, and Servier, outside the submitted work. JBAGH reports grants and other from BMS, MSD, Novartis, BioNTech, and Amgen; other from Achilles Tx, GSK, Immunocore, Ipsen, Merck Serono, Molecular Partners, Pfizer, Roche/Genentech, Sanofi, Seattle Genetics, Third Rock Ventures, and Vaximm; and personal fees from Neogene Tx, outside the submitted work. GAPH reports consulting and advisory role: Amgen, Roche, MSD, BMS, Pfizer, Novartis, Pierre Fabry, paid to the institution (UMCG); and research grant from BMS and Seerave, paid to the institution (UMCG). DP reports personal fees from BMS advisory board and Pierre Fabre advisory board, outside the submitted work. KPMS reports personal fees from Novartis, Roche, Pierre Fabre, MSD, BMS, and Abbvie, outside the submitted work. AAMvdV reports other from BMS, MSD, Merck, Sanofi, Roche, Novartis, Eisai, Ipsen, Pfizer, and Pierre Fabre, outside the submitted work. HMW reports non-financial support from Ipsen; personal fees from Roche; and personal fees and non-financial support from Astellas, outside the submitted work. All other authors have declared no conflicts of interest., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2021
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