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3. Neoadjuvant FOLFOXIRI prior to chemoradiotherapy for high-risk (“ugly”) locally advanced rectal cancer: study protocol of a single-arm, multicentre, open-label, phase II trial (MEND-IT)

Author

van den Berg, K., Schaap, D. P., Voogt, E. L. K., Buffart, T. E., Verheul, H. M. W., de Groot, J. W. B., Verhoef, C., Melenhorst, J., Roodhart, J. M. L., de Wilt, J. H. W., van Westreenen, H. L., Aalbers, A. G. J., van ‘t Veer, M., Marijnen, C. A. M., Vincent, J., Simkens, L. H. J., Peters, N. A. J. B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M. U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A. P., Bloemen, J. G., Willems, J. M. W. E., Creemers, G. J. M., Nederend, J., Rutten, H. J. T., and Burger, J. W. A.

Published
2022
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5. External validation of a lung cancer-based prediction model for two-year mortality in esophageal cancer patient cohorts

Author

Epi Methoden Team 4, Circulatory Health, JC onderzoeksprogramma Methodologie, Epi Methoden, Cancer, Epi Methoden Team 2, Berbée, M., Muijs, C. T., Voncken, F. E.M., Wee, L. S., Sosef, M., van Etten, B., van Sandick, J. W., Warmerdam, F. A.R.M., de Haan, J. J., Oldehinkel, E., van Dieren, J. M., Boersma, L., Langendijk, J. A., van der Schaaf, A., Reitsma, J. B., Schuit, E., Epi Methoden Team 4, Circulatory Health, JC onderzoeksprogramma Methodologie, Epi Methoden, Cancer, Epi Methoden Team 2, Berbée, M., Muijs, C. T., Voncken, F. E.M., Wee, L. S., Sosef, M., van Etten, B., van Sandick, J. W., Warmerdam, F. A.R.M., de Haan, J. J., Oldehinkel, E., van Dieren, J. M., Boersma, L., Langendijk, J. A., van der Schaaf, A., Reitsma, J. B., and Schuit, E.

Published
2024

7. External validation of a lung cancer-based prediction model for two-year mortality in esophageal cancer patient cohorts

Author

Berbée, M., primary, Muijs, C.T., additional, Voncken, F.E.M., additional, Wee, L.S., additional, Sosef, M., additional, Etten van, L., additional, Sandick van, J.W., additional, Warmerdam, F.A.R.M., additional, de Haan, J.J., additional, Oldehinkel, E., additional, Dieren van, J.M., additional, Boersma, L., additional, Langendijk, J.A., additional, Schaaf van der, A., additional, Reitsma, J.B., additional, and Schuit, E., additional

Published
2023
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11. Coverage of lateral lymph nodes in rectal cancer patients with routine radiotherapy practice and associated locoregional recurrence rates

Author

Sluckin, T.C., primary, Hazen, S.J.A., additional, Horsthuis, K., additional, Beets-Tan, R.G.H., additional, Antonisse, I.E., additional, Berbée, M., additional, van Bockel, L.W., additional, Boer, A.H., additional, Ceha, H.M., additional, Cnossen, J.S., additional, Geijsen, E.D., additional, den Hartogh, M.D., additional, Hendriksen, E.M., additional, Intven, M.P.W., additional, Leseman-Hoogenboom, M.M., additional, Meijnen, P., additional, Muller, K., additional, Oppedijk, V., additional, Rozema, T., additional, Rütten, H., additional, Spruit, P.H., additional, Stam, T.C., additional, Velema, L.A., additional, Verrijssen, A.E., additional, Vos-Westerman, J., additional, Tanis, P.J., additional, Marijnen, C.A.M., additional, and Kusters, M., additional

Published
2023
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12. Coverage of Lateral Lymph Nodes in Rectal Cancer Patients with Routine Radiation Therapy Practice and Associated Locoregional Recurrence Rates.

Author

Sluckin, T.C., Hazen, S.J.A., Horsthuis, K., Beets-Tan, R.G.H., Antonisse, I.E., Berbée, M., Bockel, L.W. van, Boer, A.H., Ceha, H.M., Cnossen, J.S., Geijsen, E.D., Hartogh, M.D. den, Hendriksen, E.M., Intven, M.P.W., Leseman-Hoogenboom, M.M., Meijnen, P., Muller, Karin, Oppedijk, V., Rozema, T., Rütten, H., Spruit, P.H., Stam, T.C., Velema, L.A., Verrijssen, A.E., Vos-Westerman, J., Tanis, P.J., Marijnen, C.A.M., Kusters, M., Sluckin, T.C., Hazen, S.J.A., Horsthuis, K., Beets-Tan, R.G.H., Antonisse, I.E., Berbée, M., Bockel, L.W. van, Boer, A.H., Ceha, H.M., Cnossen, J.S., Geijsen, E.D., Hartogh, M.D. den, Hendriksen, E.M., Intven, M.P.W., Leseman-Hoogenboom, M.M., Meijnen, P., Muller, Karin, Oppedijk, V., Rozema, T., Rütten, H., Spruit, P.H., Stam, T.C., Velema, L.A., Verrijssen, A.E., Vos-Westerman, J., Tanis, P.J., Marijnen, C.A.M., and Kusters, M.

Abstract

Contains fulltext : 296146.pdf (Publisher’s version ) (Closed access), PURPOSE: Involved internal iliac and obturator lateral lymph nodes (LLNs) are a known risk factor for the occurrence of ipsilateral local recurrences (LLR) in rectal cancer. This study examined coverage of LLNs with routine radiation therapy practice in the Netherlands and associated LLR rates. METHODS AND MATERIALS: Patients with a primary tumor ≤8 cm of the anorectal junction, cT3-4 stage, and at least 1 internal iliac or obturator LLN with short axis ≥5 mm who received neoadjuvant (chemo)radiation therapy, were selected from a national, cross-sectional study of patients with rectal cancer treated in the Netherlands in 2016. Magnetic resonance images and radiation therapy treatment plans were reviewed regarding segmented LLNs as gross tumor volume (GTV), location of LLNs within clinical target volume (CTV), and received proportion of the planned radiation therapy dose. RESULTS: A total of 223 out of 3057 patients with at least 1 LLN ≥5 mm were selected. Of those, 180 (80.7%) LLNs were inside the CTV, of which 60 (33.3%) were segmented as GTV. Overall, 202 LLNs (90.6%) received ≥95% of the planned dose. Four-year LLR rates were not significantly higher for LLNs situated outside the CTV compared with those inside (4.0% vs 12.5%, P = .092) or when receiving <95% versus ≥95% of the planned radiation therapy dose (7.1% vs 11.3%, P = .843), respectively. Two of 7 patients who received a dose escalation of 60 Gy developed an LLR (4-year LLR rate of 28.6%). CONCLUSIONS: This evaluation of routine radiation therapy practice showed that adequate coverage of LLNs was still associated with considerable 4-year LLR rates. Techniques resulting in better local control for patients with involved LLNs need to be explored further.

Published
2023

15. Ustilaginomycetes

Author

Bauer, R., Begerow, D., Oberwinkler, E., Piepenbring, M., Berbee, M. L., Esser, Karl, editor, Lemke, Paul A., editor, McLaughlin, David J., editor, and McLaughlin, Esther G., editor

Published
2001
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16. Neoadjuvant FOLFOXIRI prior to chemoradiotherapy for high-risk ('ugly') locally advanced rectal cancer: study protocol of a single-arm, multicentre, open-label, phase II trial (MEND-IT)

Author

van den Berg, K.F.M., Schaap, D.P., Voogt, E.L.K., Buffart, T.E., Verheul, H.M.W., de Groot, J.W.B., Verhoef, C., Melenhorst, J., Roodhart, J.M.L., de Wilt, J.H.W., van Westreenen, H.L., Aalbers, A.G.J., van 't Veer, M., Marijnen, C.A.M., Vincent, J., Simkens, L.H.J., Peters, N.A.J.B., Berbée, M., Werter, I.M., Snaebjornsson, P., Peulen, H.M.U., van Lijnschoten, I.G., Roef, M.J., Nieuwenhuijzen, G.A.P., Bloemen, J.G., Willems, J.M.W.E., Creemers, G.J.M., Nederend, J., Rutten, H.J.T., Burger, J.W.A., van den Berg, K.F.M., Schaap, D.P., Voogt, E.L.K., Buffart, T.E., Verheul, H.M.W., de Groot, J.W.B., Verhoef, C., Melenhorst, J., Roodhart, J.M.L., de Wilt, J.H.W., van Westreenen, H.L., Aalbers, A.G.J., van 't Veer, M., Marijnen, C.A.M., Vincent, J., Simkens, L.H.J., Peters, N.A.J.B., Berbée, M., Werter, I.M., Snaebjornsson, P., Peulen, H.M.U., van Lijnschoten, I.G., Roef, M.J., Nieuwenhuijzen, G.A.P., Bloemen, J.G., Willems, J.M.W.E., Creemers, G.J.M., Nederend, J., Rutten, H.J.T., and Burger, J.W.A.

Abstract

BACKGROUND: The presence of mesorectal fascia (MRF) invasion, grade 4 extramural venous invasion (EMVI), tumour deposits (TD) or extensive or bilateral extramesorectal (lateral) lymph nodes (LLN) on MRI has been suggested to identify patients with indisputable, extensive locally advanced rectal cancer (LARC), at high risk of treatment failure. The aim of this study is to evaluate whether or not intensified chemotherapy prior to neoadjuvant chemoradiotherapy improves the complete response (CR) rate in these patients.METHODS: This multicentre, single-arm, open-label, phase II trial will include 128 patients with non-metastatic high-risk LARC (hr-LARC), fit for triplet chemotherapy. To ensure a study population with indisputable, unfavourable prognostic characteristics, hr-LARC is defined as LARC with on baseline MRI at least one of the following characteristics; MRF invasion, EMVI grade 4, enlarged bilateral or extensive LLN at high risk of an incomplete resection, or TD. Exclusion criteria are the presence of a homozygous DPD deficiency, distant metastases, any chemotherapy within the past 6 months, previous radiotherapy within the pelvic area precluding standard chemoradiotherapy, and any contraindication for the planned treatment. All patients will be planned for six two-weekly cycles of FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) prior to chemoradiotherapy (25 × 2 Gy or 28 × 1.8 Gy with concomitant capecitabine). A resection will be performed following radiological confirmation of resectable disease after the completion of chemoradiotherapy. A watch and wait strategy is allowed in case of a clinical complete response. The primary endpoint is the CR rate, described as a pathological CR or a sustained clinical CR one year after chemoradiotherapy. The main secondary objectives are long-term oncological outcomes, radiological and pathological response, the number of resections with clear margins, treatment-related toxicity, perioperati

Published
2022

17. Neoadjuvant FOLFOXIRI prior to chemoradiotherapy for high-risk ('ugly') locally advanced rectal cancer:study protocol of a single-arm, multicentre, open-label, phase II trial (MEND-IT)

Author

van den Berg, K., Schaap, D. P., Voogt, E. L.K., Buffart, T. E., Verheul, H. M.W., de Groot, J. W.B., Verhoef, C., Melenhorst, J., Roodhart, J. M.L., de Wilt, J. H.W., van Westreenen, H. L., Aalbers, A. G.J., van 't Veer, M., Marijnen, C. A.M., Vincent, J., Simkens, L. H.J., Peters, N. A.J.B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M.U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A.P., Bloemen, J. G., Willems, J. M.W.E., Creemers, G. J.M., Nederend, J., Rutten, H. J.T., Burger, J. W.A., van den Berg, K., Schaap, D. P., Voogt, E. L.K., Buffart, T. E., Verheul, H. M.W., de Groot, J. W.B., Verhoef, C., Melenhorst, J., Roodhart, J. M.L., de Wilt, J. H.W., van Westreenen, H. L., Aalbers, A. G.J., van 't Veer, M., Marijnen, C. A.M., Vincent, J., Simkens, L. H.J., Peters, N. A.J.B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M.U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A.P., Bloemen, J. G., Willems, J. M.W.E., Creemers, G. J.M., Nederend, J., Rutten, H. J.T., and Burger, J. W.A.

Abstract

BACKGROUND: The presence of mesorectal fascia (MRF) invasion, grade 4 extramural venous invasion (EMVI), tumour deposits (TD) or extensive or bilateral extramesorectal (lateral) lymph nodes (LLN) on MRI has been suggested to identify patients with indisputable, extensive locally advanced rectal cancer (LARC), at high risk of treatment failure. The aim of this study is to evaluate whether or not intensified chemotherapy prior to neoadjuvant chemoradiotherapy improves the complete response (CR) rate in these patients. METHODS: This multicentre, single-arm, open-label, phase II trial will include 128 patients with non-metastatic high-risk LARC (hr-LARC), fit for triplet chemotherapy. To ensure a study population with indisputable, unfavourable prognostic characteristics, hr-LARC is defined as LARC with on baseline MRI at least one of the following characteristics; MRF invasion, EMVI grade 4, enlarged bilateral or extensive LLN at high risk of an incomplete resection, or TD. Exclusion criteria are the presence of a homozygous DPD deficiency, distant metastases, any chemotherapy within the past 6 months, previous radiotherapy within the pelvic area precluding standard chemoradiotherapy, and any contraindication for the planned treatment. All patients will be planned for six two-weekly cycles of FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) prior to chemoradiotherapy (25 × 2 Gy or 28 × 1.8 Gy with concomitant capecitabine). A resection will be performed following radiological confirmation of resectable disease after the completion of chemoradiotherapy. A watch and wait strategy is allowed in case of a clinical complete response. The primary endpoint is the CR rate, described as a pathological CR or a sustained clinical CR one year after chemoradiotherapy. The main secondary objectives are long-term oncological outcomes, radiological and pathological response, the number of resections with clear margins, treatment-related toxicity, perioperative com

Published
2022

18. Neoadjuvant FOLFOXIRI prior to chemoradiotherapy for high-risk (“ugly”) locally advanced rectal cancer: study protocol of a single-arm, multicentre, open-label, phase II trial (MEND-IT)

Author

MS Medische Oncologie, Cancer, van den Berg, K., Schaap, D. P., Voogt, E. L.K., Buffart, T. E., Verheul, H. M.W., de Groot, J. W.B., Verhoef, C., Melenhorst, J., Roodhart, J. M.L., de Wilt, J. H.W., van Westreenen, H. L., Aalbers, A. G.J., van ‘t Veer, M., Marijnen, C. A.M., Vincent, J., Simkens, L. H.J., Peters, N. A.J.B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M.U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A.P., Bloemen, J. G., Willems, J. M.W.E., Creemers, G. J.M., Nederend, J., Rutten, H. J.T., Burger, J. W.A., MS Medische Oncologie, Cancer, van den Berg, K., Schaap, D. P., Voogt, E. L.K., Buffart, T. E., Verheul, H. M.W., de Groot, J. W.B., Verhoef, C., Melenhorst, J., Roodhart, J. M.L., de Wilt, J. H.W., van Westreenen, H. L., Aalbers, A. G.J., van ‘t Veer, M., Marijnen, C. A.M., Vincent, J., Simkens, L. H.J., Peters, N. A.J.B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M.U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A.P., Bloemen, J. G., Willems, J. M.W.E., Creemers, G. J.M., Nederend, J., Rutten, H. J.T., and Burger, J. W.A.

Published
2022

24. The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care

Author

Derksen, J.W.G. (Jeroen W. G.), Vink, G.R. (Geraldine R.), Elferink, M.A.G. (Marloes), Roodhart, J.M. (Jeanine), Verkooijen, H.M. (Helena M.), Grevenstein, H.M.U. (Helma) van, Siersema, P.D. (Peter), May, A.M. (Anne M.), Koopman, M. (Miriam), Beets, G.L. (Geerard), Belt, E.J.T. (Eric), Berbée, M. (Maaike), Beverdam, F.H. (Frederique H.), Blankenburgh, R. (Ruud), Coene, P-P. (Peter Paul), van Cruijsen, H. (Hester), Dekker, J.W.T. (Jan Willem), van Dodewaard-de Jong, J.M. (Joyce M.), Erdkamp, F.L.G. (Frans ), Groot, J.W.B. (Jan Willem) de, Haringhuizen, A.W. (Annebeth W.), Helgason, H.H. (Helgi H.), Hendriks, M.P. (Mathijs P.), Hingh, I.H.J.T. (Ignace) de, Hoekstra, R. (Ronald), IJzermans, J.N.M. (Jan), Jansen, J. (Jan), Kloppenberg, F.W.H. (Frank W. H.), Lent, A.U. (Anja) van, Los, M., Meijerink, M.R. (Martijn R.), Mekenkamp, L.J.M. (Leonie J. M.), Nieboer, P. (Peter), Peeters, K.C.M.J. (Koen C.M.J.), Peters, N.A.J.B. (Natascha A. J. B.), Polee, M.B. (Marco), Pruijt, J.F.M., Punt, C.J.A. (Cornelis), van Ufford-Mannesse, P.Q. (Patricia Quarles), Rietbroek, R.C. (Ron), Schiphorst, A.H.W. (Anandi H. W.), van der Velden, A.S. (Arjan Schouten), Schrauwen, R.W.M. (Ruud W. M.), Sie, M.P.S. (Mark P. S.), Simkens, L.H.J. (L. H J), Sommeijer, D.W. (Dirkje W.), Sonneveld, D.J.A., Spierings, L.E.A. (Leontine E. A.), Stockmann, H.B.A.C. (Hein), Talsma, A.K. (Aaldert), Terheggen, F. (Frederiek), Tije, A.J. (Albert Jan) ten, Tjin-A-Ton, M.L.R. (Manuel L. R.), Valkenburg-van Iersel, L.B.J. (Liselot B. J.), Veenstra, R.P., Velden, A.M.T. van der, Vermaas, M. (Maarten), Vles, W., Vogelaar, J.F.J. (Jeroen F. J.), van Voorthuizen, T. (Theo), Vos, A.I. (Aad) de, Wegdam, J.A. (J.), Wilt, J.H.W. (Johannes) de, Zimmerman, D.D.E. (David), Derksen, J.W.G. (Jeroen W. G.), Vink, G.R. (Geraldine R.), Elferink, M.A.G. (Marloes), Roodhart, J.M. (Jeanine), Verkooijen, H.M. (Helena M.), Grevenstein, H.M.U. (Helma) van, Siersema, P.D. (Peter), May, A.M. (Anne M.), Koopman, M. (Miriam), Beets, G.L. (Geerard), Belt, E.J.T. (Eric), Berbée, M. (Maaike), Beverdam, F.H. (Frederique H.), Blankenburgh, R. (Ruud), Coene, P-P. (Peter Paul), van Cruijsen, H. (Hester), Dekker, J.W.T. (Jan Willem), van Dodewaard-de Jong, J.M. (Joyce M.), Erdkamp, F.L.G. (Frans ), Groot, J.W.B. (Jan Willem) de, Haringhuizen, A.W. (Annebeth W.), Helgason, H.H. (Helgi H.), Hendriks, M.P. (Mathijs P.), Hingh, I.H.J.T. (Ignace) de, Hoekstra, R. (Ronald), IJzermans, J.N.M. (Jan), Jansen, J. (Jan), Kloppenberg, F.W.H. (Frank W. H.), Lent, A.U. (Anja) van, Los, M., Meijerink, M.R. (Martijn R.), Mekenkamp, L.J.M. (Leonie J. M.), Nieboer, P. (Peter), Peeters, K.C.M.J. (Koen C.M.J.), Peters, N.A.J.B. (Natascha A. J. B.), Polee, M.B. (Marco), Pruijt, J.F.M., Punt, C.J.A. (Cornelis), van Ufford-Mannesse, P.Q. (Patricia Quarles), Rietbroek, R.C. (Ron), Schiphorst, A.H.W. (Anandi H. W.), van der Velden, A.S. (Arjan Schouten), Schrauwen, R.W.M. (Ruud W. M.), Sie, M.P.S. (Mark P. S.), Simkens, L.H.J. (L. H J), Sommeijer, D.W. (Dirkje W.), Sonneveld, D.J.A., Spierings, L.E.A. (Leontine E. A.), Stockmann, H.B.A.C. (Hein), Talsma, A.K. (Aaldert), Terheggen, F. (Frederiek), Tije, A.J. (Albert Jan) ten, Tjin-A-Ton, M.L.R. (Manuel L. R.), Valkenburg-van Iersel, L.B.J. (Liselot B. J.), Veenstra, R.P., Velden, A.M.T. van der, Vermaas, M. (Maarten), Vles, W., Vogelaar, J.F.J. (Jeroen F. J.), van Voorthuizen, T. (Theo), Vos, A.I. (Aad) de, Wegdam, J.A. (J.), Wilt, J.H.W. (Johannes) de, and Zimmerman, D.D.E. (David)

Abstract

Real-world data (RWD) sources are important to advance clinical oncology research and evaluate treatments in daily practice. Since 2013, the Prospective Dutch Colorectal Cancer (PLCRC) cohort, linked to the Netherlands Cancer Registry, serves as an infrastructure for scientific research collecting additional patient-reported outcomes (PRO) and biospecimens. Here we report on cohort developments and investigate to what extent PLCRC reflects the “real-world”. Clinical and demographic characteristics of PLCRC participants were compared with the general Dutch CRC population (n = 74,692, Dutch-ref). To study representativeness, standardized differences between PLCRC and Dutch-ref were calculated, and logistic regression models were evaluated on their ability to distinguish cohort participants from the Dutch-ref (AU-ROC 0.5 = preferred, implying participation independent of patient characteristics). Stratified analyses by stage and time-period (2013–2016 and 2017–Aug 2019) were performed to study the evolution towards RWD. In August 2019, 5744 patients were enrolled. Enrollment increased steeply, from 129 participants (1 hospital) in 2013 to 2136 (50 of 75 Dutch hospitals) in 2018. Low AU-ROC (0.65, 95% CI: 0.64–0.65) indicates limited ability to distinguish cohort participants from the Dutch-ref. Characteristics that remained imbalanced in the period 2017–Aug’19 compared with the Dutch-ref were age (65.0 years in PLCRC, 69.3 in the Dutch-ref) and tumor stage (40% stage-III in PLCRC, 30% in the Dutch-ref). PLCRC approaches to represent the Dutch CRC population and will ultimately meet the current demand for high-quality RWD. Efforts are ongoing to improve multidisciplinary recruitment which will further enhance PLCRC’s representativeness and its contribution to a learning healthcare system.

Published
2021
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25. The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care

Author

Derksen, JWG, Vink, GR, Elferink, MA, Roodhart, JML, Verkooijen, HM, van Grevenstein, WMU, Siersema, PD, May, AM, Koopman, M, Beets, GL, Belt, EJT, Berbée, M, Beverdam, FH, Blankenburgh, R, Coene, PPLO, Cruijsen, H, Dekker, JW, van Dodewaard-de Jong, JM, Erdkamp, FLG, Groot, JWH, Haringhuizen, AW, Helgason, HH, Hendriks, MP, de Hingh, IHJT, Hoekstra, R, IJzermans, J.N.M., Jansen, J, Kloppenberg, FWH, van Lent, AU, Los, M, Meijerink, MR, Mekenkamp, L J, Nieboer, P, Peeters, KCMJ, Peters, NA, Polée, MB, Pruijt, JFM, Punt, CJ, van Ufford-Mannesse, PQ, Rietbroek, RC, Schiphorst, AHW, van der Velden, AS, Schrauwen, RWM, Sie, MPS, Simkens, L, Sommeijer, DW, Sonneveld, DJA, Spierings, LEA, Stockmann, HB, Talsma, K, Terheggen, F, ten Tije, AJ, Tjin-a-Ton, MLR, Valkenburg-van Iersel, LBJ, Veenstra, RP, van der Velden, AMT, Vermaas, M, Vles, WJ, Vogelaar, JFJ, van Voorthuizen, T, Vos, AI, Wegdam, JA, Wilt, JHW, Zimmerman, DDE, Derksen, JWG, Vink, GR, Elferink, MA, Roodhart, JML, Verkooijen, HM, van Grevenstein, WMU, Siersema, PD, May, AM, Koopman, M, Beets, GL, Belt, EJT, Berbée, M, Beverdam, FH, Blankenburgh, R, Coene, PPLO, Cruijsen, H, Dekker, JW, van Dodewaard-de Jong, JM, Erdkamp, FLG, Groot, JWH, Haringhuizen, AW, Helgason, HH, Hendriks, MP, de Hingh, IHJT, Hoekstra, R, IJzermans, J.N.M., Jansen, J, Kloppenberg, FWH, van Lent, AU, Los, M, Meijerink, MR, Mekenkamp, L J, Nieboer, P, Peeters, KCMJ, Peters, NA, Polée, MB, Pruijt, JFM, Punt, CJ, van Ufford-Mannesse, PQ, Rietbroek, RC, Schiphorst, AHW, van der Velden, AS, Schrauwen, RWM, Sie, MPS, Simkens, L, Sommeijer, DW, Sonneveld, DJA, Spierings, LEA, Stockmann, HB, Talsma, K, Terheggen, F, ten Tije, AJ, Tjin-a-Ton, MLR, Valkenburg-van Iersel, LBJ, Veenstra, RP, van der Velden, AMT, Vermaas, M, Vles, WJ, Vogelaar, JFJ, van Voorthuizen, T, Vos, AI, Wegdam, JA, Wilt, JHW, and Zimmerman, DDE

Abstract

Real-world data (RWD) sources are important to advance clinical oncology research and evaluate treatments in daily practice. Since 2013, the Prospective Dutch Colorectal Cancer (PLCRC) cohort, linked to the Netherlands Cancer Registry, serves as an infrastructure for scientific research collecting additional patient-reported outcomes (PRO) and biospecimens. Here we report on cohort developments and investigate to what extent PLCRC reflects the “real-world”. Clinical and demographic characteristics of PLCRC participants were compared with the general Dutch CRC population (n = 74,692, Dutch-ref). To study representativeness, standardized differences between PLCRC and Dutch-ref were calculated, and logistic regression models were evaluated on their ability to distinguish cohort participants from the Dutch-ref (AU-ROC 0.5 = preferred, implying participation independent of patient characteristics). Stratified analyses by stage and time-period (2013–2016 and 2017–Aug 2019) were performed to study the evolution towards RWD. In August 2019, 5744 patients were enrolled. Enrollment increased steeply, from 129 participants (1 hospital) in 2013 to 2136 (50 of 75 Dutch hospitals) in 2018. Low AU-ROC (0.65, 95% CI: 0.64–0.65) indicates limited ability to distinguish cohort participants from the Dutch-ref. Characteristics that remained imbalanced in the period 2017–Aug’19 compared with the Dutch-ref were age (65.0 years in PLCRC, 69.3 in the Dutch-ref) and tumor stage (40% stage-III in PLCRC, 30% in the Dutch-ref). PLCRC approaches to represent the Dutch CRC population and will ultimately meet the current demand for high-quality RWD. Efforts are ongoing to improve multidisciplinary recruitment which will further enhance PLCRC’s representativeness and its contribution to a learning healthcare system.

Published
2021

26. Patient-reported outcomes after external beam radiotherapy versus brachytherapy for palliation of dysphagia in esophageal cancer: A matched comparison of two prospective trials

Author

Rossum, P.S.N. van, Jeene, P.M., Rozema, T., Braam, P.M., Lips, I.M., Muller, K., Kampen, D. van, Vermeulen, B.D., Homs, M.Y.V., Oppedijk, V., Berbée, M., Hulshof, M., Siersema, P.D., Sharouni, S.Y. El, Rossum, P.S.N. van, Jeene, P.M., Rozema, T., Braam, P.M., Lips, I.M., Muller, K., Kampen, D. van, Vermeulen, B.D., Homs, M.Y.V., Oppedijk, V., Berbée, M., Hulshof, M., Siersema, P.D., and Sharouni, S.Y. El

Abstract

Contains fulltext : 229287.pdf (Publisher’s version ) (Open Access), BACKGROUND AND PURPOSE: A matched comparison of external beam radiotherapy (EBRT) versus brachytherapy recently demonstrated that EBRT appears at least as effective for palliating dysphagia in patients with incurable esophageal cancer. The aim of this analysis was to compare patient-reported outcomes (PROs) after EBRT versus brachytherapy. MATERIALS AND METHODS: In a multicenter prospective cohort study, patients with incurable esophageal cancer requiring palliation of dysphagia were included to undergo EBRT (20 Gy in 5 fractions). This EBRT cohort was compared to the single-dose 12 Gy brachytherapy cohort of the previously reported SIREC-trial. Propensity score matching was applied to adjust for baseline imbalances. The primary endpoint of dysphagia improvement was reported previously. PROs were secondary outcomes and assessed at baseline and 3 months after treatment using EORTC QLQ-C30 and QLQ-OES18 questionnaires. RESULTS: A total of 115 enrolled EBRT patients and 93 brachytherapy patients were eligible. After matching, 69 well-balanced pairs remained. At follow-up, significant deteriorations in functioning (i.e. physical, role, social), pain, appetite loss, and trouble with taste were observed after brachytherapy. In the EBRT group, such deterioration was observed only for role functioning, while significant improvements in trouble with eating and pain were found. Between-group comparison showed mostly comparable PRO changes, but significantly favored EBRT with regard to nausea, vomiting, pain, and appetite loss. CONCLUSION: Short course EBRT results in similar or better PROs at 3 months after treatment compared to single-dose brachytherapy for the palliation of malignant dysphagia. These findings further support its use and inclusion in clinical practice guidelines.

Published
2020

31. OC-0456: Short course EBRT versus brachytherapy in the palliation of dysphagia in esophageal cancer.

Author

Jeene, P., primary, Vermeulen, B., additional, Rozema, T., additional, Braam, P., additional, Lips, I., additional, Muller, K., additional, Van Kampen, D., additional, Homs, M., additional, Oppedijk, V., additional, Berbée, M., additional, Van Rossum, P., additional, El Sharouni, S., additional, Siersema, P., additional, and Hulshof, M., additional

Published
2020
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32. PO-1793: BioXmark liquid fiducials to enable radiotherapy tumor boosting in rectal cancer feasibility trial

Author

Berbée, M., primary, Opbroek, T., additional, Paulissen, J., additional, Houben, R., additional, Van Limbergen, E., additional, Ta, B., additional, Steenbakkers, I., additional, Verhaegen, F., additional, De Ridder, R., additional, Jansen, R., additional, Melenhorst, J., additional, Bakers, F., additional, Grabsch, H., additional, Buijsen, J., additional, and Canters, R., additional

Published
2020
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33. Performing clinical 18FDG-PET/MR imaging of the mediastinum using a dedicated, patient-friendly protocol

Author

Peerlings, J., Paulis, L., Mitea, C., Bakers, F., Berbée, M., Wierts, R., Vöö, S., Backes, W., Wildberger, J., and Hoffmann, A.

Subjects
18F-FDG, PET/MR, Non-small cell lung cancer, PET/CT, Esophageal carcinoma, Mediastinum
Abstract

Purpose: To apply clinical 18FDG-PET/MRI, a trade-off between image quality (IQ), diagnostic accuracy, and patient compliance is required. This study aimed to develop a mediastinal-specific 18FDG-PET/MR protocol containing dedicated MRI-sequences able to produce robust, high-quality images with great patient compliance and diagnostic performance comparable to 18FDG-PET/CT. Methods: In this study, 15 healthy subjects and 10 patients with mediastinal malignancies (i.e., 8 non-small cell lung cancer, 2 oesophageal cancer) received 18FDG-PET/MR imaging immediately after 18FDG-PET/CT. PET/MR-sequences (T1-VIBE, T2-HASTE) on a Siemens Biograph mMR scanner were optimized by varying the following parameters: breath-hold (BH, in end-expiration), fat saturation (SPAIR), and electrocardiogram-triggering (ECG, in end-diastole). IQ of each sequence-variation was qualitatively scored on a 5-point scale by medical experts and quantitatively assessed by calculating signal-to-noise ratios (SNR), contrast relative to muscle-tissue (CR), standardized-uptake-values (SUVs), and tumour-to-blood ratios (TBRs). Differences in CR determined contrast between adjacent tissues and tumour visibility. Diagnostic accuracy of 18FDG-PET/MRI was compared to 18FDG-PET/CT, in reference to clinical reports and histo-/cytopathological analyses. Results: Quantitative analysis showed that T1-VIBE images acquired with ECG-triggering presented highest SNR for soft-tissues in the mediastinum (P0.9). However, qualitative IQ of both T1-VIBE and T2-HASTE deteriorated with the addition of SPAIR. Diagnostic performance of 18FDG-PET/MR was not significantly different from 18FDG-PET/CT with similar staging, SUVs, and TBRs. However, T-status was more often over-staged on 18FDG-PET/CT, while N-status was more frequently under-staged on 18FDG-PET/MR. Conclusion: ECG-triggered T1-VIBE sequences acquired during short, multiple breath-holds are recommended for mediastinal imaging using 18FDG-PET/MR protocols. With dedicated protocols, 18FDG-PET/MR imaging could be implemented in thoracic oncology and aid in diagnostic evaluation, tailored treatment decision-making, and personalized patient care.

Published
2019

34. 1260TiP The efficacy of the addition of TRAstuzumab and Pertuzumab to neoadjuvant chemoradiation: A randomized multi-center study in resectable HER2 overexpressing adenocarcinoma of the esophagus or gastroesophageal junction (TRAP-2)

Author

Blangé, D., Hulshof, M.C.C.M., van Berge Henegouwen, M.I., Mostert, B., Slingerland, M., Haj Mohammad, N., Grootscholten, M.C., Creemers, G-J.M., Mekenkamp, L.J.M., Fiets, E., De Haan, J.J., Jeene, P., Rozema, T., Berbee, M., Beeker, A., Beerepoot, L.V., Derks, S., Bijlsma, M.F., van Grieken, N., and van Laarhoven, H.W.M.

Published
2022
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49. 1256 poster PROSTATE IMAGE GUIDED RADIOTHERAPY USING QUANTITATIVE 3D ULTRASOUND IMAGING: INTER- AND INTRA-OPERATOR ASPECTS.

Author

Van der Meer, S., primary, Bloemen-van Gurp, E., additional, Hermans, J., additional, Heuvelmans, D., additional, Voncken, R., additional, Grubbels, C., additional, Berbée, M., additional, Seravalli, E., additional, Visser, P., additional, Lutgens, L., additional, van Gils, F., additional, and Verhaegen, F., additional

Published
2011
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