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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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10. 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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11. 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

13. 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

14. 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

15. 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

18. 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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19. 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

20. 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

25. 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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26. 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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27. 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

28. 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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40. Brachytherapy for rectal cancer

Author

Rijkmans, E.C., Marijnen, C.A.M., Nout, R.A., Peters, F.P., Creutzberg, C.L., Beets, G.L., Berbée, M., Kerkhof, E.M., and Leiden University

Subjects
Elderly patients, Radical radiotherapy, Brachytherapy, Organ preservation, Clinical complete response (cCR), Rectal cancer
Abstract

This thesis describes the use of high-dose-rate endorectal brachytherapy as a boost to external beam radiotherapy in patients with rectal cancer. With 60% clinical complete response in the HERBERT study, this treatment is very promising for use in organ preservation studies. Both toxicity of external beam radiotherapy as toxicity of brachytherapy are addressed and further improvements to the brachytherapy technique are suggested to increase tumor control while limiting toxicity.

Published
2021

41. Clinical implementation and evaluation of stereotactic liver radiotherapy in inspiration breath-hold using nasal high flow therapy and surface guidance.

Author

Hazelaar C, Canters R, Kremer K, Lubken I, Vaassen F, Buijsen J, Berbée M, and van Elmpt W

Abstract

Objective: To evaluate two years of clinical experience with markerless breath-hold liver stereotactic radiotherapy (SBRT) using non-invasive nasal high flow therapy (NHFT) for breath-hold prolonging and surface guidance (SGRT) for monitoring., Methods: Heated and humidified air was administered via a nasal cannula (40 L/min, 80% oxygen, 34 °C). Patients performed voluntary inspiration breath-holds with visual feedback. After a training session, 4-5 breath-hold CT scans were acquired to delineate an internal target volume (ITV) accounting for inter- and intra-breath-hold variations. Patients were treated in 3-8 fractions (7.5-20 Gy/fraction) using SGRT-controlled beam-hold. Patient setup was performed using SGRT and CBCT imaging. A post-treatment CBCT was acquired for evaluation purposes., Results: Fifteen patients started the training session and received treatment, of whom 10 completed treatment in breath-hold. Half of all 60-second CBCT scans were acquired during a single breath-hold. The average maximum breath-hold duration during treatment ranged from 47-108 s. Breath-hold ITV was on average 6.5 cm³/30% larger (range: 1.1-23.9 cm³/5-95%) than the largest GTV. Free-breathing ITV based on 4DCT scans was on average 16.9 cm³/47% larger (range: -2.3-58.7 cm3/-16-157%) than the breath-hold ITV. The average 3D displacement vector of the area around PTV for the post-treatment CBCT scans was 5.0 mm (range: 0.7-12.9 mm)., Conclusions: Liver SBRT in breath-hold using NHFT and SGRT is feasible for the majority of patients. An ITV reduction was observed compared to free-breathing treatments. To further decrease the PTV, internal anatomy-based breath-hold monitoring is desired., Advances in Knowledge: Non-invasive NHFT allows for prolonged breath-holding during surface-guided liver SBRT., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Institute of Radiology.)

Published
2024
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42. Dosimetry and Monte Carlo modelling of the Papillon+ contact X-ray brachytherapy device.

Author

Colson D, Yalvac B, Weterings J, Verrijssen AS, van Haaren P, Bellezzo M, Berbée M, Van Limbergen EJ, Croce O, Verhaegen F, and Reniers B

Subjects
Humans, Phantoms, Imaging, Computer Simulation, Radiometry instrumentation, Equipment Design, X-Rays, Radiotherapy Planning, Computer-Assisted methods, Monte Carlo Method, Brachytherapy instrumentation, Brachytherapy methods, Radiotherapy Dosage
Abstract

Purpose: This study aimed to develop and validate a Monte Carlo (MC) model for the Papillon+ contact x-ray brachytherapy (CXB) device, producing 50 kilovolt (kV) X-rays, specifically focusing on its application with a 25 mm diameter rectal applicator for contact therapy., Material and Methods: The validation process involved depth dose and transverse dose profile measurements using EBT3 gafchromic films positioned in a plastic water low energy range phantom. The half-value layer (HVL) was further measured and derived from the simulated X-ray spectra., Results: Excellent agreement within ±2% was achieved between the measured and simulated on-axis depth dose curves for the 25 mm rectal applicator. Transverse dose profile measurements showed a high level of agreement between the simulation and measurements, on average 3.1% in contact with the applicator at the surface of the phantom and on average 1.7% at 10 mm depth. A close agreement within 5.5% was noticed concerning the HVL between the measurement and simulation. The simulated gamma spectra and 2D-dose distribution demonstrated a soft X-ray energy spectrum and a uniform dose distribution in contact with the applicator., Conclusions: An MC model was successfully developed for the Papillon+ eBT device with a 25 mm diameter rectal applicator. The validated model, with its demonstrated accuracy in depth dose and transverse dose profile simulations, is a valuable tool for quality assurance and patient safety and, in a later phase, may be used for treatment planning, dose calculations and tissue inhomogeneity corrections., (Copyright © 2024 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Published
2024
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44. Trends in incidence, treatment, and relative survival of colorectal cancer in the Netherlands between 2000 and 2021.

Author

Swartjes H, Sijtsma FPC, Elferink MAG, van Erning FN, Moons LMG, Verheul HMW, Berbée M, Vissers PAJ, and de Wilt JHW

Subjects
Humans, Netherlands epidemiology, Male, Female, Incidence, Aged, Middle Aged, Aged, 80 and over, Adult, Survival Rate, Colorectal Neoplasms mortality, Colorectal Neoplasms epidemiology, Colorectal Neoplasms therapy, Colorectal Neoplasms pathology, Registries statistics & numerical data
Abstract

Background: The epidemiology of colorectal cancer (CRC) has changed rapidly over the years. The aim of this study was to assess the trends in incidence, treatment, and relative survival (RS) of patients diagnosed with CRC in the Netherlands between 2000 and 2021., Patients and Methods: 2 75667 patients diagnosed with CRC between 2000 and 2021 were included from the Netherlands Cancer Registry. Analyses were stratified for disease extent (localised: T1-3N0M0; regional: T4N0M0/T1-4N1-2M0; distant: T1-4N0-2M1) and localisation (colon; rectum). Trends were assessed with joinpoint regression., Results: CRC incidence increased until the mid-2010s but decreased strongly thereafter to rates comparable with the early 2000s. Amongst other trend changes, local excision rates increased for patients with localised colon (2021: 13.6 %) and rectal cancer (2021: 34.9 %). Moreover, primary tumour resection became less common in patients with distant colon (2000-2021: 60.9-12.5 %) or rectal cancer (2000-2021: 47.8-6.9 %), while local treatment of metastases rates increased. Five-year RS improved continuously for localised and regional colon (97.7 % and 72.0 % in 2017, respectively) and rectal cancer (95.2 % and 76.3 % in 2017, respectively). The rate of anti-cancer treatments decreased in distant colon (2010-2021: 80.3 % to 67.2 %; p < 0.001) and rectal cancer (2011-2021: 86.0 % to 77.0 %; p < 0.001). The improvement of five-year RS stagnated for distant colon (2010-2017: 11.2 % to 11.9 %; average percentage of change [APC]: 2.1, 95 % confidence interval [CI]: -7.6, 4.7) and rectal cancer (2009-2017: 12.7 % to 15.6 %; APC: 1.4, 95 % CI: -19.1, 5.5)., Conclusions: Major changes in the incidence and treatment of CRC between 2000 and 2021 were identified and quantified. Five-year RS increased continuously for patients with localised and regional CRC, but stagnated for patients with distant CRC, likely caused by decreased rates of anti-cancer treatment in this group., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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45. Coverage of Lateral Lymph Nodes in Rectal Cancer Patients with Routine Radiation Therapy Practice and Associated Locoregional Recurrence Rates.

Author

Sluckin TC, Hazen SJA, Horsthuis K, Beets-Tan RGH, Antonisse IE, Berbée M, van Bockel LW, Boer AH, Ceha HM, Cnossen JS, Geijsen ED, den Hartogh MD, Hendriksen EM, Intven MPW, Leseman-Hoogenboom MM, Meijnen P, Muller K, Oppedijk V, Rozema T, Rütten H, Spruit PH, Stam TC, Velema LA, Verrijssen AE, Vos-Westerman J, Tanis PJ, Marijnen CAM, and Kusters M

Subjects
Humans, Cross-Sectional Studies, Lymph Nodes diagnostic imaging, Lymph Nodes pathology, Recurrence, Retrospective Studies, Neoplasm Staging, Neoplasm Recurrence, Local pathology, Rectal Neoplasms pathology
Abstract

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Published
2023
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46. BioXmark® liquid fiducials to enable radiotherapy tumor boosting in rectal cancer, a feasibility trial.

Author

Opbroek TJS, Willems YCP, Verhaegen F, de Ridder R, Hoge C, Melenhorst J, Bakers F, Grabsch HI, Buijsen J, Van Limbergen EJ, Canters RAM, and Berbée M

Abstract

Background and Purpose: Dose-escalation in rectal cancer (RCa) may result in an increased complete response rate and thereby enable omission of surgery and organ preservation. In order to implement dose-escalation, it is crucial to develop a technique that allows for accurate image-guided radiotherapy. The aim of the current study was to determine the performance of a novel liquid fiducial marker (BioXmark®) in RCa patients during the radiotherapy course by assessing its positional stability on daily cone-beam CT (CBCT), technical feasibility, visibility on different imaging modalities and safety., Materials and Methods: Prospective, non-randomized, single-arm feasibility trial with inclusion of twenty patients referred for neoadjuvant chemoradiotherapy for locally advanced RCa. Primary study endpoint was positional stability on CBCT. Furthermore, technical aspects, safety and clinical performance of the marker, such as visibility on different imaging modalities, were evaluated., Results: Seventy-four markers from twenty patients were available for analysis. The marker was stable in 96% of the cases. One marker showed clinically relevant migration, one marker was lost before start of treatment and one marker was lost during treatment. Marker visibility was good on computed tomography (CT) and CBCT, and moderate on electronic portal imaging ( EPI ). Marker visibility on magnetic resonance imaging (MRI) was poor during response evaluation., Conclusion: The novel liquid fiducial marker demonstrated positional stability. We provide evidence of the feasibility of the novel fiducial marker for image-guided radiotherapy on daily cone beam CT for RCa patients., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Authors Berbée, Verhaegen and Van Limbergen hold a patent for a rectal brachytherapy applicator: “Endorectal probe device for effecting radiation treatment of colorectal cancerous tissue in the rectum of a human or animal subject.”, filed December 2016, F. Verhaegen, M. Bellezzo, E. van Limbergen, M. Berbée, B. Reniers, G. Fonseca, EP16204735. The patent has been licensed to Varian Medical Systems, Inc. The conduction of the trial was funded by Nanovi and the BioXmark® fiducials were provided without costs. Nanovi was not involved in the study design, collection, analysis and interpretation of data, writing of the manuscript or the decision to submit the manuscript for publication., (© 2022 MAASTRO.)

Published
2022
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47. Physical Activity Is Associated with Improved Overall Survival among Patients with Metastatic Colorectal Cancer.

Author

Smit KC, Derksen JWG, Beets GLO, Belt EJT, Berbée M, Coene PPLO, van Cruijsen H, Davidis MA, Dekker JWT, van Dodewaard-de Jong JM, Haringhuizen AW, Helgason HH, Hendriks MP, Hoekstra R, de Hingh IHJT, IJzermans JNM, Janssen JJB, Konsten JLM, Los M, Mekenkamp LJM, Nieboer P, Peeters KCMJ, Peters NAJB, Pruijt HJFM, Quarles van Ufford-Mannesse P, Rietbroek RC, Schiphorst AHW, Schouten van der Velden A, Schrauwen RWM, Sie MPS, Sommeijer DW, Sonneveld DJA, Stockmann HBAC, Tent M, Terheggen F, Tjin-A-Ton MLR, Valkenburg-van Iersel L, van der Velden AMT, Vles WJ, van Voorthuizen T, Wegdam JA, de Wilt JHW, Koopman M, May AM, and On Behalf Of The Plcrc Study Group

Abstract

Regular physical activity (PA) is associated with improved overall survival (OS) in stage I-III colorectal cancer (CRC) patients. This association is less defined in patients with metastatic CRC (mCRC). We therefore conducted a study in mCRC patients participating in the Prospective Dutch Colorectal Cancer cohort. PA was assessed with the validated SQUASH questionnaire, filled-in within a maximum of 60 days after diagnosis of mCRC. PA was quantified by calculating Metabolic Equivalent Task (MET) hours per week. American College of Sports and Medicine (ACSM) PA guideline adherence, tertiles of moderate to vigorous PA (MVPA), and sport and leisure time MVPA (MVPA-SL) were assessed as well. Vital status was obtained from the municipal population registry. Cox proportional-hazards models were used to study the association between PA determinants and all-cause mortality adjusted for prognostic patient and treatment-related factors. In total, 293 mCRC patients (mean age 62.9 ± 10.6 years, 67% male) were included in the analysis. Compared to low levels, moderate and high levels of MET-hours were significantly associated with longer OS (fully adjusted hazard ratios: 0.491, (95% CI 0.299-0.807, p value = 0.005) and 0.485 (95% CI 0.303-0.778, p value = 0.003), respectively), as were high levels of MVPA (0.476 (95% CI 0.278-0.816, p value = 0.007)) and MVPA-SL (0.389 (95% CI 0.224-0.677, p value < 0.001)), and adherence to ACSM PA guidelines compared to non-adherence (0.629 (95% CI 0.412-0.961, p value = 0.032)). The present study provides evidence that higher PA levels at diagnosis of mCRC are associated with longer OS.

Published
2022
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48. Patient-reported outcomes after external beam radiotherapy versus brachytherapy for palliation of dysphagia in esophageal cancer: A matched comparison of two prospective trials.

Author

van Rossum PSN, Jeene PM, Rozema T, Braam PM, Lips IM, Muller K, van Kampen D, Vermeulen BD, Homs MYV, Oppedijk V, Berbée M, Hulshof MCCM, Siersema PD, and El Sharouni SY

Subjects
Humans, Male, Patient Reported Outcome Measures, Prospective Studies, Brachytherapy adverse effects, Deglutition Disorders etiology, Esophageal Neoplasms complications, Esophageal Neoplasms radiotherapy, Prostatic Neoplasms
Abstract

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., (Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.)

Published
2021
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49. Lymph node response to chemoradiotherapy in oesophageal cancer patients: relationship with radiotherapy fields.

Author

Koemans WJ, Larue RTHM, Kloft M, Ruisch JE, Compter I, Riedl RG, Heij LR, van Elmpt W, Berbée M, Buijsen J, Lambin P, Sosef MN, and Grabsch HI

Subjects
Humans, Retrospective Studies, Treatment Outcome, Chemoradiotherapy, Esophageal Neoplasms pathology, Esophageal Neoplasms therapy, Lymph Nodes pathology
Abstract

Background: The presence of lymph node metastasis (LNmets) is a poor prognostic factor in oesophageal cancer (OeC) patients treated with neoadjuvant chemoradiotherapy (nCRT) followed by surgery. Tumour regression grade (TRG) in LNmets has been suggested as a predictor for survival. The aim of this study was to investigate whether TRG in LNmets is related to their location within the radiotherapy (RT) field., Methods: Histopathological TRG was retrospectively classified in 2565 lymph nodes (LNs) from 117 OeC patients treated with nCRT and surgery as: (A) no tumour, no signs of regression; (B) tumour without regression; (C) viable tumour and regression; and (D) complete response. Multivariate survival analysis was used to investigate the relationship between LN location within the RT field, pathological TRG of the LN and TRG of the primary tumour., Results: In 63 (54%) patients, viable tumour cells or signs of regression were seen in 264 (10.2%) LNs which were classified as TRG-B (n = 56), C (n = 104) or D (n = 104) LNs. 73% of B, C and D LNs were located within the RT field. There was a trend towards a relationship between LN response and anatomical LN location with respect to the RT field (p = 0.052). Multivariate analysis showed that only the presence of LNmets within the RT field with TRG-B is related to poor overall survival., Conclusion: Patients have the best survival if all LNmets show tumour regression, even if LNmets are located outside the RT field. Response in LNmets to nCRT is heterogeneous which warrants further studies to better understand underlying mechanisms.

Published
2021
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50. Short-Course External Beam Radiotherapy Versus Brachytherapy for Palliation of Dysphagia in Esophageal Cancer: A Matched Comparison of Two Prospective Trials.

Author

Jeene PM, Vermeulen BD, Rozema T, Braam PM, Lips I, Muller K, van Kampen D, Homs MYV, Oppedijk V, Berbée M, van Rossum PSN, El Sharouni S, Siersema PD, and Hulshof MCCM

Subjects
Humans, Prospective Studies, Brachytherapy, Deglutition Disorders etiology, Deglutition Disorders radiotherapy, Esophageal Neoplasms complications, Esophageal Neoplasms radiotherapy, Lung Neoplasms
Abstract

Introduction: Short-course external beam radiotherapy (EBRT) and intraluminal brachytherapy are both accepted treatments for the palliation of dysphagia in patients with incurable esophageal cancer. We compared the effects of both treatments from two prospective studies., Methods: We performed a multicenter prospective cohort study of patients with metastasized or otherwise incurable esophageal cancer requiring palliation of dysphagia from September 2016 to March 2019. Patients were treated with EBRT in five fractions of 4 Gy. Data were compared with all patients treated with a single brachytherapy dose of 12 Gy in the SIREC (Stent or Intraluminal Radiotherapy for inoperable Esophageal Cancer) trial, both between the original cohorts and between 1:1 propensity score-matched cohorts. The primary end point was an improvement of dysphagia at 3 months without reintervention. The secondary end points included toxicity and time-to-effect., Results: A total of 115 patients treated with EBRT and 93 patients who underwent brachytherapy were eligible for analysis. In the original cohorts, dysphagia improved after EBRT in 79% of patients compared with 64% after brachytherapy (p = 0.058). Propensity score matching resulted in 69 patients in each cohort well-balanced at baseline. Improvement of dysphagia was observed in 83% after EBRT versus 64% after brachytherapy (p = 0.048). In responding patients, improvement of dysphagia at 2 weeks was observed in 67% after EBRT compared with 35% after brachytherapy, and the maximum effect was reached after 4 weeks in 55% and 33%, respectively. Severe toxicity occurred in 3% of patients after EBRT compared with 13% after brachytherapy., Conclusions: Short-course EBRT appears at least as effective as brachytherapy in the palliation of dysphagia in patients with esophageal cancer., (Copyright © 2020 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

Published
2020
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