38 results on '"Coene, Peter Paul L. O."'
Search Results
2. Determinants of Physical Activity among Patients with Colorectal Cancer: From Diagnosis to 5 Years after Diagnosis
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Epi Kanker Team B, Cancer, Biostatistiek Onderwijs, Apotheek Bereidingen, Anatomie, MS CGO, MS Hematologie, MS Medische Oncologie, Epi Kanker, JC onderzoeksprogramma Cancer, Smit, Karel C, Derksen, Jeroen W G, Stellato, Rebecca K, van Lanen, Anne-Sophie, Wesselink, Evertine, Belt, Eric J Th, Cloos-van Balen, Marissa, Coene, Peter Paul L O, Dekker, Jan Willem T, de Groot, Jan Willem, Haringhuizen, Annebeth W, van Halteren, Henk K, van Heek, Tjarda T, Helgason, Helgi H, Hendriks, Mathijs P, de Hingh, Ignace H J T, Hoekstra, Ronald, Houtsma, Danny, Janssen, Johan J B, Kok, Niels, Konsten, Joop L M, Los, Maartje, Meijerink, Martijn R, Mekenkamp, Leonie J M, Peeters, Koen C M J, Polée, Marco B, Rietbroek, Ron C, Schiphorst, Anandi H W, Schrauwen, Ruud W M, Schreinemakers, Jennifer, Sie, Mark P S, Simkens, Lieke, Sonneveld, Eric J A, Terheggen, Frederiek, Valkenburg-van Iersel, Liselot, Vles, Wouter J, Wasowicz-Kemps, Daria K, de Wilt, Johannes H W, Kok, Dieuwertje E, Winkels, Renate M, Kampman, Ellen, van Duijnhoven, Fränzel J B, Koopman, Miriam, May, Anne M, Epi Kanker Team B, Cancer, Biostatistiek Onderwijs, Apotheek Bereidingen, Anatomie, MS CGO, MS Hematologie, MS Medische Oncologie, Epi Kanker, JC onderzoeksprogramma Cancer, Smit, Karel C, Derksen, Jeroen W G, Stellato, Rebecca K, van Lanen, Anne-Sophie, Wesselink, Evertine, Belt, Eric J Th, Cloos-van Balen, Marissa, Coene, Peter Paul L O, Dekker, Jan Willem T, de Groot, Jan Willem, Haringhuizen, Annebeth W, van Halteren, Henk K, van Heek, Tjarda T, Helgason, Helgi H, Hendriks, Mathijs P, de Hingh, Ignace H J T, Hoekstra, Ronald, Houtsma, Danny, Janssen, Johan J B, Kok, Niels, Konsten, Joop L M, Los, Maartje, Meijerink, Martijn R, Mekenkamp, Leonie J M, Peeters, Koen C M J, Polée, Marco B, Rietbroek, Ron C, Schiphorst, Anandi H W, Schrauwen, Ruud W M, Schreinemakers, Jennifer, Sie, Mark P S, Simkens, Lieke, Sonneveld, Eric J A, Terheggen, Frederiek, Valkenburg-van Iersel, Liselot, Vles, Wouter J, Wasowicz-Kemps, Daria K, de Wilt, Johannes H W, Kok, Dieuwertje E, Winkels, Renate M, Kampman, Ellen, van Duijnhoven, Fränzel J B, Koopman, Miriam, and May, Anne M
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- 2024
3. Nationwide Association of Surgical Performance of Minimally Invasive Esophagectomy With Patient Outcomes
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Ketel, Mirte H M, Klarenbeek, Bastiaan R, Abma, Inger, Belgers, Eric H J, Coene, Peter-Paul L O, Dekker, Jan Willem T, van Duijvendijk, Peter, Emous, Marloes, Gisbertz, Suzanne S, Haveman, Jan Willem, Heisterkamp, Joos, Nieuwenhuijzen, Grard A P, Ruurda, Jelle P, van Sandick, Johanna W, van der Sluis, Pieter C, van Det, Marc J, van Esser, Stijn, Law, Simon, de Steur, Wobbe O, Sosef, Meindert N, Wijnhoven, Bas, Hannink, Gerjon, Rosman, Camiel, van Workum, Frans, Ketel, Mirte H M, Klarenbeek, Bastiaan R, Abma, Inger, Belgers, Eric H J, Coene, Peter-Paul L O, Dekker, Jan Willem T, van Duijvendijk, Peter, Emous, Marloes, Gisbertz, Suzanne S, Haveman, Jan Willem, Heisterkamp, Joos, Nieuwenhuijzen, Grard A P, Ruurda, Jelle P, van Sandick, Johanna W, van der Sluis, Pieter C, van Det, Marc J, van Esser, Stijn, Law, Simon, de Steur, Wobbe O, Sosef, Meindert N, Wijnhoven, Bas, Hannink, Gerjon, Rosman, Camiel, and van Workum, Frans
- Abstract
IMPORTANCE: Suboptimal surgical performance is hypothesized to be associated with less favorable patient outcomes in minimally invasive esophagectomy (MIE). Establishing this association may lead to programs that promote better surgical performance of MIE and improve patient outcomes.OBJECTIVE: To investigate associations between surgical performance and postoperative outcomes after MIE.DESIGN, SETTING, AND PARTICIPANTS: In this nationwide cohort study of 15 Dutch hospitals that perform more than 20 MIEs per year, 7 masked expert MIE surgeons assessed surgical performance using videos and a previously developed and validated competency assessment tool (CAT). Each hospital submitted 2 representative videos of MIEs performed between November 4, 2021, and September 13, 2022. Patients registered in the Dutch Upper Gastrointestinal Cancer Audit between January 1, 2020, and December 31, 2021, were included to examine patient outcomes.EXPOSURE: Hospitals were divided into quartiles based on their MIE-CAT performance score. Outcomes were compared between highest (top 25%) and lowest (bottom 25%) performing quartiles. Transthoracic MIE with gastric tube reconstruction.MAIN OUTCOME AND MEASURE: The primary outcome was severe postoperative complications (Clavien-Dindo ≥3) within 30 days after surgery. Multilevel logistic regression, with clustering of patients within hospitals, was used to analyze associations between performance and outcomes.RESULTS:In total, 30 videos and 970 patients (mean [SD] age, 66.6 [9.1] years; 719 men [74.1%]) were included. The mean (SD) MIE-CAT score was 113.6 (5.5) in the highest performance quartile vs 94.1 (5.9) in the lowest. Severe postoperative complications occurred in 18.7% (41 of 219) of patients in the highest performance quartile vs 39.2% (40 of 102) in the lowest (risk ratio [RR], 0.50; 95% CI, 0.24-0.99). The highes
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- 2024
4. Early experience with robotic pancreatoduodenectomy versus open pancreatoduodenectomy: nationwide propensity-score-matched analysis
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de Graaf, Nine, primary, Zwart, Maurice J W, additional, van Hilst, Jony, additional, van den Broek, Bram, additional, Bonsing, Bert A, additional, Busch, Olivier R, additional, Coene, Peter-Paul L O, additional, Daams, Freek, additional, van Dieren, Susan, additional, van Eijck, Casper H J, additional, Festen, Sebastiaan, additional, de Hingh, Ignace H J T, additional, Lips, Daan J, additional, Luyer, Misha D P, additional, Mieog, J Sven D, additional, van Santvoort, Hjalmar C, additional, van der Schelling, George P, additional, Stommel, Martijn W J, additional, de Wilde, Roeland F, additional, Molenaar, I Quintus, additional, Groot Koerkamp, Bas, additional, and Besselink, Marc G, additional
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- 2024
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5. Population-Based Study on Risk Factors for Tumor-Positive Resection Margins in Patients with Gastric Cancer
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van der Werf, Leonie R., Cords, Charlotte, Arntz, Ivo, Belt, Eric J. T., Cherepanin, Ivan M., Coene, Peter-Paul L. O., van der Harst, Erwin, Heisterkamp, Joos, Langenhoff, Barbara S., Lamme, Bas, van Berge Henegouwen, Mark I., Lagarde, Sjoerd M., and Wijnhoven, Bas P. L.
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- 2019
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6. Esophageal cancer patients’ need for information and support in making a treatment decision between standard surgery and active surveillance
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Hermus, Merel, primary, van der Wilk, Berend J., additional, Chang, Rebecca, additional, Dekker, Jan Willem T., additional, Coene, Peter‐Paul L. O., additional, Nieuwenhuijzen, Grard A. P., additional, Rosman, Camiel, additional, Heisterkamp, Joos, additional, Hartgrink, Henk H., additional, Timmermans, Liesbeth, additional, Wijnhoven, Bas P. L., additional, van der Zijden, Charlène J., additional, van Lanschot, Jan J. B., additional, Busschbach, Jan, additional, Lagarde, Sjoerd M., additional, and Kranenburg, Leonieke W., additional
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- 2023
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7. Targeted next-generation sequencing has incremental value in the diagnostic work-up of patients with suspect pancreatic masses; a multi-center prospective cross sectional study
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Achterberg, Friso B, Mulder, Babs G Sibinga, Janssen, Quisette P, Koerkamp, Bas Groot, Hol, Lieke, Quispel, Rutger, Bonsing, Bert A, Vahrmeijer, Alexander L, van Eijck, Casper H J, Roos, Daphne, Perk, Lars E, van der Harst, Erwin, Coene, Peter-Paul L O, Doukas, Michail, Smedts, Frank M M, Kliffen, Mike, van Velthuysen, Marie-Louise F, Terpstra, Valeska, Sarasqueta, Arantza Farina, Morreau, Hans, Mieog, J Sven D, Achterberg, Friso B, Mulder, Babs G Sibinga, Janssen, Quisette P, Koerkamp, Bas Groot, Hol, Lieke, Quispel, Rutger, Bonsing, Bert A, Vahrmeijer, Alexander L, van Eijck, Casper H J, Roos, Daphne, Perk, Lars E, van der Harst, Erwin, Coene, Peter-Paul L O, Doukas, Michail, Smedts, Frank M M, Kliffen, Mike, van Velthuysen, Marie-Louise F, Terpstra, Valeska, Sarasqueta, Arantza Farina, Morreau, Hans, and Mieog, J Sven D
- Abstract
BACKGROUND: The diagnostic process of patients with suspect pancreatic lesions is often lengthy and prone to repeated diagnostic procedures due to inconclusive results. Targeted Next-Generation Sequencing (NGS) performed on cytological material obtained with fine needle aspiration (FNA) or biliary duct brushing can speed up this process. Here, we study the incremental value of NGS for establishing the correct diagnosis, and subsequent treatment plan in patients with inconclusive diagnosis after regular diagnostic work-up for suspect pancreatic lesions.METHODS: In this prospective cross-sectional cohort study, patients were screened for inclusion in four hospitals. NGS was performed with AmpliSeq Cancer Hotspot Panel v2 and v4b in patients with inconclusive cytology results or with an uncertain diagnosis. Diagnostic results were evaluated by the oncology pancreatic multidisciplinary team. The added value of NGS was determined by comparing diagnosis (malignancy, cystic lesion or benign condition) and proposed treatment plan (exploration/resection, neoadjuvant chemotherapy, follow-up, palliation or repeated FNA) before and after integration of NGS results. Final histopathological analysis or a 6-month follow-up period were used as the reference standard in case of surgical intervention or non-invasive treatment, respectively.RESULTS: In 50 of the 53 included patients, cytology material was sufficient for NGS analysis. Diagnosis before and after integration of NGS results differed in 24% of the patients. The treatment plan was changed in 32% and the diagnosis was substantiated by the NGS data in 44%. Repetition of FNA/brushing was prevented in 14% of patients. All changes in treatment plan were correctly made after integration of NGS. Integration of NGS increased overall diagnostic accuracy from 68% to 94%.INTERPRETATION: This study demonstrates the incremental diagnostic value of NGS in patients with an initial inconclusive diagnosis. Integratio
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- 2023
8. Pancreatectomy with arterial resection for periampullary cancer:outcomes after planned or unplanned events in a nationwide, multicentre cohort
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Stoop, Thomas F, Mackay, Tara M, Brada, Lilly J H, van der Harst, Erwin, Daams, Freek, Land, Freek R van 't, Kazemier, Geert, Patijn, Gijs A, van Santvoort, Hjalmar C, de Hingh, Ignace H, Bosscha, Koop, Seelen, Leonard W F, Nijkamp, Maarten W, Stommel, Martijn W J, Liem, Mike S L, Busch, Olivier R, Coene, Peter-Paul L O, van Dam, Ronald M, de Wilde, Roeland F, Mieog, J Sven D, Quintus Molenaar, I, Besselink, Marc G, van Eijck, Casper H J, Stoop, Thomas F, Mackay, Tara M, Brada, Lilly J H, van der Harst, Erwin, Daams, Freek, Land, Freek R van 't, Kazemier, Geert, Patijn, Gijs A, van Santvoort, Hjalmar C, de Hingh, Ignace H, Bosscha, Koop, Seelen, Leonard W F, Nijkamp, Maarten W, Stommel, Martijn W J, Liem, Mike S L, Busch, Olivier R, Coene, Peter-Paul L O, van Dam, Ronald M, de Wilde, Roeland F, Mieog, J Sven D, Quintus Molenaar, I, Besselink, Marc G, and van Eijck, Casper H J
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- 2023
9. GITR Ligation Improves Anti-PD1-Mediated Restoration of Human MMR-Proficient Colorectal Carcinoma Tumor-Derived T Cells
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Rakké, Yannick S, Campos Carrascosa, Lucia, van Beek, Adriaan A, de Ruiter, Valeska, van Gemerden, Rachelle S, Doukas, Michail, Doornebosch, Pascal G, Vermaas, Maarten, Ter Borg, Susan, van der Harst, Erwin, Coene, Peter Paul L O, Kliffen, Mike, Grünhagen, Dirk J, Verhoef, Cornelis, IJzermans, Jan N M, Kwekkeboom, Jaap, Sprengers, Dave, Rakké, Yannick S, Campos Carrascosa, Lucia, van Beek, Adriaan A, de Ruiter, Valeska, van Gemerden, Rachelle S, Doukas, Michail, Doornebosch, Pascal G, Vermaas, Maarten, Ter Borg, Susan, van der Harst, Erwin, Coene, Peter Paul L O, Kliffen, Mike, Grünhagen, Dirk J, Verhoef, Cornelis, IJzermans, Jan N M, Kwekkeboom, Jaap, and Sprengers, Dave
- Abstract
BACKGROUND & AIMS: In contrast to mismatch repair deficient colorectal carcinoma (CRC), MMR proficient (pMMR) CRC does not respond to immune checkpoint blockade. We studied immune checkpoint stimulation via glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR) on ex vivo functionality of human tumor-infiltrating lymphocytes (TIL) isolated from pMMR primary CRC and liver metastases (CRLM).METHODS: Using lymphocytes from resected tumor, adjacent tissues, and peripheral blood mononuclear cells (PBMC) of 132 pMMR primary CRC or CRLM patients, we determined GITR expression and the in vitro T-cell agonistic activity of recombinant GITR ligation.RESULTS: Here, we show that GITR was overexpressed on TIL when compared with other stimulatory immune checkpoints (4-1BB, OX40). Its expression was enhanced in TIL compared with PBMC and adjacent tissues. Among CD4 + TIL, GITR expression was primarily expressed by CD45RA - FoxP3 hi activated regulatory T cells. Within CD8 + TIL, GITR was predominantly expressed on functionally exhausted and putative tumor-reactive CD103 + CD39 + TIL. Strikingly, recombinant GITRL reinvigorated ex vivo TIL responses by significantly enhancing CD4 + and CD8 + TIL numbers. Dual treatment with GITRL and nivolumab (anti-PD1) enhanced CD8 + TIL expansion compared with GITRL monotherapy. Moreover, GITRL/anti-PD1 dual therapy further improved anti-PD1-mediated reinvigoration of interferon gamma secretion by exhausted CD8 TIL from primary CRC. CONCLUSIONS: GITR is overexpressed on CD4 + and CD8 + TIL from pMMR CRC and CRLM. Agonistic targeting of GITR enhances ex vivo human TIL functionality and may therefore be a promising approach for novel monotherapy or combined immunotherapies in primary pMRR CRC and CRLM.
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- 2023
10. Targeted next-generation sequencing has incremental value in the diagnostic work-up of patients with suspect pancreatic masses; a multi-center prospective cross sectional study
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Achterberg, Friso B., primary, Mulder, Babs G. Sibinga, additional, Janssen, Quisette P., additional, Koerkamp, Bas Groot, additional, Hol, Lieke, additional, Quispel, Rutger, additional, Bonsing, Bert A., additional, Vahrmeijer, Alexander L., additional, van Eijck, Casper H. J., additional, Roos, Daphne, additional, Perk, Lars E., additional, van der Harst, Erwin, additional, Coene, Peter-Paul L. O., additional, Doukas, Michail, additional, Smedts, Frank M. M., additional, Kliffen, Mike, additional, van Velthuysen, Marie-Louise F., additional, Terpstra, Valeska, additional, Sarasqueta, Arantza Farina, additional, Morreau, Hans, additional, and Mieog, J. Sven D., additional
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- 2023
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11. Multicenter fresh frozen tissue sampling in colorectal cancer: does the quality meet the standards for state of the art biomarker research?
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Lalmahomed, Z. S., Coebergh van den Braak, R. R. J., Oomen, M. H. A., Arshad, S. P., Riegman, P. H. J., IJzermans, J. N. M., Coene, Peter-Paul L. O., Dekker, Jan Willem T., Zimmerman, David D. E., Tetteroo, Geert W. M., Vles, Wouter J., Vrijland, Wietske W., and on behalf of the MATCH study working group
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- 2017
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12. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer
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Deijen, Charlotte L., Vasmel, Jeanine E., de Lange-de Klerk, Elly S. M., Cuesta, Miguel A., Coene, Peter-Paul L. O., Lange, Johan F., Meijerink, W. J. H. Jeroen, Jakimowicz, Jack J., Jeekel, Johannes, Kazemier, Geert, Janssen, Ignace M. C., Påhlman, Lars, Haglind, Eva, Bonjer, H. Jaap, Hellberg, R., Haglind, E., Kurlberg, G., Lindgren, P. G., Lindholm, E., Påhlman, L., Dahlberg, M., Raab, Y., Anderberg, B., Ewerth, S., Janson, M., Åkerlund, J. E., Smedh, K., Montgomery, A., Skullman, S., Nyström, P. O., Kald, A., Wänström, A., Dàlen, J., Svedberg, I., Edlund, G., Kressner, U., Öberg, A. N., Lundberg, O., Lindmark, G. E., Heikkinen, T., Morino, M., Giraudo, G., Lacy, A. M., Delgado, S., Macarulla Sanz, E., Díez, J. Medina, Schwandner, O., Schiedeck, T. H., Shekarriz, H., Bloechle, C., Baca, I., Weiss, O., Msika, S., Desvignes, G., Campbell, K. L., Cuschieri, A., Bonjer, H. J., Schouten, W. R., Kazemier, G., Lange, J. F., van der Harst, E., Coene, P. P. L. O., Plaisier, P., Bertleff, M. J. O. E., Cuesta, M. A., van der Broek, W., Meijerink, W. J. H. J., Jakimowicz, J. J., Nieuwenhuijzen, G., Maring, J., Kivit, J., Janssen, I. M. C., Spillenaar-Bilgen, E. J., Berends, F., and On behalf of the COLOR (COlon cancer Laparoscopic or Open Resection) study group
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- 2017
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13. Patient preferences for active surveillance vs standard surgery after neoadjuvant chemoradiotherapy in oesophageal cancer treatment: The NOSANO‐study
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Hermus, Merel, primary, van der Wilk, Berend J., additional, Chang, Rebecca T. H., additional, Collee, Gerlise, additional, Noordman, Bo J., additional, Coene, Peter‐Paul L. O., additional, Dekker, Jan Willem T., additional, Hartgrink, Henk H., additional, Heisterkamp, Joos, additional, Nieuwenhuijzen, Grard A. P., additional, Rosman, Camiel, additional, Timmermans, Liesbeth, additional, Wijnhoven, Bas P. L., additional, van der Zijden, Charlène J., additional, Busschbach, Jan J., additional, van Lanschot, J. Jan B., additional, Lagarde, Sjoerd M., additional, and Kranenburg, Leonieke W., additional
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- 2022
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14. Monocyte response after colorectal surgery: A prospective cohort study
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Edomskis, Pim P., primary, Dik, Willem A., additional, Sparreboom, Cloë L., additional, Nagtzaam, Nicole M. A., additional, van Oudenaren, Adrie, additional, Lambrichts, Daniël P. V., additional, Bayon, Yves, additional, van Dongen, Noah N. N., additional, Menon, Anand G., additional, de Graaf, Eelco J. R., additional, Coene, Peter Paul L. O., additional, Lange, Johan F., additional, and Leenen, Pieter J. M., additional
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- 2022
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15. Physical Activity Is Associated with Improved Overall Survival among Patients with Metastatic Colorectal Cancer
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Epi Kanker Team B, Cancer, MS Medische Oncologie, Epidemiology & Health Economics, JC onderzoeksprogramma Kanker, Smit, Karel C, Derksen, Jeroen W G, Beets, Geerard L O, Belt, Eric J Th, Berbée, Maaike, Coene, Peter Paul L O, van Cruijsen, Hester, Davidis, Marjan A, Dekker, Jan Willem T, van Dodewaard-de Jong, Joyce M, Haringhuizen, Annebeth W, Helgason, Helgi H, Hendriks, Mathijs P, Hoekstra, Ronald, de Hingh, Ignace H J T, IJzermans, Jan N M, Janssen, Johan J B, Konsten, Joop L M, Los, Maartje, Mekenkamp, Leonie J M, Nieboer, Peter, Peeters, Koen C M J, Peters, Natascha A J B, Pruijt, Hans J F M, Quarles van Ufford-Mannesse, Patricia, Rietbroek, Ron C, Schiphorst, Anandi H W, Schouten van der Velden, Arjan, Schrauwen, Ruud W M, Sie, Mark P S, Sommeijer, Dirkje W, Sonneveld, Dirk J A, Stockmann, Hein B A C, Tent, Marleen, Terheggen, Frederiek, Tjin-A-Ton, Manuel L R, Valkenburg-van Iersel, Liselot, van der Velden, Ankie M T, Vles, Wouter J, van Voorthuizen, Theo, Wegdam, Johannes A, de Wilt, Johannes H W, Koopman, Miriam, May, Anne M, On Behalf Of The Plcrc Study Group, Epi Kanker Team B, Cancer, MS Medische Oncologie, Epidemiology & Health Economics, JC onderzoeksprogramma Kanker, Smit, Karel C, Derksen, Jeroen W G, Beets, Geerard L O, Belt, Eric J Th, Berbée, Maaike, Coene, Peter Paul L O, van Cruijsen, Hester, Davidis, Marjan A, Dekker, Jan Willem T, van Dodewaard-de Jong, Joyce M, Haringhuizen, Annebeth W, Helgason, Helgi H, Hendriks, Mathijs P, Hoekstra, Ronald, de Hingh, Ignace H J T, IJzermans, Jan N M, Janssen, Johan J B, Konsten, Joop L M, Los, Maartje, Mekenkamp, Leonie J M, Nieboer, Peter, Peeters, Koen C M J, Peters, Natascha A J B, Pruijt, Hans J F M, Quarles van Ufford-Mannesse, Patricia, Rietbroek, Ron C, Schiphorst, Anandi H W, Schouten van der Velden, Arjan, Schrauwen, Ruud W M, Sie, Mark P S, Sommeijer, Dirkje W, Sonneveld, Dirk J A, Stockmann, Hein B A C, Tent, Marleen, Terheggen, Frederiek, Tjin-A-Ton, Manuel L R, Valkenburg-van Iersel, Liselot, van der Velden, Ankie M T, Vles, Wouter J, van Voorthuizen, Theo, Wegdam, Johannes A, de Wilt, Johannes H W, Koopman, Miriam, May, Anne M, and On Behalf Of The Plcrc Study Group
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- 2022
16. Pancreatectomy with arterial resection for periampullary cancer: outcomes after planned or unplanned events in a nationwide, multicentre cohort.
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Stoop, Thomas F., Mackay, Tara M., Brada, Lilly J. H., van der Harst, Erwin, Daams, Freek, van 't Land, Freek R., Kazemier, Geert, Patijn, Gijs A., van Santvoort, Hjalmar C., de Hingh, Ignace H., Bosscha, Koop, Seelen, Leonard W. F., Nijkamp, Maarten W., Stommel, Martijn W. J., Liem, Mike S. L., Busch, Olivier R., Coene, Peter-Paul L. O., van Dam, Ronald M., de Wilde, Roeland F., and Mieog, J. Sven D.
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ONCOLOGIC surgery ,CANCER prognosis ,PANCREATECTOMY - Published
- 2023
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17. Patient preferences for active surveillance vs standard surgery after neoadjuvant chemoradiotherapy in oesophageal cancer treatment: The NOSANO‐study.
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Hermus, Merel, van der Wilk, Berend J., Chang, Rebecca T. H., Collee, Gerlise, Noordman, Bo J., Coene, Peter‐Paul L. O., Dekker, Jan Willem T., Hartgrink, Henk H., Heisterkamp, Joos, Nieuwenhuijzen, Grard A. P., Rosman, Camiel, Timmermans, Liesbeth, Wijnhoven, Bas P. L., van der Zijden, Charlène J., Busschbach, Jan J., van Lanschot, J. Jan B., Lagarde, Sjoerd M., and Kranenburg, Leonieke W.
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PATIENT preferences ,WATCHFUL waiting ,ESOPHAGEAL cancer ,MEDICAL personnel ,CANCER treatment ,CHEMORADIOTHERAPY - Abstract
Active surveillance may be a safe and effective treatment in oesophageal cancer patients with a clinically complete response after neoadjuvant chemoradiotherapy (nCRT). In the NOSANO‐study we gained insight in patients' motive to opt for either an experimental treatment called active surveillance or for standard immediate surgery. Both qualitative and quantitative analyses methods were used. Forty patients were interviewed about their treatment preference, 3 months after completion of nCRT (T1). Data were recorded, transcribed verbatim and analysed according to the principles of grounded theory. In addition, at T1 and T2 (12 months after completion of nCRT) questionnaires on health‐related quality of life, coping, anxiety and decisional regret (only T2) were administered. Interview data analyses resulted in a conceptual model with 'dealing with threat of cancer' as the central theme. Patients preferring active surveillance tend to cope with this threat by confiding in their bodies and good outcomes. Their mind‐set is one of 'enjoy life now'. Patients preferring surgery tend to cope by minimizing uncertainty and eliminating the source of cancer. Their mind‐set is one of 'don't give up, act now'. Furthermore, questionnaire results showed that patients with a preference for standard surgery had a lower quality of life. Patient preferences are individualized and thus difficult to predict. Our model can help healthcare professionals to determine patient preferences for treatment. Coping style and mind‐set seem to be determining factors here. [ABSTRACT FROM AUTHOR]
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- 2023
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18. Preferences for active surveillance or standard oesophagectomy: discrete-choice experiment
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van der Wilk, Berend J., primary, Spronk, Inge, additional, Noordman, Bo J., additional, Eyck, Ben M., additional, Haagsma, Juanita A., additional, Coene, Peter-Paul L. O., additional, van der Harst, Erwin, additional, Heisterkamp, Joos, additional, Lagarde, Sjoerd M., additional, Wijnhoven, Bas P. L., additional, and van Lanschot, J. Jan B., additional
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- 2021
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19. 793 PATIENTS’ PREFERENCES FOR ACTIVE SURVEILLANCE OR STANDARD ESOPHAGECTOMY AFTER NEOADJUVANT CHEMORADIOTHERAPY: A DISCRETE CHOICE EXPERIMENT IN PATIENTS AFTER STANDARD ESOPHAGECTOMY
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Van Der Wilk, Berend, primary, Spronk, Inge, additional, Noordman, Bo J, additional, Eyck, Ben M, additional, Haagsma, Juanita, additional, Coene, Peter-Paul L O, additional, Harst, Erwin, additional, Heisterkamp, Joos, additional, Lagarde, Sjoerd M, additional, Wijnhoven, Bas P L, additional, and Lanschot, J Jan B, additional
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- 2021
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20. The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care
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Derksen, Jeroen W. G., Vink, Geraldine R., Elferink, Marloes A. G., Roodhart, Jeanine M. L., Verkooijen, Helena M., van Grevenstein, Wilhelmina M. U., Siersema, Peter D., May, Anne M., Koopman, Miriam, Beets, Geerard L., Belt, Eric J. Th., Berbée, Maaike, Beverdam, Frederique H., Blankenburgh, Ruud, Coene, Peter Paul L. O., van Cruijsen, Hester, Dekker, Jan Willem T., van Dodewaard-de Jong, Joyce M., Erdkamp, Frans L. G., de Groot, Jan Willem B., Haringhuizen, Annebeth W., Helgason, Helgi H., Hendriks, Mathijs P., de Hingh, Ignace H. J. T., Hoekstra, Ronald, Ijzermans, Jan N. M., Jansen, Jan, Kloppenberg, Frank W. H., van Lent, Anja U. G., Los, Maartje, Meijerink, Martijn R., Mekenkamp, Leonie J. M., Nieboer, Peter, Peeters, Koen C. M. J., Peters, Natascha A. J. B., Polée, Marco B., Pruijt, Johannes F. M., Punt, Cornelis J. A., van Ufford-Mannesse, Patricia Quarles, Rietbroek, Ron C., Schiphorst, Anandi H. W., van der Velden, Arjan Schouten, Schrauwen, Ruud W. M., Sie, Mark P. S., Simkens, Lieke, Sommeijer, Dirkje W., Sonneveld, Dirk J. A., Spierings, Leontine E. A., Stockmann, Hein B. A. C., Talsma, Koen, Terheggen, Frederiek, ten Tije, Albert J., Tjin-A-Ton, Manuel L. R., Valkenburg-van Iersel, Liselot B. J., Veenstra, Renzo P., van der Velden, Ankie M. T., Vermaas, Maarten, Vles, Wouter J., Vogelaar, Jeroen F. J., van Voorthuizen, Theo, de Vos, Aad I., Wegdam, Johannes A., de Wilt, Johannes H. W., Zimmerman, David D. E., Surgery, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Epidemiologie, CCA - Cancer Treatment and quality of life, Radiology and nuclear medicine, Internal medicine, and VU University medical center
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Male ,medicine.medical_specialty ,Colorectal cancer ,Epidemiology ,Science ,Population ,MODELS ,MEDLINE ,Logistic regression ,Representativeness heuristic ,Article ,03 medical and health sciences ,Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] ,0302 clinical medicine ,Cancer epidemiology ,Medical research ,All institutes and research themes of the Radboud University Medical Center ,SDG 3 - Good Health and Well-being ,Multidisciplinary approach ,COLON ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Registries ,education ,Aged ,Netherlands ,Aged, 80 and over ,education.field_of_study ,Multidisciplinary ,business.industry ,Middle Aged ,medicine.disease ,Cancer registry ,TRIALS ,Outcomes research ,030220 oncology & carcinogenesis ,Family medicine ,Cohort ,Medicine ,Female ,business ,Colorectal Neoplasms - 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.
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- 2021
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21. Nationwide Association of Surgical Performance of Minimally Invasive Esophagectomy With Patient Outcomes.
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Ketel, Mirte H. M., Klarenbeek, Bastiaan R., Abma, Inger, Belgers, Eric H. J., Coene, Peter-Paul L. O., Dekker, Jan Willem T., van Duijvendijk, Peter, Emous, Marloes, Gisbertz, Suzanne S., Haveman, Jan Willem, Heisterkamp, Joos, Nieuwenhuijzen, Grard A. P., Ruurda, Jelle P., van Sandick, Johanna W., van der Sluis, Pieter C., van Det, Marc J., van Esser, Stijn, Law, Simon, de Steur, Wobbe O., and Sosef, Meindert N.
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- 2024
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22. Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer.
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Eyck, Ben M., van der Wilk, Berend J., Noordman, Bo Jan, Wijnhoven, Bas P. L., Lagarde, Sjoerd M., Hartgrink, Henk H., Coene, Peter Paul L. O., Dekker, Jan Willem T., Doukas, Michail, van der Gaast, Ate, Heisterkamp, Joos, Kouwenhoven, Ewout A., Nieuwenhuijzen, Grard A. P., Pierie, Jean-Pierre E. N., Rosman, Camiel, van Sandick, Johanna W., van der Sangen, Maurice J. C., Sosef, Meindert N., van der Zaag, Edwin S., and Spaander, Manon C. W.
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ESOPHAGEAL cancer ,OVERALL survival ,CHEMORADIOTHERAPY ,DIAGNOSIS ,ESOPHAGECTOMY ,PHYTOSANITATION - Abstract
Background: The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The last patient with a clinically complete response is expected to be included in May 2021. The purpose of this update is to present all amendments to the SANO trial protocol as approved by the Institutional Research Board (IRB) before accrual is completed.Design: The SANO trial protocol has been published ( https://doi.org/10.1186/s12885-018-4034-1 ). In this ongoing, phase-III, non-inferiority, stepped-wedge, cluster randomised controlled trial, patients with cCR (i.e. after neoadjuvant chemoradiotherapy no evidence of residual disease in two consecutive clinical response evaluations [CREs]) undergo either active surveillance or standard oesophagectomy. In the active surveillance arm, CREs are repeated every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and yearly in the fourth and fifth year. In this arm, oesophagectomy is offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant metastases. The primary endpoint is overall survival.Update: Amendments to the study design involve the first cluster in the stepped-wedge design being partially randomised as well and continued accrual of patients at baseline until the predetermined number of patients with cCR is reached. Eligibility criteria have been amended, stating that patients who underwent endoscopic treatment prior to neoadjuvant chemoradiotherapy cannot be included and that patients who have highly suspected residual tumour without histological proof can be included. Amendments to the study procedures include that patients proceed to the second CRE if at the first CRE the outcome of the pathological assessment is uncertain and that patients with a non-passable stenosis at endoscopy are not considered cCR. The sample size was recalculated following new insights on response rates (34% instead of 50%) and survival (expected 2-year overall survival of 75% calculated from the moment of reaching cCR instead of 3-year overall survival of 67% calculated from diagnosis). This reduced the number of required patients with cCR from 264 to 224, but increased the required inclusions from 480 to approximately 740 patients at baseline.Conclusion: Substantial amendments were made prior to closure of enrolment of the SANO trial. These amendments do not affect the outcomes of the trial compared to the original protocol. The first results are expected late 2023. If active surveillance plus surgery as needed after neoadjuvant chemoradiotherapy for oesophageal cancer leads to non-inferior overall survival compared to standard oesophagectomy, active surveillance can be implemented as a standard of care. [ABSTRACT FROM AUTHOR]- Published
- 2021
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23. Preferences for active surveillance or standard oesophagectomy: discrete-choice experiment.
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van der Wilk, Berend J., Spronk, Inge, Noordman, Bo J., Eyck, Ben M., Haagsma, Juanita A., Coene, Peter-Paul L. O., van der Harst, Erwin, Heisterkamp, Joos, Lagarde, Sjoerd M., Wijnhoven, Bas P. L., and van Lanschot, J. Jan B.
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WATCHFUL waiting ,ESOPHAGECTOMY - Published
- 2022
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24. Completeness of pathology reports in stage II colorectal cancer
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Büttner, Stefan, primary, Lalmahomed, Zarina S., additional, Coebergh van den Braak, Robert R. J., additional, Hansen, Bettina E., additional, Coene, Peter Paul L. O., additional, Dekker, Jan Willem T., additional, Zimmerman, David D. E., additional, Tetteroo, Geert W. M., additional, Vles, Wouter J., additional, Vrijland, Wietske W., additional, Fleischeuer, Ruth E. M., additional, van der Wurff, Anneke A. M., additional, Kliffen, Mike, additional, Torenbeek, Rolf, additional, Meijers, J. H. Carel, additional, Doukas, Michael, additional, and IJzermans, Jan N. M., additional
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- 2017
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25. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer
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Deijen, Charlotte L. (author), Vasmel, Jeanine E. (author), de Lange-de Klerk, Elly S M (author), Cuesta, Miguel A. (author), Coene, Peter Paul L O (author), Lange, Johan F. (author), Meijerink, W. J H Jeroen (author), Jakimowicz, J.J. (author), Jeekel, Johannes (author), Kazemier, Geert (author), Janssen, Ignace M C (author), Påhlman, Lars (author), Haglind, Eva (author), Bonjer, H. Jaap (author), Deijen, Charlotte L. (author), Vasmel, Jeanine E. (author), de Lange-de Klerk, Elly S M (author), Cuesta, Miguel A. (author), Coene, Peter Paul L O (author), Lange, Johan F. (author), Meijerink, W. J H Jeroen (author), Jakimowicz, J.J. (author), Jeekel, Johannes (author), Kazemier, Geert (author), Janssen, Ignace M C (author), Påhlman, Lars (author), Haglind, Eva (author), and Bonjer, H. Jaap (author)
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Background: Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients included in the COlon cancer Laparoscopic or Open Resection (COLOR) trial at 10-year follow-up. Methods: Between March 1997 and March 2003, patients with non-metastatic colon cancer were recruited by 29 hospitals in eight countries and randomised to either laparoscopic or open surgery. Main inclusion criterion for the COLOR trial was solitary adenocarcinoma of the left or right colon. The primary outcome was disease-free survival at 3 years, and secondary outcomes included overall survival and recurrence. The 10-year follow-up data of all Dutch patients were collected. Analysis was by intention-to-treat. The trial was registered at ClinicalTrials.gov (NCT00387842). Results: In total, 1248 patients were randomised, of which 329 were Dutch. Fifty-eight Dutch patients were excluded and 15 were lost to follow-up, leaving 256 patients for 10-year analysis. Median follow-up was 112 months. Disease-free survival rates were 45.2 % in the laparoscopic group and 43.2 % in the open group (difference 2.0 %; 95 % confidence interval (CI) −10.3 to 14.3; p = 0.96). Overall survival rates were 48.4 and 46.7 %, respectively (difference 1.7 %; 95 % CI −10.6 to 14.0; p = 0.83). Stage-specific analysis revealed similar survival rates for both groups. Sixty-two patients were diagnosed with recurrent disease, accounting for 29.4 % in the laparoscopic group and 28.2 % in the open group (difference 1.2 %; 95 % CI −11.1 to 13.5; p = 0.73). Seven patients had port- or wound-site recurrences (laparoscopic n = 3 vs. open n = 4). Conclusions: Laparoscopic surgery for non-metastatic colon cancer is associated with similar rates of disease-free survival, overall survival and recurrences as open surgery a, Applied Ergonomics and Design
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- 2016
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26. Impact of Neoadjuvant Radiotherapy on Complications After Hartmann Procedure for Rectal Cancer
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Jonker, Frederik H. W., primary, Tanis, Pieter J., additional, Coene, Peter-Paul L. O., additional, and van der Harst, Erwin, additional
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- 2015
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27. Physical Activity Is Associated with Improved Overall Survival among Patients with Metastatic Colorectal Cancer.
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Smit, Karel C., Derksen, Jeroen W. G., Beets, Geerard L. O., Belt, Eric J. Th., Berbée, Maaike, Coene, Peter Paul L. O., van Cruijsen, Hester, Davidis, Marjan A., Dekker, Jan Willem T., van Dodewaard-de Jong, Joyce M., Haringhuizen, Annebeth W., Helgason, Helgi H., Hendriks, Mathijs P., Hoekstra, Ronald, de Hingh, Ignace H. J. T., IJzermans, Jan N. M., Janssen, Johan J. B., Konsten, Joop L. M., Los, Maartje, and Mekenkamp, Leonie J. M.
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METASTASIS ,COLORECTAL cancer ,PHYSICAL activity ,CANCER patients ,QUESTIONNAIRES ,DESCRIPTIVE statistics ,OVERALL survival ,PROPORTIONAL hazards models - Abstract
Simple Summary: Physical activity is linked to longer survival among non-metastasized colorectal cancer patients. It is unclear if physical activity is also beneficial for survival among patients with metastatic colorectal cancer. We researched this question in our study of 293 patients with metastatic colorectal cancer. We found that participants who reported higher levels of physical activity at diagnosis lived longer compared to patients who reported low activity levels. Furthermore, adherence to the physical activity guidelines for cancer survivors was related to prolonged survival. Our findings suggest that patients with metastatic colorectal cancer also benefit from being physically active. Future studies are needed to investigate whether improving exercise levels after diagnosis of metastasis is also beneficial and what kind of exercise interventions are most optimal for possibly improving survival time of patients with metastatic colorectal cancer. 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. [ABSTRACT FROM AUTHOR]
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- 2022
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28. Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer: a stepped-wedge cluster randomised trial.
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Noordman, Bo Jan, Wijnhoven, Bas P. L., Lagarde, Sjoerd M., Boonstra, Jurjen J., Coene, Peter Paul L. O., Dekker, Jan Willem T., Doukas, Michael, van der Gaast, Ate, Heisterkamp, Joos, Kouwenhoven, Ewout A., Nieuwenhuijzen, Grard A. P., Pierie, Jean-Pierre E. N., Rosman, Camiel, van Sandick, Johanna W., van der Sangen, Maurice J. C., Sosef, Meindert N., Spaander, Manon C. W., Valkema, Roelf, van der Zaag, Edwin S., and Steyerberg, Ewout W.
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TREATMENT of esophageal cancer ,CHEMORADIOTHERAPY ,ESOPHAGECTOMY ,QUALITY of life ,ONCOLOGIC surgery - Abstract
Background: Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer.Methods: This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4-6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6-8 weeks after CRE-I. CRE-II will include 18F-FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not undergo surgery, quality of life, clinical irresectability (cT4b) rate, radical resection rate, postoperative complications, progression-free survival, distant dissemination rate, and cost-effectiveness. We hypothesise that active surveillance leads to non-inferior survival, improved quality of life and a reduction in costs, compared to standard oesophagectomy.Discussion: If active surveillance and surgery as needed after nCRT leads to non-inferior survival compared to standard oesophagectomy, this organ-sparing approach can be implemented as a standard of care. [ABSTRACT FROM AUTHOR]- Published
- 2018
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29. Intraoperative Music to Promote Patient Outcome (IMPROMPTU): A Double-Blind Randomized Controlled Trial.
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Fu VX, Lagarde SM, Favoccia CT, Heisterkamp J, van Oers AE, Coene PLO, Koopman JSHA, van den Berg SAA, Dik WA, Jeekel J, and Wijnhoven BPL
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- Adult, Humans, Male, Aged, Female, Analgesics, Opioid therapeutic use, Pain, Postoperative etiology, Pain, Postoperative prevention & control, Double-Blind Method, Music, Esophageal Neoplasms surgery, Esophageal Neoplasms drug therapy, Stomach Neoplasms drug therapy
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Introduction: Perioperative music can have beneficial effects on postoperative pain, anxiety, opioid requirement, and the physiological stress response to surgery. The aim was to assess the effects of intraoperative music during general anesthesia in patients undergoing surgery for esophagogastric cancer., Materials and Methods: The IMPROMPTU study was a double-blind, placebo-controlled, randomized multicenter trial. Adult patients undergoing surgery for stage II-III esophagogastric cancer were eligible. Exclusion criteria were a hearing impairment, insufficient Dutch language knowledge, corticosteroids use, or objection to hearing unknown music. Patients wore active noise-cancelling headphones intraoperatively with preselected instrumental classical music (intervention) or no music (control). Computerized randomization with centralized allocation, stratified according to surgical procedure using variable block sizes, was employed. Primary endpoint was postoperative pain on the first postoperative day. Secondary endpoints were postoperative pain during the first postoperative week, postoperative opioid requirement, intraoperative medication requirement, the stress response to surgery, postoperative complication rate, length of stay, and mortality, with follow-up lasting 30 d., Results: From November 2018 to September 2020, 145 patients were assessed and 83 randomized. Seventy patients (music n = 31, control n = 39) were analyzed. Median age was 70 [IQR 63-70], and 48 patients (69%) were male. Music did not reduce postoperative pain (numeric rating scale 1.8 (SD0.94) versus 2.0 (1.0), mean difference -0.28 [95% CI -0.76-0.19], P = 0.236). No statistically significant differences were seen in medication requirement, stress response, complication rate, or length of stay., Conclusions: Intraoperative, preselected, classical music during esophagogastric cancer surgery did not significantly improve postoperative outcome and recovery when compared to no music using noise-cancelling headphones., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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30. Determinants of Physical Activity among Patients with Colorectal Cancer: From Diagnosis to 5 Years after Diagnosis.
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Smit KC, Derksen JWG, Stellato RK, VAN Lanen AS, Wesselink E, Belt EJT, Balen MC, Coene PPLO, Dekker JWT, DE Groot JW, Haringhuizen AW, VAN Halteren HK, VAN Heek TT, Helgason HH, Hendriks MP, DE Hingh IHJT, Hoekstra R, Houtsma D, Janssen JJB, Kok N, Konsten JLM, Los M, Meijerink MR, Mekenkamp LJM, Peeters KCMJ, Polée MB, Rietbroek RC, Schiphorst AHW, Schrauwen RWM, Schreinemakers J, Sie MPS, Simkens L, Sonneveld EJA, Terheggen F, Iersel LV, Vles WJ, Wasowicz-Kemps DK, DE Wilt JHW, Kok DE, Winkels RM, Kampman E, VAN Duijnhoven FJB, Koopman M, and May AM
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- Male, Humans, Female, Exercise, Cohort Studies, Fatigue, Quality of Life, Colorectal Neoplasms diagnosis
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Introduction: Physical activity (PA) is associated with higher quality of life and probably better prognosis among colorectal cancer (CRC) patients. This study focuses on determinants of PA among CRC patients from diagnosis until 5 yr postdiagnosis., Methods: Sociodemographic and disease-related factors of participants of two large CRC cohort studies were combined. Moderate-to-vigorous PA during sport and leisure time (MVPA-SL) was measured at diagnosis (T0) and 6, 12, 24, and 60 months (T6 to T60) postdiagnosis, using the SQUASH questionnaire. Mixed-effects models were performed to identify sociodemographic and disease-related determinants of MVPA-SL, separately for stage I-III colon (CC), stage I-III rectal cancer (RC), and stage IV CRC (T0 and T6 only). Associations were defined as consistently present when significant at ≥4 timepoints for the stage I-III subsets. MVPA-SL levels were compared with an age- and sex-matched sample of the general Dutch population., Results: In total, 2905 CC, 1459 RC and 436 stage IV CRC patients were included. Patients with higher fatigue scores, and women compared with men had consistently lower MVPA-SL levels over time, regardless of tumor type and stage. At T6, having a stoma was significantly associated with lower MVPA-SL among stage I-III RC patients. Systemic therapy and radiotherapy were not significantly associated with MVPA-SL changes at T6. Compared with the general population, MVPA-SL levels of CRC patients were lower at all timepoints, most notably at T6., Conclusions: Female sex and higher fatigue scores were consistent determinants of lower MVPA-SL levels among all CRC patients, and MVPA-SL levels were lowest at 6 months postdiagnosis. Our results can inform the design of intervention studies aimed at improving PA, and guide healthcare professionals in optimizing individualized support., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American College of Sports Medicine.)
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- 2024
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31. Surgeon's steering behaviour towards patients to participate in a cluster randomised trial on active surveillance for oesophageal cancer: A qualitative study.
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de Veer MR, Hermus M, van der Zijden CJ, van der Wilk BJ, Wijnhoven BPL, Stiggelbout AM, Dekker JWT, Coene PPLO, Busschbach JJ, van Lanschot JJB, Lagarde SM, and Kranenburg LW
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- Humans, Watchful Waiting, Neoadjuvant Therapy, Esophageal Neoplasms surgery, Surgeons
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Introduction: Few studies have been conducted into how physicians use steering behaviour that may persuade patients to choose for a particular treatment, let alone to participate in a randomised trial. The aim of this study is to assess if and how surgeons use steering behaviour in their information provision to patients in their choice to participate in a stepped-wedge cluster randomised trial investigating an organ sparing treatment in (curable) oesophageal cancer (SANO trial)., Materials and Methods: A qualitative study was performed. Thematic content analysis was applied to audiotaped and transcribed consultations of twenty patients with eight different oncological surgeons in three Dutch hospitals. Patients could choose to participate in a clinical trial in which an experimental treatment of 'active surveillance' (AS) was offered. Patients who did not want to participate underwent standard treatment: neoadjuvant chemoradiotherapy followed by oesophagectomy., Results: Surgeons used various techniques to steer patients towards one of the two options, mostly towards AS. The presentation of pros and cons of treatment options was imbalanced: positive framing of AS was used to steer patients towards the choice for AS, and negative framing of AS to make the choice for surgery more attractive. Further, steering language, i.e. suggestive language, was used, and surgeons seemed to use the timing of the introduction of the different treatment options, to put more focus on one of the treatment options., Conclusion: Awareness of steering behaviour can help to guide physicians in more objectively informing patients on participation in future clinical trials., 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 © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2023
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32. Feasibility, safety, and efficacy of stereotactic body radiotherapy combined with intradermal heat-killed mycobacterium obuense (IMM-101) vaccination for non-progressive locally advanced pancreatic cancer, after induction chemotherapy with (modified)FOLFIRINOX - The LAPC-2 trial.
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van 't Land FR, Latifi D, Moskie M, Homs MYV, Bosscha K, Bonsing BA, Mieog SD, van der Harst E, Coene PLO, Wijsman JH, van der Schelling GP, Groot Koerkamp B, Nuyttens JJ, and van Eijck CHJ
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- Humans, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Feasibility Studies, Hot Temperature, Induction Chemotherapy, Nontuberculous Mycobacteria, Pancreatic Neoplasms, Radiosurgery adverse effects
- Abstract
Background and Purpose: In this phase I/II trial, non-progressive locally advanced pancreatic cancer (LAPC) patients after (modified)FOLFIRINOX therapy were treated with stereotactic body radiotherapy (SBRT) combined with heat-killed mycobacterium (IMM-101) vaccinations. We aimed to assess safety, feasibility, and efficacy of this treatment approach., Materials and Methods: On five consecutive days, patients received a total of 40 Gray (Gy) of SBRT with a dose of 8 Gy per fraction. Starting two weeks prior to SBRT, they in addition received six bi-weekly intradermal vaccinations with one milligram of IMM-101. The primary outcomes were the number of grade 4 or higher adverse events and the one-year progression free-survival (PFS) rate., Results: Thirty-eight patients were included and started study treatment. Median follow-up was 28.4 months (95 %CI 24.3 - 32.6). We observed one grade 5, no grade 4 and thirteen grade 3 adverse events, none related to IMM-101. The one-year PFS rate was 47 %, the median PFS was 11.7 months (95 %CI 11.0 - 12.5) and the median overall survival was 19.0 months (95 %CI 16.2 - 21.9). Eight (21 %) tumors were resected, of which 6 (75 %) were R0 resections. Outcomes were comparable with the outcomes of the patients from the previous LAPC-1 trial, in which LAPC patients were treated with SBRT, without IMM-101., Conclusion: Combination treatment with IMM-101 and SBRT was safe and feasible for non-progressive locally advanced pancreatic cancer patients after (modified)FOLFIRINOX. No improvement in the progression-free survival could be demonstrated by adding IMM-101 to SBRT., 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 © 2023. Published by Elsevier B.V.)
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- 2023
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33. GITR Ligation Improves Anti-PD1-Mediated Restoration of Human MMR-Proficient Colorectal Carcinoma Tumor-Derived T Cells.
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Rakké YS, Campos Carrascosa L, van Beek AA, de Ruiter V, van Gemerden RS, Doukas M, Doornebosch PG, Vermaas M, Ter Borg S, van der Harst E, Coene PPLO, Kliffen M, Grünhagen DJ, Verhoef C, IJzermans JNM, Kwekkeboom J, and Sprengers D
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- Humans, Immunotherapy, Lymphocytes, Tumor-Infiltrating, Receptors, Tumor Necrosis Factor metabolism, T-Lymphocytes, Regulatory, Colorectal Neoplasms metabolism, Liver Neoplasms metabolism, Glucocorticoid-Induced TNFR-Related Protein metabolism
- Abstract
Background & Aims: In contrast to mismatch repair deficient colorectal carcinoma (CRC), MMR proficient (pMMR) CRC does not respond to immune checkpoint blockade. We studied immune checkpoint stimulation via glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR) on ex vivo functionality of human tumor-infiltrating lymphocytes (TIL) isolated from pMMR primary CRC and liver metastases (CRLM)., Methods: Using lymphocytes from resected tumor, adjacent tissues, and peripheral blood mononuclear cells (PBMC) of 132 pMMR primary CRC or CRLM patients, we determined GITR expression and the in vitro T-cell agonistic activity of recombinant GITR ligation., Results: Here, we show that GITR was overexpressed on TIL when compared with other stimulatory immune checkpoints (4-1BB, OX40). Its expression was enhanced in TIL compared with PBMC and adjacent tissues. Among CD4
+ TIL, GITR expression was primarily expressed by CD45RA- FoxP3hi activated regulatory T cells. Within CD8+ TIL, GITR was predominantly expressed on functionally exhausted and putative tumor-reactive CD103+ CD39+ TIL. Strikingly, recombinant GITRL reinvigorated ex vivo TIL responses by significantly enhancing CD4+ and CD8+ TIL numbers. Dual treatment with GITRL and nivolumab (anti-PD1) enhanced CD8+ TIL expansion compared with GITRL monotherapy. Moreover, GITRL/anti-PD1 dual therapy further improved anti-PD1-mediated reinvigoration of interferon gamma secretion by exhausted CD8 TIL from primary CRC., Conclusions: GITR is overexpressed on CD4+ and CD8+ TIL from pMMR CRC and CRLM. Agonistic targeting of GITR enhances ex vivo human TIL functionality and may therefore be a promising approach for novel monotherapy or combined immunotherapies in primary pMRR CRC and CRLM., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2023
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34. Efficacy and feasibility of stereotactic radiotherapy after folfirinox in patients with locally advanced pancreatic cancer (LAPC-1 trial).
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Suker M, Nuyttens JJ, Eskens FALM, Haberkorn BCM, Coene PLO, van der Harst E, Bonsing BA, Vahrmeijer AL, Mieog JSD, Jan Swijnenburg R, Roos D, Koerkamp BG, and van Eijck CHJ
- Abstract
Background: We conducted a multicentre phase II trial to investigate feasibility and antitumor activity of sequential FOLFIRINOX and Stereotactic Body Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC), (LAPC-1 trial)., Methods: Patients with biopsy-proven LAPC treated in four hospitals in the Netherlands between December 2014 and June 2017. Patients received 8 cycles of FOLFIRINOX followed by SBRT (5 fractions/8 Gy) if no tumour progression after the FOLFIRINOX treatment was observed. Primary outcome was 1-year overall survival (OS). Secondary outcomes were median OS, 1-year progression-free survival (PFS), treatment-related toxicity, and resection rate. The study is registered with ClinicalTrials.gov, NCT02292745, and is completed., Findings: Fifty patients were included. Nineteen (38%) patients did not receive all 8 cycles of FOLFIRINOX, due to toxicity ( n = 12), disease progression ( n = 6), or patients' preference ( n = 1). Thirty-nine (78%) patients received the SBRT treatment. The 1-year OS and PFS were 64% (95% CI: 50%-76%) and 34% (95% CI: 22%-48%), respectively. Thirty grade 3 or 4 adverse events were observed during FOLFIRINOX. Two (5%) grade 3 or 4 adverse events after SBRT were observed. Two (5%) patients died due to a gastro-intestinal bleeding within three months after SBRT were observed. Six (12%) patients underwent a resection, all resulting in a complete (R0) resection. Two patients had a complete pathological response., Interpretation: FOLFIRINOX followed by SBRT in patients with LAPC is feasible and shows relevant antitumor activity. In 6 (12%) patients a potentially curative resection could be pursued following this combined treatment, with a complete histological response being observed in two patients., Competing Interests: We declare no competing interests., (© 2019 Published by Elsevier Ltd.)
- Published
- 2019
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35. Impact of low skeletal muscle mass and density on short and long-term outcome after resection of stage I-III colorectal cancer.
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van Vugt JLA, Coebergh van den Braak RRJ, Lalmahomed ZS, Vrijland WW, Dekker JWT, Zimmerman DDE, Vles WJ, Coene PLO, and IJzermans JNM
- Subjects
- Adult, Aged, Colorectal Neoplasms diagnosis, Colorectal Neoplasms epidemiology, Comorbidity trends, Disease-Free Survival, Female, Follow-Up Studies, Humans, Male, Middle Aged, Netherlands epidemiology, Postoperative Period, Prospective Studies, Risk Factors, Sarcopenia diagnosis, Survival Rate trends, Time Factors, Tomography, X-Ray Computed, Body Mass Index, Colectomy, Colorectal Neoplasms surgery, Muscle, Skeletal diagnostic imaging, Neoplasm Staging, Sarcopenia epidemiology
- Abstract
Background: Preoperative low skeletal muscle mass and density are associated with increased postoperative morbidity in patients undergoing curative colorectal cancer (CRC) surgery. However, the long-term effects of low skeletal muscle mass and density remain uncertain., Methods: Patients with stage I-III CRC undergoing surgery, enrolled in a prospective observational cohort study, were included. Skeletal muscle mass and density were measured on CT. Patients with high and low skeletal muscle mass and density were compared regarding postoperative complications, disease-free survival (DFS), overall survival (OS), and cancer-specific survival (CSS)., Results: In total, 816 patients (53.9% males, median age 70) were included; 50.4% had low skeletal muscle mass and 64.1% low density. The severe postoperative complication rate was significantly higher in patients with low versus high skeletal muscle and density (20.9% versus 13.6%, p = 0.006; 20.0% versus 11.8%, p = 0.003). Low skeletal muscle mass (OR 1.91, p = 0.018) and density (OR 1.87, p = 0.045) were independently associated with severe postoperative complications. Ninety-day mortality was higher in patients with low skeletal muscle mass and density compared with patients with high skeletal muscle mass and density (3.6% versus 1.7%, p = 0.091; 3.4% versus 1.0%, p = 0.038). No differences in DFS were observed. After adjustment for covariates such as age and comorbidity, univariate differences in OS and CSS diminished., Conclusions: Low skeletal muscle mass and density are associated with short-term, but not long-term, outcome in patients undergoing CRC surgery. These findings recommend putting more emphasis on preoperative management of patients at risk for surgical complications, but do not support benefit for long-term outcome., (Copyright © 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)
- Published
- 2018
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36. The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037).
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Swank HA, Vermeulen J, Lange JF, Mulder IM, van der Hoeven JA, Stassen LP, Crolla RM, Sosef MN, Nienhuijs SW, Bosker RJ, Boom MJ, Kruyt PM, Swank DJ, Steup WH, de Graaf EJ, Weidema WF, Pierik RE, Prins HA, Stockmann HB, Tollenaar RA, van Wagensveld BA, Coene PP, Slooter GD, Consten EC, van Duijn EB, Gerhards MF, Hoofwijk AG, Karsten TM, Neijenhuis PA, Blanken-Peeters CF, Cense HA, Mannaerts GH, Bruin SC, Eijsbouts QA, Wiezer MJ, Hazebroek EJ, van Geloven AA, Maring JK, D'Hoore AJ, Kartheuser A, Remue C, van Grevenstein HM, Konsten JL, van der Peet DL, Govaert MJ, Engel AF, Reitsma JB, and Bemelman WA
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- Adolescent, Adult, Aged, Aged, 80 and over, Anastomosis, Surgical, Colectomy, Colostomy, Female, Humans, Intestinal Perforation etiology, Laparoscopy, Middle Aged, Peritonitis etiology, Treatment Outcome, Diverticulitis complications, Intestinal Perforation surgery, Peritoneal Lavage methods, Peritonitis surgery
- Abstract
Background: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis)., Methods/design: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs., Discussion: The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis., Trial Registration: Nederlands Trial Register NTR2037.
- Published
- 2010
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37. [Hospital mortality after emergency surgery for perforated diverticulitis].
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Vermeulen J, Gosselink MP, Hop WC, Lange JF, Coene PP, van der Harst E, Weidema WF, and Mannaerts GH
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- Adult, Age Factors, Aged, Aged, 80 and over, Anastomosis, Surgical mortality, Anastomosis, Surgical statistics & numerical data, Digestive System Surgical Procedures mortality, Diverticulitis surgery, Female, Humans, Intestinal Perforation surgery, Male, Middle Aged, Postoperative Complications mortality, Retrospective Studies, Risk Factors, Severity of Illness Index, Young Adult, Diverticulitis mortality, Emergency Service, Hospital statistics & numerical data, Hospital Mortality, Intestinal Perforation mortality
- Abstract
Objective: To assess which factors predict in-hospital mortality after emergency surgery for acute perforated diverticulitis., Design: Multicenter retrospective study., Method: From 1995-2005 a total of 291 patients underwent surgery to treat perforated diverticulitis in five teaching hospitals in Rotterdam, the Netherlands. The relation to postoperative mortality of patient-related risk factors such as age, gender and classification according to the American Society of Anesthesiologists (ASA); disease severity factors such as Hinchey score and Mannheim peritonitis index (MPI); surgery-related risk factors, such as type of surgery, e.g. Hartmann’s procedure (HP) or resection with primary anastomosis; surgeon, and time of operation were evaluated using multivariate analysis., Results: The total postoperative in-hospital mortality was 29%. HP was performed 211 times and primary anastomosis was performed 75 times. HP was significantly more frequently performed in patients with higher values of age, ASA, Hinchey and MPI (all: p < 0.01). Multiple logistic regression analysis showed that age, ASA classification, Hinchey score, MPI and the absence of a specialist gastrointestinal surgeon during surgery, were important prognostic factors of mortality. Surgical technique was not related to postoperative mortality (adjusted odds ratio for mortality (HP versus primary anastomosis): 1.3; 95% CI: 0.6-2.9; p = 0.54)., Conclusion: The type of surgery did not appear to be a risk factor for high postoperative mortality. As well as patient-related risk factors, including age, ASA and severity of disease scores, such as Hinchey score and MPI, the absence of a specialist gastrointestinal surgeon during surgery was found to be a factor associated with high mortality risk.
- Published
- 2009
38. Outcome after emergency surgery for acute perforated diverticulitis in 200 cases.
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Vermeulen J, Akkersdijk GP, Gosselink MP, Hop WC, Mannaerts GH, van der Harst E, Coene PP, Weidema WF, and Lange JF
- Subjects
- Aged, Anastomosis, Surgical, Colostomy, Diverticulitis, Colonic complications, Diverticulitis, Colonic mortality, Emergencies, Female, Humans, Incidence, Intestinal Perforation etiology, Intestinal Perforation mortality, Length of Stay, Male, Middle Aged, Multivariate Analysis, Netherlands, Peritonitis etiology, Peritonitis surgery, Postoperative Complications, Reoperation, Risk Factors, Survival Rate, Treatment Outcome, Diverticulitis, Colonic surgery, Intestinal Perforation surgery
- Abstract
Background: Mortality and morbidity rates of acute perforated diverticulitis remain high. The ideal treatment is still controversial. The object of this study was to compare patients with perforated diverticulitis treated either by resection with primary anastomosis (PA) or Hartmann's procedure (HP)., Methods: A multicenter study was carried out on 200 consecutive patients with acute perforated diverticulitis who were presented in the surgical units of four affiliated teaching hospitals in Rotterdam, The Netherlands, between 1995 and 2005. Mortality and morbidity were compared in relation to type of surgery, ASA classification, age, gender, Mannheim Peritonitis Index (MPI), Hinchey score, surgeon's experience, and the time of operation., Results: There was a tendency for more severely affected patients (Hinchey, MPI, ASA and age) to undergo HP. Multivariate logistic regression analysis showed no significant difference in mortality between HP and PA. After HP, more patients needed one or more reinterventions to treat postoperative complications compared to PA. Besides, HP resulted in a longer total hospital and intensive care unit stay. Specialist colorectal surgeons performed significantly more frequently a PA instead of a HP and had fewer postoperative complications than general surgeons. The time of operation did not influence the choice of surgical procedure., Conclusion: Selected patients with perforated diverticulitis can be managed well by PA, as it does not seem to be inferior to HP in terms of severe postoperative complications that need surgical or radiological reintervention and mortality. This decision should be made while taking into account the patient's concomitant diseases, response on preoperative resuscitation and the availability of a surgeon experienced in colorectal surgery.
- Published
- 2007
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