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226 results on '"Brandt-Kerkhof, A."'

1. An observational cohort of patients with colorectal peritoneal metastases or pseudomyxoma peritonei treated with CRS-HIPEC: Development and first results of the Dutch CRS-HIPEC quality registry

Author

van Erning, Felice N., van den Heuvel, Teun B.M., Sijtsma, Femke P.C., Boerma, Djamila, Brandt-Kerkhof, Alexandra R.M., Bremers, André J., van Duyn, Eino B., van Grevenstein, Helma M.U., Hemmer, Patrick H.J., Kok, Niels F.M., Madsen, Eva, de Reuver, Philip R., Wiezer, René J., Witkamp, Arjan J., Nienhuijs, Simon W., Poelmann, Floris B., Tuynman, Jurriaan B., Been, Lucas B., Rovers, Koen P., and de Hingh, Ignace H.J.T.

Published
2024
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2. Development of a prediction model for recurrence in patients with colorectal peritoneal metastases undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Author

Dietz, Michelle V., Hannink, Gerjon, Said, Ibrahim, van der Zant, Femke A., van de Vlasakker, Vincent C.J., Brandt-Kerkhof, Alexandra R.M., Verhoef, Cornelis, Bremers, Andreas J.A., de Wilt, Johannes H.W., Hemmer, Patrick H.J., de Hingh, Ignace H.J.T., de Reuver, Philip R., and Madsen, Eva V.E.

Published
2024
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3. Perioperative Systemic Therapy Versus Cytoreductive Surgery and HIPEC Alone for Resectable Colorectal Peritoneal Metastases: Patient-Reported Outcomes of a Randomized Phase II Trial

Author

Bakkers, C., Rovers, K. P., Rijken, A., Simkens, G. A. A. M., Bonhof, C. S., Nienhuijs, S. W., Burger, J. W. A., Creemers, G. J. M., Brandt-Kerkhof, A. R. M., Tuynman, J. B., Aalbers, A. G. J., Wiezer, M. J., de Reuver, P. R., van Grevenstein, W. M. U., Hemmer, P. H. J., Punt, C. J. A., Tanis, P. J., Mols, F., and de Hingh, I. H. J. T.

Published
2023
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5. Intraperitoneal Chemotherapy for Unresectable Peritoneal Surface Malignancies

Author

Guchelaar, Niels A. D., Noordman, Bo J., Koolen, Stijn L. W., Mostert, Bianca, Madsen, Eva V. E., Burger, Jacobus W. A., Brandt-Kerkhof, Alexandra R. M., Creemers, Geert-Jan, de Hingh, Ignace H. J. T., Luyer, Misha, Bins, Sander, van Meerten, Esther, Lagarde, Sjoerd M., Verhoef, Cornelis, Wijnhoven, Bas P. L., and Mathijssen, Ron. H. J.

Published
2023
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6. Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases: protocol of the multicentre, open-label, phase II, INTERACT-II trial

Author

Jacobus W A Burger, Cornelis Verhoef, Eva V E Madsen, Robin J Lurvink, Joost Nederend, Onno Kranenburg, Geert-Jan M Creemers, Simon W Nienhuijs, Alexandra R M Brandt-Kerkhof, Esther van Meerten, Stijn L W Koolen, Ignace H J T de Hingh, Ron H J Mathijssen, Niels A D Guchelaar, Vincent C J van de Vlasakker, Teun B M van den Heuvel, Ramon J F Bax, and Irene E G van Hellemond

Subjects
Medicine
Abstract

Introduction The peritoneum is the second most affected organ for the dissemination of colorectal cancer (CRC). Patients with colorectal peritoneal metastases (CPM) face a poor prognosis, despite the majority of patients being treated with palliative systemic therapy. The efficacy of palliative systemic therapy is limited due to the plasma-peritoneum barrier. The poor prognosis of unresectable CPM patients has resulted in the development of new treatment strategies where systemic therapy is combined with local, intraperitoneal chemotherapy. In the recently published phase I study, the maximum tolerated dose and thus the recommended phase II dose of intraperitoneal irinotecan was investigated and determined to be 75 mg. In the present study, the overall survival after treatment with 75 mg irinotecan with concomitant mFOLFOX4 and bevacizumab will be investigated.Materials and methods In this single-arm phase II study in two Dutch tertiary referral centres, 85 patients are enrolled. Eligibility criteria are an adequate performance status and organ function, histologically confirmed microsatellite stable and unresectable CPM, no previous palliative therapy for CRC, no systemic therapy20, too extensive small bowel involvement), a peritoneal access port and a port-a-cath are placed for administration of intraperitoneal and intravenous chemotherapy, respectively. Patients may undergo up to 12 cycles of study treatment. Each cycle consists of intravenous mFOLFOX4 with bevacizumab and concomitant intraperitoneal irinotecan (75 mg), which is repeated every 2 weeks, with a maximum of 12 cycles. Modified FOLFOX-4 regimen consists of 85 mg/m2 oxaliplatin plus 200 mg/m2 LV and 5-FU 400 mg/m2 bolus on day 1 followed by 1600 mg/m2 5-FU as a 46 hours infusion. Study treatment ends after the 12th cycle, or earlier in case of disease progression or unacceptable toxicity. The primary outcome is overall survival and key secondary outcomes are progression-free survival, safety (measured by the amount of grade ≥3 adverse events (Common Terminology Criteria for Adverse Events V.5.0)), patient-reported outcomes and pharmacokinetics of irinotecan. It is hypothesised that the trial treatment will lead to a 4 month increase in overall survival; from a median of 12.2 to 16.2 months.Ethics and dissemination This study is approved by the Dutch Authority (CCMO, the Hague, the Netherlands), by a central medical ethics committee (MEC-U, Nieuwegein, the Netherlands) and by the institutional research boards of both research centres. Results will be submitted for publication in peer-reviewed medical journals and presented to patients and healthcare professionals.Trial registration number NCT06003998.

Published
2024
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7. Adjuvant dendritic cell-based immunotherapy after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in patients with malignant peritoneal mesothelioma: a phase II clinical trial

Author

Nadine L de Boer, Job P van Kooten, Cornelis Verhoef, Joachim G J V Aerts, Eva V E Madsen, Alexandra R M Brandt-Kerkhof, Marcella Willemsen, Michelle V Dietz, Katrien L A Quintelier, Madelief Vink, Yvan Saeys, and Sofie Van Gassen

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background Malignant peritoneal mesothelioma (MPM) is an aggressive malignancy with a poor prognosis. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) improves survival outcomes, but recurrence rates remain high. Dendritic cell-based immunotherapy (DCBI) showed promising results in patients with pleural mesothelioma. The primary aim of this trial was to determine feasibility of adjuvant DCBI after CRS-HIPEC.Methods This open-label, single-center, phase II clinical trial, performed in the Erasmus MC Cancer Institute Rotterdam, the Netherlands, included patients with epithelioid MPM. 4–6 weeks before CRS-HIPEC leukapheresis was performed. 8–10 weeks after surgery, DCBI was administered three times biweekly. Feasibility was defined as administration of at least three adjuvant vaccinations in 75% of patients. Comprehensive immune cell profiling was performed on peripheral blood samples prior to and during treatment.Results All patients who received CRS-HIPEC (n=16) were successfully treated with adjuvant DCBI. No severe toxicity related to DCBI was observed. Median progression-free survival (PFS) was 12 months (IQR 5–23) and median overall survival was not reached. DCBI was associated with increased proliferation of circulating natural killer cells and CD4+ T-helper (Th) cells. Co-stimulatory molecules, including ICOS, HLA-DR, and CD28 were upregulated predominantly on memory or proliferating Th-cells and minimally on CD8+ cytotoxic T-lymphocytes (CTLs) after treatment. However, an increase in CD8+ terminally differentiated effector memory (Temra) cells positively correlated with PFS, whereas co-expression of ICOS and Ki67 on CTLs trended towards a positive correlation.Conclusions Adjuvant DCBI after CRS-HIPEC in patients with MPM was feasible and safe, and showed promising survival outcomes. DCBI had an immune modulatory effect on lymphoid cells and induced memory T-cell activation. Moreover, an increase of CD8+ Temra cells was more pronounced in patients with longer PFS. These data provide rationale for future combination treatment strategies.Trial registration number NTR7060; Dutch Trial Register (NTR).

Published
2023
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12. Minimizing Population Health Loss in Times of Scarce Surgical Capacity During the Coronavirus Disease 2019 Crisis and Beyond: A Modeling Study

Author

Bangma, Chris, Beetz, Ivo, Bindels, Patrick, Brandt-Kerkhof, Alexandra, van Diepen, Danielle, Dirven, Clemens, Galema, Tjebbe, Goudzwaard, Jeanette, Hazes, Mieke, Lagarde, Sjoerd, Polinder-Bos, Harmke, Roes, Eva Maria, Takkenberg, Hanneke, van Vledder, Mark, Gravesteijn, Benjamin, Krijkamp, Eline, Busschbach, Jan, Geleijnse, Geert, Helmrich, Isabel Retel, Bruinsma, Sophie, van Lint, Céline, van Veen, Ernest, Steyerberg, Ewout, Verhoef, Kees, van Saase, Jan, Lingsma, Hester, and Baatenburg de Jong, Rob

Published
2021
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14. Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases:Protocol of the multicentre, open-label, phase II, INTERACT-II trial

Author

Van De Vlasakker, Vincent C.J., Guchelaar, Niels A.D., Van Den Heuvel, Teun B.M., Lurvink, Robin J., Van Meerten, Esther, Bax, Ramon J.F., Creemers, Geert Jan M., Van Hellemond, Irene E.G., Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., Nederend, Joost, Koolen, Stijn L.W., Nienhuijs, Simon W., Kranenburg, Onno, De Hingh, Ignace H.J.T., Verhoef, Cornelis, Mathijssen, Ron H.J., Burger, Jacobus W.A., Van De Vlasakker, Vincent C.J., Guchelaar, Niels A.D., Van Den Heuvel, Teun B.M., Lurvink, Robin J., Van Meerten, Esther, Bax, Ramon J.F., Creemers, Geert Jan M., Van Hellemond, Irene E.G., Brandt-Kerkhof, Alexandra R.M., Madsen, Eva V.E., Nederend, Joost, Koolen, Stijn L.W., Nienhuijs, Simon W., Kranenburg, Onno, De Hingh, Ignace H.J.T., Verhoef, Cornelis, Mathijssen, Ron H.J., and Burger, Jacobus W.A.

Abstract

Introduction:The peritoneum is the second most affected organ for the dissemination of colorectal cancer (CRC). Patients with colorectal peritoneal metastases (CPM) face a poor prognosis, despite the majority of patients being treated with palliative systemic therapy. The efficacy of palliative systemic therapy is limited due to the plasma-peritoneum barrier. The poor prognosis of unresectable CPM patients has resulted in the development of new treatment strategies where systemic therapy is combined with local, intraperitoneal chemotherapy. In the recently published phase I study, the maximum tolerated dose and thus the recommended phase II dose of intraperitoneal irinotecan was investigated and determined to be 75 mg. In the present study, the overall survival after treatment with 75 mg irinotecan with concomitant mFOLFOX4 and bevacizumab will be investigated. Materials and methods:In this single-arm phase II study in two Dutch tertiary referral centres, 85 patients are enrolled. Eligibility criteria are an adequate performance status and organ function, histologically confirmed microsatellite stable and unresectable CPM, no previous palliative therapy for CRC, no systemic therapy<6 months for CRC prior to enrolment and no previous cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS and HIPEC). Patients will undergo a diagnostic laparoscopy as standard work-up for CPM and if the peritoneal disease is considered unresectable (eg, Peritoneal Cancer Index (PCI)>20, too extensive small bowel involvement), a peritoneal access port and a port-a-cath are placed for administration of intraperitoneal and intravenous chemotherapy, respectively. Patients may undergo up to 12 cycles of study treatment. Each cycle consists of intravenous mFOLFOX4 with bevacizumab and concomitant intraperitoneal irinotecan (75 mg), which is repeated every 2 weeks, with a maximum of 12 cycles. Modified FOLFOX-4 regimen consists of 8

Published
2024

15. Development of a prediction model for recurrence in patients with colorectal peritoneal metastases undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Author

Dietz, Michelle V, Hannink, Gerjon, Said, Ibrahim, van der Zant, Femke A, van de Vlasakker, Vincent C J, Brandt-Kerkhof, Alexandra R M, Verhoef, Cornelis, Bremers, Andreas J A, de Wilt, Johannes H W, Hemmer, Patrick H J, de Hingh, Ignace H J T, de Reuver, Philip R, Madsen, Eva V E, Dietz, Michelle V, Hannink, Gerjon, Said, Ibrahim, van der Zant, Femke A, van de Vlasakker, Vincent C J, Brandt-Kerkhof, Alexandra R M, Verhoef, Cornelis, Bremers, Andreas J A, de Wilt, Johannes H W, Hemmer, Patrick H J, de Hingh, Ignace H J T, de Reuver, Philip R, and Madsen, Eva V E

Abstract

INTRODUCTION: Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) improves survival outcomes for selected patients with colorectal peritoneal metastases (PM), but recurrence rates are high. The aim of this study was to develop a tool to predict recurrence in patients with colorectal PM that undergo CRS-HIPEC.MATERIALS AND METHODS: For this retrospective cohort study, data of patients that underwent CRS-HIPEC for colorectal PM from four Dutch HIPEC centers were used. Exclusion criteria were perioperative systemic therapy and peritoneal cancer index (PCI) ≥20. Nine previously identified factors were considered as predictors: gender, age, primary tumor characteristics (location, nodal stage, differentiation, and mutation status), synchronous liver metastases, preoperative Carcino-Embryonal Antigen (CEA), and peritoneal cancer index (PCI). The prediction model was developed using multivariable Cox regression and validated internally using bootstrapping. The performance of the model was evaluated by discrimination and calibration.RESULTS: In total, 408 patients were included. During the follow-up, recurrence of disease occurred in 318 patients (78%). Significant predictors of recurrence were PCI (HR 1.075, 95% CI 1.044-1.108) and primary tumor location (left sided HR 0.719, 95% CI 0.550-0.939). The prediction model for recurrence showed fair discrimination with a C-index of 0.64 (95% CI 0.62, 0.66) after internal validation. The model was well-calibrated with good agreement between the predicted and observed probabilities.CONCLUSION: We developed a prediction tool that could aid in the prediction of recurrence in patients with colorectal PM who undergo CRS-HIPEC.

Published
2024

18. Dedicated MRI staging versus surgical staging of peritoneal metastases in colorectal cancer patients considered for CRS-HIPEC; the DISCO randomized multicenter trial

Author

M. P. Engbersen, C. J. V. Rijsemus, J. Nederend, A. G. J. Aalbers, I. H. J. T. de Hingh, V. Retel, D. M. J. Lambregts, E. J. R. J. Van der Hoeven, D. Boerma, M. J. Wiezer, M. De Vries, E. V. E. Madsen, A. R. M. Brandt-Kerkhof, S. Van Koeverden, P. R. De Reuver, R. G. H. Beets-Tan, N. F. M. Kok, and M. J. Lahaye

Subjects
Colorectal peritoneal metastases, CRS-HIPEC, Surgical staging, MRI, RCT, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Selecting patients with peritoneal metastases from colorectal cancer (CRCPM) who might benefit from cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is challenging. Computed tomography generally underestimates the peritoneal tumor load. Diagnostic laparoscopy is often used to determine whether patients are amenable for surgery. Magnetic resonance imaging (MRI) has shown to be accurate in predicting completeness of CRS. The aim of this study is to determine whether MRI can effectively reduce the need for surgical staging. Methods The study is designed as a multicenter randomized controlled trial (RCT) of colorectal cancer patients who are deemed eligible for CRS-HIPEC after conventional CT staging. Patients are randomly assigned to either MRI based staging (arm A) or to standard surgical staging with or without laparoscopy (arm B). In arm A, MRI assessment will determine whether patients are eligible for CRS-HIPEC. In borderline cases, an additional diagnostic laparoscopy is advised. The primary outcome is the number of unnecessary surgical procedures in both arms defined as: all surgeries in patients with definitely inoperable disease (PCI > 24) or explorative surgeries in patients with limited disease (PCI

Published
2021
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20. A population‐based study on the prognostic impact of primary tumor sidedness in patients with peritoneal metastases from colon cancer

Author

Nadine L. deBoer, Koen Rovers, Jacobus W.A. Burger, Eva V. E. Madsen, Alexandra R. M. Brandt‐Kerkhof, Niels F. M. Kok, Johannes H. W. deWilt, Philip H. deReuver, Amanda Bos, Ignace H. J. T. deHingh, and Cornelis Verhoef

Subjects
Colon cancer, peritoneal metastases, primary tumor sidedness, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Primary tumor location is an established prognostic factor in patients with (metastatic) colon cancer. Colon tumors can be divided into left‐sided and right‐sided tumors. The aim of this study was to determine the impact of primary tumor location on treatment and overall survival (OS) in patients with peritoneal metastases (PM) from colon cancer. This study is a retrospective, population‐based cohort study. Records of patients diagnosed with colon cancer and synchronous PM, from 1995 through 2016, were retrieved from the Netherlands Cancer Registry (NCR). Data on diagnosis, staging, and treatment were extracted from the medical records by specifically trained NCR personnel. Information on survival status was updated annually using a computerized link with the national civil registry. In total, 7930 patients were included in this study; 4555 (57.4%) had a right‐sided and 3375 (42.6%) had a left‐sided primary tumor. In multivariable analysis right‐sided primary tumor was associated with worse OS (HR: 1.11, 95% CI 1.03‐1.19, P = .007). Of all patients diagnosed with PM, 564 (7.1%) underwent cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS‐HIPEC). Patients with left‐sided primary tumors were more often candidates for CRS‐HIPEC (6.5% vs. 8.0%, P = .008). OS of patients with right‐ and left‐sided tumors who underwent CRS‐HIPEC did not significantly differ. In conclusion, primary right‐sided colon cancer was an independent prognostic factor for decreased OS in patients diagnosed with synchronous PM. In patients treated with CRS‐HIPEC location of the primary tumor did not influence survival.

Published
2020
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21. Dedicated MRI staging versus surgical staging of peritoneal metastases in colorectal cancer patients considered for CRS-HIPEC; the DISCO randomized multicenter trial

Author

Engbersen, M. P., Rijsemus, C. J. V., Nederend, J., Aalbers, A. G. J., de Hingh, I. H. J. T., Retel, V., Lambregts, D. M. J., Van der Hoeven, E. J. R. J., Boerma, D., Wiezer, M. J., De Vries, M., Madsen, E. V. E., Brandt-Kerkhof, A. R. M., Van Koeverden, S., De Reuver, P. R., Beets-Tan, R. G. H., Kok, N. F. M., and Lahaye, M. J.

Published
2021
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22. Treatment and survival of locally recurrent rectal cancer: A cross-sectional population study 15 years after the Dutch TME trial

Author

Aalbers, A.G.J., Acherman, Y., Algie, G.D., Alting von Geusau, B., Amelung, F., Aukema, T.S., Bakker, I.S., Bartels, S.A., Basha, S., Bastiaansen, A.J.N.M., Belgers, E., Bleeker, W., Blok, J., Bosker, R.J.I., Bosmans, J.W., Boute, M.C., Bouvy, N.D., Bouwman, H., Brandt-Kerkhof, A., Brinkman, D.J., Bruin, S., Bruns, E.R.J., Burbach, J.P.M., Burger, J.W.A., Buskens, C.J., Clermonts, S., Coene, P.P.L.O., Compaan, C., Consten, E.C.J., Darbyshire, T., de Mik, S.M.L., de Graaf, E.J.R., de Groot, I., tot Nederveen Cappel, RJ de Vos, de Wilt, J.H.W., van der Wolde, J., Boer, FC den, Dekker, J.W.T., Demirkiran, A., Derkx-Hendriksen, M., Dijkstra, F.R., van Duijvendijk, P., Dunker, M.S., Eijsbouts, Q.E., Fabry, H., Ferenschild, F., Foppen, J.W., Furnee, E.J.B., Gerhards, M.F., Gerven, P., Gooszen, J.A.H., Govaert, J.A., Van Grevenstein, W.M.U., Haen, R., Harlaar, J.J., van der Harst, E., Havenga, K., Heemskerk, J., Heeren, J.F., Heijnen, B., Heres, P., Hoff, C., Hogendoorn, W., Hoogland, P., Huijbers, A., Janssen, P., Jongen, A.C., Jonker, F.H., Karthaus, E.G., Keijzer, A., Ketel, J.M.A., Klaase, J., Kloppenberg, F.W.H., Kool, M.E., Kortekaas, R., Kruyt, P.M., Kuiper, J.T., Lamme, B., Lange, J.F., Lettinga, T., Lips, D.J., Logeman, F., Lutke Holzik, M.F., Madsen, E., Mamound, A., Marres, C.C., Masselink, I., Meerdink, M., Menon, A.G., Mieog, J.S., Mierlo, D., Musters, G.D., Nieuwenhuijzen, G.A.P., Neijenhuis, P.A., Nonner, J., Oostdijk, M., Oosterling, S.J., Paul, P.M.P., Peeters, K.C.M.J., Pereboom, I.T.A., Polat, F., Poortman, P., Raber, M., Reiber, B.M.M., Renger, R.J., van Rossem, C.C., Rutten, H.J., Rutten, A., Schaapman, R., Scheer, M., Schoonderwoerd, L., Schouten, N., Schreuder, A.M., Schreurs, W.H., Simkens, G.A., Slooter, G.D., Sluijmer, H.C.E., Smakman, N., Smeenk, R., Snijders, H.S., Sonneveld, D.J.A., Spaansen, B., Bilgen, EJ Spillenaar, Steller, E., Steup, W.H., Steur, C., Stortelder, E., Straatman, J., Swank, H.A., Sietses, C., Groen, H.A., Hoeve, HG ten, Riele, WW ter, Thorensen, I.M., Tip-Pluijm, B., Toorenvliet, B.R., Tseng, L., Tuynman, J.B., van Bastelaar, J., van Beek, S.C., van de Ven, A.W.H., van de Weijer, M.A.J., van den Berg, C., van den Bosch, I., van der Bilt, J.D.W., van der Hagen, S.J., van der Hul, R., van der Schelling, G., van der Spek, A., van der Wielen, N., van Duyn, E., van Eekelen, C., van Essen, J.A., van Gangelt, K., van Geloven, A.A.W., van Kessel, C., van Loon, Y.T., van Rijswijk, A., van Rooijen, S.J., van Sprundel, T., van Steensel, L., van Tets, W.F., van Westreenen, H.L., Veltkamp, S., Verhaak, T., Verheijen, P.M., Versluis-Ossenwaarde, L., Vijfhuize, S., Vles, W.J., Voeten, S.C., Vogelaar, F.J., Vrijland, W.W., Westerduin, E., Westerterp, M.E., Wetzel, M., Wevers, K.P., Wiering, B., Witjes, C.D.M., Wouters, M.W., Yauw, S.T.K., van der Zaag, E.S., Zeestraten, E.C., Zimmerman, D.D.E., Zwieten, T., Detering, Robin, Karthaus, Eleonora G., Borstlap, Wernard A.A., Marijnen, Corrie A.M., van de Velde, Cornelis J.H., Bemelman, Willem A., Beets, Geerard L., Tanis, Pieter J., and Aalbers, Arend G.J.

Published
2019
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26. Adjuvant dendritic cell-based immunotherapy after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in patients with malignant peritoneal mesothelioma: a phase II clinical trial

Author

Dietz, Michelle V, primary, Quintelier, Katrien L A, additional, van Kooten, Job P, additional, de Boer, Nadine L, additional, Vink, Madelief, additional, Brandt-Kerkhof, Alexandra R M, additional, Verhoef, Cornelis, additional, Saeys, Yvan, additional, Aerts, Joachim G J V, additional, Willemsen, Marcella, additional, Van Gassen, Sofie, additional, and Madsen, Eva V E, additional

Published
2023
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27. Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6)

Author

Koen P. Rovers, Checca Bakkers, Geert A. A. M. Simkens, Jacobus W. A. Burger, Simon W. Nienhuijs, Geert-Jan M. Creemers, Anna M. J. Thijs, Alexandra R. M. Brandt-Kerkhof, Eva V. E. Madsen, Ninos Ayez, Nadine L. de Boer, Esther van Meerten, Jurriaan B. Tuynman, Miranda Kusters, Nina R. Sluiter, Henk M. W. Verheul, Hans J. van der Vliet, Marinus J. Wiezer, Djamila Boerma, Emma C. E. Wassenaar, Maartje Los, Cornelis B. Hunting, Arend G. J. Aalbers, Niels F. M. Kok, Koert F. D. Kuhlmann, Henk Boot, Myriam Chalabi, Schelto Kruijff, Lukas B. Been, Robert J. van Ginkel, Derk Jan A. de Groot, Rudolf S. N. Fehrmann, Johannes H. W. de Wilt, Andreas J. A. Bremers, Philip R. de Reuver, Sandra A. Radema, Karin H. Herbschleb, Wilhelmina M. U. van Grevenstein, Arjen J. Witkamp, Miriam Koopman, Nadia Haj Mohammad, Eino B. van Duyn, Walter J. B. Mastboom, Leonie J. M. Mekenkamp, Joost Nederend, Max J. Lahaye, Petur Snaebjornsson, Cornelis Verhoef, Hanneke W. M. van Laarhoven, Aeilko H. Zwinderman, Jeanette M. Bouma, Onno Kranenburg, Iris van ‘t Erve, Remond J. A. Fijneman, Marcel G. W. Dijkgraaf, Patrick H. J. Hemmer, Cornelis J. A. Punt, Pieter J. Tanis, Ignace H. J. T. de Hingh, Dutch Peritoneal Oncology Group (DPOG), and Dutch Colorectal Cancer Group (DCCG)

Subjects
Colorectal neoplasms, Peritoneal neoplasms, Cytoreduction surgical procedures, Hyperthermia, induced, Neoadjuvant therapy, Adjuvant chemotherapy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Upfront cytoreductive surgery with HIPEC (CRS-HIPEC) is the standard treatment for isolated resectable colorectal peritoneal metastases (PM) in the Netherlands. This study investigates whether addition of perioperative systemic therapy to CRS-HIPEC improves oncological outcomes. Methods This open-label, parallel-group, phase II-III, randomised, superiority study is performed in nine Dutch tertiary referral centres. Eligible patients are adults who have a good performance status, histologically or cytologically proven resectable PM of a colorectal adenocarcinoma, no systemic colorectal metastases, no systemic therapy for colorectal cancer within six months prior to enrolment, and no previous CRS-HIPEC. Eligible patients are randomised (1:1) to perioperative systemic therapy and CRS-HIPEC (experimental arm) or upfront CRS-HIPEC alone (control arm) by using central randomisation software with minimisation stratified by a peritoneal cancer index of 0–10 or 11–20, metachronous or synchronous PM, previous systemic therapy for colorectal cancer, and HIPEC with oxaliplatin or mitomycin C. At the treating physician’s discretion, perioperative systemic therapy consists of either four 3-weekly neoadjuvant and adjuvant cycles of capecitabine with oxaliplatin (CAPOX), six 2-weekly neoadjuvant and adjuvant cycles of 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX), or six 2-weekly neoadjuvant cycles of 5-fluorouracil/leucovorin with irinotecan (FOLFIRI) followed by four 3-weekly (capecitabine) or six 2-weekly (5-fluorouracil/leucovorin) adjuvant cycles of fluoropyrimidine monotherapy. Bevacizumab is added to the first three (CAPOX) or four (FOLFOX/FOLFIRI) neoadjuvant cycles. The first 80 patients are enrolled in a phase II study to explore the feasibility of accrual and the feasibility, safety, and tolerance of perioperative systemic therapy. If predefined criteria of feasibility and safety are met, the study continues as a phase III study with 3-year overall survival as primary endpoint. A total of 358 patients is needed to detect the hypothesised 15% increase in 3-year overall survival (control arm 50%; experimental arm 65%). Secondary endpoints are surgical characteristics, major postoperative morbidity, progression-free survival, disease-free survival, health-related quality of life, costs, major systemic therapy related toxicity, and objective radiological and histopathological response rates. Discussion This is the first randomised study that prospectively compares oncological outcomes of perioperative systemic therapy and CRS-HIPEC with upfront CRS-HIPEC alone for isolated resectable colorectal PM. Trial registration Clinicaltrials.gov/NCT02758951, NTR/NTR6301, ISRCTN/ISRCTN15977568, EudraCT/2016–001865-99.

Published
2019
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28. Impact of centralization of care for malignant peritoneal mesothelioma

Author

Job P. van Kooten, Cornedine J. de Gooijer, Jan H. von der Thüsen, Alexandra R.M. Brandt-Kerkhof, Arend G.J. Albers, Max J. Lahaye, Kim Monkhorst, Jacobus A. Burgers, Joachim G.J.V. Aerts, Cornelis Verhoef, Eva V.E. Madsen, Surgery, Pathology, and Pulmonary Medicine

Subjects
Oncology, SDG 3 - Good Health and Well-being, Surgery, General Medicine
Abstract

Background: Malignant peritoneal mesothelioma (MPM) is a rare and aggressive cancer that has a poor prognosis. An earlier population-based study found that the majority of Dutch patients do not receive anti-cancer treatment. In 2015, Dutch Malignant Mesothelioma care was centralized in two expert centers. We reviewed treatment patterns at these centers, to assess the impact of centralization of MPM care in the Netherlands. Methods: Data from all patients referred to the Dutch MPM expert centers from 2014 to 2020, were retrospectively collected. Descriptive statistics regarding referrals, patient and tumor characteristics, and treatment patterns were provided. Population-based incidence rates were provided by the Netherlands Cancer Registry. Results: From 2014 to 2020, 78 patients were referred to the Dutch Mesothelioma expert centers, of whom 32 were female (41%). From 2014 to 2017, 27 patients were referred, whereas 51 patients were referred from 2018 to 2020. This represents about 24% and 61% of the estimated population incidence, respectively. Treatment patterns were comparable between both periods. Between 2014 and 2018, 33% of patients underwent surgery, 44% systemic therapy, and 22% received best supportive care (BSC), while this was 29%, 37%, and 33% respectively from 2018 to 2020. Conclusion: Centralization of care for patients with MPM resulted in an increase of annual referrals to the Dutch mesothelioma expert centers. While population-based incidence did not change during the study period, the absolute number of patients receiving treatment at our centers did increase. This might be considered a first important step towards better treatment for patients with this fatal disease.

Published
2023

29. Intraperitoneal Chemotherapy for Unresectable Peritoneal Surface Malignancies

Author

Niels A. D. Guchelaar, Bo J. Noordman, Stijn L. W. Koolen, Bianca Mostert, Eva V. E. Madsen, Jacobus W. A. Burger, Alexandra R. M. Brandt-Kerkhof, Geert-Jan Creemers, Ignace H. J. T. de Hingh, Misha Luyer, Sander Bins, Esther van Meerten, Sjoerd M. Lagarde, Cornelis Verhoef, Bas P. L. Wijnhoven, Ron. H. J. Mathijssen, Medical Oncology, Surgery, and Pharmacy

Subjects
PHASE-I TRIAL, ADVANCED GASTRIC-CANCER, LABORATORY BENCH, SDG 3 - Good Health and Well-being, RECURRENT OVARIAN, CYTOREDUCTIVE SURGERY, DOSE-ESCALATION, AEROSOL CHEMOTHERAPY, Pharmacology (medical), PANCREATIC DUCTAL ADENOCARCINOMA, NAB-PACLITAXEL, OVARIAN-CANCER
Abstract

Malignancies of the peritoneal cavity are associated with a dismal prognosis. Systemic chemotherapy is the gold standard for patients with unresectable peritoneal disease, but its intraperitoneal effect is hampered by the peritoneal-plasma barrier. Intraperitoneal chemotherapy, which is administered repeatedly into the peritoneal cavity through a peritoneal implanted port, could provide a novel treatment modality for this patient population. This review provides a systematic overview of intraperitoneal used drugs, the performed clinical studies so far, and the complications of the peritoneal implemental ports. Several anticancer drugs have been studied for intraperitoneal application, with the taxanes paclitaxel and docetaxel as the most commonly used drug. Repeated intraperitoneal chemotherapy, mostly in combination with systemic chemotherapy, has shown promising results in Phase I and Phase II studies for several tumor types, such as gastric cancer, ovarian cancer, colorectal cancer, and pancreatic cancer. Two Phase III studies for intraperitoneal chemotherapy in gastric cancer have been performed so far, but the results regarding the superiority over standard systemic chemotherapy alone, are contradictory. Pressurized intraperitoneal administration, known as PIPAC, is an alternative way of administering intraperitoneal chemotherapy, and the first prospective studies have shown a tolerable safety profile. Although intraperitoneal chemotherapy might be a standard treatment option for patients with unresectable peritoneal disease, more Phase II and Phase III studies focusing on tolerability profiles, survival rates, and quality of life are warranted in order to establish optimal treatment schedules and to establish a potential role for intraperitoneal chemotherapy in the approach to unresectable peritoneal disease.

Published
2023

30. Pressurized aerosol versus catheter-based intraperitoneal chemotherapy in patients with extensive colorectal peritoneal metastases – comparing results of two early phase trials.

Author

Van Den Heuvel, Teun, Van de Vlasakker, Vincent C.J., Rauwerdink, Paulien, van Eerden, Ruben A.G., de Boer, Nadine L., van Kooten, Job P., Lurvink, Robin J., Madsen, Eva V.E., Brandt-Kerkhof, Alexandra R.M., van Meerten, Esther, Nienhuijs, Simon W., Rovers, Koen P.B., Bakkers, Checca, Verhoef, Cornelis, Mathijssen, Ron H.J., Boerma, Djamila, de Hingh, Ignace H.J.T., and Burger, Jacobus W.A.

Published
2024
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32. A prospective cohort of patients with colorectal peritoneal metastases treated with CRS-HIPEC: development and first results of the Dutch HIPEC quality registry

Author

van Erning, Felice N., Van Den Heuvel, Teun, Sijtsma, Femke, Boerma, Djamilla, Brandt-Kerkhof, Alexandra R.M., Bremers, Andre, van Duyn, Eino B., van Grevenstein, Wilhelmina M.U., Hemmer, Patrick H.J., Kok, Niels, Madsen, Eva V.E., de Reuver, Philip R., Wiezer, Rene J., Witkamp, Arjen, Nienhuijs, Simon W., Poelmann, Floris, Tuynman, Jurriaan, Been, Lukas, Rovers, Koen P., and de Hingh, Ignace H.J.T.

Published
2024
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33. Phase I study of intraperitoneal irinotecan combined with palliative systemic chemotherapy in patients with colorectal peritoneal metastases

Author

van Eerden, Ruben A G, primary, de Boer, Nadine L, additional, van Kooten, Job P, additional, Bakkers, Checca, additional, Dietz, Michelle V, additional, Creemers, Geert-Jan M, additional, Buijs, Sanne M, additional, Bax, Ramon, additional, de Man, Femke M, additional, Lurvink, Robin J, additional, Diepeveen, Marjolein, additional, Brandt-Kerkhof, Alexandra R M, additional, van Meerten, Esther, additional, Koolen, Stijn L W, additional, de Hingh, Ignace H J T, additional, Verhoef, Cornelis, additional, Mathijssen, Ron H J, additional, and Burger, Jacobus W A, additional

Published
2023
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34. Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6)

Author

Rovers, Koen P., Bakkers, Checca, Simkens, Geert A. A. M., Burger, Jacobus W. A., Nienhuijs, Simon W., Creemers, Geert-Jan M., Thijs, Anna M. J., Brandt-Kerkhof, Alexandra R. M., Madsen, Eva V. E., Ayez, Ninos, de Boer, Nadine L., van Meerten, Esther, Tuynman, Jurriaan B., Kusters, Miranda, Sluiter, Nina R., Verheul, Henk M. W., van der Vliet, Hans J., Wiezer, Marinus J., Boerma, Djamila, Wassenaar, Emma C. E., Los, Maartje, Hunting, Cornelis B., Aalbers, Arend G. J., Kok, Niels F. M., Kuhlmann, Koert F. D., Boot, Henk, Chalabi, Myriam, Kruijff, Schelto, Been, Lukas B., van Ginkel, Robert J., de Groot, Derk Jan A., Fehrmann, Rudolf S. N., de Wilt, Johannes H. W., Bremers, Andreas J. A., de Reuver, Philip R., Radema, Sandra A., Herbschleb, Karin H., van Grevenstein, Wilhelmina M. U., Witkamp, Arjen J., Koopman, Miriam, Haj Mohammad, Nadia, van Duyn, Eino B., Mastboom, Walter J. B., Mekenkamp, Leonie J. M., Nederend, Joost, Lahaye, Max J., Snaebjornsson, Petur, Verhoef, Cornelis, van Laarhoven, Hanneke W. M., Zwinderman, Aeilko H., Bouma, Jeanette M., Kranenburg, Onno, van ‘t Erve, Iris, Fijneman, Remond J. A., Dijkgraaf, Marcel G. W., Hemmer, Patrick H. J., Punt, Cornelis J. A., Tanis, Pieter J., and de Hingh, Ignace H. J. T.

Published
2019
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35. Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC): 5-Year Results of a Randomized Multicenter Trial.

Author

Zwanenburg, Emma Sophia, El Klaver, Charlotte, Wisselink, Daniel D., Punt, Cornelis J.A., Snaebjornsson, P., Crezee, Johannes, Aalbers, Arend G.J., Brandt-Kerkhof, Alexandra R.M., Bremers, Andre J.A., Burger, Pim J.W.A., Fabry, Hans F.J., Ferenschild, Floris T.J., Festen, Sebastiaan, van Grevenstein, Wilhemina M.U., Hemmer, Patrick H.J., de Hingh, Ignace H.J.T., Kok, Niels F.M., Kusters, M., Musters, G.D., and Schoonderwoerd, Lotte

Published
2024
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36. Intraperitoneal irinotecan combined with systemic chemotherapy for extensive peritoneal carcinomatosis of colorectal origin: The phase I and phase II INTERACT trials

Author

van Eerden, Ruben A.G., primary, Van De Vlasakker, Vincent, additional, Guchelaar, Niels A.D., additional, de Boer, Nadine L., additional, van kooten, Job P., additional, Bakkers, Checca, additional, Dietz, Michelle, additional, Creemers, Geert-Jan M., additional, Buijs, Sanne M., additional, Bax, Ramon, additional, de Man, Femke M., additional, Lurvink, Robin J., additional, Diepeveen, Marjolein, additional, Brandt-Kerkhof, Alexandra R.M., additional, van Meerten, Esther, additional, Koolen, Stijn L.W., additional, de Hingh, Ignace H.J.T., additional, Verhoef, Cornelis, additional, Mathijssen, Ron H.J., additional, and Burger, Pim W.A., additional

Published
2023
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37. Intraperitoneal Paclitaxel for Patients with Primary Malignant Peritoneal Mesothelioma – a Phase I/II Dose Escalation and Safety Study: INTERACT MESO

Author

Van Kooten, J.P., primary, Dietz, Michelle, additional, Guchelaar, Niels, additional, Brandt-Kerkhof, Alexandra, additional, Koolen, Stijn, additional, Jacobus, Burger, additional, Mathijssen, Ron, additional, Verhoef, Cornelis, additional, Aerts, Joachim, additional, and Madsen, Eva, additional

Published
2023
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38. Adjuvant dendritic cell-based immunotherapy after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in patients with malignant peritoneal mesothelioma:a phase II clinical trial

Author

Dietz, Michelle V., Quintelier, Katrien L.A., van Kooten, Job P., de Boer, Nadine L., Vink, Madelief, Brandt-Kerkhof, Alexandra R.M., Verhoef, Cornelis, Saeys, Yvan, Aerts, Joachim G.J.V., Willemsen, Marcella, Van Gassen, Sofie, Madsen, Eva V.E., Dietz, Michelle V., Quintelier, Katrien L.A., van Kooten, Job P., de Boer, Nadine L., Vink, Madelief, Brandt-Kerkhof, Alexandra R.M., Verhoef, Cornelis, Saeys, Yvan, Aerts, Joachim G.J.V., Willemsen, Marcella, Van Gassen, Sofie, and Madsen, Eva V.E.

Abstract

BACKGROUND: Malignant peritoneal mesothelioma (MPM) is an aggressive malignancy with a poor prognosis. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) improves survival outcomes, but recurrence rates remain high. Dendritic cell-based immunotherapy (DCBI) showed promising results in patients with pleural mesothelioma. The primary aim of this trial was to determine feasibility of adjuvant DCBI after CRS-HIPEC. METHODS: This open-label, single-center, phase II clinical trial, performed in the Erasmus MC Cancer Institute Rotterdam, the Netherlands, included patients with epithelioid MPM. 4-6 weeks before CRS-HIPEC leukapheresis was performed. 8-10 weeks after surgery, DCBI was administered three times biweekly. Feasibility was defined as administration of at least three adjuvant vaccinations in 75% of patients. Comprehensive immune cell profiling was performed on peripheral blood samples prior to and during treatment. RESULTS: All patients who received CRS-HIPEC (n=16) were successfully treated with adjuvant DCBI. No severe toxicity related to DCBI was observed. Median progression-free survival (PFS) was 12 months (IQR 5-23) and median overall survival was not reached. DCBI was associated with increased proliferation of circulating natural killer cells and CD4+ T-helper (Th) cells. Co-stimulatory molecules, including ICOS, HLA-DR, and CD28 were upregulated predominantly on memory or proliferating Th-cells and minimally on CD8+ cytotoxic T-lymphocytes (CTLs) after treatment. However, an increase in CD8+ terminally differentiated effector memory (Temra) cells positively correlated with PFS, whereas co-expression of ICOS and Ki67 on CTLs trended towards a positive correlation. CONCLUSIONS: Adjuvant DCBI after CRS-HIPEC in patients with MPM was feasible and safe, and showed promising survival outcomes. DCBI had an immune modulatory effect on lymphoid cells and induced memory T-cell activation. Moreover, an increase of CD8+ Temra cells wa

Published
2023

39. Perioperative Systemic Therapy Versus Cytoreductive Surgery and HIPEC Alone for Resectable Colorectal Peritoneal Metastases:Patient-Reported Outcomes of a Randomized Phase II Trial

Author

Bakkers, C., Rovers, K. P., Rijken, A., Simkens, G. A.A.M., Bonhof, C. S., Nienhuijs, S. W., Burger, J. W.A., Creemers, G. J.M., Brandt-Kerkhof, A. R.M., Tuynman, J. B., Aalbers, A. G.J., Wiezer, M. J., de Reuver, P. R., van Grevenstein, W. M.U., Hemmer, P. H.J., Punt, C. J.A., Tanis, P. J., Mols, F., de Hingh, I. H.J.T., Bakkers, C., Rovers, K. P., Rijken, A., Simkens, G. A.A.M., Bonhof, C. S., Nienhuijs, S. W., Burger, J. W.A., Creemers, G. J.M., Brandt-Kerkhof, A. R.M., Tuynman, J. B., Aalbers, A. G.J., Wiezer, M. J., de Reuver, P. R., van Grevenstein, W. M.U., Hemmer, P. H.J., Punt, C. J.A., Tanis, P. J., Mols, F., and de Hingh, I. H.J.T.

Abstract

Background: As part of a randomized phase II trial in patients with isolated resectable colorectal peritoneal metastases (CPMs), the present study compared patient-reported outcomes (PROs) of patients treated with perioperative systemic therapy versus cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS–HIPEC) alone. Also, PROs of patients receiving perioperative systemic therapy were explored. Patients and Methods: Eligible patients were randomized to perioperative systemic therapy (experimental) or CRS–HIPEC alone (control). PROs were assessed using EORTC QLQ-C30, QLQ-CR29, and EQ-5D-5L questionnaires at baseline, after neoadjuvant treatment (experimental), and at 3 and 6 months postoperatively. Linear mixed modeling was used to compare five predefined PROs (visual analog scale, global health status, physical functioning, fatigue, C30 summary score) between arms and to longitudinally analyze PROs in the experimental arm. Results: Of 79 analyzed patients, 37 (47%) received perioperative systemic therapy. All predefined PROs were comparable between arms at all timepoints and returned to baseline at 3 or 6 months postoperatively. The experimental arm had worsening of fatigue [mean difference (MD) + 14, p = 0.001], loss of appetite (MD + 15, p = 0.003), hair loss (MD + 18, p < 0.001), and loss of taste (MD + 27, p < 0.001) after neoadjuvant treatment. Except for loss of appetite, these PROs returned to baseline at 3 or 6 months postoperatively. Conclusions: In patients with resectable CPM randomized to perioperative systemic therapy or CRS–HIPEC alone, PROs were comparable between arms and returned to baseline postoperatively. Together with the trial’s previously reported feasibility and safety data, these findings show acceptable tolerability of perioperative systemic therapy in this setting.

Published
2023

40. ASO Visual Abstract:Treatment and Survival Outcomes of Patients with Colorectal Peritoneal Metastases Deemed Ineligible for Cytoreductive Surgery (CRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Results of a Retrospective Study

Author

Dietz, Michelle V., Ziekman, Merijn J., van Kooten, Job P., Brandt-Kerkhof, Alexandra R.M., van Meerten, Esther, Verhoef, Cornelis, Madsen, Eva V.E., Dietz, Michelle V., Ziekman, Merijn J., van Kooten, Job P., Brandt-Kerkhof, Alexandra R.M., van Meerten, Esther, Verhoef, Cornelis, and Madsen, Eva V.E.

Published
2023

41. Impact of centralization of care for malignant peritoneal mesothelioma:A historical cohort study from the Dutch mesothelioma expert centers

Author

van Kooten, Job P., de Gooijer, Cornedine J., von der Thüsen, Jan H., Brandt-Kerkhof, Alexandra R.M., Albers, Arend G.J., Lahaye, Max J., Monkhorst, Kim, Burgers, Jacobus A., Aerts, Joachim G.J.V., Verhoef, Cornelis, Madsen, Eva V.E., van Kooten, Job P., de Gooijer, Cornedine J., von der Thüsen, Jan H., Brandt-Kerkhof, Alexandra R.M., Albers, Arend G.J., Lahaye, Max J., Monkhorst, Kim, Burgers, Jacobus A., Aerts, Joachim G.J.V., Verhoef, Cornelis, and Madsen, Eva V.E.

Abstract

Background: Malignant peritoneal mesothelioma (MPM) is a rare and aggressive cancer that has a poor prognosis. An earlier population-based study found that the majority of Dutch patients do not receive anti-cancer treatment. In 2015, Dutch Malignant Mesothelioma care was centralized in two expert centers. We reviewed treatment patterns at these centers, to assess the impact of centralization of MPM care in the Netherlands. Methods: Data from all patients referred to the Dutch MPM expert centers from 2014 to 2020, were retrospectively collected. Descriptive statistics regarding referrals, patient and tumor characteristics, and treatment patterns were provided. Population-based incidence rates were provided by the Netherlands Cancer Registry. Results: From 2014 to 2020, 78 patients were referred to the Dutch Mesothelioma expert centers, of whom 32 were female (41%). From 2014 to 2017, 27 patients were referred, whereas 51 patients were referred from 2018 to 2020. This represents about 24% and 61% of the estimated population incidence, respectively. Treatment patterns were comparable between both periods. Between 2014 and 2018, 33% of patients underwent surgery, 44% systemic therapy, and 22% received best supportive care (BSC), while this was 29%, 37%, and 33% respectively from 2018 to 2020. Conclusion: Centralization of care for patients with MPM resulted in an increase of annual referrals to the Dutch mesothelioma expert centers. While population-based incidence did not change during the study period, the absolute number of patients receiving treatment at our centers did increase. This might be considered a first important step towards better treatment for patients with this fatal disease.

Published
2023

42. Intraperitoneal Chemotherapy for Unresectable Peritoneal Surface Malignancies

Author

Guchelaar, Niels A.D., Noordman, Bo J., Koolen, Stijn L.W., Mostert, Bianca, Madsen, Eva V.E., Burger, Jacobus W.A., Brandt-Kerkhof, Alexandra R.M., Creemers, Geert Jan, de Hingh, Ignace H.J.T., Luyer, Misha, Bins, Sander, van Meerten, Esther, Lagarde, Sjoerd M., Verhoef, Cornelis, Wijnhoven, Bas P.L., Mathijssen, Ron H.J., Guchelaar, Niels A.D., Noordman, Bo J., Koolen, Stijn L.W., Mostert, Bianca, Madsen, Eva V.E., Burger, Jacobus W.A., Brandt-Kerkhof, Alexandra R.M., Creemers, Geert Jan, de Hingh, Ignace H.J.T., Luyer, Misha, Bins, Sander, van Meerten, Esther, Lagarde, Sjoerd M., Verhoef, Cornelis, Wijnhoven, Bas P.L., and Mathijssen, Ron H.J.

Abstract

Malignancies of the peritoneal cavity are associated with a dismal prognosis. Systemic chemotherapy is the gold standard for patients with unresectable peritoneal disease, but its intraperitoneal effect is hampered by the peritoneal-plasma barrier. Intraperitoneal chemotherapy, which is administered repeatedly into the peritoneal cavity through a peritoneal implanted port, could provide a novel treatment modality for this patient population. This review provides a systematic overview of intraperitoneal used drugs, the performed clinical studies so far, and the complications of the peritoneal implemental ports. Several anticancer drugs have been studied for intraperitoneal application, with the taxanes paclitaxel and docetaxel as the most commonly used drug. Repeated intraperitoneal chemotherapy, mostly in combination with systemic chemotherapy, has shown promising results in Phase I and Phase II studies for several tumor types, such as gastric cancer, ovarian cancer, colorectal cancer, and pancreatic cancer. Two Phase III studies for intraperitoneal chemotherapy in gastric cancer have been performed so far, but the results regarding the superiority over standard systemic chemotherapy alone, are contradictory. Pressurized intraperitoneal administration, known as PIPAC, is an alternative way of administering intraperitoneal chemotherapy, and the first prospective studies have shown a tolerable safety profile. Although intraperitoneal chemotherapy might be a standard treatment option for patients with unresectable peritoneal disease, more Phase II and Phase III studies focusing on tolerability profiles, survival rates, and quality of life are warranted in order to establish optimal treatment schedules and to establish a potential role for intraperitoneal chemotherapy in the approach to unresectable peritoneal disease.

Published
2023

43. ASO Visual Abstract

Author

Dietz, Michelle V., Ziekman, Merijn J., van Kooten, Job P., Brandt-Kerkhof, Alexandra R.M., van Meerten, Esther, Verhoef, Cornelis, Madsen, Eva V.E., Pulmonary Medicine, Surgery, and Medical Oncology

Subjects
Oncology, Surgery
Published
2023

44. Treatment and Survival Outcomes for Patients with Colorectal Peritoneal Metastases Deemed Ineligible for Cytoreductive Surgery (CRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Results of a Retrospective Study

Author

Michelle V. Dietz, Merijn J. Ziekman, Job P. van Kooten, Alexandra R. M. Brandt-Kerkhof, Esther van Meerten, Cornelis Verhoef, Eva V. E. Madsen, Surgery, and Medical Oncology

Subjects
Oncology, Surgery
Abstract

Background: Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a treatment option for selected patients with colorectal peritoneal metastases (PM). This report provides an overview of treatment and survival outcomes for patients deemed ineligible for CRS-HIPEC. Methods: Colorectal PM patients referred to a tertiary center from 2014 to 2020 that were ineligible for CRS-HIPEC were included. Patient, tumor, and treatment characteristics were provided. Survival analyses were performed using the Kaplan-Meier method. Results: Of 476 patients referred for CRS-HIPEC, 227 (48%) were deemed ineligible. Median follow-up was 15 months [IQR 10–22]. Data on follow-up treatment was available for 198 patients, of which 73% received systemic therapy. These patients had a median overall survival (OS) of 17 months [IQR 9–25]. For patients receiving best supportive care (BSC) median OS was 4 months [IQR 2–9]. The main reason for ineligibility was extensive PM (42%), with a median OS of 11 months [IQR 5–18]. Patients deemed ineligible due to (extensive) liver (9%) or lung metastases (8%) showed longer OS (median 22 months, IQR 8–27, and 24 months, IQR 12–29, respectively) than patients with extensive PM (median 11 months, IQR 5–18) or distant lymph node metastases (median 14 months, IQR 4–25). Conclusion: The main reason for CRS-HIPEC ineligibility was extensive PM. The majority of patients received systemic therapy. Patients deemed ineligible due to extra-peritoneal metastases had better survival outcomes than patients deemed ineligible due to extensive PM.

Published
2023

45. Long-term stoma-related reinterventions after anterior resection for rectal cancer with or without anastomosis: population data from the Dutch snapshot study

Author

Hazen, S. J. A., Vogel, I., Borstlap, W. A. A., Dekker, J. W. T., Tuynman, J. B., Tanis, P. J., Kusters, M., Deijen, C. L., den Dulk, M., Bonjer, H. J., van de Velde, C. J., Aalbers, A. G. J., Acherman, Y., Algie, G. D., von Geusau, B. Alting, Amelung, F., Aukema, T. S., Bakker, I. S., Bartels, S. A., Basha, S., Bastiaansen, A. J. N. M., Belgers, E., Bleeker, W., Blok, J., Bosker, R. J. I., Bosmans, J. W., Boute, M. C., Bouvy, N. D., Bouwman, H., Brandt-Kerkhof, A., Brinkman, D. J., Bruin, S., Bruns, E. R. J., Burbach, J. P. M., Burger, J. W. A., Buskens, C. J., de Mik, S. M. L., van Duijvendijk, P., Gooszen, J. A. H., Hoogland, P., Lamme, B., Marres, C. C., Musters, G. D., van Rossem, C. C., Schreuder, A. M., Swank, H. A., van beek, S. C., van Westreenen, H. L., Westerduin, E., Surgery, CCA - Imaging and biomarkers, CCA - Cancer Treatment and quality of life, Amsterdam Gastroenterology Endocrinology Metabolism, APH - Global Health, APH - Quality of Care, CCA - Cancer biology and immunology, Anatomy and neurosciences, General practice, Obstetrics and gynaecology, VU University medical center, Amsterdam Reproduction & Development (AR&D), Graduate School, CCA - Cancer Treatment and Quality of Life, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
medicine.medical_specialty, Colorectal cancer, Anastomosis, medicine.medical_treatment, digestive system, Stoma, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], medicine, Rectal cancer, business.industry, Gastroenterology, Colostomy, Permanent stoma, Anterior resection, medicine.disease, digestive system diseases, Colorectal surgery, Surgery, medicine.anatomical_structure, surgical procedures, operative, Sphincter, Hartmann’s procedure, business, Cohort study, Abdominal surgery
Abstract

Item does not contain fulltext BACKGROUND: The aim of this study was to analyze the stoma-related reinterventions, complications and readmissions after an anterior resection for rectal cancer, based on a cross-sectional nationwide cohort study with 3-year follow-up. METHODS: Rectal cancer patients who underwent a resection with either a functional anastomosis, a defunctioned anastomosis, or Hartmann's procedure (HP) with an end colostomy in 2011 in 71 Dutch hospitals were included. The primary outcome was number of stoma-related reinterventions. RESULTS: Of the 2095 patients with rectal cancer, 1400 patients received an anterior resection and were included in this study; 257 received an initially functional anastomosis, 741 a defunctioned anastomosis, and 402 patients a HP. Of the 1400 included patients, 62% were males, 38% were females and the mean age was 67 years (SD 11.1). Following a primary functional anastomosis, 48 (19%) patients received a secondary stoma. Stoma-related complications occurred in six (2%) patients, requiring reintervention in one (0.4%) case. In the defunctioned anastomosis group, stoma-related complications were present in 92 (12%) patients, and required reintervention in 23 (3%) patients, in 10 (1%) of these more than 1 year after initial resection. Stoma-related complications occurred in 92 (23%) patients after a HP, and required reintervention in 39 (10%) patients in 17 (4%) of cases more than 1 year after initial resection. The permanent stoma rate was 11% and 20%, in the functional anastomosis and the defuctioned anastomosis group, respectively. The end colostomy in the HP group was reversed in 4% of cases. CONCLUSIONS: Construction of a stoma after resection for rectal cancer with preservation of the sphincter is accompanied with long-term stoma-related morbidity. Stoma complications are more frequent after a HP. Even after 1 year, a significant number of reinterventions are required.

Published
2022

46. Treatment and Survival Outcomes for Patients with Colorectal Peritoneal Metastases Deemed Ineligible for Cytoreductive Surgery (CRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Results of a Retrospective Study

Author

Dietz, Michelle V., primary, Ziekman, Merijn J., additional, van Kooten, Job P., additional, Brandt-Kerkhof, Alexandra R. M., additional, van Meerten, Esther, additional, Verhoef, Cornelis, additional, and Madsen, Eva V. E., additional

Published
2022
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47. The influence of hospital volume on long-term oncological outcome after rectal cancer surgery

Author

Jonker, Frederik H. W., Hagemans, Jan A. W., Burger, Jacobus W. A., Verhoef, Cornelis, Borstlap, Wernard A. A., Tanis, Pieter J., Aalbers, A., Acherman, Y., Algie, G. D., Alting von Geusau, B., Amelung, F., Aukema, T. S., Bakker, I. S., Bartels, S. A., Basha, S., Bastiaansen, A. J. N. M., Belgers, E., Bemelman, W. A., Bleeker, W., Blok, J., Bosker, R. J. I., Bosmans, J. W., Boute, M. C., Bouvy, N. D., Bouwman, H., Brandt-Kerkhof, A., Brinkman, D. J., Bruin, S., Bruns, E. R. J., Burbach, J. P. M., Clermonts, S., Coene, P. P. L. O., Compaan, C., Consten, E. C. J., Darbyshire, T., de Mik, S. M. L., de Graaf, E. J. R., de Groot, I., de vos tot Nederveen Cappel, R. J. L., de Wilt, J. H. W., van der Wolde, J., den Boer, F. C., Dekker, J. W. T., Demirkiran, A., Derkx-Hendriksen, M., Dijkstra, F. R., van Duijvendijk, P., Dunker, M. S., Eijsbouts, Q. E., Fabry, H., Ferenschild, F., Foppen, J. W., Furnée, E. J. B., Gerhards, M. F., Gerven, P., Gooszen, J. A. H., Govaert, J. A., Van Grevenstein, W. M. U., Haen, R., Harlaar, J. J., Harst, E., Havenga, K., Heemskerk, J., Heeren, J. F., Heijnen, B., Heres, P., Hoff, C., Hogendoorn, W., Hoogland, P., Huijbers, A., Gooszen, J. A. H., Janssen, P., Jongen, A. C., Karthaus, E. G., Keijzer, A., Ketel, J. M. A., Klaase, J., Kloppenberg, F. W. H., Kool, M. E., Kortekaas, R., Kruyt, P. M., Kuiper, J. T., Lamme, B., Lange, J. F., Lettinga, T., Lips, D. J., Logeman, F., Lutke Holzik, M. F., Madsen, E., Mamound, A., Marres, C. C., Masselink, I., Meerdink, M., Menon, A. G., Mieog, J. S., Mierlo, D., Musters, G. D., Neijenhuis, P. A., Nonner, J., Oostdijk, M., Oosterling, S. J., Paul, P. M. P., Peeters, K. C. M. J. C., Pereboom, I. T. A., Polat, F., Poortman, P., Raber, M., Reiber, B. M. M., Renger, R. J., van Rossem, C. C., Rutten, H. J., Rutten, A., Schaapman, R., Scheer, M., Schoonderwoerd, L., Schouten, N., Schreuder, A. M., Schreurs, W. H., Simkens, G. A., Slooter, G. D., Sluijmer, H. C. E., Smakman, N., Smeenk, R., Snijders, H. S., Sonneveld, D. J. A., Spaansen, B., Spillenaar Bilgen, E. J., Steller, E., Steup, W. H., Steur, C., Stortelder, E., Straatman, J., Swank, H. A., Sietses, C., ten Berge, H. A., ten hoeve, H. G., ter Riele, W. W., Thorensen, I. M., Tip-Pluijm, B., Toorenvliet, B. R., Tseng, L., Tuynman, J. B., van Bastelaar, J., van beek, S. C., van de Ven, A. W. H., van de Weijer, M. A. J., van den Berg, C., van den Bosch, I., van der Bilt, J. D. W., van der Hagen, S. J., van der hul, R., van der Schelling, G., van der Spek, A., van der Wielen, N., van duyn, E., van Eekelen, C., van Essen, J. A., van Gangelt, K., van Geloven, A. A. W., van kessel, C., van Loon, Y. T., van Rijswijk, A., van Rooijen, S. J., van Sprundel, T., van Steensel, L., van Tets, W. F., van Westreenen, H. L., Veltkamp, S., Verhaak, T., Verheijen, P. M., Versluis-Ossenwaarde, L., Vijfhuize, S., Vles, W. J., Voeten, S., Vogelaar, F. J., Vrijland, W. W., Westerduin, E., Westerterp, M. E., Wetzel, M., Wevers, K., Wiering, B., Witjes, A. C., Wouters, M. W., Yauw, S. T. K., Zeestraten, E. C., Zimmerman, D. D., Zwieten, T., and Dutch Snapshot Research Group

Published
2017
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49. Perioperative Systemic Therapy vs Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Alone for Resectable Colorectal Peritoneal Metastases A Phase 2 Randomized Clinical Trial

Author

Arjen J. Witkamp, Joost Nederend, Andreas J A Bremers, Philip R. de Reuver, Wilhelmina M U van Grevenstein, Henk M.W. Verheul, Koen P. Rovers, Max J. Lahaye, Niels F. M. Kok, Jurriaan B. Tuynman, Checca Bakkers, Maartje Los, Ignace H. J. T. de Hingh, Anna M.J. Thijs, Patrick H. J. Hemmer, Alexandra R. M. Brandt-Kerkhof, Miriam Koopman, Onno Kranenburg, Petur Snaebjornsson, Marcel G. W. Dijkgraaf, Simon W. Nienhuijs, Arend G. J. Aalbers, Schelto Kruijff, Jacobus W. A. Burger, Tineke E. Buffart, Derk Jan A. de Groot, Esther van Meerten, Iris van 't Erve, Geert-Jan Creemers, Miranda Kusters, Pieter J. Tanis, Eva V. E. Madsen, Remond J.A. Fijneman, Kathelijn S. Versteeg, Djamila Boerma, Cornelis J A Punt, Marinus J. Wiezer, Surgery, CCA - Cancer Treatment and quality of life, Amsterdam Gastroenterology Endocrinology Metabolism, Internal medicine, VU University medical center, Epidemiology and Data Science, APH - Methodology, Oncology, CCA - Cancer Treatment and Quality of Life, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Epidemiologie, and RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy

Subjects
Male, PROGNOSIS, medicine.medical_treatment, CARCINOMATOSIS, MULTICENTER, Hyperthermic Intraperitoneal Chemotherapy, 030230 surgery, Peritoneal Neoplasms/secondary, law.invention, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], NEOADJUVANT CHEMOTHERAPY, 0302 clinical medicine, FOLFOX, Randomized controlled trial, law, Adenocarcinoma/secondary, Adjuvant/adverse effects, Neoadjuvant therapy, Original Investigation, Bevacizumab/administration & dosage, Cytoreduction Surgical Procedures, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Middle Aged, OPEN-LABEL, CANCER, Neoadjuvant Therapy, Fluorouracil/administration & dosage, Capecitabine/administration & dosage, 030220 oncology & carcinogenesis, FOLFIRI, Leucovorin/administration & dosage, Hyperthermic intraperitoneal chemotherapy, Female, medicine.drug, medicine.medical_specialty, Camptothecin/administration & dosage, Capecitabine, 03 medical and health sciences, Chemotherapy, Adjuvant/adverse effects, Oxaliplatin/administration & dosage, REGRESSION, medicine, MANAGEMENT, Chemotherapy, Humans, Organoplatinum Compounds/administration & dosage, Perioperative Period, Response Evaluation Criteria in Solid Tumors, Aged, Colorectal Neoplasms/pathology, HIPEC, business.industry, Perioperative, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Irinotecan, Mitomycin/administration & dosage, Feasibility Studies, business, CONSENSUS
Abstract

Contains fulltext : 238268.pdf (Publisher’s version ) (Closed access) IMPORTANCE: To date, no randomized clinical trials have investigated perioperative systemic therapy relative to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) alone for resectable colorectal peritoneal metastases (CPM). OBJECTIVE: To assess the feasibility and safety of perioperative systemic therapy in patients with resectable CPM and the response of CPM to neoadjuvant treatment. DESIGN, SETTING, AND PARTICIPANTS: An open-label, parallel-group phase 2 randomized clinical trial in all 9 Dutch tertiary centers for the surgical treatment of CPM enrolled participants between June 15, 2017, and January 9, 2019. Participants were patients with pathologically proven isolated resectable CPM who did not receive systemic therapy within 6 months before enrollment. INTERVENTIONS: Randomization to perioperative systemic therapy or CRS-HIPEC alone. Perioperative systemic therapy comprised either four 3-week neoadjuvant and adjuvant cycles of CAPOX (capecitabine and oxaliplatin), six 2-week neoadjuvant and adjuvant cycles of FOLFOX (fluorouracil, leucovorin, and oxaliplatin), or six 2-week neoadjuvant cycles of FOLFIRI (fluorouracil, leucovorin, and irinotecan) and either four 3-week adjuvant cycles of capecitabine or six 2-week adjuvant cycles of fluorouracil with leucovorin. Bevacizumab was added to the first 3 (CAPOX) or 4 (FOLFOX/FOLFIRI) neoadjuvant cycles. MAIN OUTCOMES AND MEASURES: Proportions of macroscopic complete CRS-HIPEC and Clavien-Dindo grade 3 or higher postoperative morbidity. Key secondary outcomes were centrally assessed rates of objective radiologic and major pathologic response of CPM to neoadjuvant treatment. Analyses were done modified intention-to-treat in patients starting neoadjuvant treatment (experimental arm) or undergoing upfront surgery (control arm). RESULTS: In 79 patients included in the analysis (43 [54%] men; mean [SD] age, 62 [10] years), experimental (n = 37) and control (n = 42) arms did not differ significantly regarding the proportions of macroscopic complete CRS-HIPEC (33 of 37 [89%] vs 36 of 42 [86%] patients; risk ratio, 1.04; 95% CI, 0.88-1.23; P = .74) and Clavien-Dindo grade 3 or higher postoperative morbidity (8 of 37 [22%] vs 14 of 42 [33%] patients; risk ratio, 0.65; 95% CI, 0.31-1.37; P = .25). No treatment-related deaths occurred. Objective radiologic and major pathologic response rates of CPM to neoadjuvant treatment were 28% (9 of 32 evaluable patients) and 38% (13 of 34 evaluable patients), respectively. CONCLUSIONS AND RELEVANCE: In this randomized phase 2 trial in patients diagnosed with resectable CPM, perioperative systemic therapy seemed feasible, safe, and able to induce response of CPM, justifying a phase 3 trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02758951.

Published
2021

50. The Impact of Low Skeletal Muscle Mass on Short- and Long-Term Outcomes After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Author

Michelle V. Dietz, Job P. van Kooten, Jeroen L. A. van Vugt, Alexandra R. M. Brandt-Kerkhof, Cornelis Verhoef, Eva V. E. Madsen, and Surgery

Subjects
Oncology, SDG 3 - Good Health and Well-being, Surgery
Abstract

Background Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a potentially curative treatment for peritoneal metastases from colorectal cancer (CRC) or pseudomyxoma peritonei (PMP). Because of the considerable morbidity of this treatment, optimal patient selection is key. This study aimed to assess the impact of low skeletal muscle mass (SMM) on outcomes after CRS-HIPEC. Methods Patients who underwent CRS-HIPEC between 2014 and 2020 at a tertiary center were included. SMM was measured on computed tomography by means of the L3 muscle index. Postoperative complications and survival outcomes were compared between groups by use of logistic regression and Kaplan-Meier survival analyses. Results Of 284 included patients, 149 had low SMM. Occurrence of severe postoperative complications did not differ between groups (28.9% for patients with low vs. 34.1% for patients with normal SMM). Low SMM was not associated with postoperative complications (p = 0.344). For CRC patients, no significant differences were observed in disease-free (DFS) or overall survival (OS) between patients with low (median DFS 7 months [IQR 4–14], median OS 33 months [IQR 14–NR]) and patients with normal SMM (median DFS 8 months [IQR 5–20], median OS 35 months [IQR 18–NR]). Regarding PMP, survival outcomes did not significantly differ between groups (3-year DFS 47.3% for patients with low SMM vs. 54.5% for patients with normal SMM, p = 0.676; 3-year OS 70.8% vs. 90.9% respectively, p = 0.172). Conclusions Low SMM could not be identified as a predictor of severe complications or survival outcomes after CRS-HIPEC.

Published
2022

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