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1,151 results on '"Koopman, Miriam"'

352. ASO Visual Abstract: Survival of Patients with Deficient Mismatch Repair Versus Proficient Mismatch Repair Metastatic Colorectal Cancer Receiving Curative-Intent Local Treatment of Metastases in a Nationwide Cohort.

Author

Zwart, Koen, van der Baan, Frederieke H., Punt, Cornelis J. A., Wensink, G. Emerens, Bolhuis, Karen, Laclé, Miangela M., van Grevenstein, Wilhelmina M. U., Hagendoorn, Jeroen, de Hingh, Ignace H., Koopman, Miriam, Vink, Geraldine, and Roodhart, Jeanine

Published
2023
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353. The impact of liver resection on the dihydrouracil: uracil plasma ratio in patients with colorectal liver metastases

Author

Jacobs, Bart A W, Snoeren, Nikol, Samim, Morsal, Rosing, Hilde, de Vries, Niels, Deenen, Maarten J, Beijnen, Jos H, Schellens, Jan H M, Koopman, Miriam, van Hillegersberg, Richard, Jacobs, Bart A W, Snoeren, Nikol, Samim, Morsal, Rosing, Hilde, de Vries, Niels, Deenen, Maarten J, Beijnen, Jos H, Schellens, Jan H M, Koopman, Miriam, and van Hillegersberg, Richard

Abstract

PURPOSE: The dihydrouracil (DHU):uracil (U) plasma ratio is a promising marker for identification of dihydropyrimidine dehydrogenase (DPD)-deficient patients. The objective of this study was to determine the effect of liver resection on the DHU:U plasma ratio in patients with colorectal liver metastases (CRLM).METHODS: An observational study was performed in which DHU:U plasma ratios in patients with CRLM were analyzed prior to and 1 day after liver resection. In addition, the DHU:U plasma ratio was quantified in six additional patients 4-8 weeks after liver resection to explore long-term effects on the DHU:U plasma ratio. Quantification of U and DHU plasma levels was performed using a validated ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) assay.RESULTS: The median (range) DHU:U plasma ratio in 15 patients prior to liver resection was 10.7 (2.6-14.4) and was significantly reduced to 5.5 (< quantification limit (LLOQ-10.5) 1 day after resection (p = 0.0026). This reduction was caused by a decrease in DHU plasma levels from 112.0 (79.8-153) ng/mL to 41.2 (< LLOQ-160) ng/mL 1 day after resection (p = 0.0004). Recovery of the DHU:U plasma ratio occurred 4-8 weeks after liver resection, which was shown by a median (range) DHU:U plasma ratio in six patients of 9.1 (6.9-14.5).CONCLUSION: Liver resection leads to very low DHU:U plasma ratios 1 day after liver resection, which is possibly caused by a reduction in DPD activity. Quantification of the DHU:U plasma ratios directly after liver resection could lead to false-positive identification of DPD deficiency and is therefore not advised.

Published
2018

354. DPYD genotype-guided dose individualisation of fluoropyrimidine therapy in patients with cancer: a prospective safety analysis

Author

Henricks, Linda M, Lunenburg, Carin A T C, de Man, Femke M, Meulendijks, Didier, Frederix, Geert W J, Kienhuis, Emma, Creemers, Geert-Jan, Baars, Arnold, Dezentjé, Vincent O, Imholz, Alexander L T, Jeurissen, Frank J F, Portielje, Johanna E A, Jansen, Rob L H, Hamberg, Paul, Ten Tije, Albert J, Droogendijk, Helga J, Koopman, Miriam, Nieboer, Peter, van de Poel, Marlène H W, Mandigers, Caroline M P W, Rosing, Hilde, Beijnen, Jos H, Werkhoven, Erik van, van Kuilenburg, André B P, van Schaik, Ron H N, Mathijssen, Ron H J, Swen, Jesse J, Gelderblom, Hans, Cats, Annemieke, Guchelaar, Henk-Jan, Schellens, Jan H M, Henricks, Linda M, Lunenburg, Carin A T C, de Man, Femke M, Meulendijks, Didier, Frederix, Geert W J, Kienhuis, Emma, Creemers, Geert-Jan, Baars, Arnold, Dezentjé, Vincent O, Imholz, Alexander L T, Jeurissen, Frank J F, Portielje, Johanna E A, Jansen, Rob L H, Hamberg, Paul, Ten Tije, Albert J, Droogendijk, Helga J, Koopman, Miriam, Nieboer, Peter, van de Poel, Marlène H W, Mandigers, Caroline M P W, Rosing, Hilde, Beijnen, Jos H, Werkhoven, Erik van, van Kuilenburg, André B P, van Schaik, Ron H N, Mathijssen, Ron H J, Swen, Jesse J, Gelderblom, Hans, Cats, Annemieke, Guchelaar, Henk-Jan, and Schellens, Jan H M

Abstract

BACKGROUND: Fluoropyrimidine treatment can result in severe toxicity in up to 30% of patients and is often the result of reduced activity of the key metabolic enzyme dihydropyrimidine dehydrogenase (DPD), mostly caused by genetic variants in the gene encoding DPD (DPYD). We assessed the effect of prospective screening for the four most relevant DPYD variants (DPYD*2A [rs3918290, c.1905+1G>A, IVS14+1G>A], c.2846A>T [rs67376798, D949V], c.1679T>G [rs55886062, DPYD*13, I560S], and c.1236G>A [rs56038477, E412E, in haplotype B3]) on patient safety and subsequent DPYD genotype-guided dose individualisation in daily clinical care.METHODS: In this prospective, multicentre, safety analysis in 17 hospitals in the Netherlands, the study population consisted of adult patients (≥18 years) with cancer who were intended to start on a fluoropyrimidine-based anticancer therapy (capecitabine or fluorouracil as single agent or in combination with other chemotherapeutic agents or radiotherapy). Patients with all tumour types for which fluoropyrimidine-based therapy was considered in their best interest were eligible. We did prospective genotyping for DPYD*2A, c.2846A>T, c.1679T>G, and c.1236G>A. Heterozygous DPYD variant allele carriers received an initial dose reduction of 25% (c.2846A>T and c.1236G>A) or 50% (DPYD*2A and c.1679T>G), and DPYD wild-type patients were treated according to the current standard of care. The primary endpoint of the study was the frequency of severe (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 grade ≥3) overall fluoropyrimidine-related toxicity across the entire treatment duration. We compared toxicity incidence between DPYD variant allele carriers and DPYD wild-type patients on an intention-to-treat basis, and relative risks (RRs) for severe toxicity were compared between the current study and a historical cohort of DPYD variant allele carriers treated with full dose fluor

Published
2018

355. Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer : Supported by the ARCAD Group

Author

Goey, Kaitlyn K. H., Sorbye, Halfdan, Glimelius, Bengt, Adams, Richard A., Andre, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Diaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heineman, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans-Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G. H., Punt, Cornelis J. A., Koopman, Miriam, Goey, Kaitlyn K. H., Sorbye, Halfdan, Glimelius, Bengt, Adams, Richard A., Andre, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Diaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heineman, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans-Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G. H., Punt, Cornelis J. A., and Koopman, Miriam

Abstract

Background: Patient characteristics and stratification factors are key features influencing trial outcomes. However, there is substantial heterogeneity in reporting of patient characteristics and use of stratification factors in phase 3 trials investigating systemic treatment of metastatic colorectal cancer (mCRC). We aimed to develop a minimum set of essential baseline characteristics and stratification factors to include in such trials. Methods: We performed a modified, two-round Delphi survey among international experts with wide experience in the conduct and methodology of phase 3 trials of systemic treatment of mCRC. Results: Thirty mCRC experts from 15 different countries completed both consensus rounds. A total of 14 patient characteristics were included in the recommended set: age, performance status, primary tumour location, primary tumour resection, prior chemotherapy, number of metastatic sites, liver-only disease, liver involvement, surgical resection of metastases, synchronous versus metachronous metastases, (K)RAS and BRAF mutation status, microsatellite instability/mismatch repair status and number of prior treatment lines. A total of five patient characteristics were considered the most relevant stratification factors: RAS/BRAF mutation status, performance status, primary tumour sidedness and liver-only disease. Conclusions: This survey provides a minimum set of essential baseline patient characteristics and stratification factors to include in phase 3 trials of systemic treatment of mCRC. Inclusion of these patient characteristics and strata in study protocols and final study reports will improve interpretation of trial results and facilitate cross-study comparisons.

Published
2018
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356. Reporting of patient characteristics and stratification factors in phase 3 trials investigating first-line systemic treatment of metastatic colorectal cancer : A systematic review

Author

Goey, Kaitlyn K. H., Mahmoud, Remi, Sørbye, Halfdan, Glimelius, Bengt, Köhne, Claus-Henning, Sargent, Daniel J., Punt, Cornelis J. A., van Oijen, Martijn G. H., Koopman, Miriam, Goey, Kaitlyn K. H., Mahmoud, Remi, Sørbye, Halfdan, Glimelius, Bengt, Köhne, Claus-Henning, Sargent, Daniel J., Punt, Cornelis J. A., van Oijen, Martijn G. H., and Koopman, Miriam

Abstract

Background: Patient characteristics and stratification factors are important factors influencing trial outcomes. Uniform reporting on these parameters would facilitate cross-study comparisons and extrapolation of trial results to clinical practice. In 2007, standardisation on patient characteristics reporting and stratification in metastatic colorectal cancer (mCRC) trials was proposed. We investigated the reporting of prognostic factors and implementation of this proposal in mCRC trials published from 2005 to 2016. Methods: We searched PubMed and Embase (January 2005 – June 2016) for first-line phase 3 mCRC trials. Patient characteristics reporting and use of stratification factors were extracted and analysed for adherence to the proposal from 2007. Results: Sixty-seven trials (35,315 patients) were identified, reporting 48 different patient characteristics (median: 9 [range: 5–18] per study). Age, gender, performance status (PS), primary tumour site and adjuvant chemotherapy were frequently reported (87%–100%), in contrast to laboratory values, such as alkaline phosphatase, lactate dehydrogenase and white blood cell count (10%–25%). We identified 29 different stratification factors (median: 3 [range: 1–9] per study). The most common strata were PS and treatment centre (>60%). A median of 8/12 (range: 4–11) of the proposed parameters was reported. Although the percentage of studies reporting each factor slightly increased over time, there was no significant correlation between publication year and adherence to the proposal from 2007. Conclusions: We observed persistent heterogeneity in the reporting of patient characteristics and use of stratification factors in first-line mCRC trials. The proposal from 2007 has not led to increased uniformity of patient characteristics reporting and use of stratification over time. There is an urgent need to address this issue to improve the interpretation of trial results.

Published
2018
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357. Tumour budding is associated with the mesenchymal colon cancer subtype and RAS/RAF mutations : a study of 1320 colorectal cancers with Consensus Molecular Subgroup (CMS) data

Author

Trinh, Anne, Lädrach, Claudia, Dawson, Heather E., ten Hoorn, Sanne, Kuppen, Peter J.K., Reimers, Marlies S., Koopman, Miriam, Punt, Cornelis J.A., Lugli, Alessandro, Vermeulen, Louis, Zlobec, Inti, Trinh, Anne, Lädrach, Claudia, Dawson, Heather E., ten Hoorn, Sanne, Kuppen, Peter J.K., Reimers, Marlies S., Koopman, Miriam, Punt, Cornelis J.A., Lugli, Alessandro, Vermeulen, Louis, and Zlobec, Inti

Published
2018

358. Reporting of patient characteristics and stratification factors in phase 3 trials investigating first-line systemic treatment of metastatic colorectal cancer : A systematic review

Author

Goey, Kaitlyn K.H., Mahmoud, Remi, Sørbye, Halfdan, Glimelius, Bengt, Köhne, Claus Henning, Sargent, Daniel J., Punt, Cornelis J.A., van Oijen, Martijn G.H., Koopman, Miriam, Goey, Kaitlyn K.H., Mahmoud, Remi, Sørbye, Halfdan, Glimelius, Bengt, Köhne, Claus Henning, Sargent, Daniel J., Punt, Cornelis J.A., van Oijen, Martijn G.H., and Koopman, Miriam

Published
2018

359. Inventory of oncologists' unmet needs for tools to support decision-making about palliative treatment for metastatic colorectal cancer

Author

Engelhardt, Ellen G., Révész, Dóra, Tamminga, Hans J., Punt, Cornelis J.A., Koopman, Miriam, Onwuteaka-Philipsen, Bregje D., Steyerberg, Ewout W., De Vet, Henrica C.W., Coupé, Veerle M.H., Engelhardt, Ellen G., Révész, Dóra, Tamminga, Hans J., Punt, Cornelis J.A., Koopman, Miriam, Onwuteaka-Philipsen, Bregje D., Steyerberg, Ewout W., De Vet, Henrica C.W., and Coupé, Veerle M.H.

Published
2018

360. DPYD genotype-guided dose individualisation of fluoropyrimidine therapy in patients with cancer : a prospective safety analysis

Author

Henricks, Linda M., Lunenburg, Carin A.T.C., de Man, Femke M., Meulendijks, Didier, Frederix, Geert W.J., Kienhuis, Emma, Creemers, Geert Jan, Baars, Arnold, Dezentjé, Vincent O., Imholz, Alexander L.T., Jeurissen, Frank J.F., Portielje, Johanna E.A., Jansen, Rob L.H., Hamberg, Paul, ten Tije, Albert J., Droogendijk, Helga J., Koopman, Miriam, Nieboer, Peter, van de Poel, Marlène H.W., Mandigers, Caroline M.P.W., Rosing, Hilde, Beijnen, Jos H., Werkhoven, Erik van, van Kuilenburg, André B.P., van Schaik, Ron H.N., Mathijssen, Ron H.J., Swen, Jesse J., Gelderblom, Hans, Cats, Annemieke, Guchelaar, Henk Jan, Schellens, Jan H.M., Henricks, Linda M., Lunenburg, Carin A.T.C., de Man, Femke M., Meulendijks, Didier, Frederix, Geert W.J., Kienhuis, Emma, Creemers, Geert Jan, Baars, Arnold, Dezentjé, Vincent O., Imholz, Alexander L.T., Jeurissen, Frank J.F., Portielje, Johanna E.A., Jansen, Rob L.H., Hamberg, Paul, ten Tije, Albert J., Droogendijk, Helga J., Koopman, Miriam, Nieboer, Peter, van de Poel, Marlène H.W., Mandigers, Caroline M.P.W., Rosing, Hilde, Beijnen, Jos H., Werkhoven, Erik van, van Kuilenburg, André B.P., van Schaik, Ron H.N., Mathijssen, Ron H.J., Swen, Jesse J., Gelderblom, Hans, Cats, Annemieke, Guchelaar, Henk Jan, and Schellens, Jan H.M.

Published
2018

361. Personalizing survival predictions in advanced colorectal cancer : The ARCAD nomogram project

Author

Sjoquist, Katrin M, Renfro, Lindsay A, Simes, R John, Tebbutt, Niall C, Clarke, Stephen, Seymour, Matthew T, Adams, Richard A, Maughan, Timothy S, Saltz, Leonard, Goldberg, Richard M, Schmoll, Hans-Joachim, Van Cutsem, Eric, Douillard, Jean-Yves, Hoff, Paulo M, Hecht, Joel Randolph, Tournigand, Christophe, Punt, Cornelis J A, Koopman, Miriam, Hurwitz, Herbert, Heinemann, Volker, Falcone, Alfredo, Porschen, Rainer, Fuchs, Charles, Diaz-Rubio, Eduardo, Aranda, Enrique, Bokemeyer, Carsten, Souglakos, Ioannis, Kabbinavar, Fairooz F, Chibaudel, Benoist, Meyers, Jeffrey P, Sargent, Daniel J, De Gramont, Aimery, Zalcberg, John R, Fondation Aide et Recherche en Cancerologie Digestive Group, Sjoquist, Katrin M, Renfro, Lindsay A, Simes, R John, Tebbutt, Niall C, Clarke, Stephen, Seymour, Matthew T, Adams, Richard A, Maughan, Timothy S, Saltz, Leonard, Goldberg, Richard M, Schmoll, Hans-Joachim, Van Cutsem, Eric, Douillard, Jean-Yves, Hoff, Paulo M, Hecht, Joel Randolph, Tournigand, Christophe, Punt, Cornelis J A, Koopman, Miriam, Hurwitz, Herbert, Heinemann, Volker, Falcone, Alfredo, Porschen, Rainer, Fuchs, Charles, Diaz-Rubio, Eduardo, Aranda, Enrique, Bokemeyer, Carsten, Souglakos, Ioannis, Kabbinavar, Fairooz F, Chibaudel, Benoist, Meyers, Jeffrey P, Sargent, Daniel J, De Gramont, Aimery, Zalcberg, John R, and Fondation Aide et Recherche en Cancerologie Digestive Group

Published
2018

362. Matching the model with the evidence : comparing discrete event simulation and state-transition modeling for time-to-event predictions in a cost-effectiveness analysis of treatment in metastatic colorectal cancer patients

Author

Degeling, Koen, Franken, Mira D., May, Anne M., van Oijen, Martijn G.H., Koopman, Miriam, Punt, Cornelis J.A., IJzerman, Maarten J., Koffijberg, Hendrik, Degeling, Koen, Franken, Mira D., May, Anne M., van Oijen, Martijn G.H., Koopman, Miriam, Punt, Cornelis J.A., IJzerman, Maarten J., and Koffijberg, Hendrik

Published
2018

364. Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer : Supported by the ARCAD Group

Author

Goey, Kaitlyn K.H., Sørbye, Halfdan, Glimelius, Bengt, Adams, Richard A., André, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Díaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heinemann, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, Van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G.H., Punt, Cornelis J.A., Koopman, Miriam, Goey, Kaitlyn K.H., Sørbye, Halfdan, Glimelius, Bengt, Adams, Richard A., André, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Díaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heinemann, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, Van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G.H., Punt, Cornelis J.A., and Koopman, Miriam

Published
2018

365. The impact of liver resection on the dihydrouracil : uracil plasma ratio in patients with colorectal liver metastases

Author

Jacobs, Bart A.W., Snoeren, Nikol, Samim, Morsal, Rosing, Hilde, de Vries, Niels, Deenen, Maarten J., Beijnen, Jos H., Schellens, Jan H.M., Koopman, Miriam, van Hillegersberg, Richard, Jacobs, Bart A.W., Snoeren, Nikol, Samim, Morsal, Rosing, Hilde, de Vries, Niels, Deenen, Maarten J., Beijnen, Jos H., Schellens, Jan H.M., Koopman, Miriam, and van Hillegersberg, Richard

Published
2018

366. Loss of Chromosome 18q11.2-q12.1 Is Predictive for Survival in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab

Author

Van Dijk, Erik, Biesma, Hedde D., Cordes, Martijn, Smeets, Dominiek, Neerincx, Maarten, Das, Sudipto, Eijk, Paul P., Murphy, Verena, Barat, Anna, Bacon, Orna, Prehn, Jochen H.M., Betge, Johannes, Gaiser, Timo, Fender, Bozena, Meijer, Gerrit A., McNamara, Deborah A., Klinger, Rut, Koopman, Miriam, Ebert, Matthias P.A., Kay, Elaine W., Hennessey, Bryan T., Verheul, Henk M.W., Gallagher, William M., O’Connor, Darran P., Punt, Cornelis J.A., Loupakis, Fotios, Lambrechts, Diether, Byrne, Annette T., Van Grieken, Nicole C.T., Ylstra, Bauke, Van Dijk, Erik, Biesma, Hedde D., Cordes, Martijn, Smeets, Dominiek, Neerincx, Maarten, Das, Sudipto, Eijk, Paul P., Murphy, Verena, Barat, Anna, Bacon, Orna, Prehn, Jochen H.M., Betge, Johannes, Gaiser, Timo, Fender, Bozena, Meijer, Gerrit A., McNamara, Deborah A., Klinger, Rut, Koopman, Miriam, Ebert, Matthias P.A., Kay, Elaine W., Hennessey, Bryan T., Verheul, Henk M.W., Gallagher, William M., O’Connor, Darran P., Punt, Cornelis J.A., Loupakis, Fotios, Lambrechts, Diether, Byrne, Annette T., Van Grieken, Nicole C.T., and Ylstra, Bauke

Published
2018

368. The impact of liver resection on the dihydrouracil: uracil plasma ratio in patients with colorectal liver metastases

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Jacobs, Bart A W, Snoeren, Nikol, Samim, Morsal, Rosing, Hilde, de Vries, Niels, Deenen, Maarten J, Beijnen, Jos H, Schellens, Jan H M, Koopman, Miriam, van Hillegersberg, Richard, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Jacobs, Bart A W, Snoeren, Nikol, Samim, Morsal, Rosing, Hilde, de Vries, Niels, Deenen, Maarten J, Beijnen, Jos H, Schellens, Jan H M, Koopman, Miriam, and van Hillegersberg, Richard

Published
2018

369. DPYD genotype-guided dose individualisation of fluoropyrimidine therapy in patients with cancer: a prospective safety analysis

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Henricks, Linda M, Lunenburg, Carin A T C, de Man, Femke M, Meulendijks, Didier, Frederix, Geert W J, Kienhuis, Emma, Creemers, Geert-Jan, Baars, Arnold, Dezentjé, Vincent O, Imholz, Alexander L T, Jeurissen, Frank J F, Portielje, Johanna E A, Jansen, Rob L H, Hamberg, Paul, Ten Tije, Albert J, Droogendijk, Helga J, Koopman, Miriam, Nieboer, Peter, van de Poel, Marlène H W, Mandigers, Caroline M P W, Rosing, Hilde, Beijnen, Jos H, Werkhoven, Erik van, van Kuilenburg, André B P, van Schaik, Ron H N, Mathijssen, Ron H J, Swen, Jesse J, Gelderblom, Hans, Cats, Annemieke, Guchelaar, Henk-Jan, Schellens, Jan H M, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Henricks, Linda M, Lunenburg, Carin A T C, de Man, Femke M, Meulendijks, Didier, Frederix, Geert W J, Kienhuis, Emma, Creemers, Geert-Jan, Baars, Arnold, Dezentjé, Vincent O, Imholz, Alexander L T, Jeurissen, Frank J F, Portielje, Johanna E A, Jansen, Rob L H, Hamberg, Paul, Ten Tije, Albert J, Droogendijk, Helga J, Koopman, Miriam, Nieboer, Peter, van de Poel, Marlène H W, Mandigers, Caroline M P W, Rosing, Hilde, Beijnen, Jos H, Werkhoven, Erik van, van Kuilenburg, André B P, van Schaik, Ron H N, Mathijssen, Ron H J, Swen, Jesse J, Gelderblom, Hans, Cats, Annemieke, Guchelaar, Henk-Jan, and Schellens, Jan H M

Published
2018

370. Inventory of oncologists' unmet needs for tools to support decision-making about palliative treatment for metastatic colorectal cancer

Author

Endocriene Oncologie, UMC Utrecht, Engelhardt, Ellen G., Révész, Dóra, Tamminga, Hans J., Punt, Cornelis J.A., Koopman, Miriam, Onwuteaka-Philipsen, Bregje D., Steyerberg, Ewout W., De Vet, Henrica C.W., Coupé, Veerle M.H., Endocriene Oncologie, UMC Utrecht, Engelhardt, Ellen G., Révész, Dóra, Tamminga, Hans J., Punt, Cornelis J.A., Koopman, Miriam, Onwuteaka-Philipsen, Bregje D., Steyerberg, Ewout W., De Vet, Henrica C.W., and Coupé, Veerle M.H.

Published
2018

371. Bevacizumab-based first-line chemotherapy in elderly patients with metastatic colorectal cancer: An individual patient data based meta-analysis

Author

UMC Utrecht, MS Medische Oncologie, Koch, Christine, Schwing, Anna M., Herrmann, Eva, Borner, Markus, Diaz-Rubio, Eduardo, Dotan, Efrat, Feliu, Jaime, Okita, Natsuko, Souglakos, John, Arkenau, Hendrik T., Porschen, Rainer, Koopman, Miriam, Punt, Cornelis J.A., de Gramont, Aimery, Tournigand, Christophe, Zeuzem, Stefan, Trojan, Joerg, UMC Utrecht, MS Medische Oncologie, Koch, Christine, Schwing, Anna M., Herrmann, Eva, Borner, Markus, Diaz-Rubio, Eduardo, Dotan, Efrat, Feliu, Jaime, Okita, Natsuko, Souglakos, John, Arkenau, Hendrik T., Porschen, Rainer, Koopman, Miriam, Punt, Cornelis J.A., de Gramont, Aimery, Tournigand, Christophe, Zeuzem, Stefan, and Trojan, Joerg

Published
2018

372. Tumour budding is associated with the mesenchymal colon cancer subtype and RAS/RAF mutations: a study of 1320 colorectal cancers with Consensus Molecular Subgroup (CMS) data

Author

UMC Utrecht, MS Medische Oncologie, Trinh, Anne, Lädrach, Claudia, Dawson, Heather E., ten Hoorn, Sanne, Kuppen, Peter J.K., Reimers, Marlies S., Koopman, Miriam, Punt, Cornelis J.A., Lugli, Alessandro, Vermeulen, Louis, Zlobec, Inti, UMC Utrecht, MS Medische Oncologie, Trinh, Anne, Lädrach, Claudia, Dawson, Heather E., ten Hoorn, Sanne, Kuppen, Peter J.K., Reimers, Marlies S., Koopman, Miriam, Punt, Cornelis J.A., Lugli, Alessandro, Vermeulen, Louis, and Zlobec, Inti

Published
2018

373. Reporting of patient characteristics and stratification factors in phase 3 trials investigating first-line systemic treatment of metastatic colorectal cancer: A systematic review

Author

UMC Utrecht, Onderzoek Medische Oncologie, Cancer, Externen Med. Onco, MS MDL 1, MS Medische Oncologie, Goey, Kaitlyn K.H., Mahmoud, Remi, Sørbye, Halfdan, Glimelius, Bengt, Köhne, Claus Henning, Sargent, Daniel J., Punt, Cornelis J.A., van Oijen, Martijn G.H., Koopman, Miriam, UMC Utrecht, Onderzoek Medische Oncologie, Cancer, Externen Med. Onco, MS MDL 1, MS Medische Oncologie, Goey, Kaitlyn K.H., Mahmoud, Remi, Sørbye, Halfdan, Glimelius, Bengt, Köhne, Claus Henning, Sargent, Daniel J., Punt, Cornelis J.A., van Oijen, Martijn G.H., and Koopman, Miriam

Published
2018

374. DPYD genotype-guided dose individualisation of fluoropyrimidine therapy in patients with cancer: a prospective safety analysis

Author

Apotheek Opleiding, UMC Utrecht, HEE, Child Health, JC onderzoeksprogramma Methodologie, MS Medische Oncologie, Henricks, Linda M., Lunenburg, Carin A.T.C., de Man, Femke M., Meulendijks, Didier, Frederix, Geert W.J., Kienhuis, Emma, Creemers, Geert Jan, Baars, Arnold, Dezentjé, Vincent O., Imholz, Alexander L.T., Jeurissen, Frank J.F., Portielje, Johanna E.A., Jansen, Rob L.H., Hamberg, Paul, ten Tije, Albert J., Droogendijk, Helga J., Koopman, Miriam, Nieboer, Peter, van de Poel, Marlène H.W., Mandigers, Caroline M.P.W., Rosing, Hilde, Beijnen, Jos H., Werkhoven, Erik van, van Kuilenburg, André B.P., van Schaik, Ron H.N., Mathijssen, Ron H.J., Swen, Jesse J., Gelderblom, Hans, Cats, Annemieke, Guchelaar, Henk Jan, Schellens, Jan H.M., Apotheek Opleiding, UMC Utrecht, HEE, Child Health, JC onderzoeksprogramma Methodologie, MS Medische Oncologie, Henricks, Linda M., Lunenburg, Carin A.T.C., de Man, Femke M., Meulendijks, Didier, Frederix, Geert W.J., Kienhuis, Emma, Creemers, Geert Jan, Baars, Arnold, Dezentjé, Vincent O., Imholz, Alexander L.T., Jeurissen, Frank J.F., Portielje, Johanna E.A., Jansen, Rob L.H., Hamberg, Paul, ten Tije, Albert J., Droogendijk, Helga J., Koopman, Miriam, Nieboer, Peter, van de Poel, Marlène H.W., Mandigers, Caroline M.P.W., Rosing, Hilde, Beijnen, Jos H., Werkhoven, Erik van, van Kuilenburg, André B.P., van Schaik, Ron H.N., Mathijssen, Ron H.J., Swen, Jesse J., Gelderblom, Hans, Cats, Annemieke, Guchelaar, Henk Jan, and Schellens, Jan H.M.

Published
2018

375. Matching the model with the evidence: comparing discrete event simulation and state-transition modeling for time-to-event predictions in a cost-effectiveness analysis of treatment in metastatic colorectal cancer patients

Author

Onderzoek Medische Oncologie, Cancer, Epidemiology & Health Economics, JC onderzoeksprogramma Kanker, MS Medische Oncologie, HEE, Circulatory Health, Degeling, Koen, Franken, Mira D., May, Anne M., van Oijen, Martijn G.H., Koopman, Miriam, Punt, Cornelis J.A., IJzerman, Maarten J., Koffijberg, Hendrik, Onderzoek Medische Oncologie, Cancer, Epidemiology & Health Economics, JC onderzoeksprogramma Kanker, MS Medische Oncologie, HEE, Circulatory Health, Degeling, Koen, Franken, Mira D., May, Anne M., van Oijen, Martijn G.H., Koopman, Miriam, Punt, Cornelis J.A., IJzerman, Maarten J., and Koffijberg, Hendrik

Published
2018

376. Personalizing survival predictions in advanced colorectal cancer: The ARCAD nomogram project

Author

MS Medische Oncologie, Cancer, Sjoquist, Katrin M, Renfro, Lindsay A, Simes, R John, Tebbutt, Niall C, Clarke, Stephen, Seymour, Matthew T, Adams, Richard A, Maughan, Timothy S, Saltz, Leonard, Goldberg, Richard M, Schmoll, Hans-Joachim, Van Cutsem, Eric, Douillard, Jean-Yves, Hoff, Paulo M, Hecht, Joel Randolph, Tournigand, Christophe, Punt, Cornelis J A, Koopman, Miriam, Hurwitz, Herbert, Heinemann, Volker, Falcone, Alfredo, Porschen, Rainer, Fuchs, Charles, Diaz-Rubio, Eduardo, Aranda, Enrique, Bokemeyer, Carsten, Souglakos, Ioannis, Kabbinavar, Fairooz F, Chibaudel, Benoist, Meyers, Jeffrey P, Sargent, Daniel J, De Gramont, Aimery, Zalcberg, John R, Fondation Aide et Recherche en Cancerologie Digestive Group, MS Medische Oncologie, Cancer, Sjoquist, Katrin M, Renfro, Lindsay A, Simes, R John, Tebbutt, Niall C, Clarke, Stephen, Seymour, Matthew T, Adams, Richard A, Maughan, Timothy S, Saltz, Leonard, Goldberg, Richard M, Schmoll, Hans-Joachim, Van Cutsem, Eric, Douillard, Jean-Yves, Hoff, Paulo M, Hecht, Joel Randolph, Tournigand, Christophe, Punt, Cornelis J A, Koopman, Miriam, Hurwitz, Herbert, Heinemann, Volker, Falcone, Alfredo, Porschen, Rainer, Fuchs, Charles, Diaz-Rubio, Eduardo, Aranda, Enrique, Bokemeyer, Carsten, Souglakos, Ioannis, Kabbinavar, Fairooz F, Chibaudel, Benoist, Meyers, Jeffrey P, Sargent, Daniel J, De Gramont, Aimery, Zalcberg, John R, and Fondation Aide et Recherche en Cancerologie Digestive Group

Published
2018

377. Monitoring potentially modifiable lifestyle factors in cancer survivors: A narrative review on currently available methodologies and innovations for large-scale surveillance

Author

Epi Infectieziekten Team 2, Onderzoek Medische Oncologie, Cancer, MS Medische Oncologie, Unit C (laboranten rath), Trialbureau Beeld, Epi Kanker Team A, Circulatory Health, JC onderzoeksprogramma Kanker, Epidemiology & Health Economics, Epi Kanker Team 1, Derksen, Jeroen W.G., Beijer, Sandra, Koopman, Miriam, Verkooijen, Helena M., van de Poll-Franse, Lonneke V., May, Anne M., Epi Infectieziekten Team 2, Onderzoek Medische Oncologie, Cancer, MS Medische Oncologie, Unit C (laboranten rath), Trialbureau Beeld, Epi Kanker Team A, Circulatory Health, JC onderzoeksprogramma Kanker, Epidemiology & Health Economics, Epi Kanker Team 1, Derksen, Jeroen W.G., Beijer, Sandra, Koopman, Miriam, Verkooijen, Helena M., van de Poll-Franse, Lonneke V., and May, Anne M.

Published
2018

378. Impact of different palliative systemic treatments on skeletal muscle mass in metastatic colorectal cancer patients

Author

Julius Centrum, Onderzoek Medische Oncologie, Cancer, JC onderzoeksprogramma Kanker, Epi Kanker Team 1, UMC Utrecht, Researchgr. Systems Radiology, Infection & Immunity, Circulatory Health, Beeldverwerking ISI, Brain, MS Medische Oncologie, Kurk, Sophie A, Peeters, Petra H M, Dorresteijn, Bram, de Jong, Pim A, Jourdan, Marion, Kuijf, Hugo J, Punt, Cornelis J A, Koopman, Miriam, May, Anne M, Julius Centrum, Onderzoek Medische Oncologie, Cancer, JC onderzoeksprogramma Kanker, Epi Kanker Team 1, UMC Utrecht, Researchgr. Systems Radiology, Infection & Immunity, Circulatory Health, Beeldverwerking ISI, Brain, MS Medische Oncologie, Kurk, Sophie A, Peeters, Petra H M, Dorresteijn, Bram, de Jong, Pim A, Jourdan, Marion, Kuijf, Hugo J, Punt, Cornelis J A, Koopman, Miriam, and May, Anne M

Published
2018

379. Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group

Author

Team 1 Hemat, Onderzoek Medische Oncologie, Cancer, Goey, Kaitlyn K.H., Sørbye, Halfdan, Glimelius, Bengt, Adams, Richard A., André, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Díaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heinemann, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, Van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G.H., Punt, Cornelis J.A., Koopman, Miriam, Team 1 Hemat, Onderzoek Medische Oncologie, Cancer, Goey, Kaitlyn K.H., Sørbye, Halfdan, Glimelius, Bengt, Adams, Richard A., André, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Díaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heinemann, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, Van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G.H., Punt, Cornelis J.A., and Koopman, Miriam

Published
2018

380. Loss of Chromosome 18q11.2-q12.1 Is Predictive for Survival in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab

Author

MS Mondziekten/Kaakchirurgie, MS Medische Oncologie, Van Dijk, Erik, Biesma, Hedde D., Cordes, Martijn, Smeets, Dominiek, Neerincx, Maarten, Das, Sudipto, Eijk, Paul P., Murphy, Verena, Barat, Anna, Bacon, Orna, Prehn, Jochen H.M., Betge, Johannes, Gaiser, Timo, Fender, Bozena, Meijer, Gerrit A., McNamara, Deborah A., Klinger, Rut, Koopman, Miriam, Ebert, Matthias P.A., Kay, Elaine W., Hennessey, Bryan T., Verheul, Henk M.W., Gallagher, William M., O’Connor, Darran P., Punt, Cornelis J.A., Loupakis, Fotios, Lambrechts, Diether, Byrne, Annette T., Van Grieken, Nicole C.T., Ylstra, Bauke, MS Mondziekten/Kaakchirurgie, MS Medische Oncologie, Van Dijk, Erik, Biesma, Hedde D., Cordes, Martijn, Smeets, Dominiek, Neerincx, Maarten, Das, Sudipto, Eijk, Paul P., Murphy, Verena, Barat, Anna, Bacon, Orna, Prehn, Jochen H.M., Betge, Johannes, Gaiser, Timo, Fender, Bozena, Meijer, Gerrit A., McNamara, Deborah A., Klinger, Rut, Koopman, Miriam, Ebert, Matthias P.A., Kay, Elaine W., Hennessey, Bryan T., Verheul, Henk M.W., Gallagher, William M., O’Connor, Darran P., Punt, Cornelis J.A., Loupakis, Fotios, Lambrechts, Diether, Byrne, Annette T., Van Grieken, Nicole C.T., and Ylstra, Bauke

Published
2018

381. The impact of liver resection on the dihydrouracil: uracil plasma ratio in patients with colorectal liver metastases

Author

Cancer, Arts-assistenten Radiologie, Onderzoek Beeld, MS CGO, MS Medische Oncologie, Team 2 Hemat, Divisie Beeld & Oncologie, Jacobs, Bart A.W., Snoeren, Nikol, Samim, Morsal, Rosing, Hilde, de Vries, Niels, Deenen, Maarten J., Beijnen, Jos H., Schellens, Jan H.M., Koopman, Miriam, van Hillegersberg, Richard, Cancer, Arts-assistenten Radiologie, Onderzoek Beeld, MS CGO, MS Medische Oncologie, Team 2 Hemat, Divisie Beeld & Oncologie, Jacobs, Bart A.W., Snoeren, Nikol, Samim, Morsal, Rosing, Hilde, de Vries, Niels, Deenen, Maarten J., Beijnen, Jos H., Schellens, Jan H.M., Koopman, Miriam, and van Hillegersberg, Richard

Published
2018

383. Informing metastatic colorectal cancer patients by quantifying multiple scenarios for survival time based on real‐life data.

Author

Hamers, Patricia A. H., Elferink, Marloes A. G., Stellato, Rebecca K., Punt, Cornelis J. A., May, Anne M., Koopman, Miriam, and Vink, Geraldine R.

Subjects
SURVIVAL analysis (Biometry), COLORECTAL cancer, METASTASIS, CANCER patients, PATIENT selection, HEREDITARY nonpolyposis colorectal cancer
Abstract

Reported median overall survival (mOS) in metastatic colorectal cancer (mCRC) patients participating in systemic therapy trials has increased to over 30 months. It is uncertain whether trial results translate to real‐life populations. Moreover, patients prefer presentation of multiple survival scenarios. Population‐based data of all stage IV CRC patients diagnosed between 2008 and 2016 were obtained from the Netherlands Cancer Registry, which has a case ascertainment completeness surpassing 95%. We calculated the following percentiles (scenarios) of OS per year of diagnosis for the total population, and for treatment subgroups: 10th (best‐case), 25th (upper‐typical), 50th (median), 75th (lower‐typical) and 90th (worst‐case). Twenty‐five percent of patients did not receive any antitumor treatment. From 2008 to 2016, mOS of the total population (n = 27275) remained unchanged at approximately 12 months. OS improved only for the upper‐typical and best‐case patients; by 4.2 to 29.1 months (P <.001), and by 6 to 62 months (P <.001), respectively. No clinically relevant change was observed among patients who received systemic therapy, with mOS close to 15 months and best‐case scenario approximately 40 months. A clinically relevant improvement in survival over time was observed in patients who initially received metastasectomy and/or HIPEC only. In contrast to the wide belief based on trial data that mOS of mCRC patients receiving systemic therapy has improved substantially, improvement could not be demonstrated in our real‐life population. Clinicians should consider quoting multiple survival scenarios based on real‐life data instead of point estimates from clinical trials, when informing patients about their life expectancy. What's new? Clinical trials on first‐line systemic therapy in metastatic colorectal cancer (mCRC) patients suggest a marked improvement in median overall survival (mOS). However, uncertainty exists in how the survival reported in trials relates to the real‐life mCRC population. This is the first population‐based study providing multiple scenarios for patient survival. The results show that real‐life mCRC patients receiving systemic therapy have a shorter mOS compared to trial patients, likely reflecting patient selection in clinical trials. Clinicians should consider presenting multiple scenarios for survival based on real‐life data instead of point estimates from clinical trials when informing patients about their life expectancy. [ABSTRACT FROM AUTHOR]

Published
2021
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386. Additional file 1: of Accounting for parameter uncertainty in the definition of parametric distributions used to describe individual patient variation in health economic models

Author

Degeling, Koen, IJzerman, Maarten, Koopman, Miriam, and Koffijberg, Hendrik

Abstract

Includes: 1.1) Detailed discussion of the Bootstrap approach, 1.2) Detailed discussion of the MVNorm approach, 1.3) Description of the simulation study model, 1.4) Description of the case study model, 1.5) Parameter estimates for the simulation study, 1.6) Kullback-Leibler Divergence for the simulation study, 1.7) Incremental cost-effectiveness planes for all case study analyses, 1.8) CEACs for all case study analyses, and 1.9) References. (PDF 722 kb)

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

Author

Rovers, Koen P., Bakkers, Checca, Nienhuijs, Simon W., Burger, Jacobus W. A., Creemers, Geert-Jan M., Thijs, Anna M. J., Brandt-Kerkhof, Alexandra R. M., Madsen, Eva V. E., van Meerten, Esther, Tuynman, Jurriaan B., Kusters, Miranda, Versteeg, Kathelijn S., Aalbers, Arend G. J., Kok, Niels F. M., Buffart, Tineke E., Wiezer, Marinus J., Boerma, Djamila, Los, Maartje, de Reuver, Philip R., Bremers, Andreas J. A., Verheul, Henk M. W., Kruijff, Schelto, de Groot, Derk Jan A., Witkamp, Arjen J., van Grevenstein, Wilhelmina M. U., Koopman, Miriam, Nederend, Joost, Lahaye, Max J., Kranenburg, Onno, Fijneman, Remond J. A., van ’t Erve, Iris, Snaebjornsson, Petur, Hemmer, Patrick H. J., Dijkgraaf, Marcel G. W., Punt, Cornelis J. A., Tanis, Pieter J., and de Hingh, Ignace H. J. T.

Abstract

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
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388. Model-based evaluation of the cost effectiveness of 3 versus 6 months' adjuvant chemotherapy in high-risk stage II colon cancer patients.

Author

Jongeneel, Gabrielle, Greuter, Marjolein J. E., van Erning, Felice N., Koopman, Miriam, Vink, Geraldine R., Punt, Cornelis J. A., and Coupé, Veerle M. H.

Subjects
ADJUVANT treatment of cancer, COST effectiveness, COLON cancer, CANCER patients, CANCER chemotherapy
Abstract

Background: Our aim was to evaluate the cost effectiveness of 3 months' adjuvant chemotherapy versus 6 months in high-risk (T4 stage + microsatellite stable) stage II colon cancer (CC) patients. Methods: Using the validated PATTERN Markov cohort model, which simulates the disease progression of stage II CC patients from diagnosis to death, we first evaluated a reference strategy in which high-risk patients were treated with chemotherapy for 6 months. In the second strategy, treatment duration was shortened to 3 months. Both strategies were evaluated for CAPOX (capecitabine plus oxaliplatin) and FOLFOX (fluorouracil, leucovorin and oxaliplatin). Based on trial data, we assumed that shortened treatment duration compared with a 6-month regimen was equally effective for CAPOX and less effective for FOLFOX. Adverse events were highest in the 6-month strategy. Analyses were conducted from a societal perspective using a lifelong time horizon. Outcomes were number of CC deaths per 1000 patients and total discounted costs and quality-adjusted life-years (QALYs) per patient (pp). Incremental net monetary benefit (iNMB) was calculated using a willingness-to-pay value of €50,000/QALY. Results: For CAPOX, the 6-month strategy resulted in 316 CC deaths per 1000 patients, 6.71 QALYs pp and total costs of €41,257 pp. The 3-month strategy resulted in an equal number of CC deaths, but higher QALYs (6.80 pp) and lower costs (€37,645 pp), leading to a iNMB of €8454 per person for 3 months versus 6 months. For FOLFOX, the 6-month strategy resulted in 316 CC deaths per 1000 patients, 6.71 QALYs pp and total costs of €47,135 pp. The 3-month strategy resulted in more CC deaths (393), lower QALYs (6.19 pp) and lower costs (€44,389 pp). An iNMB of −€23,189 was found for 3 months versus 6 months. Conclusion: Our findings indicate that 3 months' adjuvant chemotherapy should be considered as standard of care in high-risk stage II CC patients for CAPOX, but not for FOLFOX. [ABSTRACT FROM AUTHOR]

Published
2020
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389. Estimating adjuvant treatment effects in Stage II colon cancer: Comparing the synthesis of randomized clinical trial data to real‐world data.

Author

Jongeneel, Gabrielle, Klausch, Thomas, Erning, Felice N., Vink, Geraldine R., Koopman, Miriam, Punt, Cornelis J.A., Greuter, Marjolein J.E., and Coupé, Veerle M.H.

Subjects
TREATMENT effectiveness, CLINICAL trials, COLON cancer, PROPENSITY score matching, ADJUVANT treatment of cancer, PYRIMIDINES
Abstract

There is an ongoing discussion regarding the impact of adjuvant chemotherapy in Stage II colon cancer. We therefore estimated adjuvant treatment effect in Stage II colon cancer using pooled disease‐free survival (DFS) data from randomized clinical trials (RCT approach) and compared this to real‐world data (RWD approach) estimates. First, we estimated the treatment effect in RCTs by (i) searching relevant trials reporting DFS data, (ii) generating patient‐level data from reported DFS data and (iii) estimating treatment effect in the patient‐level data. Second, the treatment effect was estimated in an observational cohort of 1,947 patients provided by the Netherlands Cancer Registry using three propensity score methods; matching, weighting and stratification. In the RCT approach, patient‐level data of 4,489 patients (events: 853) were generated from seven trials which compared two of the following treatment arms: control, 5FU/LV or FOLFOX. A Cox model was used to estimate a hazard ratio (HR) of 0.77 (0.43;1.10) for 5FU/LV vs. control and 0.93 (0.72;1.15) for FOLFOX vs. 5FU/LV. In the RWD approach, HRs for any adjuvant treatment vs. control were 0.95 (0.50;1.80), 0.88 (0.24;3.21) and 1.05 (0.04;2.06) using matching, weighting and stratification, respectively. There was no significant difference with the estimates from the RCT approach (interaction test, p > 0.10). The RCT data suggest a clinically relevant benefit of adjuvant chemotherapy in terms of DFS, but the estimate did not reach statistical significance. Stratified analyses are required to evaluate whether treatment effect differs in specific subgroups. What's new? There is an ongoing discussion regarding the impact of adjuvant chemotherapy in stage II colon cancer. This study presents the most recent pooled estimate based on available RCT data since 1999, resulting in a pooled hazard ratio of 0.77 (95% CI 0.43;1.10) for fluoropyrimidine compared to no treatment. Even though no significant treatment effect was found, neither in the RCT approach nor in the real‐world data approach, the RCT data suggest a clinically‐relevant benefit of adjuvant chemotherapy. To improve guidance in treatment decisions, larger sample sizes, pooling of true patient‐level data with covariate information, and subgroup specific analyses are required. [ABSTRACT FROM AUTHOR]

Published
2020
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390. The Impact of Primary Tumor Location in Synchronous Metastatic Colorectal Cancer: Differences in Metastatic Sites and Survival.

Author

Brouwer, Nelleke P. M., van der Kruijssen, Dave E. W., Hugen, Niek, de Hingh, Ignace H. J. T., Nagtegaal, Iris D., Verhoeven, Rob H. A., Koopman, Miriam, and de Wilt, Johannes H. W.

Abstract

Purpose: We explored differences in survival between primary tumor locations, hereby focusing on the role of metastatic sites in synchronous metastatic colorectal cancer (mCRC). Methods: Data for patients diagnosed with synchronous mCRC between 1989 and 2014 were retrieved from the Netherlands Cancer registry. Relative survival and relative excess risks (RER) were analyzed by primary tumor location (right colon (RCC), left colon (LCC), and rectum). Metastatic sites were reported per primary tumor location. Survival was analyzed for metastatic sites combined and for single metastatic sites. Results: In total, 36,297 patients were included in this study. Metastatic sites differed significantly between primary tumor locations, with liver-only metastases in 43%, 54%, and 52% of RCC, LCC, and rectal cancer patients respectively (p < 0.001). Peritoneal metastases were most prevalent in RCC patients (33%), and lung metastases were most prevalent in rectal cancer patients (28%). Regardless of the location of metastases, patients with RCC had a worse survival compared with LCC (RER 0.81, 95% CI 0.78–0.83) and rectal cancer (RER 0.73, 95% CI 0.71–0.76). The survival disadvantage for RCC remained present, even in cases with metastasectomy for liver-only disease (LCC: RER 0.66, 95% CI 0.57–0.76; rectal cancer: RER 0.84, 95% CI 0.66–1.06). Conclusions: This study showed significant differences in relative survival between primary tumor locations in synchronous mCRC, which can only be partially explained by distinct metastatic sites. Our findings support the concept that RCC, LCC and rectal cancer should be considered distinct entities in synchronous mCRC. [ABSTRACT FROM AUTHOR]

Published
2020
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391. Loss of skeletal muscle index and survival in patients with metastatic colorectal cancer: Secondary analysis of the phase 3 CAIRO3 trial.

Author

Kurk, Sophie A., Peeters, Petra H. M., Dorresteijn, Bram, Jong, Pim A., Jourdan, Marion, Creemers, Geert‐Jan M., Erdkamp, Frans L. G., Jongh, Felix E., Kint, Peter A. M., Poppema, Boelo J., Radema, Sandra A., Simkens, Lieke H. J., Tanis, Bea C., Tjin‐A‐Ton, Manuel L. R., Van Der Velden, Ankie, Punt, Cornelis J. A., Koopman, Miriam, and May, Anne M.

Subjects
SKELETAL muscle, COLORECTAL cancer, METASTASIS, SECONDARY analysis, BODY mass index
Abstract

Background: Low skeletal muscle index (SMI) in metastatic colorectal cancer (mCRC) patients is associated with poor outcomes. The prognostic impact of SMI changes during consecutive palliative systemic treatments is unknown. Methods: This is a retrospective analysis of the phase 3 CAIRO3 study. The CAIRO3 study randomized 557 patients between maintenance capecitabine + bevacizumab (CAP‐B) or observation, after six cycles capecitabine + oxaliplatin + bevacizumab (CAPOX‐B). Upon first disease progression (PD1), CAPOX‐B was reintroduced until second progression (PD2). SMI was assessed by computed tomography (CT) (total 1355 scans). SMI and body mass index (BMI) changes were analyzed for three time‐periods; p1: during initial CAPOX‐B, p2: randomization to PD1, and p3: PD1 to PD2. The association between absolute and change in SMI and BMI (both per 1 standard deviation) during p1‐p3, with PD1, PD2, and survival was studied by Cox regression models. Results: This analysis included 450 of the 557 patients randomized in the CAIRO3 study. Mean SMI decreased during p1: mean −0.6 SMI units [95% CI −1.07;‐0.26] and p3: −2.2 units [−2.7;‐1.8], whereas during p2, SMI increased + 1.2 units [0.8‐1.6]. BMI changes did not reflect changes in SMI. SMI loss during p2 and p3 was significantly associated with shorter survival (HR 1.19 [1.09‐1.35]; 1.54 [1.31‐1.79], respectively). Sarcopenia at PD1 was significantly associated with early PD2 (HR 1.40 [1.10‐1.70]). BMI loss independent of SMI loss was only associated with shorter overall survival during p3 (HR 1.35 [1.14‐1.63]). Conclusions: In mCRC patients, SMI loss during palliative systemic treatment was related with early disease progression and reduced survival. BMI did not reflect changes in SMI and could not identify patients at risk of poor outcome during early treatment lines. [ABSTRACT FROM AUTHOR]

Published
2020
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392. DPYD genotype-guided dose individualisation of fluoropyrimidine therapy in patients with cancer: a prospective safety analysis

Author

Henricks, Linda M, primary, Lunenburg, Carin A T C, additional, de Man, Femke M, additional, Meulendijks, Didier, additional, Frederix, Geert W J, additional, Kienhuis, Emma, additional, Creemers, Geert-Jan, additional, Baars, Arnold, additional, Dezentjé, Vincent O, additional, Imholz, Alexander L T, additional, Jeurissen, Frank J F, additional, Portielje, Johanna E A, additional, Jansen, Rob L H, additional, Hamberg, Paul, additional, ten Tije, Albert J, additional, Droogendijk, Helga J, additional, Koopman, Miriam, additional, Nieboer, Peter, additional, van de Poel, Marlène H W, additional, Mandigers, Caroline M P W, additional, Rosing, Hilde, additional, Beijnen, Jos H, additional, Werkhoven, Erik van, additional, van Kuilenburg, André B P, additional, van Schaik, Ron H N, additional, Mathijssen, Ron H J, additional, Swen, Jesse J, additional, Gelderblom, Hans, additional, Cats, Annemieke, additional, Guchelaar, Henk-Jan, additional, and Schellens, Jan H M, additional

Published
2018
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394. Tumour budding is associated with the mesenchymal colon cancer subtype and RAS/RAF mutations: a study of 1320 colorectal cancers with Consensus Molecular Subgroup (CMS) data

Author

Trinh, Anne, primary, Lädrach, Claudia, additional, Dawson, Heather E., additional, ten Hoorn, Sanne, additional, Kuppen, Peter J. K., additional, Reimers, Marlies S., additional, Koopman, Miriam, additional, Punt, Cornelis J. A., additional, Lugli, Alessandro, additional, Vermeulen, Louis, additional, and Zlobec, Inti, additional

Published
2018
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395. Copy number load predicts outcome of metastatic colorectal cancer patients receiving bevacizumab combination therapy

Author

Smeets, Dominiek, primary, Miller, Ian S., additional, O’Connor, Darran P., additional, Das, Sudipto, additional, Moran, Bruce, additional, Boeckx, Bram, additional, Gaiser, Timo, additional, Betge, Johannes, additional, Barat, Ana, additional, Klinger, Rut, additional, van Grieken, Nicole C. T., additional, Cremolini, Chiara, additional, Prenen, Hans, additional, Mazzone, Massimiliano, additional, Depreeuw, Jeroen, additional, Bacon, Orna, additional, Fender, Bozena, additional, Brady, Joseph, additional, Hennessy, Bryan T., additional, McNamara, Deborah A., additional, Kay, Elaine, additional, Verheul, Henk M., additional, Maarten, Neerincx, additional, Gallagher, William M., additional, Murphy, Verena, additional, Prehn, Jochen H. M., additional, Koopman, Miriam, additional, Punt, Cornelis J. A., additional, Loupakis, Fotios, additional, Ebert, Matthias P. A., additional, Ylstra, Bauke, additional, Lambrechts, Diether, additional, and Byrne, Annette T., additional

Published
2018
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396. Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group

Author

Goey, Kaitlyn K.H., primary, Sørbye, Halfdan, additional, Glimelius, Bengt, additional, Adams, Richard A., additional, André, Thierry, additional, Arnold, Dirk, additional, Berlin, Jordan D., additional, Bodoky, György, additional, de Gramont, Aimery, additional, Díaz-Rubio, Eduardo, additional, Eng, Cathy, additional, Falcone, Alfredo, additional, Grothey, Axel, additional, Heinemann, Volker, additional, Hochster, Howard S., additional, Kaplan, Richard S., additional, Kopetz, Scott, additional, Labianca, Roberto, additional, Lieu, Christopher H., additional, Meropol, Neal J., additional, Price, Timothy J., additional, Schilsky, Richard L., additional, Schmoll, Hans-Joachim, additional, Shacham-Shmueli, Einat, additional, Shi, Qian, additional, Sobrero, Alberto F., additional, Souglakos, John, additional, Van Cutsem, Eric, additional, Zalcberg, John, additional, van Oijen, Martijn G.H., additional, Punt, Cornelis J.A., additional, and Koopman, Miriam, additional

Published
2018
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398. Loss of Chromosome 18q11.2-q12.1 Is Predictive for Survival in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab

Author

van Dijk, Erik, primary, Biesma, Hedde D., additional, Cordes, Martijn, additional, Smeets, Dominiek, additional, Neerincx, Maarten, additional, Das, Sudipto, additional, Eijk, Paul P., additional, Murphy, Verena, additional, Barat, Anna, additional, Bacon, Orna, additional, Prehn, Jochen H.M., additional, Betge, Johannes, additional, Gaiser, Timo, additional, Fender, Bozena, additional, Meijer, Gerrit A., additional, McNamara, Deborah A., additional, Klinger, Rut, additional, Koopman, Miriam, additional, Ebert, Matthias P.A., additional, Kay, Elaine W., additional, Hennessey, Bryan T., additional, Verheul, Henk M.W., additional, Gallagher, William M., additional, O'Connor, Darran P., additional, Punt, Cornelis J.A., additional, Loupakis, Fotios, additional, Lambrechts, Diether, additional, Byrne, Annette T., additional, van Grieken, Nicole C.T., additional, and Ylstra, Bauke, additional

Published
2018
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399. Abstract 2579: Loss of chromosome 18q11.2-18q12.1 is predictive for progression-free survival in metastatic colorectal cancer patients treated with bevacizumab

Author

Dijk, Erik van, primary, Biesma, Hedde, additional, Cordes, Martijn, additional, Smeets, Dominiek, additional, Neerincx, Maarten, additional, Das, Sudipto, additional, Murphy, Verena, additional, Barat, Anna, additional, Bacon, Orna, additional, Prehn, Jochen H.M., additional, Betge, Johannes, additional, Timo, Gaiser, additional, Fender, Bozena, additional, Meijer, Gerrit A., additional, McNamara, Deborah A., additional, Klinger, Rut, additional, Koopman, Miriam, additional, Ebert, Matthias P.A., additional, Kay, Elaina W., additional, Hennessey, Bryan T., additional, Verheul, Henk M.W., additional, Gallagher, William M., additional, O'Connor, Darran P., additional, Punt, Cornelis J.A., additional, Loupakis, Fotios, additional, Lambrechts, Diether, additional, Byrne, Annette, additional, Grieken, Nicole C.T. van, additional, and Ylstra, Bauke, additional

Published
2018
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400. Reporting of patient characteristics and stratification factors in phase 3 trials investigating first-line systemic treatment of metastatic colorectal cancer: A systematic review

Author

Goey, Kaitlyn K.H., primary, Mahmoud, Remi, additional, Sørbye, Halfdan, additional, Glimelius, Bengt, additional, Köhne, Claus-Henning, additional, Sargent, Daniel J., additional, Punt, Cornelis J.A., additional, van Oijen, Martijn G.H., additional, and Koopman, Miriam, additional

Published
2018
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