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1. Immune monitoring in mesothelioma patients identifies novel immune-modulatory functions of gemcitabine associating with clinical response

Author

Floris Dammeijer, Cornedine J. De Gooijer, Mandy van Gulijk, Melanie Lukkes, Larissa Klaase, Lysanne A. Lievense, Cynthia Waasdorp, Merel Jebbink, Gerben P. Bootsma, Jos A. Stigt, Bonne Biesma, Margaretha E.H. Kaijen-Lambers, Joanne Mankor, Heleen Vroman, Robin Cornelissen, Paul Baas, Vincent Van der Noort, Jacobus A. Burgers, and Joachim G. Aerts

Subjects
Malignant mesothelioma, Lymphocytes, Myeloid-derived suppressor cells, Gemcitabine, Immunotherapy, Medicine, Medicine (General), R5-920
Abstract

Background: Gemcitabine is a frequently used chemotherapeutic agent but its effects on the immune system are incompletely understood. Recently, the randomized NVALT19-trial revealed that maintenance gemcitabine after first-line chemotherapy significantly prolonged progression-free survival (PFS) compared to best supportive care (BSC) in malignant mesothelioma. Whether these effects are paralleled by changes in circulating immune cell subsets is currently unknown. These analyses could offer improved mechanistic insights into the effects of gemcitabine on the host and guide development of effective combination therapies in mesothelioma. Methods: We stained peripheral blood mononuclear cells (PBMCs) and myeloid-derived suppressor cells (MDSCs) at baseline and 3 weeks following start of gemcitabine or BSC treatment in a subgroup of mesothelioma patients included in the NVALT19-trial. In total, 24 paired samples including both MDSCs and PBMCs were included. We performed multicolour flow-cytometry to assess co-inhibitory and-stimulatory receptor- and cytokine expression and matched these parameters with PFS and OS. Findings: Gemcitabine treatment was significantly associated with an increased NK-cell- and decreased T-regulatory cell proliferation whereas the opposite occurred in control patients. Furthermore, myeloid-derived suppressor cells (MDSCs) frequencies were lower in gemcitabine-treated patients and this correlated with increased T-cell proliferation following treatment. Whereas gemcitabine variably altered co-inhibitory receptor expression, co-stimulatory molecules including ICOS, CD28 and HLA-DR were uniformly increased across CD4+ T-helper, CD8+ T- and NK-cells. Although preliminary in nature, the increase in NK-cell proliferation and PD-1 expression in T cells following gemcitabine treatment was associated with improved PFS and OS. Interpretation: Gemcitabine treatment was associated with widespread effects on circulating immune cells of mesothelioma patients with responding patients displaying increased NK-cell and PD-1 + T-cell proliferation. These exploratory data provide a platform for future on treatment-biomarker development and novel combination treatment strategies.

Published
2021
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2. Knowledge gaps in patients with COPD and their proxies

Author

Nienke Nakken, Daisy J. A. Janssen, Esther H. A. van den Bogaart, Jean W. M. Muris, Jan H. Vercoulen, Frank L. Custers, Gerben P. Bootsma, Michiel H. M. Gronenschild, Emiel F. M. Wouters, and Martijn A. Spruit

Subjects
COPD, Education, Family, Informal carer, Knowledge, Proxy, Diseases of the respiratory system, RC705-779
Abstract

Abstract Background Although proxies of patients with chronic obstructive pulmonary disease (COPD) need health-related knowledge to support patients in managing their disease, their current level of knowledge remains unknown. We aimed to compare health-related knowledge (generic and COPD-related knowledge) between patients with COPD and their resident proxies. Methods In this cross-sectional study, we included stable patients with moderate to very severe COPD and their resident proxies (n = 194 couples). Thirty-four statements about generic health and COPD-related topics were assessed in patients and proxies separately. Statements could be answered by ‘true’, ‘false’, or ‘do not know’. This study is approved by the Medical Research Ethics Committees United (MEC-U), the Netherlands (NL42721.060.12/M12–1280). Results Patients answered on average 17% of the statements incorrect, and 19% with ‘do not know’. The same figure (19%) for the incorrect and unknown statements was shown by proxies. Patients who attended pulmonary rehabilitation previously answered more statements correct (about three) compared to patients who did not attend pulmonary rehabilitation. More correct answers were reported by: younger patients, patients with a higher level of education, patients who previously participated in pulmonary rehabilitation, patients with better cognitive functioning, and patients with a COPD diagnosis longer ago. Conclusions Proxies of patients with COPD as well as patients themselves answer about two third of 34 knowledge statements about COPD correct. So, both patients and proxies seem to have an incomplete knowledge about COPD and general health. Therefore, education about general health and COPD should be offered to all subgroups of patients with COPD and their proxies. Trial registration This study is registered in the Dutch Trial Register ( NTR3941 ). Registered 19 April 2013.

Published
2017
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3. Endosonography With or Without Confirmatory Mediastinoscopy for Resectable Lung Cancer: A Randomized Clinical Trial

Author

Jelle E. Bousema, Marcel G.W. Dijkgraaf, Erik H.F.M. van der Heijden, Ad F.T.M. Verhagen, Jouke T. Annema, Frank J.C. van den Broek, Nicole E. Papen-Botterhuis, Maggy Youssef-El Soud, Wim J. van Boven, Johannes M.A. Daniels, David J. Heineman, Harmen R. Zandbergen, Pepijn Brocken, Thirza Horn, Willem H. Steup, Jerry Braun, Rajen S.R.S. Ramai, Naomi Beck, Fieke Hoeijmakers, Nicole P. Barlo, Martijn van Dorp, W. Hermien Schreurs, Anne-Marie C. Dingemans, Roy T.M. Sprooten, Jos G. Maessen, Niels J.M. Claessens, Jan-Willem H.P. Lardenoije, Birgitta I. Hiddinga, Caroline Van De Wauwer, Anthonie J. van der Wekken, Wessel E. Hanselaar, Robert ThJ Kortekaas, Martin P. Bard, Herman Rijna, Gerben P. Bootsma, Yvonne L.J. Vissers, Eelco J. Veen, Cor H. van der Leest, Emanuel Citgez, Eino B. van Duyn, Geertruid M.H. Marres, Eric R. van Thiel, Paul E. van Schil, Jan P. van Meerbeeck, Reinier Wener, Niels Smakman, Femke van der Meer, Mohammed D. Saboerali, Anne Marie Bosch, Wouter K. de Jong, Charles C. van Rossem, W. Johan Lie, Ewout A. Kouwenhoven, A. Jeske Staal-van den Brekel, Nike M. Hanneman, Roxane Heller-Baan, and Valentin J.J.M. Noyez

Subjects
Cancer Research, Oncology
Abstract

PURPOSE Resectable non–small-cell lung cancer (NSCLC) with a high probability of mediastinal nodal involvement requires mediastinal staging by endosonography and, in the absence of nodal metastases, confirmatory mediastinoscopy according to current guidelines. However, randomized data regarding immediate lung tumor resection after systematic endosonography versus additional confirmatory mediastinoscopy before resection are lacking. METHODS Patients with (suspected) resectable NSCLC and an indication for mediastinal staging after negative systematic endosonography were randomly assigned to immediate lung tumor resection or confirmatory mediastinoscopy followed by tumor resection. The primary outcome in this noninferiority trial (noninferiority margin of 8% that previously showed to not compromise survival, Pnoninferior < .0250) was the presence of unforeseen N2 disease after tumor resection with lymph node dissection. Secondary outcomes were 30-day major morbidity and mortality. RESULTS Between July 17, 2017, and October 5, 2020, 360 patients were randomly assigned, 178 to immediate lung tumor resection (seven dropouts) and 182 to confirmatory mediastinoscopy first (seven dropouts before and six after mediastinoscopy). Mediastinoscopy detected metastases in 8.0% (14/175; 95% CI, 4.8 to 13.0) of patients. Unforeseen N2 rate after immediate resection (8.8%) was noninferior compared with mediastinoscopy first (7.7%) in both intention-to-treat (Δ, 1.03%; UL 95% CIΔ, 7.2%; Pnoninferior = .0144) and per-protocol analyses (Δ, 0.83%; UL 95% CIΔ, 7.3%; Pnoninferior = .0157). Major morbidity and 30-day mortality was 12.9% after immediate resection versus 15.4% after mediastinoscopy first ( P = .4940). CONCLUSION On the basis of our chosen noninferiority margin in the rate of unforeseen N2, confirmatory mediastinoscopy after negative systematic endosonography can be omitted in patients with resectable NSCLC and an indication for mediastinal staging.

Published
2023

4. Life-prolonging treatment restrictions and outcomes in patients with cancer and COVID-19: an update from the Dutch Oncology COVID-19 Consortium

Author

Karlijn de Joode, Jolien Tol, Paul Hamberg, Marissa Cloos, Elisabeth A. Kastelijn, Jessica S.W. Borgers, Veerle J.A.A. Nuij, Yarne Klaver, Gerarda J.M. Herder, Pim G.N.J. Mutsaers, Daphne W. Dumoulin, Esther Oomen-de Hoop, Nico G.J. van Diemen, Eduard J. Libourel, Erica J. Geraedts, Gerben P. Bootsma, Cor H. van der Leest, Anne L. Peerdeman, Karin H. Herbschleb, Otto J. Visser, Haiko J. Bloemendal, Hanneke W.M. van Laarhoven, Elisabeth G.E. de Vries, Lizza E.L. Hendriks, Laurens V. Beerepoot, Hans M. Westgeest, Franchette W.P.J. van den Berkmortel, John B.A.G. Haanen, Anne-Marie C. Dingemans, Astrid A.M. van der Veldt, A. Becker-Commissaris, F. Terheggen, B.E.E.M. van den Borne, L.J.C. van Warmerdam, L. van Leeuwen, F.S. van der Meer, M.A. Tiemessen, D.M. van Diepen, L. Strobbe, J.A.F. Koekkoek, P. Brocken, J.C. Drooger, R. Heller, J.W.B. de Groot, J.A. Stigt, C.C.M. Pitz, M. Slingerland, F.J. Borm, B.C.M. Haberkorn, S.C. van 't Westeinde, M.J.B. Aarts, J.W.G. van Putten, M. Youssef, G.A. Cirkel, C.R. van Rooijen, E. Citgez, N.P. Barlo, B.M.J. Scholtes, R.H.T. Koornstra, N.J.M. Claessens, L.M. Faber, C.H. Rikers, R.A.W. van de Wetering, G.L. Veurink, B.W. Bouter, I. Houtenbos, M.P.L. Bard, G. Douma, M. Jalving, T.J.N. Hiltermann, O.C.J. Schuurbiers-Siebers, K.P.M. Suijkerbuijk, A.S.R. van Lindert, A.J. van de Wouw, V.E.M. van den Boogaart, S.D. Bakker, E. Looysen, W.K. de Jong, E.J.M. Siemerink, A.J. Staal, B. Franken, W.H. van Geffen, Pulmonologie, MUMC+: MA Med Staf Spec Longziekten (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), Medical Oncology, Hematology, Pulmonary Medicine, Radiology & Nuclear Medicine, Urology, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Translational Immunology Groningen (TRIGR), Targeted Gynaecologic Oncology (TARGON), Oncology, CCA - Cancer Treatment and Quality of Life, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
Oncology, Male, Cancer Research, Fatal outcome, IMPACT, Patient characteristics, Withholding Treatment/statistics & numerical data, Risk Factors, Neoplasms, Pandemic, 80 and over, Netherlands, Original Research, COVID-19/epidemiology, Cancer, Aged, 80 and over, RISK, SARS-CoV-2/isolation & purification, Middle Aged, Mortality/trends, Prognosis, Hospitalization, Survival Rate, Urological cancers Radboud Institute for Health Sciences [Radboudumc 15], Cancer treatment, Female, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Netherlands/epidemiology, SDG 3 - Good Health and Well-being, Intensive care, Internal medicine, Treatment restrictions, medicine, Humans, In patient, Mortality, Lung cancer, Aged, Hospitalization/statistics & numerical data, SARS-CoV-2, business.industry, Advanced care planning, COVID-19, medicine.disease, Life Support Care/statistics & numerical data, Life Support Care, Withholding Treatment, business, Neoplasms/epidemiology
Abstract

Aim of the study: The coronavirus disease 2019 (COVID-19) pandemic significantly impacted cancer care. In this study, clinical patient characteristics related to COVID-19 outcomes and advanced care planning, in terms of non-oncological treatment restrictions (e.g. do not-resuscitate codes), were studied in patients with cancer and COVID-19. Methods: The Dutch Oncology COVID-19 Consortium registry was launched in March 2020 in 45 hospitals in the Netherlands, primarily to identify risk factors of a severe COVID-19 outcome in patients with cancer. Here, an updated analysis of the registry was performed, and treatment restrictions (e.g. do-not-intubate codes) were studied in relation to COVID19 outcomes in patients with cancer. Oncological treatment restrictions were not taken into account. Results: Between 27th March 2020 and 4th February 2021, 1360 patients with cancer and COVID-19 were registered. Follow-up data of 830 patients could be validated for this analysis. Overall, 230 of 830 (27.7%) patients died of COVID-19, and 60% of the remaining 600 patients with resolved COVID-19 were admitted to the hospital. Patients with haematological malignancies or lung cancer had a higher risk of a fatal outcome than other solid tumours. No correlation between anticancer therapies and the risk of a fatal COVID-19 outcome was found. In terms of end-of-life communication, 50% of all patients had restrictions regarding life prolonging treatment (e.g. do-not-intubate codes). Most identified patients with treatment restrictions had risk factors associated with fatal COVID-19 outcome. Conclusion: There was no evidence of a negative impact of anticancer therapies on COVID-19 outcomes. Timely end-of-life communication as part of advanced care planning could save patients from prolonged suffering and decrease burden in intensive care units. Early discussion of treatment restrictions should therefore be part of routine oncological care, especially during the COVID-19 pandemic. 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Published
2022

5. Patient versus proxy-reported problematic activities of daily life in patients with COPD

Author

Nienke, Nakken, Daisy J A, Janssen, Esther H A, van den Bogaart, Monique, van Vliet, Geeuwke J, de Vries, Gerben P, Bootsma, Michiel H M, Gronenschild, Jeannet M L, Delbressine, Jean W M, Muris, Emiel F M, Wouters, and Martijn A, Spruit

Subjects
Male, Canada, Middle Aged, Severity of Illness Index, Proxy, Disability Evaluation, Pulmonary Disease, Chronic Obstructive, Cross-Sectional Studies, Activities of Daily Living, Quality of Life, Humans, Female, Self Report, Aged
Abstract

Loved ones (proxies) of patients with COPD are confronted with the patients' limitations in activities of daily living (ADLs). However, it remains unknown whether proxies are able to correctly estimate the problematic ADLs of the patient. Therefore, we aimed to investigate the level of agreement between patient-reported and proxy-reported problematic ADLs of the patient.Stable outpatients with moderate to very severe COPD (n = 194) and their resident proxies (n = 194) were included in this cross-sectional study. Patients' problematic ADLs were assessed in the domains 'self-care', 'mobility', 'productivity' and 'leisure' using the Canadian Occupational Performance Measure (COPM) in both patients and resident proxies. Furthermore, the perceived performance and satisfaction for important problematic ADLs were rated on a 10-point scale.In total, 830 problematic ADLs were reported by patients, and 735 by proxies. Agreement in reporting problematic ADLs within a domain was poor (productivity and leisure; κ; = 0.20 and 0.16, respectively) to fair (self-care and mobility; κ = 0.32 and 0.22, respectively). Similar performance and satisfaction scores, for equally reported problematic ADLs, were given by 24.0% and 17.6% of the pairs, respectively.Proxies were often not able to identify the patients' most important problematic ADLs. Moreover, when patient and proxy agreed about the presence of a specific problematic ADL, the perception of the performance and the satisfaction with that performance differed within most pairs. This emphasizes the importance of involving proxies, besides patients alone, in identifying patients' problematic ADLs.

Published
2016

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