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1. First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases (CAIRO5): an open-label, multicentre, randomised, controlled, phase 3 study from the Dutch Colorectal Cancer Group.

Author

Bond, M.J.G., Bolhuis, K., Loosveld, O.J.L., Groot, J.W.B. de, Droogendijk, H., Helgason, H.H., Hendriks, M.P, Klaase, J.M., Kazemier, G., Liem, M.S.L., Rijken, A.M., Verhoef, C., Wilt, J.H.W. de, Jong, K.P. de, Gerhards, M.F., Amerongen, M.J. van, Engelbrecht, M.R.W., Lienden, K.P. van, Molenaar, I.Q., Valk, B. de, Haberkorn, B.C.M., Kerver, E.D., Erdkamp, F., Alphen, R.J. van, Mathijssen-van Stein, D., Komurcu, A., Lopez-Yurda, M., Swijnenburg, R.J., Punt, C.J.A., Bond, M.J.G., Bolhuis, K., Loosveld, O.J.L., Groot, J.W.B. de, Droogendijk, H., Helgason, H.H., Hendriks, M.P, Klaase, J.M., Kazemier, G., Liem, M.S.L., Rijken, A.M., Verhoef, C., Wilt, J.H.W. de, Jong, K.P. de, Gerhards, M.F., Amerongen, M.J. van, Engelbrecht, M.R.W., Lienden, K.P. van, Molenaar, I.Q., Valk, B. de, Haberkorn, B.C.M., Kerver, E.D., Erdkamp, F., Alphen, R.J. van, Mathijssen-van Stein, D., Komurcu, A., Lopez-Yurda, M., Swijnenburg, R.J., and Punt, C.J.A.

Abstract

01 juli 2023, Item does not contain fulltext, BACKGROUND: Patients with initially unresectable colorectal cancer liver metastases might qualify for local treatment with curative intent after reducing the tumour size by induction systemic treatment. We aimed to compare the currently most active induction regimens. METHODS: In this open-label, multicentre, randomised, phase 3 study (CAIRO5), patients aged 18 years or older with histologically confirmed colorectal cancer, known RAS/BRAF(V600E) mutation status, WHO performance status of 0-1, and initially unresectable colorectal cancer liver metastases were enrolled at 46 Dutch and one Belgian secondary and tertiary centres. Resectability or unresectability of colorectal cancer liver metastases was assessed centrally by an expert panel of liver surgeons and radiologists, at baseline and every 2 months thereafter by predefined criteria. Randomisation was done centrally with the minimisation technique via a masked web-based allocation procedure. Patients with right-sided primary tumour site or RAS or BRAF(V600E) mutated tumours were randomly assigned (1:1) to receive FOLFOX or FOLFIRI plus bevacizumab (group A) or FOLFOXIRI plus bevacizumab (group B). Patients with left-sided and RAS and BRAF(V600E) wild-type tumours were randomly assigned (1:1) to receive FOLFOX or FOLFIRI plus bevacizumab (group C) or FOLFOX or FOLFIRI plus panitumumab (group D), every 14 days for up to 12 cycles. Patients were stratified by resectability of colorectal cancer liver metastases, serum lactate dehydrogenase concentration, choice of irinotecan versus oxaliplatin, and BRAF(V600E) mutation status (for groups A and B). Bevacizumab was administered intravenously at 5 mg/kg. Panitumumab was administered intravenously at 6 mg/kg. FOLFIRI consisted of intravenous infusion of irinotecan at 180 mg/m(2) with folinic acid at 400 mg/m(2), followed by bolus fluorouracil at 400 mg/m(2) intravenously, followed by continuous infusion of fluorouracil at 2400 mg/m(2). FOLFOX consisted of oxaliplatin at

Published
2023

2. 352P Cost-effectiveness of CDK4/6 inhibitors in first- vs second-line for advanced breast cancer (ABC) in the phase III SONIA trial (BOOG 2017-03)

Author

Wortelboer, N., Kent, S., Konings, I.R., Van Ommen-Nijhof, A., van der Noort, V., van den Pol, E., Páez, C. Guerrero, van Bekkum, M., Droogendijk, H.J., Erdkamp, F., Houtsma, D., Oosterkamp, H.M., van der Padt-Pruijsten, A., Siemerink, E.J., Tol, J., van Zweeden, A.A., van Leeuwen-Stok, A.E., Sonke, G.S., Jager, A., and Blommestein, H.M.

Published
2024
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4. Quality of Life Is Associated With Survival in Patients With Gastric Cancer: Results From the Randomized CRITICS Trial

Author

van Amelsfoort, R. M., Walraven, I., Kieffer, J., Jansen, E. P. M., Cats, A., van Grieken, N. C. T., Meershoek-Klein Kranenbarg, E., Putter, H., van Sandick, J. W., Sikorska, K., van de Velde, C. J. H., Aaronson, N. K., Verheij, M., Boot, H., Trip, A., van Coevorden, F., Vanhoutvin, S., Swellengrebel, H. A. M., Hulshof, M. C. C. M., van Berge Henegouwen, M. I., van Laarhoven, H. W. M., Loosveld, O. J. L., ten Tije, A. J., Erdkamp, F. L. G., Warmerdam, F. A. R. M., van der Peet, D. L., Verheul, H. M. W., Portielje, J. E. A., Spillenaar Bilgen, E. J., Poleé, M. B., Geenen, M. M., Neelis, K. J., Slingerland, M., Jansen, R. L. H., van Spronsen, D. J., Tanis, B. C., van Hillegersberg, R., Koopman, M., den Boer, M. O., Creemers, G. J., van den Berg, H. P., Baars, A., Appels, M. I. E., Smit, J. M., Muller, E. W., de Boer, J., van Dijk, M. A., van der Gaast, A., Otten, J. M. M. B., Ceha, H. M., Radiotherapy, CCA - Cancer Treatment and Quality of Life, Surgery, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Oncology, Pathology, Amsterdam Gastroenterology Endocrinology Metabolism, Internal medicine, CCA - Cancer Treatment and quality of life, Medical oncology, and Medical Oncology

Subjects
Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], All institutes and research themes of the Radboud University Medical Center, SDG 3 - Good Health and Well-being, Oncology, Stomach Neoplasms, Urological cancers Radboud Institute for Health Sciences [Radboudumc 15], Surveys and Questionnaires, Quality of Life, Humans, Prognosis, Neoadjuvant Therapy
Abstract

Background: The evaluation of health-related quality of life (HRQoL) in clinical trials has become increasingly important because it addresses the impact of treatment from the patient’s perspective. The primary aim of this study was to investigate the effect of postoperative chemotherapy and chemoradiotherapy (CRT) after neoadjuvant chemotherapy and surgery with extended (D2) lymphadenectomy on HRQoL in the CRITICS trial. Second, we investigated the potential prognostic value of pretreatment HRQoL on event-free survival (EFS) and overall survival (OS). Patients and Methods: Patients in the CRITICS trial were asked to complete HRQoL questionnaires (EORTC Quality-of-Life Questionnaire-Core 30 and Quality-of-Life Questionnaire gastric cancer–specific module) at baseline, after preoperative chemotherapy, after surgery, after postoperative chemotherapy or CRT, and at 12 months follow-up. Patients with at least 1 evaluable questionnaire (645 of 788 randomized patients) were included in the HRQoL analyses. The predefined endpoints included dysphagia, pain, physical functioning, fatigue, and Quality-of-Life Questionnaire-Core 30 summary score. Linear mixed modeling was used to assess differences over time and at each time point. Associations of baseline HRQoL with EFS and OS were investigated using multivariate Cox proportional hazards analyses. Results: At completion of postoperative chemo(radio)therapy, the chemotherapy group had significantly better physical functioning (P=.02; Cohen’s effect size = 0.42) and less dysphagia (P=.01; Cohen’s effect size = 0.38) compared with the CRT group. At baseline, worse social functioning (hazard ratio [HR], 2.20; 95% CI, 1.36–3.55; P=.001), nausea (HR, 1.89; 95% CI, 1.39–2.56; PP=.007), and histologic subtype (diffuse vs intestinal: HR, 1.94; 95% CI, 1.42–2.67; PP=.003) were significantly associated with worse EFS and OS. Conclusions: In the CRITICS trial, the chemotherapy group had significantly better physical functioning and less dysphagia after postoperative treatment. HRQoL scales at baseline were significantly associated with EFS and OS.

Published
2022
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5. Maintenance treatment with capecitabine and bevacizumab versus observation in metastatic colorectal cancer: updated results and molecular subgroup analyses of the phase 3 CAIRO3 study

Author

Goey, K. K. H., Elias, S. G., van Tinteren, H., Laclé, M. M., Willems, S. M., Offerhaus, G. J. A., de Leng, W. W. J., Strengman, E., ten Tije, A. J., Creemers, G.-J. M., van der Velden, A., de Jongh, F. E., Erdkamp, F. L. G., Tanis, B. C., Punt, C. J. A., and Koopman, M.

Published
2017
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10. Cancer associated thrombosis in everyday practice: perspectives from GARFIELD-VTE

Author

Weitz, J.I., Haas, S., Ageno, W., Goldhaber, S.Z., Turpie, A.G.G., Goto, S., Angchaisuksiri, P., Nielsen, J.D., Kayani, G., Farjat, A.E., Schellong, S., Bounameaux, H., Mantovani, L.G., Prandoni, P., Kakkar, A.K., Loualidi, A., Colak, A., Bezuidenhout, A., Abdool-Carrim, A., Azeddine, A., Beyers, A., Dees, A., Mohamed, A., Aksoy, A., Abiko, A., Watanabe, A., Krichell, A., Fernandez, A.A., Tosetto, A., Khotuntsov, A., Oropallo, A., Slocombe, A., Kelly, A., Clark, A., Gad, A., Arouni, A., Schmidt, A., Berni, A., Kleiban, A.J., Machowski, A., Kazakov, A., Galvez, A., Lockman, A., Falanga, A., Chauhan, A., Riera-Mestre, A., Mazzone, A., D'Angelo, A., Herdy, A., Kato, A., Salem, A.A.E.E.M., Husin, A., Erdelyi, B., Jacobson, B., Amann-Vesti, B., Battaloglu, B., Wilson, B., Cosmi, B., Francois, B.J., Toufek, B., Hunt, B., Natha, B., Mustafa, B., Kho, B.C.S., Carine, B., Zidel, B., Dominique, B., Christophe, B., Trimarco, B., Luo, C., Cuneo, C.A., Diaz, C.J.S., Schwencke, C., Cader, C., Yavuz, C., Zaidman, C.J., Lunn, C., C. -C., W., Toh, C.H., Chiang, C.-., Elisa, C., Hsia, C.-., Huang, C.-., Kwok, C.-.K., Ward, C., Opitz, C., Jeanneret-Gris, C., C. Y., H., Bidi, C.L., Smith, C., Brauer, C., Lodigiani, C., Francis, C., Wu, C., Staub, D., Theodoro, D., Poli, D., Acevedo, D.-., Adler, D., Jimenez, D., Keeling, D., Scott, D., Imberti, D., Creagh, D., Helene, D.-., Hagemann, D., Le Roux, D., Skowasch, D., Belenky, D., Dorokhov, D., Petrov, D., Zateyshchikov, D., Prisco, D., Moller, D., Kucera, D., Esheiba, E.M., Panchenko, E., Dominique, E., Dogan, E., Kubat, E., Diaz, E.D., Tse, E.W.C., Yeo, E., Hashas, E., Grochenig, E., Tiraferri, E., Blessing, E., Michele, E.O., Usandizaga, E., Porreca, E., Ferroni, F., Nicolas, F., Ayala-Paredes, F., Koura, F., Henry, F., Cosmi, F., Erdkamp, F., Kamalov, G., Dalmau, G.-., Damien, G., Klein, G., Shah, G., Hollanders, G., Merli, G., Plassmann, G., Platt, G., Poirier, G., Sokurenko, G., Haddad, G., Ali, G., Agnelli, G., Gan, G.G., Kaye-Eddie, G., Le Gal, G., Allen, G., Esperon, G.A.L., Jean-Paul, G., Gerofke, H., Elali, H., Burianova, H., Ohler, H.-., Wang, H., Darius, H., Gogia, H.S., Striekwold, H., Gibbs, H., Hasanoglu, H., Turker, H., Franow, H., De Raedt, H., Schroe, H., Eldin, H.S., Zidan, H., Nakamura, H., Kim, H.Y., Lawall, H., Zhu, H., Tian, H., Yhim, H.-., Cate, H., Hwang, H.G., Shim, H., Kim, I., Libov, I., Sonkin, I., Suchkov, I., Song, I.-., Kiris, I., Staroverov, I., Looi, I., De La Azuela Tenorio, I.M., Savas, I., Gordeev, I., Podpera, I., Lee, J.H., Sathar, J., Welker, J., Beyer-Westendorf, J., Kvasnicka, J., Vanwelden, J., Kim, J.Y., Svobodova, J., Gujral, J., Marino, J., Galvar, J.T., Kassis, J., Kuo, J.-., Shih, J.-., Kwon, J.H., Joh, J.H., Park, J.H., Kim, J.S., Yang, J., Krupicka, J., Lastuvka, J., Pumprla, J., Vesely, J., Souto, J.C., Correa, J.A., Duchateau, J., Fletcher, J.P., del Toro, J., Paez, J.G.C., Nielsen, J., Filho, J.D.A., Saraiva, J., Peromingo, J.A.D., Lara, J.G., Fedele, J.L., Surinach, J.M., Chacko, J., Muntaner, J.A., Benitez, J.C.A., Abril, J.M.H., Humphrey, J., Bono, J., Kanda, J., Boondumrongsagoon, J., Yiu, K.H., Chansung, K., Boomars, K., Burbury, K., Kondo, K., Karaarslan, K., Takeuchi, K., Kroeger, K., Zrazhevskiy, K., Svatopluk, K., Shyu, K.-., Vandenbosch, K., Chang, K.-., Chiu, K.-., Jean-Manuel, K., Wern, K.J., Ueng, K.-., Norasetthada, L., Binet, L., Chew, L.P., Zhang, L., Cristina, L.M., Tick, L., Schiavi, L.B., Wong, L.L.L., Borges, L., Botha, L., Capiau, L., Timmermans, L., Lopez, L.E., Ria, L., Blasco, L.M., Guzman, L.A., Cervera, L.F., Isabelle, M., Bosch, M.M., de los Rios Ibarra, M., Fernandez, M.N., Carrier, M., Barrionuevo, M.R., Gamba, M.A.A., Cattaneo, M., Moia, M., Bowers, M., Chetanachan, M., Berli, M.A., Fixley, M., Faghih, M., Stuecker, M., Schul, M., Banyai, M., Koretzky, M., Myriam, M., Gaffney, M.E., Hirano, M., Kanemoto, M., Nakamura, M., Tahar, M., Emmanuel, M., Kovacs, M., Leahy, M., Levy, M., Munch, M., Olsen, M., De Pauw, M., Gustin, M., Van Betsbrugge, M., Boyarkin, M., Homza, M., Koto, M., Abdool-Gaffar, M., Nagib, M.A.F., Dessoki, M.E., Khan, M., Mohamed, M., Kim, M.H., Lee, M.-., Soliman, M., Ahmed, M.S., Bary, M.S.A., Moustafa, M.A., Hameed, M., Kanko, M., Majumder, M., Zubareva, N., Mumoli, N., Abdullah, N.A.N., Makruasi, N., Paruk, N., Kanitsap, N., Duda, N., Nordin, N., Nyvad, O., Barbarash, O., Gurbuz, O., Vilamajo, O.G., Flores, O.N., Gur, O., Oto, O., Marchena, P.J., Carroll, P., Lang, P., Maccallum, P., von Bilderling, P.B., Blombery, P., Verhamme, P., Jansky, P., Bernadette, P., De Vleeschauwer, P., Hainaut, P., Ferrini, P.M., Iamsai, P., Christian, P., Viboonjuntra, P., Rojnuckarin, P., Ho, P., Mutirangura, P., Wells, R., Martinez, R., Miranda, R.T., Kroening, R., Ratsela, R., Reyes, R.L., de Leon, R.F.D., Wong, R.S.M., Alikhan, R., Jerwan-Keim, R., Otero, R., Murena-Schmidt, R., Canevascini, R., Ferkl, R., White, R., Van Herreweghe, R., Santoro, R., Klamroth, R., Mendes, R., Prosecky, R., Cappelli, R., Spacek, R., Singh, R., Griffin, S., S. H., N., Chunilal, S., Middeldorp, S., Nakazawa, S., Toh, S.G., Christophe, S., Isbir, S., Raymundo, S., Ting, S.K., Motte, S., Aktogu, S.O., Donders, S., Cha, S.I., Nam, S.-., Marie-Antoinette, S.-., Maasdorp, S., Sun, S., Wang, S., Essameldin, S.M., Sholkamy, S.M., Kuki, S., Yoshida, S., Matsuoka, S., Mcrae, S., Watt, S., Patanasing, S., Jean-Leopold, S.-., Wongkhantee, S., Bang, S.-., Testa, S., Zemek, S., Behrens, S., Dominique, S., Mellor, S., Singh, S.S.G., Datta, S., Chayangsu, S., Solymoss, S., Everington, T., Abdel-Azim, T.A.A., Suwanban, T., Adademir, T., Hart, T., Beatrice, T., Luvhengo, T., Horacek, T., Zeller, T., Boussy, T., Reynolds, T., Biss, T., Chao, T.-., Casabella, T.S., Onodera, T., Numbenjapon, T., Gerdes, V., Cech, V., Krasavin, V., Tolstikhin, V., Bax, W.A., Malek, W.F.A., W. K., H., Pharr, W., Jiang, W., Lin, W.-., Zhang, W., Tseng, W.-., Lai, W.-., De Backer, W., Haverkamp, W., Yoshida, W., Korte, W., Choi, W., Kim, Y.-., Tanabe, Y., Ohnuma, Y., Mun, Y.-., Balthazar, Y., Park, Y., Shibata, Y., Burov, Y., Subbotin, Y., Coufal, Z., Yang, Z., Jing, Z., Pulmonary Medicine, Clinical Genetics, Internal Medicine, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, ACS - Diabetes & metabolism, Weitz, J, Haas, S, Ageno, W, Goldhaber, S, Turpie, A, Goto, S, Angchaisuksiri, P, Nielsen, J, Kayani, G, Farjat, A, Schellong, S, Bounameaux, H, Mantovani, L, Prandoni, P, Kakkar, A, GARFIELD-VTE, I, Falanga, A, MUMC+: HVC Trombosezorg (8), RS: Carim - B04 Clinical thrombosis and Haemostasis, MUMC+: HVC Pieken Trombose (9), MUMC+: MA Alg Interne Geneeskunde (9), Interne Geneeskunde, and Biochemie

Subjects
Male, Time Factors, Settore MED/09 - Medicina Interna, 030204 cardiovascular system & hematology, PROPHYLAXIS, 0302 clinical medicine, Recurrence, Risk Factors, Cause of Death, Neoplasms, Prospective Studies, Registries, 030212 general & internal medicine, DEEP-VEIN THROMBOSIS, Cancer, Aged, 80 and over, Venous Thrombosis, Hematology, Incidence (epidemiology), Anticoagulant, Hazard ratio, Middle Aged, Treatment Outcome, Female, CLINICAL-PRACTICE GUIDELINES, Cardiology and Cardiovascular Medicine, Venous thromboembolism, Adult, medicine.medical_specialty, Registry, medicine.drug_class, Hemorrhage, Malignancy, Anticoagulation, Risk Assessment, 03 medical and health sciences, Fibrinolytic Agents, SDG 3 - Good Health and Well-being, Internal medicine, medicine, MANAGEMENT, Humans, cardiovascular diseases, Aged, business.industry, Anticoagulants, medicine.disease, Confidence interval, RISK-FACTORS, Observational study, Pulmonary Embolism, business
Abstract

Venous thromboembolism (VTE) is common in cancer patients and is an important cause of morbidity and mortality. The Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE (ClinicalTrials.gov: NCT02155491) is a prospective, observational study of 10,684 patients with objectively diagnosed VTE from 415 sites in 28 countries. We compared baseline characteristics, VTE treatment patterns, and 1-year outcomes (mortality, recurrent VTE and major bleeding) in 1075 patients with active cancer, 674 patients with a history of cancer, and 8935 patients without cancer. Patients with active cancer and history of cancer were older than cancer-free patients, with median ages of 64.8, 68.9, and 58.4 years, respectively. The most common sites of active cancer were lung (14.5%), colorectal (11.0%), breast (10.6%), and gynaecological (10.3%). Active cancer patients had a higher incidence of upper limb and vena cava thrombosis than cancer-free patients (9.0% vs 4.8% and 5.1% vs 1.4%, respectively), and were more likely to receive parenteral anticoagulation as monotherapy than cancer-free patients (57.8% vs 12.1%), and less likely to receive DOACs (14.2% vs 50.6%). Rates of death, recurrent VTE, and major bleeding were higher in active cancer patients than in cancer-free patients, with hazard ratios (95% confidence intervals) of 14.2 (12.1-16.6), 1.6 (1.2-2.0) and 3.8 (2.9-5.0), respectively. VTE was the second most common cause of death in patients with active cancer or history of cancer. In patients with VTE, those with active cancer are at higher risk of death, recurrence, and major bleeding than those without cancer.

Published
2020

11. Variability of cost trajectories over the last year of life in patients with advanced breast cancer in the Netherlands

Author

Schneider, P.P., Pouwels, X.G.L.V., Passos, V.L., Ramaekers, B.L.T., Geurts, S.M.E., Ibragimova, K.I.E., de Boer, M., Erdkamp, F., Vriens, B.E.P.J., van de Wouw, A.J., den Boer, M.O., Pepels, M.J., Tjan-Heijnen, V.C.G., and Joore, M.A.

Abstract

Objective\ud In breast cancer patients, treatment at the end of life accounts for a major share of medical spending. However, little is known about the variability of cost trajectories between patients. This study aims to identify underlying latent groups of advanced breast cancer patients with similar cost trajectories over the last year before death.\ud \ud Methods\ud Data from deceased advanced breast cancer patients, diagnosed between 2010 and 2017, were retrieved from the Southeast Netherlands Advanced Breast Cancer (SONABRE) Registry. Costs of hospital care over the last twelve months before death were analyzed, and the variability of longitudinal patterns between patients were explored using group-based trajectory modeling. Descriptive statistics and multinomial logistic regression were applied to investigate differences between the identified latent groups.\ud \ud Results\ud We included 558 patients. Over the last twelve months before death, mean hospital costs were €2,255 (SD = €492) per month. Costs increased over the last five months and reached a maximum of €3,614 in the last month of life, driven by hospital admissions, while spending for medication declined over the last three months of life. Based on patients’ individual cost trajectories, we identified six latent groups with distinct longitudinal patterns, of which only two showed a marked increase in costs over the last twelve months before death. Latent groups were constituted of heterogeneous patients, and clinical characteristics explained membership only to a limited extent.\ud \ud Conclusions\ud The average costs of advanced breast cancer patients increased towards the end of life. However, we uncovered several latent groups of patients with divergent cost trajectories, which did not reflect the overall increasing trend. The mechanisms underlying the variability in cost trajectories warrants further research.

Published
2020

13. A randomized phase II study investigating the addition of the specific COX-2 inhibitor celecoxib to docetaxel plus carboplatin as first-line chemotherapy for stage IC to IV epithelial ovarian cancer, Fallopian tube or primary peritoneal carcinomas: the DoCaCel study

Author

Reyners, A. K. L., de Munck, L., Erdkamp, F. L. G., Smit, W. M., Hoekman, K., Lalisang, R. I., de Graaf, H., Wymenga, A. N. M., Polee, M., Hollema, H., van Vugt, M. A. T. M., Schaapveld, M., and Willemse, P. H. B.

Published
2012
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14. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Gligorov, J, Ataseven, B, Verrill, M, de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Lauer, S, Shing, M, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, Weigel, M, Wischnik, A, Wojcinski, S, Ziegler-Lohr, K, Aravantinos, G, Ardavanis, A, Fountzilas, G, Gogas, H, Kakolyris, S, Mavroudis, D, Papadimitriou, C, Papandreou, C, Papazisis, K, Castro, H, Hernandez-Monroy, C, Ngan, R, Yeo, W, Bittner, N, Boer, K, Csejtei, A, Horvath, Z, Kocsis, J, Mangel, L, Mezei, K, Nagy, Z, Szanto, J, Atmakusuma, D, Fadjari, H, Kurnianda, D, Prayogo, N, Tanggo, E, Coate, L, Hennessy, B, Kelly, C, Martin, M, Nasim, S, O'Connor, M, Aieta, M, Allegrini, G, Amadori, D, Bidoli, P, Biti, G, Bordonaro, R, Bottini, A, Carterni, G, Cavanna, L, Cazzaniga, M, Cognetti, F, Contu, A, Cruciani, G, Donadio, M, Falcone, A, Farci, D, Forcignano, R, Frassoldati, A, Gaion, F, Gamucci, T, Giotta, F, Livi, L, Lorusso, V, Maiello, E, Marchetti, P, Mariani, G, Mion, M, Moscetti, L, Musolino, A, Pazzola, A, Pedrazzoli, P, Pigi, A, de Placido, S, Caremoli, E, Santoro, A, Tienghi, A, Ahn, J, Lee, K, Lee, S, Seo, J, Sohn, J, Cesas, A, Juozaityte, E, Cheah, N, Chong, F, Devi, B, Phua, V, Teoh, D, Ching, L, Yusof, M, Corona, J, Dominguez, A, Mendoza, R, Hernandez, C, Ramiro, A, Santos, J, Espinosa, P, Villarreal Garza, C, Errihani, H, Bakker, S, van den Berkmortel, F, Blaisse, R, Huinink, D, van den Bosch, J, Braun, J, Dercksen, M, Droogendijk, H, Erdkamp, F, Haringhuizen, A, de Jongh, F, Kok, T, Los, M, Madretsma, S, Terwogt, J, van der Padt, A, van Rossum-Schornagel, Q, Smilde, T, de Valk, B, van der Velden, A, van Warmerdam, L, van de Wouw, A, North, R, Kersten, C, Mjaaland, I, Wist, E, Aziz, Z, Masood, N, Rashid, K, Shah, M, Alcedo, J, Aleman, D, Neciosup, S, Reategui, R, Valdiviezo, N, Vera, L, Fernando, G, Roque, F, Strebel, H, Krzemieniecki, K, Litwiniuk, M, Mruk, A, Pienkowski, T, Sawrycki, P, Slomian, G, Tomczak, P, Afonso, N, Cardoso, F, Damasceno, M, Nave, M, Badulescu, F, Ciule, L, Curescu, S, Eniu, A, Filip, D, Grecea, D, Jinga, D, Lungulescu, D, Oprean, C, Stanculeanu, D, Turdean, M, Dvornichenko, V, Emelyanov, S, Lichinitser, M, Manikhas, A, Sakaeva, D, Shirinkin, V, Stroyakovskiy, D, Abulkhair, O, Zekri, J, Filipovic, S, Kovcin, V, Nedovic, J, Pesic, J, Vasovic, S, Ng, R, Bystricky, B, Leskova, J, Mardiak, J, Misurova, E, Wagnerova, M, Takac, I, Demetriou, G, Dreosti, L, Govender, P, Jordaan, J, Veersamy, P, Romero, J, Lopez, N, Arias, C, Chacon, J, Aramburo, A, Morales, L, Garcia, M, Estevez, L, Garcia-Palomo Perez, A, Garcia Saenz, J, Garcia Sanchis, L, Cubells, L, Cortijo, L, Santiago, S, De Aranguiz, B, Manas, J, Gallego, P, Cussac, A, Ferrandiz, C, Garrido, M, Alvarez, P, Vega, J, Del Prado, P, Janez, N, Murillo, S, Rosales, A, Jaso, L, Fernandez, I, Martorell, A, Carrion, R, Simon, S, Alcibar, A, Lorenzo, J, Garcia, V, Asensio, T, Maicas, M, Villanueva Silva, M, Killander, F, Svensson, J, Fehr, M, Hauser, N, Muller, A, Pagani, O, Passmann-Kegel, H, Popescu, R, Rabaglio, M, Rauch, D, Schlatter, C, Zaman, K, Chang, T, Huang, C, Wang, H, Yu, J, Bandidwattanawong, C, Maneechavakajorn, J, Seetalarom, K, Dejthevaporn, T, Somwangprasert, A, Vongsaisuwon, M, Akbulut, H, Altundag, K, Arican, A, Bozcuk, H, Eralp, Y, Idris, M, Isikdogan, A, Senol, C, Sevinc, A, Uygun, K, Yucel, E, Yucel, I, Yumuk, F, Shparyk, Y, Voitko, N, Jaloudi, M, Adams, J, Agrawal, R, Ahmed, S, Alhasso, A, Allerton, R, Anwar, S, Archer, C, Ashford, R, Barraclough, L, Bertelli, G, Bishop, J, Branson, T, Butt, M, Chakrabarti, A, Chakraborti, P, Churn, M, Crowley, C, Davis, R, Dhadda, A, Eldeeb, H, Fraser, J, Hall, J, Hickish, T, Hogg, M, Howe, T, Joffe, J, Kelleher, M, Kelly, S, Kendall, A, Kristeleit, H, Lumsden, G, Macmillan, C, Macpherson, I, Malik, Z, Mithal, N, Neal, A, Panwar, U, Proctor, A, Proctor, S, Raj, S, Rehman, S, Sandri, I, Scatchard, K, Sherwin, E, Sims, E, Singer, J, Smith, S, Tahir, S, Taylor, W, Tsalic, M, Wardley, A, Waters, S, Wheatley, D, Wright, K, Yuille, F, Alonso, I, Artagaveytia, N, Rodriguez, R, Arbona, E, Garcia, Y, Lion, L, Marcano, D, Van Thuan, T, Gligorov J., Ataseven B., Verrill M., de Laurentiis M., Jung K. H., Azim H. A., Al-Sakaff N., Lauer S., Shing M., Pivot X., Koroveshi D., Bouzid K., Casalnuovo M., Cascallar D., Korbenfeld E. P., Bastick P., Beith J., Colosimo M., Friedlander M., Ganju V., Green M., Patterson K., Redfern A., Richardson G., Ceric T., Gordana K., Beato C. A., Ferrari M., Hegg R., Helena V., Ismael G. F., Lessa A. E., Mano M., Morelle A., Nogueira J. A., Timcheva K., Tomova A., Tsakova M., Zlatareva-Petrova A., Asselah J., Assi H., Brezden-Masley C., Chia S., Freedman O., Harb M., Joy A. A., Kulkarni S., Prady C., Gaete A. A. A., Matamala L., Torres R., Yanez E., Franco S., Urrego M., Gugic D., Vrbanec D., Melichar B., Prausova J., Vyzula R., Pilarte R. G., Leon M. I., Munoz R., Ramos G., Azeem H. A., Aziz A. A., El Zawahry H., Osegueda F. R., Alexandre J., Artignan X., Barletta H., Beguier E., Berdah J. -F., Marty C. B., Bollet M., Bourgeois H., Bressac C., Burki F., Campone M., Coeffic D., Cojocarasu O. Z., Dagada C., Dalenc F., Del Piano F., Desauw C., Desmoulins I., Dohollou N., Egreteau J., Ferrero J. -M., Foa C., Garidi R., Gasnault L., Guardiola E., Hamizi S., Jarcau R., Jacquin J. -P., Jaubert D., Jolimoy G., Mineur H. L., Largillier R., Leduc B., Martin P., Melis A., Monge J., Moullet I., Mousseau M., Nguyen S., Orfeuvre H., Petit T., Priou F., Bach I. S., Simon H., Stefani L., Uwer L., Youssef A., Aktas B., von der Assen A., Augustin D., Balser C., Bauer L. -E., Bechtner C., Beyer G., Brucker C., Buckner U., Busch S., Christensen B., Deryal M., Farrokh A., Faust E., Friedrichs K., Graf H., Griesshammer M., Grischke E. -M., Hanle C., Heider A., Henschen S., Hesse T., Jackisch C., Kisro J., Kohler A., Kuemmel S., Lampe D., Lantzsch T., Latos K., Lex B., Liedtke C., Luedders D., Maintz C., Muller V., Overkamp F., Park-Simon T. -W., Paul M., Prechtl A., Ringsdorf U., Runnebaum I., Ruth S., Salat C., Scheffen I., Schilling J., Schmatloch S., Schmidt M., Schneeweiss A., Schrader I., Seipelt G., Simon E., Stefek A., Stickeler E., Thill M., Tio J., Tuczek A., Warm M., Weigel M., Wischnik A., Wojcinski S., Ziegler-Lohr K., Aravantinos G., Ardavanis A., Fountzilas G., Gogas H., Kakolyris S., Mavroudis D., Papadimitriou C., Papandreou C., Papazisis K., Castro H., Hernandez-Monroy C. E., Ngan R., Yeo W., Bittner N., Boer K., Csejtei A., Horvath Z., Kocsis J., Mangel L. C., Mezei K., Nagy Z., Szanto J., Atmakusuma D., Fadjari H., Kurnianda D., Prayogo N., Tanggo E. H., Coate L., Hennessy B., Kelly C., Martin M., Nasim S., O'Connor M., Aieta M., Allegrini G., Amadori D., Bidoli P., Biti G., Bordonaro R., Bottini A., Carterni G., Cavanna L., Cazzaniga M., Cognetti F., Contu A., Cruciani G., Donadio M., Falcone A., Farci D., Forcignano R. C., Frassoldati A., Gaion F., Gamucci T., Giotta F., Livi L., Lorusso V., Maiello E., Marchetti P., Mariani G., Mion M., Moscetti L., Musolino A., Pazzola A., Pedrazzoli P., Pigi A., de Placido S., Caremoli E. R., Santoro A., Tienghi A., Ahn J. -S., Lee K. S., Lee S. H., Seo J. H., Sohn J. -H., Cesas A., Juozaityte E., Cheah N. L. C., Chong F. L. T., Devi B. C. R., Phua V., Teoh D., Ching L. W., Yusof M., Corona J., Dominguez A., Mendoza R. L. G., Hernandez C. A., Ramiro A. J., Santos J. M., Espinosa P. M., Villarreal Garza C. M., Errihani H., Bakker S., van den Berkmortel F., Blaisse R. J. B., Huinink D. T. B., van den Bosch J., Braun J. J., Dercksen M. W., Droogendijk H., Erdkamp F., Haringhuizen A., de Jongh F. E., Kok T. C., Los M., Madretsma S., Terwogt J. M. M., van der Padt A., van Rossum-Schornagel Q. C., Smilde T. J., de Valk B., van der Velden A., van Warmerdam L., van de Wouw A. J., North R., Kersten C., Mjaaland I., Wist E., Aziz Z., Masood N., Rashid K., Shah M., Alcedo J. C., Aleman D., Neciosup S., Reategui R., Valdiviezo N., Vera L., Fernando G., Roque F., Strebel H. M., Krzemieniecki K., Litwiniuk M., Mruk A., Pienkowski T., Sawrycki P., Slomian G., Tomczak P., Afonso N., Cardoso F., Damasceno M., Nave M., Badulescu F., Ciule L., Curescu S., Eniu A., Filip D., Grecea D., Jinga D. -C., Lungulescu D., Oprean C. M., Stanculeanu D. L., Turdean M., Dvornichenko V., Emelyanov S., Lichinitser M., Manikhas A., Sakaeva D., Shirinkin V., Stroyakovskiy D., Abulkhair O., Zekri J., Filipovic S., Kovcin V., Nedovic J., Pesic J., Vasovic S., Ng R., Bystricky B., Leskova J., Mardiak J., Misurova E., Wagnerova M., Takac I., Demetriou G. S., Dreosti L., Govender P., Jordaan J. P., Veersamy P., Romero J. L. A., Lopez N. B., Arias C. C., Chacon J., Aramburo A. F., Morales L. A. F., Garcia M., Estevez L. G., Garcia-Palomo Perez A., Garcia Saenz J. A., Garcia Sanchis L., Cubells L. G., Cortijo L. G., Santiago S. G., De Aranguiz B. H. F., Manas J. J. I., Gallego P. J., Cussac A. L., Ferrandiz C. L., Garrido M. L., Alvarez P. L., Vega J. M. L., Del Prado P. M., Janez N. M., Murillo S. M., Rosales A. M., Jaso L. M., Fernandez I. P., Martorell A. P., Carrion R. P., Simon S. P., Alcibar A. P., Lorenzo J. P., Garcia V. Q., Asensio T. R. Y. C., Maicas M. D. T., Villanueva Silva M. J., Killander F., Svensson J. H., Fehr M., Hauser N., Muller A., Pagani O., Passmann-Kegel H., Popescu R., Rabaglio M., Rauch D., Schlatter C., Zaman K., Chang T. -W., Huang C. -S., Wang H. -C., Yu J. -C., Bandidwattanawong C., Maneechavakajorn J., Seetalarom K., Dejthevaporn T. S., Somwangprasert A., Vongsaisuwon M., Akbulut H., Altundag K., Arican A., Bozcuk H., Eralp Y., Idris M., Isikdogan A., Senol C. H., Sevinc A., Uygun K., Yucel E., Yucel I., Yumuk F., Shparyk Y., Voitko N., Jaloudi M., Adams J., Agrawal R., Ahmed S., Alhasso A., Allerton R., Anwar S., Archer C., Ashford R., Barraclough L., Bertelli G., Bishop J., Branson T., Butt M., Chakrabarti A., Chakraborti P., Churn M., Crowley C., Davis R., Dhadda A., Eldeeb H., Fraser J., Hall J., Hickish T., Hogg M., Howe T., Joffe J., Kelleher M., Kelly S., Kendall A., Kristeleit H., Lumsden G., Macmillan C., MacPherson I., Malik Z., Mithal N., Neal A., Panwar U., Proctor A., Proctor S. J., Raj S., Rehman S., Sandri I., Scatchard K., Sherwin E., Sims E., Singer J., Smith S., Tahir S., Taylor W., Tsalic M., Wardley A., Waters S., Wheatley D., Wright K., Yuille F., Alonso I., Artagaveytia N., Rodriguez R., Arbona E., Garcia Y., Lion L., Marcano D., Van Thuan T., Gligorov, J, Ataseven, B, Verrill, M, de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Lauer, S, Shing, M, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, Weigel, M, Wischnik, A, Wojcinski, S, Ziegler-Lohr, K, Aravantinos, G, Ardavanis, A, Fountzilas, G, Gogas, H, Kakolyris, S, Mavroudis, D, Papadimitriou, C, Papandreou, C, Papazisis, K, Castro, H, Hernandez-Monroy, C, Ngan, R, Yeo, W, Bittner, N, Boer, K, Csejtei, A, Horvath, Z, Kocsis, J, Mangel, L, Mezei, K, Nagy, Z, Szanto, J, Atmakusuma, D, Fadjari, H, Kurnianda, D, Prayogo, N, Tanggo, E, Coate, L, Hennessy, B, Kelly, C, Martin, M, Nasim, S, O'Connor, M, Aieta, M, Allegrini, G, Amadori, D, Bidoli, P, Biti, G, Bordonaro, R, Bottini, A, Carterni, G, Cavanna, L, Cazzaniga, M, Cognetti, F, Contu, A, Cruciani, G, Donadio, M, Falcone, A, Farci, D, Forcignano, R, Frassoldati, A, Gaion, F, Gamucci, T, Giotta, F, Livi, L, Lorusso, V, Maiello, E, Marchetti, P, Mariani, G, Mion, M, Moscetti, L, Musolino, A, Pazzola, A, Pedrazzoli, P, Pigi, A, de Placido, S, Caremoli, E, Santoro, A, Tienghi, A, Ahn, J, Lee, K, Lee, S, Seo, J, Sohn, J, Cesas, A, Juozaityte, E, Cheah, N, Chong, F, Devi, B, Phua, V, Teoh, D, Ching, L, Yusof, M, Corona, J, Dominguez, A, Mendoza, R, Hernandez, C, Ramiro, A, Santos, J, Espinosa, P, Villarreal Garza, C, Errihani, H, Bakker, S, van den Berkmortel, F, Blaisse, R, Huinink, D, van den Bosch, J, Braun, J, Dercksen, M, Droogendijk, H, Erdkamp, F, Haringhuizen, A, de Jongh, F, Kok, T, Los, M, Madretsma, S, Terwogt, J, van der Padt, A, van Rossum-Schornagel, Q, Smilde, T, de Valk, B, van der Velden, A, van Warmerdam, L, van de Wouw, A, North, R, Kersten, C, Mjaaland, I, Wist, E, Aziz, Z, Masood, N, Rashid, K, Shah, M, Alcedo, J, Aleman, D, Neciosup, S, Reategui, R, Valdiviezo, N, Vera, L, Fernando, G, Roque, F, Strebel, H, Krzemieniecki, K, Litwiniuk, M, Mruk, A, Pienkowski, T, Sawrycki, P, Slomian, G, Tomczak, P, Afonso, N, Cardoso, F, Damasceno, M, Nave, M, Badulescu, F, Ciule, L, Curescu, S, Eniu, A, Filip, D, Grecea, D, Jinga, D, Lungulescu, D, Oprean, C, Stanculeanu, D, Turdean, M, Dvornichenko, V, Emelyanov, S, Lichinitser, M, Manikhas, A, Sakaeva, D, Shirinkin, V, Stroyakovskiy, D, Abulkhair, O, Zekri, J, Filipovic, S, Kovcin, V, Nedovic, J, Pesic, J, Vasovic, S, Ng, R, Bystricky, B, Leskova, J, Mardiak, J, Misurova, E, Wagnerova, M, Takac, I, Demetriou, G, Dreosti, L, Govender, P, Jordaan, J, Veersamy, P, Romero, J, Lopez, N, Arias, C, Chacon, J, Aramburo, A, Morales, L, Garcia, M, Estevez, L, Garcia-Palomo Perez, A, Garcia Saenz, J, Garcia Sanchis, L, Cubells, L, Cortijo, L, Santiago, S, De Aranguiz, B, Manas, J, Gallego, P, Cussac, A, Ferrandiz, C, Garrido, M, Alvarez, P, Vega, J, Del Prado, P, Janez, N, Murillo, S, Rosales, A, Jaso, L, Fernandez, I, Martorell, A, Carrion, R, Simon, S, Alcibar, A, Lorenzo, J, Garcia, V, Asensio, T, Maicas, M, Villanueva Silva, M, Killander, F, Svensson, J, Fehr, M, Hauser, N, Muller, A, Pagani, O, Passmann-Kegel, H, Popescu, R, Rabaglio, M, Rauch, D, Schlatter, C, Zaman, K, Chang, T, Huang, C, Wang, H, Yu, J, Bandidwattanawong, C, Maneechavakajorn, J, Seetalarom, K, Dejthevaporn, T, Somwangprasert, A, Vongsaisuwon, M, Akbulut, H, Altundag, K, Arican, A, Bozcuk, H, Eralp, Y, Idris, M, Isikdogan, A, Senol, C, Sevinc, A, Uygun, K, Yucel, E, Yucel, I, Yumuk, F, Shparyk, Y, Voitko, N, Jaloudi, M, Adams, J, Agrawal, R, Ahmed, S, Alhasso, A, Allerton, R, Anwar, S, Archer, C, Ashford, R, Barraclough, L, Bertelli, G, Bishop, J, Branson, T, Butt, M, Chakrabarti, A, Chakraborti, P, Churn, M, Crowley, C, Davis, R, Dhadda, A, Eldeeb, H, Fraser, J, Hall, J, Hickish, T, Hogg, M, Howe, T, Joffe, J, Kelleher, M, Kelly, S, Kendall, A, Kristeleit, H, Lumsden, G, Macmillan, C, Macpherson, I, Malik, Z, Mithal, N, Neal, A, Panwar, U, Proctor, A, Proctor, S, Raj, S, Rehman, S, Sandri, I, Scatchard, K, Sherwin, E, Sims, E, Singer, J, Smith, S, Tahir, S, Taylor, W, Tsalic, M, Wardley, A, Waters, S, Wheatley, D, Wright, K, Yuille, F, Alonso, I, Artagaveytia, N, Rodriguez, R, Arbona, E, Garcia, Y, Lion, L, Marcano, D, Van Thuan, T, Gligorov J., Ataseven B., Verrill M., de Laurentiis M., Jung K. H., Azim H. A., Al-Sakaff N., Lauer S., Shing M., Pivot X., Koroveshi D., Bouzid K., Casalnuovo M., Cascallar D., Korbenfeld E. P., Bastick P., Beith J., Colosimo M., Friedlander M., Ganju V., Green M., Patterson K., Redfern A., Richardson G., Ceric T., Gordana K., Beato C. A., Ferrari M., Hegg R., Helena V., Ismael G. F., Lessa A. E., Mano M., Morelle A., Nogueira J. A., Timcheva K., Tomova A., Tsakova M., Zlatareva-Petrova A., Asselah J., Assi H., Brezden-Masley C., Chia S., Freedman O., Harb M., Joy A. A., Kulkarni S., Prady C., Gaete A. A. A., Matamala L., Torres R., Yanez E., Franco S., Urrego M., Gugic D., Vrbanec D., Melichar B., Prausova J., Vyzula R., Pilarte R. G., Leon M. I., Munoz R., Ramos G., Azeem H. A., Aziz A. A., El Zawahry H., Osegueda F. R., Alexandre J., Artignan X., Barletta H., Beguier E., Berdah J. -F., Marty C. B., Bollet M., Bourgeois H., Bressac C., Burki F., Campone M., Coeffic D., Cojocarasu O. Z., Dagada C., Dalenc F., Del Piano F., Desauw C., Desmoulins I., Dohollou N., Egreteau J., Ferrero J. -M., Foa C., Garidi R., Gasnault L., Guardiola E., Hamizi S., Jarcau R., Jacquin J. -P., Jaubert D., Jolimoy G., Mineur H. L., Largillier R., Leduc B., Martin P., Melis A., Monge J., Moullet I., Mousseau M., Nguyen S., Orfeuvre H., Petit T., Priou F., Bach I. S., Simon H., Stefani L., Uwer L., Youssef A., Aktas B., von der Assen A., Augustin D., Balser C., Bauer L. -E., Bechtner C., Beyer G., Brucker C., Buckner U., Busch S., Christensen B., Deryal M., Farrokh A., Faust E., Friedrichs K., Graf H., Griesshammer M., Grischke E. -M., Hanle C., Heider A., Henschen S., Hesse T., Jackisch C., Kisro J., Kohler A., Kuemmel S., Lampe D., Lantzsch T., Latos K., Lex B., Liedtke C., Luedders D., Maintz C., Muller V., Overkamp F., Park-Simon T. -W., Paul M., Prechtl A., Ringsdorf U., Runnebaum I., Ruth S., Salat C., Scheffen I., Schilling J., Schmatloch S., Schmidt M., Schneeweiss A., Schrader I., Seipelt G., Simon E., Stefek A., Stickeler E., Thill M., Tio J., Tuczek A., Warm M., Weigel M., Wischnik A., Wojcinski S., Ziegler-Lohr K., Aravantinos G., Ardavanis A., Fountzilas G., Gogas H., Kakolyris S., Mavroudis D., Papadimitriou C., Papandreou C., Papazisis K., Castro H., Hernandez-Monroy C. E., Ngan R., Yeo W., Bittner N., Boer K., Csejtei A., Horvath Z., Kocsis J., Mangel L. C., Mezei K., Nagy Z., Szanto J., Atmakusuma D., Fadjari H., Kurnianda D., Prayogo N., Tanggo E. H., Coate L., Hennessy B., Kelly C., Martin M., Nasim S., O'Connor M., Aieta M., Allegrini G., Amadori D., Bidoli P., Biti G., Bordonaro R., Bottini A., Carterni G., Cavanna L., Cazzaniga M., Cognetti F., Contu A., Cruciani G., Donadio M., Falcone A., Farci D., Forcignano R. C., Frassoldati A., Gaion F., Gamucci T., Giotta F., Livi L., Lorusso V., Maiello E., Marchetti P., Mariani G., Mion M., Moscetti L., Musolino A., Pazzola A., Pedrazzoli P., Pigi A., de Placido S., Caremoli E. R., Santoro A., Tienghi A., Ahn J. -S., Lee K. S., Lee S. H., Seo J. H., Sohn J. -H., Cesas A., Juozaityte E., Cheah N. L. C., Chong F. L. T., Devi B. C. R., Phua V., Teoh D., Ching L. W., Yusof M., Corona J., Dominguez A., Mendoza R. L. G., Hernandez C. A., Ramiro A. J., Santos J. M., Espinosa P. M., Villarreal Garza C. M., Errihani H., Bakker S., van den Berkmortel F., Blaisse R. J. B., Huinink D. T. B., van den Bosch J., Braun J. J., Dercksen M. W., Droogendijk H., Erdkamp F., Haringhuizen A., de Jongh F. E., Kok T. C., Los M., Madretsma S., Terwogt J. M. M., van der Padt A., van Rossum-Schornagel Q. C., Smilde T. J., de Valk B., van der Velden A., van Warmerdam L., van de Wouw A. J., North R., Kersten C., Mjaaland I., Wist E., Aziz Z., Masood N., Rashid K., Shah M., Alcedo J. C., Aleman D., Neciosup S., Reategui R., Valdiviezo N., Vera L., Fernando G., Roque F., Strebel H. M., Krzemieniecki K., Litwiniuk M., Mruk A., Pienkowski T., Sawrycki P., Slomian G., Tomczak P., Afonso N., Cardoso F., Damasceno M., Nave M., Badulescu F., Ciule L., Curescu S., Eniu A., Filip D., Grecea D., Jinga D. -C., Lungulescu D., Oprean C. M., Stanculeanu D. L., Turdean M., Dvornichenko V., Emelyanov S., Lichinitser M., Manikhas A., Sakaeva D., Shirinkin V., Stroyakovskiy D., Abulkhair O., Zekri J., Filipovic S., Kovcin V., Nedovic J., Pesic J., Vasovic S., Ng R., Bystricky B., Leskova J., Mardiak J., Misurova E., Wagnerova M., Takac I., Demetriou G. S., Dreosti L., Govender P., Jordaan J. P., Veersamy P., Romero J. L. A., Lopez N. B., Arias C. C., Chacon J., Aramburo A. F., Morales L. A. F., Garcia M., Estevez L. G., Garcia-Palomo Perez A., Garcia Saenz J. A., Garcia Sanchis L., Cubells L. G., Cortijo L. G., Santiago S. G., De Aranguiz B. H. F., Manas J. J. I., Gallego P. J., Cussac A. L., Ferrandiz C. L., Garrido M. L., Alvarez P. L., Vega J. M. L., Del Prado P. M., Janez N. M., Murillo S. M., Rosales A. M., Jaso L. M., Fernandez I. P., Martorell A. P., Carrion R. P., Simon S. P., Alcibar A. P., Lorenzo J. P., Garcia V. Q., Asensio T. R. Y. C., Maicas M. D. T., Villanueva Silva M. J., Killander F., Svensson J. H., Fehr M., Hauser N., Muller A., Pagani O., Passmann-Kegel H., Popescu R., Rabaglio M., Rauch D., Schlatter C., Zaman K., Chang T. -W., Huang C. -S., Wang H. -C., Yu J. -C., Bandidwattanawong C., Maneechavakajorn J., Seetalarom K., Dejthevaporn T. S., Somwangprasert A., Vongsaisuwon M., Akbulut H., Altundag K., Arican A., Bozcuk H., Eralp Y., Idris M., Isikdogan A., Senol C. H., Sevinc A., Uygun K., Yucel E., Yucel I., Yumuk F., Shparyk Y., Voitko N., Jaloudi M., Adams J., Agrawal R., Ahmed S., Alhasso A., Allerton R., Anwar S., Archer C., Ashford R., Barraclough L., Bertelli G., Bishop J., Branson T., Butt M., Chakrabarti A., Chakraborti P., Churn M., Crowley C., Davis R., Dhadda A., Eldeeb H., Fraser J., Hall J., Hickish T., Hogg M., Howe T., Joffe J., Kelleher M., Kelly S., Kendall A., Kristeleit H., Lumsden G., Macmillan C., MacPherson I., Malik Z., Mithal N., Neal A., Panwar U., Proctor A., Proctor S. J., Raj S., Rehman S., Sandri I., Scatchard K., Sherwin E., Sims E., Singer J., Smith S., Tahir S., Taylor W., Tsalic M., Wardley A., Waters S., Wheatley D., Wright K., Yuille F., Alonso I., Artagaveytia N., Rodriguez R., Arbona E., Garcia Y., Lion L., Marcano D., and Van Thuan T.

Abstract

Aim To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). Methods Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. Results In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. Conclusion SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.

Published
2017

19. PCN517 VARIABILITY OF COST TRAJECTORIES OVER THE LAST YEAR OF LIFE; AN EXPLORATIVE STUDY IN PATIENTS WITH ADVANCED BREAST CANCER IN THE NETHERLANDS

Author

Schneider, P., primary, Pouwels, X., additional, Lima Passos, V., additional, Ramaekers, B., additional, Geurts, S.M.E., additional, Ibragimova, K.I.E., additional, de Boer, M., additional, Erdkamp, F., additional, Vriens, B.E.P.J., additional, van de Wouw, A.J., additional, den Boer, M.O., additional, Pepels, M.J., additional, Tjan-Heijnen, V.C.G., additional, and Joore, M., additional

Published
2019
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20. The relative effectiveness of eribulin for advanced breast cancer treatment: a study of the southeast Netherlands advanced breast cancer registry

Author

Pouwels, X. G. L. V., primary, Geurts, S. M. E., additional, Ramaekers, B. L. T., additional, Erdkamp, F., additional, Vriens, B. E. P. J., additional, Aaldering, K. N. A., additional, van de Wouw, A. J., additional, Dercksen, M. W., additional, Smilde, T. J., additional, Peters, N. A. J. B., additional, Riel, J. M. van, additional, Pepels, M. J., additional, Heijnen-Mommers, J., additional, Joore, M. A., additional, Tjan-Heijnen, V. C. G., additional, and de Boer, M., additional

Published
2019
Full Text
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23. Nationwide comprehensive gastro-intestinal cancer cohorts : The 3P initiative

Author

van den Braak, R. R. J. Coebergh, van Rijssen, L. B., van Kleef, J. J., Vink, G. R., Berbee, M., Henegouwen, M. I. van Berge, Bloemendal, H. J., Bruno, M. J., Burgmans, M. C., Busch, O. R. C., Coene, P. P. L. O., Coupe, V. M. H., Dekker, J. W. T., van Eijck, C. H. J., Elferink, M. A. G., Erdkamp, F. L. G., van Grevenstein, W. M. U., de Groot, J. W. B., van Grieken, N. C. T., de Hingh, I. H. J. T., Hulshof, M. C. C. M., Ijzermans, J. N. M., Kwakkenbos, L., Lemmens, V. E. P. P., Los, M., Meijer, G. A., Molenaar, I. Q., Nieuwenhuijzen, G. A. P., de Noo, M. E., van de Poll-Franse, L. V., Punt, C. J. A., Rietbroek, R. C., Roeloffzen, W. W. H., Rozema, T., Ruurda, J. P., van Sandick, J. W., Schiphorst, A. H. W., Schipper, H., Siersema, P. D., Slingerland, M., Sommeijer, D. W., Spaander, M. C. W., Sprangers, M. A. G., Stockmann, H. B. A. C., Strijker, M., van Tienhoven, G., Timmermans, L. M., Tjin-a-Ton, M. L. R., van der Velden, A. M. T., Verhaar, M. J., Verkooijen, H. M., Vles, W. J., de Vos-Geelen, J. M. P. G. M., Wilmink, J. W., Zimmerman, D. D. E., van Oijen, M. G. H., Koopman, M., Besselink, M. G. H., van Laarhoven, H. W. M., van den Braak, R. R. J. Coebergh, van Rijssen, L. B., van Kleef, J. J., Vink, G. R., Berbee, M., Henegouwen, M. I. van Berge, Bloemendal, H. J., Bruno, M. J., Burgmans, M. C., Busch, O. R. C., Coene, P. P. L. O., Coupe, V. M. H., Dekker, J. W. T., van Eijck, C. H. J., Elferink, M. A. G., Erdkamp, F. L. G., van Grevenstein, W. M. U., de Groot, J. W. B., van Grieken, N. C. T., de Hingh, I. H. J. T., Hulshof, M. C. C. M., Ijzermans, J. N. M., Kwakkenbos, L., Lemmens, V. E. P. P., Los, M., Meijer, G. A., Molenaar, I. Q., Nieuwenhuijzen, G. A. P., de Noo, M. E., van de Poll-Franse, L. V., Punt, C. J. A., Rietbroek, R. C., Roeloffzen, W. W. H., Rozema, T., Ruurda, J. P., van Sandick, J. W., Schiphorst, A. H. W., Schipper, H., Siersema, P. D., Slingerland, M., Sommeijer, D. W., Spaander, M. C. W., Sprangers, M. A. G., Stockmann, H. B. A. C., Strijker, M., van Tienhoven, G., Timmermans, L. M., Tjin-a-Ton, M. L. R., van der Velden, A. M. T., Verhaar, M. J., Verkooijen, H. M., Vles, W. J., de Vos-Geelen, J. M. P. G. M., Wilmink, J. W., Zimmerman, D. D. E., van Oijen, M. G. H., Koopman, M., Besselink, M. G. H., and van Laarhoven, H. W. M.

Published
2018

24. Nationwide comprehensive gastro-intestinal cancer cohorts: The 3P initiative

Author

Cancer, Onderzoek Medische Oncologie, MS Medische Oncologie, MS CGO, Trialbureau Beeld, Epi Kanker Team A, Circulatory Health, JC onderzoeksprogramma Kanker, van den Braak, R. R. J. Coebergh, van Rijssen, L. B., van Kleef, J. J., Vink, G. R., Berbee, M., Henegouwen, M. I. van Berge, Bloemendal, H. J., Bruno, M. J., Burgmans, M. C., Busch, O. R. C., Coene, P. P. L. O., Coupe, V. M. H., Dekker, J. W. T., van Eijck, C. H. J., Elferink, M. A. G., Erdkamp, F. L. G., van Grevenstein, W. M. U., de Groot, J. W. B., van Grieken, N. C. T., de Hingh, I. H. J. T., Hulshof, M. C. C. M., Ijzermans, J. N. M., Kwakkenbos, L., Lemmens, V. E. P. P., Los, M., Meijer, G. A., Molenaar, I. Q., Nieuwenhuijzen, G. A. P., de Noo, M. E., van de Poll-Franse, L. V., Punt, C. J. A., Rietbroek, R. C., Roeloffzen, W. W. H., Rozema, T., Ruurda, J. P., van Sandick, J. W., Schiphorst, A. H. W., Schipper, H., Siersema, P. D., Slingerland, M., Sommeijer, D. W., Spaander, M. C. W., Sprangers, M. A. G., Stockmann, H. B. A. C., Strijker, M., van Tienhoven, G., Timmermans, L. M., Tjin-a-Ton, M. L. R., van der Velden, A. M. T., Verhaar, M. J., Verkooijen, H. M., Vles, W. J., de Vos-Geelen, J. M. P. G. M., Wilmink, J. W., Zimmerman, D. D. E., van Oijen, M. G. H., Koopman, M., Besselink, M. G. H., van Laarhoven, H. W. M., Cancer, Onderzoek Medische Oncologie, MS Medische Oncologie, MS CGO, Trialbureau Beeld, Epi Kanker Team A, Circulatory Health, JC onderzoeksprogramma Kanker, van den Braak, R. R. J. Coebergh, van Rijssen, L. B., van Kleef, J. J., Vink, G. R., Berbee, M., Henegouwen, M. I. van Berge, Bloemendal, H. J., Bruno, M. J., Burgmans, M. C., Busch, O. R. C., Coene, P. P. L. O., Coupe, V. M. H., Dekker, J. W. T., van Eijck, C. H. J., Elferink, M. A. G., Erdkamp, F. L. G., van Grevenstein, W. M. U., de Groot, J. W. B., van Grieken, N. C. T., de Hingh, I. H. J. T., Hulshof, M. C. C. M., Ijzermans, J. N. M., Kwakkenbos, L., Lemmens, V. E. P. P., Los, M., Meijer, G. A., Molenaar, I. Q., Nieuwenhuijzen, G. A. P., de Noo, M. E., van de Poll-Franse, L. V., Punt, C. J. A., Rietbroek, R. C., Roeloffzen, W. W. H., Rozema, T., Ruurda, J. P., van Sandick, J. W., Schiphorst, A. H. W., Schipper, H., Siersema, P. D., Slingerland, M., Sommeijer, D. W., Spaander, M. C. W., Sprangers, M. A. G., Stockmann, H. B. A. C., Strijker, M., van Tienhoven, G., Timmermans, L. M., Tjin-a-Ton, M. L. R., van der Velden, A. M. T., Verhaar, M. J., Verkooijen, H. M., Vles, W. J., de Vos-Geelen, J. M. P. G. M., Wilmink, J. W., Zimmerman, D. D. E., van Oijen, M. G. H., Koopman, M., Besselink, M. G. H., and van Laarhoven, H. W. M.

Published
2018

25. Nationwide comprehensive gastro-intestinal cancer cohorts: The 3P initiative

Author

Coebergh Van Den Braak, R. R. J., Van Rijssen, L. B., Van Kleef, J. J., Vink, G. R., Berbee, M., Van Berge Henegouwen, M. I., Bloemendal, H. J., Bruno, M. J., Burgmans, M. C., Busch, O. R. C., Coene, P. P. L. O., Coupé, V. M. H., Dekker, J. W. T., Van Eijck, C. H. J., Elferink, M. A. G., Erdkamp, F. L. G., Van Grevenstein, W. M. U., De Groot, J. W. B., Van Grieken, N. C. T., De Hingh, I. H. J. T., Hulshof, M. C. C. M., Ijzermans, J. N. M., Kwakkenbos, L., Lemmens, V. E. P. P., Los, M., Meijer, G. A., Molenaar, I. Q., Nieuwenhuijzen, G. A. P., De Noo, M. E., van de Poll-Franse, L.V., Punt, C. J. A., Rietbroek, R. C., Roeloffzen, W. W. H., Rozema, T., Ruurda, J. P., Van Sandick, J. W., Schiphorst, A. H. W., Schipper, H., Siersema, P. D., Slingerland, M., Sommeijer, D. W., Spaander, M. C. W., Sprangers, M. A. G., Stockmann, H. B. A. C., Strijker, M., Van Tienhoven, G., Timmermans, L. M., Tjin-a-ton, M. L. R., Van Der Velden, A. M. T., Verhaar, M. J., Verkooijen, H. M., Vles, W. J., De Vos-geelen, J. M. P. G. M., Wilmink, J. W., Zimmerman, D. D. E., Van Oijen, M. G. H., Koopman, M., Besselink, M. G. H., Van Laarhoven, H. W. M., Coebergh Van Den Braak, R. R. J., Van Rijssen, L. B., Van Kleef, J. J., Vink, G. R., Berbee, M., Van Berge Henegouwen, M. I., Bloemendal, H. J., Bruno, M. J., Burgmans, M. C., Busch, O. R. C., Coene, P. P. L. O., Coupé, V. M. H., Dekker, J. W. T., Van Eijck, C. H. J., Elferink, M. A. G., Erdkamp, F. L. G., Van Grevenstein, W. M. U., De Groot, J. W. B., Van Grieken, N. C. T., De Hingh, I. H. J. T., Hulshof, M. C. C. M., Ijzermans, J. N. M., Kwakkenbos, L., Lemmens, V. E. P. P., Los, M., Meijer, G. A., Molenaar, I. Q., Nieuwenhuijzen, G. A. P., De Noo, M. E., van de Poll-Franse, L.V., Punt, C. J. A., Rietbroek, R. C., Roeloffzen, W. W. H., Rozema, T., Ruurda, J. P., Van Sandick, J. W., Schiphorst, A. H. W., Schipper, H., Siersema, P. D., Slingerland, M., Sommeijer, D. W., Spaander, M. C. W., Sprangers, M. A. G., Stockmann, H. B. A. C., Strijker, M., Van Tienhoven, G., Timmermans, L. M., Tjin-a-ton, M. L. R., Van Der Velden, A. M. T., Verhaar, M. J., Verkooijen, H. M., Vles, W. J., De Vos-geelen, J. M. P. G. M., Wilmink, J. W., Zimmerman, D. D. E., Van Oijen, M. G. H., Koopman, M., Besselink, M. G. H., and Van Laarhoven, H. W. M.

Abstract

Background: The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients.Material and methods: All patients aged 18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future.Results: In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing.Conclusion: A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses

Published
2018

26. The relative effectiveness of eribulin for advanced breast cancer treatment: a study of the southeast Netherlands advanced breast cancer registry.

Author

Pouwels, X. G. L. V., Geurts, S. M. E., Ramaekers, B. L. T., Erdkamp, F., Vriens, B. E. P. J., Aaldering, K. N. A., van de Wouw, A. J., Dercksen, M. W., Smilde, T. J., Peters, N. A. J. B., Riel, J. M. van, Pepels, M. J., Heijnen-Mommers, J., Joore, M. A., Tjan-Heijnen, V. C. G., and de Boer, M.

Subjects
BREAST cancer prognosis, ALGORITHMS, BREAST tumors, CANCER chemotherapy, CONFIDENCE intervals, REPORTING of diseases, MEDICAL practice, TUMOR classification, TREATMENT effectiveness, PROPORTIONAL hazards models, KAPLAN-Meier estimator, ERIBULIN, ODDS ratio
Abstract

Background: Eribulin provided significant overall survival (OS) benefit in heavily pretreated advanced breast cancer patients in the EMBRACE trial. We investigated the use of eribulin in daily clinical practice, the relative effectiveness of eribulin versus non-eribulin chemotherapy, and the safety of eribulin in real-world patients included in the SOutheast Netherlands Advanced BREast cancer (SONABRE) registry. Material and methods: Patients treated with eribulin and eligible patients for eribulin who received a different chemotherapy (i.e., non-eribulin group) in ten hospitals in 2013–2017 were included. A multivariate matching algorithm was applied to correct for differences in baseline characteristics between the groups, including the number of previous treatment lines. Progression-free survival (PFS) and OS of eribulin were compared with the matched non-eribulin group through Kaplan-Meier curves and multivariate Cox proportional hazard models. The occurrence of dose delay and reduction was described. Results: Forty-five patients received eribulin according to its registration criteria and 74 patients were eligible for eribulin but received non-eribulin chemotherapy. Matching increased the similarity in baseline characteristics between the eribulin and non-eribulin groups. Median PFS was 3.5 months (95% confidence interval (CI): 2.7–5.5) in the eribulin group and 3.2 months (95% CI: 2.0–4.8) in the matched non-eribulin group (adjusted hazard ratio (HR): 0.83, 95% CI: 0.49–1.38). Median OS was 5.9 months (95% CI: 4.6–11.0) and 5.2 months (95% CI: 4.6–9.5) in the eribulin and non-eribulin groups, respectively (adjusted HR: 0.66, 95% CI: 0.38–1.13). Dose delay or reduction occurred in 14 patients (31%) receiving eribulin. Conclusions: No difference in PFS and OS was observed between eribulin and non-eribulin treated patients. Eribulin had a manageable toxicity profile. [ABSTRACT FROM AUTHOR]

Published
2020
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27. Impact of sarcopenia on dose limiting toxicities in metastatic colorectal cancer patients (mCRC pts) receiving palliative systemic treatment

Author

Kurk, S., primary, Peeters, P., additional, Stellato, R., additional, Dorresteijn, B., additional, Jourdan, M., additional, Creemers, G.-J., additional, Erdkamp, F., additional, de Jongh, F., additional, Kint, P., additional, Poppema, B., additional, Radema, S., additional, Simkens, L., additional, Tanis, B., additional, Tjin-A-Ton, M., additional, Van der Velden, A., additional, Punt, C.J.A., additional, Koopman, M., additional, and May, A., additional

Published
2017
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28. Efficacy of two times four versus continuous eight cycles of paclitaxel/bevacizumab as first-line chemotherapy in metastatic breast cancer: The Stop&Go study of the Dutch Breast Cancer Research Group (BOOG)

Author

Claessens, A., primary, Bos, M., additional, de Groot, S., additional, van Leeuwen-Stok, E., additional, Lopez-Yurda, M., additional, Honkoop, A., additional, de Graaf, H., additional, van Druten, E., additional, van Warmerdam, L., additional, van der Sangen, M., additional, Tjan-Heijnen, V., additional, and Erdkamp, F., additional

Published
2017
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29. Abstract S1-03: First results from the multicenter phase III DATA study comparing 3 versus 6 years of anastrozole after 2-3 years of tamoxifen in postmenopausal women with hormone receptor-positive early breast cancer

Author

Tjan-Heijnen, VC, primary, Van Hellemond, IE, additional, Peer, PG, additional, Swinkels, AC, additional, Smorenburg, CH, additional, Van der Sangen, M, additional, Kroep, JR, additional, De Graaf, H, additional, Honkoop, AH, additional, Erdkamp, F, additional, Van den Berkmortel, FW, additional, Kitzen, JJ, additional, De Boer, M, additional, De Roos, WK, additional, Linn, SC, additional, Imholz, AL, additional, and Seynaeve, C, additional

Published
2017
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30. Efficacy and safety of ribociclib (LEE011) + letrozole in elderly patients with hormone receptor-positive (HR+), HER2-negative (HER2−) advanced breast cancer (ABC) in MONALEESA-2

Author

Sonke, G.S., primary, Hart, L.L., additional, Campone, M., additional, Erdkamp, F., additional, Janni, W., additional, Verma, S., additional, Villanueva, C., additional, Jakobsen, E., additional, Alba, E., additional, Wist, E., additional, Favret, A.M., additional, Bachelot, T., additional, Hegg, R., additional, Wheatley-Price, P., additional, Souami, F., additional, Sutradhar, S., additional, Miller, M., additional, Germa, C., additional, and Burris, H.A., additional

Published
2017
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32. Dose-dense epirubicin and paclitaxel with G-CSF: a study of decreasing intervals in metastatic breast cancer

Author

Lalisang, R I, Voest, E E, Wils, J A, Nortier, J W, Erdkamp, F L, Hillen, H F, Wals, J, Schouten, H C, and Blijham, G H

Subjects
paclitaxel, combination chemotherapy, breast neoplasms, Regular Article, epirubicin, dose-intensive
Abstract

Anthracyclines and taxanes are very effective drugs in the treatment of advanced breast cancer. With G-CSF support, the dose-intensity of this combination can be increased by reducing the interval between chemotherapy cycles, the so-called ‘shortening of cycle time’. We treated 36 patients with advanced breast cancer in a multicentre phase I/II study. The treatment regimen consisted of epirubicin 75 mg m−2followed by paclitaxel 135 mg m−2(3 h) in combination with G-CSF. At least six patients were treated in each cohort and were evaluated over the first three cycles. Starting at an interval of 14 days, in subsequent cohorts of patients the interval could be shortened to 10 days. An 8-day interval was not feasible due mainly to incomplete neutrophil recovery at the day of the next scheduled cycle. In the 10-day interval cohort it was feasible to increase the paclitaxel dose to 175 mg m−2. The haematological and non-haematological toxicity was relatively mild. No cumulative myelosuppression was observed over at least three consecutive cycles. In combination with G-CSF, epirubicin 75 mg m−2and paclitaxel 175 mg m−2could be safely administered every 10 days over at least three cycles, enabling a dose intensity of 52 and 122 mg m−2per week, respectively. © 2000 Cancer Research Campaign

Published
2000

33. Abstract P1-10-09: Are patients with breast cancer undergoing adjuvant treatment able to follow an exercise program with a moderate to high intensity?

Author

May, AM, primary, Boer, JH, additional, Velthuis, M, additional, Steins Bisschop, CN, additional, Los, M, additional, Erdkamp, F, additional, ten Bokkel Huinink, D, additional, Bloemendal, HJ, additional, Rodenhuis, C, additional, de Roos, MAJ, additional, Verhaar, M, additional, van der Wall, E, additional, and Peeters, PHM, additional

Published
2016
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35. Neutropenia management and granulocyte colony-stimulating factor use in patients with solid tumours receiving myelotoxic chemotherapy-findings from clinical practice

Author

Krzemieniecki, K, Sevelda, P, Erdkamp, F, Smakal, M, Schwenkglenks, Matthias, Puertas, J, Trojan, A, Szabo, Z, Bendall, K, Maenpaa, J, Krzemieniecki, K, Sevelda, P, Erdkamp, F, Smakal, M, Schwenkglenks, Matthias, Puertas, J, Trojan, A, Szabo, Z, Bendall, K, and Maenpaa, J

Abstract

PURPOSE: Clinical practice adherence to current guidelines that recommend primary prophylaxis (PP) with granulocyte colony-stimulating factors (G-CSFs) for patients at high (≥20 %) overall risk of febrile neutropenia (FN) was evaluated. METHODS: Adult patients with breast cancer, non-small cell lung cancer (NSCLC), small-cell lung cancer (SCLC), or ovarian cancer were enrolled if myelotoxic chemotherapy was planned, and they had an investigator-assessed overall FN risk ≥20 %. The primary outcome was FN incidence. RESULTS: In total, 1,347 patients were analysed (breast cancer, n = 829; NSCLC, n = 224; SCLC, n = 137; ovarian cancer, n = 157). Patients with breast cancer exhibited fewer individual FN risk factors than patients with other cancers and were far more likely to have received a high-FN-risk chemotherapy regimen. However, a substantial proportion of all patients (45-80 % across tumour types) did not receive G-CSF PP in alignment with investigator risk assessment and guideline recommendations. FN occurred in 127 patients overall (9 %, 95% confidence interval (CI) 8-11 %), and incidence was higher in SCLC (15 %) than other tumour types (8 % in ovarian and NSCLC, 9 % in breast cancer). A post hoc analysis of G-CSF use indicated that G-CSF prophylaxis was not given within the recommended timeframe after chemotherapy (within 1-3 days) or was not continued across all cycles in 39 % of patients. CONCLUSIONS: FN risk assessment was predominantly based on clinical judgement and individual risk factors, and guidelines regarding G-CSF PP for patients at high FN risk were not consistently followed. Improved education of physicians may enable more fully informed neutropenia management in patients with solid tumours.

Published
2014

39. Use of Liposomal Doxorubicin for Metastatic Breast Cancer Management Across Europe: Results of Eos (European Observatory & Survey)

Author

Lorusso, V., primary, Śmiałowska-Janiszewska, A., additional, Krzemieniecki, K., additional, Novoa, S. Antolín, additional, Mefti, F., additional, Janssen, J., additional, Steger, G.G., additional, Bird, B., additional, Turazza, M., additional, Yosef, H., additional, Albuisson, E., additional, Barnadas, A., additional, Batist, G., additional, De Mouzon, J., additional, Erdkamp, F., additional, Leonard, R., additional, Namer, M., additional, Maumus-Robert, S., additional, and Aapro, M.S., additional

Published
2014
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40. Anthracycline cardiotoxicity in the elderly cancer patient: a SIOG expert position paper

Author

Aapro, M, Bernard-Marty, C, Brain, E G C, Batist, G, Erdkamp, F, Krzemieniecki, K, Leonard, R, Lluch, Jorge A., Monfardini, S, Ryberg, M, Soubeyran, P, Wedding, U, Aapro, M, Bernard-Marty, C, Brain, E G C, Batist, G, Erdkamp, F, Krzemieniecki, K, Leonard, R, Lluch, Jorge A., Monfardini, S, Ryberg, M, Soubeyran, P, and Wedding, U

Abstract

BACKGROUND: Comorbidities and risk factors likely to complicate treatment are common in elderly cancer patients. Anthracyclines remain the cornerstone of first-line therapy for non-Hodgkin's lymphoma (NHL) and metastatic and early breast cancer but can cause congestive heart failure. Elderly patients are at increased risk of this event and measures to reduce it should be considered. METHODS: A committee of experts in breast cancer and NHL met under the auspices of the International Society for Geriatric Oncology to review the literature and make recommendations, based on level of evidence, for the assessment, treatment and monitoring of elderly patients requiring anthracyclines. Results and recommendations: Use of anthracycline-based chemotherapy illustrates many of the dilemmas facing elderly cancer patients. Age in itself should not prevent access to potentially curative treatment or treatment that prolongs life or improves its quality. The risk of cardiotoxicity with conventional anthracyclines is increased by the following factors: an existing or history of heart failure or cardiac dysfunction; hypertension, diabetes and coronary artery disease; older age (independent of comorbidities and performance status); prior treatment with anthracyclines; higher cumulative dose of anthracyclines and short infusion duration. The fact that cumulative and irreversible cardiotoxicity is likely to be greater in this population than among younger patients calls for effective pretreatment screening for risk factors, rigorous monitoring of cardiac function and early intervention. Use of liposomal anthracycline formulations, prolonging the infusion time for conventional anthracyclines and cardioprotective measures should be considered. However, when treatment is being given with curative intent, care should be taken to ensure reduced cardiotoxicity is not achieved at the expense of efficacy.

Published
2011

43. Therapeutic management of metastatic breast cancer across Europe: European observatory and survey (EOS).

Author

Krzemieniecki, K., primary, Antolín Novoa, S., additional, Gozy, M., additional, Schumacher, C., additional, Steger, G. G., additional, Carteni', G., additional, Bird, B. R., additional, Albuisson, E., additional, Barnadas, A., additional, Batist, G., additional, De Mouzon, J., additional, Erdkamp, F., additional, Leonard, R. C. F., additional, Lueck, H., additional, Namer, M., additional, Venturini, M., additional, Ronga, P., additional, Maumus-Robert, S., additional, and Aapro, M. S., additional

Published
2011
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50. Randomized study comparing efficacy/toxicity of monotherapy trastuzumab followed by monotherapy docetaxel at progression, and combination trastuzumab/docetaxel as first-line chemotherapy in HER2-neu positive, metastatic breast cancer (MBC) (HERTAX study)

Author

Bontenbal, M., primary, Seynaeve, C., additional, Stouthard, J., additional, Bos, M., additional, Braun, H., additional, Erdkamp, F. L., additional, van Deijk, G., additional, Schmitz, P., additional, Van der Stelt-Frissen, I., additional, Hamberg, P., additional, and Klijn, J., additional

Published
2008
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