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4 results on '"Oever, D. Ten"'

1. Lipegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in Dutch patients

Author

Timmer-Bonte, J.N.H., Ouwerkerk, J., Faber, L.M., Kerkhofs, L.G., Laterveer, L., Oever, D. Ten, Rees, B.P. van, and Linden, P.W. Van Der

Subjects
Other Research Radboud Institute for Health Sciences [Radboudumc 0]
Abstract

Item does not contain fulltext BACKGROUND: Chemotherapy (CT)-induced neutropenia and febrile neutropenia (FN) can lead to changes in the treatment plan, potentially worsening the cancer outcome. This study evaluated the effect of the glycopegylated granulocyte-colony stimulating factor lipegfilgrastim, used as primary (PP) or secondary prophylaxis (SP), on treatment modifications in adult patients receiving cytotoxic CT with or without biological/targeted therapy (BT) for solid and haematological tumours. METHODS: This phase 4, prospective, observational study was conducted in eight centres in the Netherlands, in 2015-2017. Other study objectives were to characterise the population of cancer patients receiving lipegfilgrastim, to evaluate the incidence of CT-induced neutropenic events, and to assess safety. RESULTS: Of 142 patients, 73.94% had breast cancer and 55.63% received CT in the adjuvant setting. Most patients received lipegfilgrastim as PP (74.65%) and were at low (34.51%) or high risk (39.44%) of FN. CT dose delays were recorded for 22.64% and 36.11% of patients receiving lipegfilgrastim for PP and SP, respectively. CT dose reductions were recorded for 2.11% of patients; no CT dose omissions and one BT dose omission occurred. FN and grade III/IV neutropenia were reported for 5.63% and 9.86% of patients, respectively; associated hospitalisations were rare. The most frequently lipegfilgrastimrelated adverse events (AE) were myalgia, bone pain, and back pain. Serious AEs (55) were reported for 30 (21.13%) patients. There were two deaths, unrelated to lipegfilgrastim administration. CONCLUSION: Administration of lipegfilgrastim in routine clinical practice in the Netherlands results in limited CT/BT dose modifications and low incidence of neutropenic events, with no new safety concerns.

Published
2020

2. Optimal treatment of opioid induced constipation in daily clinical practice - an observational study

Author

Neefjes, E.C.W., Wijngaart, H. van der, Vorst, M.J.D.L. van der, Oever, D. Ten, Vliet, H.J. van der, Beeker, A., Rhodius, C.A., Berg, H.Pieter van den, Berkhof, J., Verheul, H.M.W., Neefjes, E.C.W., Wijngaart, H. van der, Vorst, M.J.D.L. van der, Oever, D. Ten, Vliet, H.J. van der, Beeker, A., Rhodius, C.A., Berg, H.Pieter van den, Berkhof, J., and Verheul, H.M.W.

Abstract

Contains fulltext : 207395.pdf (publisher's version ) (Open Access), BACKGROUND: Opioids are prescribed in over 40% of patients with advanced cancer, but side effects occur frequently. In this study we evaluated the development and treatment of opioid induced constipation (OIC), and OIC resolving effect of methylnaltrexone for different opioid subtypes in daily clinical practice. METHODS: Patients with cancer using opioids were included in a retrospective chart analysis. Baseline characteristics, data on opioid use, laxative use, and OIC were collected. Patients with OIC who were prescribed methylnaltrexone, were included in a prospective observational trial (NCT01955213). RESULTS: Thirty-nine of 327 patients (pts) with cancer who were treated with opioids suffered from OIC (overall prevalence 12%; 95%-CI: 8-15%). The prevalence of OIC was similar in patients treated with oxycodone or fentanyl (12 of 81 pts. vs. 18 of 110 pts., RR 0.9; 95%CI 0.4-2.0). The morphine equivalent daily dose did not significantly differ between opioid subtypes (fentanyl 89 mg (IQR 60-180) vs. oxycodone 40 mg (40-80), P = 0.231). Twenty-two individual patients (7%) were admitted for OIC. Most effective laxatives in admitted patients were enemas, methylnaltrexone, or 4-l polyethylene-glycol solution. In the prospective observational study, the effect of methylnaltrexone could be evaluated in 23 patients. Eleven patients achieved the primary endpoint of >/=2 laxation responses out of the first four doses methylnaltrexone, independent of opioid subtype. CONCLUSIONS: OIC is a burdensome clinical problem independent of opioid subtype. Timely intensification of prophylactic laxative treatment, especially when opioid doses increase, may help to prevent OIC. Clinically overt OIC requires a more intensive laxative regimen with for example methylnaltrexone. TRIAL REGISTRATION: NCT01955213 .

Published
2019

3. Outcome of Nonsurgical Management of Extra-Abdominal, Trunk, and Abdominal Wall Desmoid-Type Fibromatosis: A Population-Based Study in the Netherlands

Author

Broekhoven, D.L.M. van, Verschoor, A.J., Dalen, T. van, Grunhagen, D.J., Bakker, M.A. den, Gelderblom, H., Bovee, J., Haas, R.L.M., Bonenkamp, H., Coevorden, F. van, Oever, D. Ten, Graaf, W.T.A. van der, Flucke, U.E., Pras, E., Reyners, A.K., Westermann, A.M., Oldenburger, F., Verhoef, C., Steeghs, N., Broekhoven, D.L.M. van, Verschoor, A.J., Dalen, T. van, Grunhagen, D.J., Bakker, M.A. den, Gelderblom, H., Bovee, J., Haas, R.L.M., Bonenkamp, H., Coevorden, F. van, Oever, D. Ten, Graaf, W.T.A. van der, Flucke, U.E., Pras, E., Reyners, A.K., Westermann, A.M., Oldenburger, F., Verhoef, C., and Steeghs, N.

Abstract

Contains fulltext : 196649.pdf (publisher's version ) (Open Access), Introduction: Nonsurgical management of patients with desmoid-type fibromatosis (DF) is increasing. This study tries to provide insight on type, usage, and outcome of first-line nonsurgical management strategies. Patients and Methods: From the Dutch Pathology Registry (PALGA), patients with extra-abdominal or trunk/abdominal wall DF, diagnosed between 1993 and 2013, were identified. First-line treatment was analyzed. Best response (BR) using RECIST criteria from start of treatment/surveillance until change of treatment or last follow-up was analyzed. Results: Ninety-one of the 1141 identified patients had first-line nonsurgical management. The percentage of patients treated nonsurgically increased from 0.6% in 1993-1998 to 12.8% in 2009-2013. Thirty-seven patients had surveillance (41%), 35 radiotherapy (38%), and 19 systemic treatment (21%). BR for surveillance was complete response (CR) in 2/37, partial response (PR) in 4/37, stable disease (SD) in 21/37, progressive disease (PD) in 5/37, and unknown in 5/37 patients. BR for radiotherapy was CR in 4/35, PR in 11/35, SD in 16/35, and unknown in 4/35. BR for systemic treatment was CR in 1/19, PR in 1/19, SD in 10/19, PD in 2/19, and unknown in 5/19. Totally, 91% of patients did not progress. Discussion: Given the low percentage (9%) of PD of nonsurgical management, these data can be used in shared decision making with the patient regarding optimal treatment.

Published
2018

4. Translating the ABC-02 trial into daily practice: outcome of palliative treatment in patients with unresectable biliary tract cancer treated with gemcitabine and cisplatin

Author

Dierks, J., Gaspersz, M.P., Belkouz, A., Vugt, J.L.A. van, Coelen, R.J.S., Groot, J.W.B. de, Tije, A.J. Ten, Meijer, W.G., Pruijt, J.F., Voorthuizen, T. van, Spronsen, D.J. van, Rentinck, M., Oever, D. Ten, Smit, J.M., Otten, H.M., Gulik, T.M. van, Wilmink, J.W., Koerkamp, B. Groot, Klumpen, H., Dierks, J., Gaspersz, M.P., Belkouz, A., Vugt, J.L.A. van, Coelen, R.J.S., Groot, J.W.B. de, Tije, A.J. Ten, Meijer, W.G., Pruijt, J.F., Voorthuizen, T. van, Spronsen, D.J. van, Rentinck, M., Oever, D. Ten, Smit, J.M., Otten, H.M., Gulik, T.M. van, Wilmink, J.W., Koerkamp, B. Groot, and Klumpen, H.

Abstract

Contains fulltext : 193309.pdf (publisher's version ) (Open Access), BACKGROUND: Biliary tract cancer (BTC) is an uncommon cancer with an unfavorable prognosis. Since 2010, the standard of care for patients with unresectable BTC is palliative treatment with gemcitabine plus cisplatin, based on the landmark phase III ABC-02 trial. This current study aims to evaluate the efficacy and safety of gemcitabine and cisplatin in patients with unresectable cholangiocarcinoma and gallbladder cancer in daily practice that meet the criteria for the ABC-02 trial in comparison to patients who did not. METHODS: Patients diagnosed with unresectable BTC between 2010 and 2015 with an indication for gemcitabine and cisplatin were included. We divided these patients into three groups: (I) patients who received chemotherapy and met the criteria of the ABC-02 trial, (II) patients who received chemotherapy and did not meet these criteria and (III) patients who had an indication for chemotherapy, but received best supportive care without chemotherapy. Primary outcome was overall survival (OS) and secondary outcome was progression-free survival (PFS). RESULTS: We collected data of 208 patients, of which 138 (66.3%) patients received first line chemotherapy with gemcitabine and cisplatin. Median OS of 69 patients in group I, 63 patients in group II and 65 patients in group III was 9.6 months (95%CI = 6.7-12.5), 9.5 months (95%CI = 7.7-11.3) and 7.6 months (95%CI = 5.0-10.2), respectively. Median PFS was 6.0 months (95%CI = 4.4-7.6) in group I and 5.1 months (95%CI = 3.7-6.5) in group II. Toxicity and number of dose reductions (p = .974) were comparable between the two chemotherapy groups. CONCLUSION: First-line gemcitabine and cisplatin is an effective and safe treatment for patients with unresectable BTC who do not meet the eligibility criteria for the ABC-02 trial. Median OS, PFS and treatment side effects were comparable between the patients who received chemotherapy (group I vs. group II).

Published
2018

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