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1.
Eur J Cancer ; 207: 114153, 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38870747

ABSTRACT

BACKGROUND: Frailty in newly-diagnosed multiple myeloma (NDMM) patients is associated with treatment-related toxicity, which negatively affects health-related quality of life (HRQoL). Currently, data on changes in HRQoL of frail and intermediate-fit MM patients during active treatment and post-treatment follow-up are absent. METHODS: The HOVON123 study (NTR4244) was a phase II trial in which NDMM patients ≥ 75 years were treated with nine dose-adjusted cycles of Melphalan-Prednisone-Bortezomib (MPV). Two HRQoL instruments (EORTC QLQ-C30 and -MY20) were obtained before start of treatment, after 3 and 9 months of treatment and 6 and 12 months after treatment for patients who did not yet start second-line treatment. HRQoL changes and/or differences in frail and intermediate-fit patients (IMWG frailty score) were reported only when both statistically significant (p < 0.005) and clinically relevant (>MID). RESULTS: 137 frail and 71 intermediate-fit patients were included in the analysis. Compliance was high and comparable in both groups. At baseline, frail patients reported lower global health status, lower physical functioning scores and more fatigue and pain compared to intermediate-fit patients. Both groups improved in global health status and future perspective; polyneuropathy complaints worsened over time. Frail patients improved over time in physical functioning, fatigue and pain. Improvement in global health status occurred earlier than in intermediate-fit patients. CONCLUSION: HRQoL improved during anti-myeloma treatment in both intermediate-fit and frail MM patients. In frail patients, improvement occurred faster and, in more domains, which was retained during follow-up. This implies that physicians should not withhold safe and effective therapies from frail patients in fear of HRQoL deterioration.

2.
J Thromb Haemost ; 12(7): 1066-75, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24750783

ABSTRACT

BACKGROUND: Because the number of elderly von Willebrand disease (VWD) patients is increasing, the pathophysiology of aging in VWD has become increasingly relevant. OBJECTIVES: To assess age-related changes in von Willebrand factor (VWF) and factor VIII (FVIII) levels and to compare age-related differences in bleeding phenotype between elderly VWD patients and those < 65 years. We also studied co-morbidity in elderly patients. PATIENTS/METHODS: We included VWD patients with VWF levels ≤ 30 U dL(-1) in the nationwide cross-sectional 'Willebrand in the Netherlands' (WiN-) study. Patients reported bleeding episodes and treatment of VWD in the year preceding inclusion and during life. This was compared between VWD patients older (n = 71) and younger (16-64 years, n = 593) than 65 years. In elderly patients, age-related changes in VWF and FVIII levels were studied longitudinally by including all historically measured levels. All medical records were examined for co-morbidity. RESULTS: In elderly type 1 patients, a decade age increase was associated with a 3.5 U dL(-1) (95% CI, -0.6 to 7.6) VWF:Ag increase and 7.1 U dL(-1) (95% CI, 0.7 to 13.4) FVIII:C increase. This increase was not observed in elderly type 2 patients. Elderly type 2 patients reported significantly more bleeding symptoms in the year preceding inclusion than younger patients (16/27, 59% vs. 87/221, 39%; P = 0.048), which was not observed in type 1 VWD. CONCLUSIONS: von Willebrand factor parameters and bleeding phenotype evolve with increasing age in VWD. VWF and FVIII levels increase with age in type 1 patients with no mitigation in bleeding phenotype. In type 2 patients VWF parameters do not increase with age and in these patients aging is accompanied by increased bleeding.


Subject(s)
Aging , von Willebrand Diseases/physiopathology , von Willebrand Diseases/therapy , von Willebrand Factor/metabolism , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Cross-Sectional Studies , Female , Hemorrhage , Hospitalization , Humans , Male , Middle Aged , Netherlands , Phenotype , Young Adult
4.
Haemophilia ; 19(3): 370-7, 2013 May.
Article in English | MEDLINE | ID: mdl-23496171

ABSTRACT

Ageing haemophilia patients are increasingly confronted with ischaemic heart disease (IHD). Treatment is complex because of the delicate equilibrium between bleeding and thrombosis. In 2009, we developed an institutional guideline on how to treat IHD in this patient population. The aim of this study was to evaluate feasibility and safety of this guideline. Haemophilia patients who underwent coronary angiography or percutaneous coronary intervention between January 2009 and June 2012 were included in the current case series. Nine diagnostic or therapeutic cardiac catheterizations were performed in six haemophilia patients. One patient with moderate haemophilia B was included, whereas the other patients had mild haemophilia A. In six of nine procedures, access to the circulation was gained via the radial artery. Only bare-metal stents were implanted, after which dual antiplatelet treatment was given for at least 4 weeks. During cardiac catheterization/intervention and dual antiplatelet treatment, clotting factor levels were corrected. No thrombotic or clinically relevant bleeding complications occurred. In one patient, a low-titre inhibitor recurred 10 months after catheterization. In-stent restenosis was diagnosed in one patient. This case series indicates that treatment according to the guideline is feasible and safe. Furthermore, based on the case series and developments in new guidelines for non-haemophilic patients with IHD, some adjustments on the 2009 guideline are proposed.


Subject(s)
Cardiac Catheterization , Hemophilia A/diagnosis , Hemophilia B/diagnosis , Myocardial Ischemia/drug therapy , Platelet Aggregation Inhibitors/therapeutic use , Aged , Coronary Angiography , Guidelines as Topic , Hemophilia A/complications , Hemophilia B/complications , Humans , Male , Middle Aged , Myocardial Ischemia/complications , Prospective Studies , Radial Artery/diagnostic imaging , Stents
5.
Vox Sang ; 105(2): 144-9, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23517250

ABSTRACT

INTRODUCTION: Bleeding is increasingly considered an important end point in clinical platelet transfusion studies. Accurate recording and adjudication into well-defined bleeding grades, however, remains a major challenge. METHODS: We developed a computer algorithm for automatic adjudication. The algorithm's results were compared to those of three independent adjudicators. RESULTS: For one of 1186 bleeding days, the clinical report form (CRF) was filled out incorrectly, and the algorithm therefore missed one grade-1 skin bleed. For two bleeding days, the adjudicators incorrectly classified a grade-2 skin bleed as grade-1 while the algorithm correctly classified these days. The algorithm saved approximately six person-hours of adjudication time for the adjudication of 1186 days from 60 patients. DISCUSSION: The algorithm can be an invaluable tool for adjudicating large amounts of bleeding data.


Subject(s)
Algorithms , Electronic Data Processing/methods , Hemorrhage , Medical Records Systems, Computerized , Female , Hemorrhage/classification , Hemorrhage/diagnosis , Humans , Male , Platelet Transfusion , Time Factors , World Health Organization
6.
Transfus Med ; 22(6): 426-31, 2012 Dec.
Article in English | MEDLINE | ID: mdl-23036067

ABSTRACT

BACKGROUND: The reported percentage of haemato-oncological patients experiencing bleeding complications is highly variable, ranging from 5 to 70%, posing a major problem for comparison of clinical platelet transfusion trials using bleeding complications as a primary endpoint. In a pilot study we assessed the impact of the design of scoring of bleeding on the percentage of patients with WHO grade 2 or higher bleeding grades. STUDY DESIGN AND METHODS: We performed a prospective, observational study using a rigorous bleeding observation system in thrombocytopenic patients with haemato-oncological disorders. Endpoints of the study were the percentage of patients and days with bleeding WHO grade ≥ 2 comparing designs in which skin bleeding represent a continuation of a previous bleed or a new bleed. RESULTS: In four participating hospitals 64 patients suffering 870 evaluable thrombocytopenic days (platelet count < 80 × 10(9) L(-1)) were included. At least one episode of bleeding grade ≥ 2 occurred in 36 patients (56%). Most grade 2 bleeding complications occurred mucocutaneously. The percentage of days with bleeding of grade ≥ 2 was 16% but decreases to 8% when only newly developed skin bleeding was included. CONCLUSION: Rigorous daily observation results in a bleeding incidence that is comparable to recent reportings applying the same method. The results of this study show that censoring for stable skin bleeding has a profound effect on bleeding incidence per day. The clinical relevance of rigorous or clinically judged bleeding scores as an endpoint remains to be defined.


Subject(s)
Hematologic Neoplasms , Hemorrhage , Platelet Transfusion , Adult , Aged , Female , Hematologic Neoplasms/blood , Hematologic Neoplasms/complications , Hematologic Neoplasms/epidemiology , Hematologic Neoplasms/therapy , Hemorrhage/blood , Hemorrhage/epidemiology , Hemorrhage/etiology , Hemorrhage/therapy , Humans , Incidence , Male , Middle Aged , Platelet Count , Prospective Studies , Thrombocytopenia/blood , Thrombocytopenia/epidemiology , Thrombocytopenia/etiology , Thrombocytopenia/therapy
7.
Clin Immunol ; 142(3): 280-90, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22197071

ABSTRACT

From 1997, plasma-derived C1-inhibitor concentrate (Cetor®) has been available to HAE and AAE patients. Recently, a virus reducing 15 nm nanofiltration step has been introduced in the production process. A randomized, double-blind controlled cross-over study was performed to compare the pharmacokinetics (PK) of nanofiltered (C1-INH-NF) with conventional C1-inhibitor (C1-INH). Efficacy and safety were investigated in an open-label, on-demand and a prophylactic study. No differences in pharmacokinetic parameters between C1-INH and C1-INH-NF were found (13 non-symptomatic HAE patients). Both C1-inhibitor products equally increased plasma C4 levels. In the on-demand study, 14 acute angioedema attacks in 8 patients were analyzed. In the prophylactic study, 1 AAE and 5 HAE patients experienced in total 31 attacks during 748 observation days. In total 180,000 units of C1-INH-NF were administered. No product-related adverse events occurred, and no anti-C1-antibodies were induced. Nanofiltration in the production process of C1-inhibitor did not affect the pharmacokinetics, efficacy, and safety.


Subject(s)
Angioedemas, Hereditary/drug therapy , Complement C1 Inhibitor Protein/therapeutic use , Adult , Angioedemas, Hereditary/prevention & control , Complement C1 Inhibitor Protein/adverse effects , Complement C1 Inhibitor Protein/pharmacokinetics , Female , Humans , Male , Middle Aged
8.
Thromb Haemost ; 106(5): 885-92, 2011 Nov.
Article in English | MEDLINE | ID: mdl-21947221

ABSTRACT

A nation-wide cross-sectional study was initiated to assess gynaecological and obstetrical symptoms in an unselected cohort of women with moderate and severe von Willebrand disease (VWD) in the Netherlands. A total of 423 women aged ≥16 years were included. Bleeding severity was measured using the Tosetto Bleeding Score (BS). Menorrhagia, defined as occurrence of ≥2 menorrhagia symptoms, was reported by 81%. Of all VWD women, 78% received any kind of treatment for menorrhagia and 20% underwent a hysterectomy predominantly because of severe menstrual bleeding. Over half of the women reported more blood loss than can be expected with a normal delivery. In 52% of reported pregnancy losses curettage was needed because of bleeding. Mean number of live births was 1.9, which is comparable with the general Dutch population. In conclusion, women with moderate or severe VWD frequently have menorrhagia in need of treatment, and 20% of the VWD women underwent a hysterectomy. Bleeding complications occurred in over 50% of the women after childbirth or pregnancy loss. Progeny seems not to be affected in women with moderate or severe VWD.


Subject(s)
Menorrhagia/etiology , Postpartum Hemorrhage/etiology , von Willebrand Diseases/complications , von Willebrand Diseases/diagnosis , Abortion, Spontaneous/etiology , Adolescent , Adult , Aged , Aged, 80 and over , Analysis of Variance , Blood Coagulation Tests , Cross-Sectional Studies , Female , Fetal Death/etiology , Health Surveys , Humans , Hysterectomy , Live Birth , Menorrhagia/blood , Menorrhagia/diagnosis , Menorrhagia/surgery , Middle Aged , Netherlands , Postpartum Hemorrhage/blood , Postpartum Hemorrhage/diagnosis , Postpartum Hemorrhage/surgery , Pregnancy , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Treatment Outcome , Young Adult , von Willebrand Diseases/blood
9.
Neth J Med ; 64(7): 243-7, 2006.
Article in English | MEDLINE | ID: mdl-16929086

ABSTRACT

Paraneoplastic cerebellar degeneration (PCD) can present as a severe and (sub)acute cerebellar syndrome. PCD can accompany different kinds of neoplasms including small cell lung cancer, adenocarcinoma of the breast and ovary, and Hodgkin's lymphoma. A 34-year-old patient is described with acute dysarthria, gait ataxia and diplopia. Despite extensive laboratory and radiological evaluations in this patient with rapidly deteriorating cerebellar syndrome, the diagnosis of a paraneoplastic syndrome was only made after several months, when an anti-Tr antibody was detected in his serum. The search for Hodgkin's disease as concomitant disorder was then started and resulted in stage II B disease. The patient was successively treated with six courses of etoposide, bleomycin, vinblastine and dexamethasone and radiotherapy, which resulted in a complete remission of the Hodgkin's disease. After starting therapy the cerebellar degeneration stabilised. The pathogenesis of neuronal damage in central nervous system paraneoplastic disorders such as the one we describe is not completely understood. Antitumour therapy is assumed to be the important cornerstone in stabilising the neurological condition. Improvement of the cerebellar syndrome in anti-Tr autoantibody paraneoplastic disease is a rare achievement. Early recognition of the concomitant disorders (anti-Tr autoantibody disease and Hodgkin's lymphoma) is of crucial importance.


Subject(s)
Cerebellum/pathology , Hodgkin Disease/diagnosis , Paraneoplastic Cerebellar Degeneration/diagnosis , Adult , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bleomycin/administration & dosage , Cerebellum/diagnostic imaging , Dexamethasone/administration & dosage , Etoposide/administration & dosage , Hodgkin Disease/drug therapy , Hodgkin Disease/etiology , Hodgkin Disease/pathology , Hodgkin Disease/radiotherapy , Humans , Male , Neoplasm Staging , Paraneoplastic Cerebellar Degeneration/complications , Paraneoplastic Cerebellar Degeneration/drug therapy , Paraneoplastic Cerebellar Degeneration/pathology , Paraneoplastic Cerebellar Degeneration/radiotherapy , Positron-Emission Tomography , Radiotherapy, Adjuvant , Remission Induction , Tomography, X-Ray Computed , Vinblastine/administration & dosage
10.
Ned Tijdschr Geneeskd ; 146(29): 1368, 2002 Jul 20.
Article in Dutch | MEDLINE | ID: mdl-12162175

ABSTRACT

A 69-year-old woman who was treated for a spindle cell carcinoma of the upper jaw developed tumour emboli causing ischaemia and infarction of fingertips, small intestine, spleen, pancreas and kidneys.


Subject(s)
Infarction/complications , Intestine, Small/pathology , Ischemia/complications , Neoplastic Cells, Circulating/pathology , Sepsis/etiology , Aged , Carcinoma/therapy , Female , Fingers/blood supply , Humans , Kidney/blood supply , Maxillary Neoplasms/therapy , Pancreas/blood supply , Skin/pathology , Spleen/blood supply
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