Wojciech Homenda - Academia.edu (original) (raw)

Papers by Wojciech Homenda

Hematologic Malignancies, 2016

National and regional population-based registries are, provided diagnostic accuracy and full cove... more National and regional population-based registries are, provided diagnostic accuracy and full coverage of the target population, indispensible tools for epidemiological research. CML registries with a more comprehensive reporting may also provide complementary data on treatment outcome to those obtained from clinical trials. Reports from several European CML registries consistently show a crude annual incidence of 0.7–1.3/100,000, median age at diagnosis of 56–60 years and a male/female ratio of 1.2–1.7. The incidence of CML has been stable over time. Worldwide, variations in reported incidence of CML may be due to methodological issues, but a true difference between different geographical areas and/or ethnical subgroups cannot be excluded. The prevalence of CML is less well known but has been estimated to 10–12/100,000 inhabitants with a steady increase due to the dramatic improvement in survival of these patients. In recent population-based studies, CML patients have an overall survival that is comparable to that shown in large clinical trials, though relative survival in patients >70 years is still decreased. The importance of socioeconomic factors and health-care setting for outcome, a possible increased risk of secondary cancer in CML and possible long-term adverse off-target effects related to the use of tyrosine kinase inhibitors, are areas of ongoing epidemiological research.

Pomeranian journal of life sciences, Jul 20, 2016

Thrombotic thrombocytopenic purpura (TTP) and systemic lupus erythematosus (SLE) are two separate... more Thrombotic thrombocytopenic purpura (TTP) and systemic lupus erythematosus (SLE) are two separate diseases, whose clinical symptoms may be similar. The coexistence of these two diseases is very rare. We present the case report of a 29-year-old female patient with simultaneous diagnosis of TTP and SLE. The purpose of this article is to draw attention to the diagnostic difficulties which may result from the coexistence of both diseases.

Leukemia & Lymphoma, Nov 10, 2016

Chronic lymphocytic leukemia (CLL) is an incurable disease. Quality of life during treatment and ... more Chronic lymphocytic leukemia (CLL) is an incurable disease. Quality of life during treatment and periods of subsequent remission is therefore vital. Health-related quality of life (HRQoL) was compared in relapsed CLL during and after treatment with ofatumumab combined with fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide alone. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 v3 and QLQ-CLL16 were used to assess HRQoL in this open-label, phase 3 study. Improvements in prespecified domains of patient-reported outcomes (Global Health Status [GHS]/HRQoL and B symptom scores) were recorded in both treatment arms after three cycles and were sustained after 18 months of follow-up. The two treatment arms were not significantly different at the nominal 0.05 level for GHS/HRQoL (p = .7278) or B symptoms (p = .5968). Small improvements in quality of life were maintained after therapy. The addition of ofatumumab was without any adverse impact on HRQoL (NCT00824265).

Health science journal, 2021

The POEMS syndrome is a rare disorder manifesting with polyneuropathy and plasma cell dyscrasia a... more The POEMS syndrome is a rare disorder manifesting with polyneuropathy and plasma cell dyscrasia accompanied by other multisystemic symptoms. Sensorimotor demyelinating, axonal and mixed types of polyneuropathy are the most disturbing problems of patients often leading to disability. Here we present two patients successfully treated with autologous hematopoietic stem cells transplantation. Symptoms of the POEMS syndrome entirely resolved after the treatment. Nerve conduction studies were used to follow-up patients in complete remission for few years to analyze dynamics of nerves regeneration. Despite patients clinical performance improvement, the recovery of nerve conduction was not complete. In both patients nerves of upper limbs function was restored to the greater extent than in lower limbs. Improvement or stabilization of impairment of sensory nerves conduction was followed by similar motor nerves conduction dynamic in a given limb. In addition, worsening of the electrophysiological features was observed, completing the picture of complex and subtle changes of conduction after the POEMS syndrome treatment.

Leukemia & Lymphoma, Oct 12, 2016

In this multicenter, open-label, phase III study, patients with relapsed chronic lymphocytic leuk... more In this multicenter, open-label, phase III study, patients with relapsed chronic lymphocytic leukemia (CLL) were randomized (1:1) to receive ofatumumab plus fludarabine and cyclophosphamide (OFA + FC) or FC alone; the primary endpoint being progression-free survival (PFS) assessed by an independent review committee (IRC). Between March 2009 and January 2012, 365 patients were randomized (OFA + FC: n = 183; FC: n = 182). Median IRC-assessed PFS was 28.9 months with OFA + FC versus 18.8 months with FC (hazard ratio = 0.67; 95% confidence interval, 0.51-0.88; p = .0032). Grade ≥3 adverse events (≤60 days after last dose) were reported in 134 (74%) OFA + FC-treated patients compared with 123 (69%) FC-treated patients. Of these, neutropenia was the most common (89 [49%] vs. 64 [36%]). OFA + FC improved PFS with manageable safety for patients with relapsed CLL compared with FC alone, thus providing an alternative treatment option for patients with relapsed CLL. www.clinicaltrials.gov (NCT00824265).

International Journal of Laboratory Hematology, Mar 21, 2011

Erythrophagocytosis by neutrophils is a rare morphological phenomenon described in patients with ... more Erythrophagocytosis by neutrophils is a rare morphological phenomenon described in patients with clonal malignancies of haematopoiesis with myelodysplasia and in some haemolytic conditions including paroxysmal cold haemoglobinuria, haemolysis caused by snake-bite, sickle cell anaemia and other defects of red cells. We describe a female patient who presented with acquired haemolytic anaemia. Erythrophagocytosis was found in around 35% of neutrophils of the peripheral blood. A similar picture was seen in the bone marrow, but with additional erythrophagocytosis by macrophages. These two processes were considered as the main causes of anaemia, but the first one seemed to be predominant. Malignancies, autoimmunisation disorders and infections were excluded. Immunosuppressive therapy with corticosteroids was implemented, but had to be stopped because of side effects. Long-term normalization of peripheral blood morphology was achieved after splenectomy. Splenectomy may be considered a therapeutic option for patients with diagnosed neutrophil erythrophagocytic hyperactivity. Therapy with corticosteroids is also possible, but the long-term effects remain unknown.

Blood, Nov 29, 2018

Introduction: COMPLEMENT 2 is a phase III, randomized, open-label study, which compared the effic... more Introduction: COMPLEMENT 2 is a phase III, randomized, open-label study, which compared the efficacy of ofatumumab (OFA) in combination with fludarabine and cyclophosphamide (FC) vs FC therapy alone in patients (pts) with relapsed chronic lymphocytic leukemia (CLL). In a previous interim analysis (2015) performed based on 194 progression-free survival (PFS) events, OFA+FC showed significant improvement of PFS and was well tolerated compared to FC in pts with relapsed CLL. Here, we report the 5-year follow-up of overall survival (OS) and safety profile of the drugs evaluated in this study. Methods: Based on stratification factors (number of prior CLL therapies and Binet stage), pts with relapsed CLL were randomized 1:1 to Arm A (OFA+FC) and Arm B (FC alone). Arm A received OFA intravenously (IV) (300 mg on day 1, cycle [c] 1; 1000 mg on day 8, c1; and 1000 mg on day 1, c2-6) in addition to FC (F [IV]: 25 mg/m2 and C [IV]: 250 mg/m2 on days 1-3, c1-6). Arm B received FC only. Pts who had achieved a complete response or partial response following at least 1 prior CLL therapy, but whose disease had progressed after &amp;amp;gt;6 months (mo) were included in the present study. The primary endpoint was PFS. Key secondary endpoints were OS, time to next treatment (TTNT), and safety. During the primary analysis for PFS, all the type 1 error (1-sided alpha 0.025) was spent, resulting in no alpha remaining for inferential interpretation of the final analysis for OS. The final analysis results will be used for descriptive and supportive purposes only. Results: A total of 365 pts were randomly assigned to receive OFA+FC (n=183) or FC (n=182) in the final analysis. Overall, 119 (65%) and 102 (56%) pts completed the scheduled OFA+FC and FC treatments, respectively. Adverse events (AEs) were the main reason for treatment discontinuation in both treatment arms (50 [27%] pts in the OFA+FC arm and 52 [29%] in the FC arm). A total of 332 (91%) pts entered the follow-up phase, 172 (94%) from the OFA+FC arm and 160 (88%) from the FC arm. The follow-up phase for the OFA+FC and FC arms was approximately 41 mo and 23 mo, respectively. Baseline characteristics were similar in both arms. Median PFS was not assessed for the final analysis because the final results for the primary endpoint of PFS were reported as part of the primary analysis. PFS was 28.9 mo for OFA+FC and 18.8 mo for FC (hazard ratio [HR]=0.67, 95% confidence interval [CI]: 0.51, 0.88; p=0.0032). The final OS analysis was performed based on 82 events in the OFA+FC arm and 83 events in the FC arm. Median OS was 62.6 mo (95% CI: 44.58, NA) and 46.2 mo (95% CI: 37.72, 56.57) for the OFA+FC and FC arms, respectively (HR=0.80, 95% CI: 0.59, 1.09; p=0.143) (Figure 1). Median TTNT in the OFA+FC and FC arms was 53 mo and 40.1 mo, respectively (HR=0.77, 95% CI: 0.55, 1.08; p=0.114). As per the primary analysis, the overall response rate (95% CI) by independent review committee assessment (IRC) was 84% (77%, 89%) for OFA+FC and 68% (60%, 74%) for FC (p=0.0003). Other secondary endpoints (in mo) for OFA+FC vs FC were IRC-assessed median time to response (1 vs 1; HR=1.08, 95% CI: 0.85, 1.37; p=0.45), median duration of response (29.6 vs 24.9; HR=0.77, 95% CI: 0.56, 1.05; p=0.09), and median time to progression (42.1 vs 26.8; HR=0.63, 95% CI: 0.45, 0.87; p=0.004). All AEs and AEs of grade 3, 4, and 5 by preferred term (≥10%) are presented in Table 1. Serious drug-related AEs (≥2%) in the OFA+FC arm were pneumonia (8%), neutropenia and febrile neutropenia (7% each), and thrombocytopenia, pancytopenia, and pyrexia (2% each). Myelodysplastic syndrome was the most frequently reported secondary malignancy observed in ≥1% of pts (OFA+FC, 3 [2%]; FC, 2 [1%]). A total of 82 (45%) and 83 (47%) pts died during the study in the OFA+FC and FC arms, respectively; 2 (1%) and 6 (3%) died up to 60 days after the end of treatment, and 74 (41%) and 69 (39%) after &amp;amp;gt;60 days. Three (2%) on-treatment deaths were reported in the OFA+FC arm and 4 (2%) in the FC arm. Conclusion: This final analysis confirmed the results of the primary analysis that addition of OFA to FC resulted in improvement of OS and TTNT by approximately 16 mo and 13 mo, respectively, compared to FC alone. Of note, the trend in the OS improvement seems to be maintained in the present long-term follow-up at 5 years. No new safety concerns have emerged in the long-term follow-up after treatment with OFA+FC, and the treatment was well tolerated. Disclosures Grosicki: Affimed: Research Funding. Lech-Maranda:Roche: Consultancy; Jansen-Cilag: Consultancy; Novartis: Consultancy; BMS: Consultancy; Amgen: Consultancy. Loscertales:Janssen: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria. Homenda:Janssen: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Rigel: Consultancy, Honoraria; Roche: Consultancy, Honoraria; Acerta: Consultancy, Honoraria.…

American Journal of Hematology, May 15, 2018

Spleen tyrosine kinase (Syk) signaling is central to phagocytosis-based, antibody-mediated platel... more Spleen tyrosine kinase (Syk) signaling is central to phagocytosis-based, antibody-mediated platelet destruction in adults with immune thrombocytopenia (ITP). Fostamatinib, an oral Syk inhibitor, produced sustained on-treatment responses in a phase 2 ITP study. In two parallel, phase 3, multicenter, randomized, double-blind, placebo-controlled trials (FIT1 and FIT2), patients with persistent/chronic ITP were randomized 2:1 to fostamatinib (n 5 101) or placebo (n 5 49) at 100 mg BID for 24 weeks with a dose increase in nonresponders to 150 mg BID after 4 weeks. The primary endpoint was stable response (platelets 50 000/lL at 4 of 6 biweekly visits, weeks 14-24, without rescue therapy). Baseline median platelet count was 16 000/lL; median duration of ITP was 8.5 years. Stable responses occurred in 18% of patients on fostamatinib vs. 2% on placebo (P 5 .0003). Overall responses (defined retrospectively as 1 platelet count 50 000/lL within the first 12 weeks on treatment) occurred in 43% of patients on fostamatinib vs. 14% on placebo (P 5 .0006). Median time to response was 15 days (on 100 mg bid), and 83% responded within 8 weeks. The most common adverse events were diarrhea (31% on fostamatinib vs. 15% on placebo), hypertension (28% vs. 13%), nausea (19% vs. 8%), dizziness (11% vs. 8%), and ALT increase (11% vs. 0%). Most events were mild or moderate and resolved spontaneously or with medical management (antihypertensive, anti-motility agents). Fostamatinib produced clinically-meaningful responses in ITP patients including those who failed splenectomy, thrombopoietic agents, and/or rituximab. Fostamatinib is a novel ITP treatment option that targets an important mechanism of ITP pathogenesis.

Blood, Dec 3, 2015

Introduction: The randomized COMPLEMENT 2 study demonstrated a statistically significant improvem... more Introduction: The randomized COMPLEMENT 2 study demonstrated a statistically significant improvement in independent reviewer committee-assessed median progression-free survival (PFS) in patients with relapsed chronic lymphocytic leukemia (CLL) who were treated with ofatumumab plus fludarabine and cyclophosphamide (OFC) compared with fludarabine and cyclophosphamide (FC) alone (28.9 vs. 18.8 months, p=0.0032) and that the addition of O was well tolerated (Robak T, et al. Haematologica 2015;100:abstract LB219). Moreover, the median overall survival was 56.4 months in the OFC arm and 45.8 months in the FC arm (p=0.1410) with a median follow-up of 34 months. In addition to the PFS benefit, it is important to consider the impact of adding O to FC on health-related quality of life (HRQoL) and patient-reported symptoms. Methods: In the COMPLEMENT 2 trial, patients with relapsed CLL (N=365) were randomized to either OFC or FC. F and C were administered as intravenous infusions (F: 25 mg/m2, Days 1-3 every 28 days for 6 cycles; C: 250 mg/m2, Days 1-3 every 28 days for 6 cycles). O was also administered intravenously (Cycle 1: 300 mg Day 1 and 1000 mg Day 8, subsequent cycles: 1000 mg Day 1). During the trial, the EORTC QLQ-C30 v3.0 and the QLQ-CLL16 questionnaires were administered at baseline, during Cycle 4 of 6 and throughout follow-up. Specified patient-reported endpoints were HRQoL as reported by the global health status/QoL domain of the QLQ-C30 questionnaire and a B symptom index including patient-reported symptoms of fatigue, night sweats, temperature changes, and weight loss as reported by certain items of the QLQ-C30 and QLQ-CLL16 questionnaires. Results: The least square mean change in HRQoL, measured on a scale scored from 0 (worse) to 100 (best), improved between baseline and Cycle 4 by 8.3 points in the OFC arm vs. 4.8 points in the FC arm. Although there was no significant difference between the least square mean changes in the two arms (p=0.09), the OFC arm surpassed the 5-point difference defined as being a clinically relevant change (Osoba D, et al. J Clin Oncol 1998;16;139-144). The least square mean change in B symptom index, measured on a scale of 0-100 with 0 meaning no symptoms, improved from baseline to Cycle 4 by 5.6 points and 4.5 points in the OFC and FC arms, respectively, with no significant difference between the arms (p=0.49). Patients who achieved a complete or partial response to therapy showed a larger mean improvement in B symptoms (OFC 6.5 improvement, FC 7.5 improvement) than those who did not respond (OFC 4.3 improvement, FC 3.5 worsening of symptoms) but these differences between the arms were not significant (p=0.51 and p=0.22, respectively). During follow-up, patients who did not progress maintained a consistent level of HRQoL in both arms (Figure). Conclusion: This study demonstrates durable improvements in both HRQoL and patient-reported B symptoms for patients being treated for relapsed CLL. Although there are no significant differences observed between the OFC and FC treatment arms in terms of the least square mean change in HRQoL or B symptom scores, the improvement in PFS in the OFC arm reported previously (Robak T, et al. Haematologica 2015;100:abstract LB219) suggests that these patients may enjoy HRQoL and symptom improvements for a longer duration. Figure 1. Least Squares Mean Change in HRQoL from Baseline Figure 1. Least Squares Mean Change in HRQoL from Baseline Disclosures Robak: GlaxoSmithKline: Research Funding; Novartis: Consultancy, Honoraria, Research Funding. Off Label Use: Ofatumumab (Arzerra) is approved in the frontline and refractory CLL setting but not in relapsed CLL. This Abstract presents the Health related quality of life and patient reported outcomes in patients receiving ofatumumab in combination with fludarabine and cyclophosphamide (FC) versus FC alone. Kryachok:GlaxoSmithKline: Honoraria, Other: Investigator for Study. Homenda:GlaxoSmithKline: Honoraria, Other: Intestigator in Clinical Trial - OMB110913 (COMPLEMENT 2). Blonski:GlaxoSmithKline: Research Funding. McKeown:GlaxoSmithKline: Equity Ownership; Novartis: Employment, Equity Ownership. Chang:GlaxoSmithKline: Equity Ownership; Novartis: Employment, Equity Ownership. Manson:GlaxoSmithKline: Employment, Equity Ownership; Novartis: Employment, Equity Ownership. Lisby:Genmab: Employment. Gupta:Novartis: Employment, Equity Ownership; GlaxoSmithKline: Equity Ownership.

Medical Science and Technology, Mar 20, 2007

Folia Cardiologica, 2021

This article is available in open access under Creative Common Attribution-Non-Commercial-No Deri... more This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license, allowing to download articles and share them with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially.

Health science journal, 2021

1Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Pol... more 1Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland; 2Department of Cancer Prevention, Faculty of Public Heath, Medical University of Silesia, Katowice, Poland; 3Department of Hematology, Institute of Haematology and Transfusion Medicine, Warsaw, Poland; 4Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore, India; 5Makiivka City Hospital #2 of Donetsk Region, Makiivka, Ukraine; 6Department of Medical Oncology, Wroclaw Medical University, Wroclaw, Poland; 7Russian Research Institute of Hematology and Transfusiology, St. Petersburg, Russian Federation; 8Hospital Universitario de La Princesa, IIS-IP, Madrid, Spain; 9Oncohematology Department, National Cancer Institute, Kiev, Ukraine; 10Medical University of Bialystok, Bialystok, Poland; 11Khmelnytskyi Regional Hospital, Khmelnytskyi, Ukraine; 12Department of Hematology, Janusz Korczak Hospital, Slupsk, Poland; 13GlaxoSmithKline, Uxbridge, UK; 14GlaxoSmithKlin...

Leukemia & Lymphoma, 2020

All patients were required to provide written informed consent prior to enrolling in the study.

Blood, 2018

Leukemia & Lymphoma, 2016

European Journal of Haematology, 2016

The epidemiology of myelodysplastic syndromes (MDS) differs among countries. Here, we present the... more The epidemiology of myelodysplastic syndromes (MDS) differs among countries. Here, we present the first epidemiological indices determined for Poland. Twenty-one haematological centres participated in the study. Patients diagnosed with MDS and acute myeloid leukaemia (AML) with 20-29% blasts were enrolled. Data collection was conducted for strictly predefined period. The overall crude incidence rate for all MDS subtypes was 1.95 (95% CI, 1.81-2.09) per 100 000 person-years: 2.46 (95% CI, 2.24-2.69) for males and 1.47 (95% CI, 1.31-1.65) for females; after excluding AML cases, the indices were as follows: 2.35 (95% CI, 2.08-2.66) for males and 1.27 (95% CI, 1.08-1.5) for females. Prevalence rate was 6.2 per 100 000 persons (95% CI, 5.96-6.45), that is 6.86 (95% CI, 6.49-7.24) for males and 5.58 (95% CI, 5.26-5.92) for females. Both incidence and prevalence increased with increasing age. The most frequently diagnosed MDS subtype was refractory cytopenia with multilineage dysplasia (RCMD), responsible for 30.3% of all newly diagnosed MDSs. RCMD is the most frequent MDS subtype in Poland. Incidence and prevalence indices are lower than those reported for other populations, which probably results from inadequate diagnosis of potential cases of this disease.

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Wiadomości Lekarskie, Feb 1, 2005

We present the case of 27-year-old male, physical training teacher in whom the first clinical sig... more We present the case of 27-year-old male, physical training teacher in whom the first clinical sign of idiopathic thrombocytosis was myocardial infarction. The infarct was complicated by heart arrest caused by ventricular fibrillation. Streptolysis (streptokinase) was used in treatment. Thrombocytosis 842 G/l was observed in blood tests at admission. To estimate its cause the bone marrow biopsy and trepanobiopsy of hip bone were performed. Tests were performed to exclude the secondary cause of thrombocytosis. The coronarography did not show relevant stenoses of coronary arteries. The results let diagnose myocardial infarction in a patient with essential thrombocytosis.

Hematologic Malignancies, 2016

Pomeranian journal of life sciences, Jul 20, 2016

Leukemia & Lymphoma, Nov 10, 2016

Health science journal, 2021

Leukemia & Lymphoma, Oct 12, 2016

International Journal of Laboratory Hematology, Mar 21, 2011

Blood, Nov 29, 2018

American Journal of Hematology, May 15, 2018

Blood, Dec 3, 2015

Medical Science and Technology, Mar 20, 2007

Folia Cardiologica, 2021

Health science journal, 2021

Leukemia & Lymphoma, 2020

All patients were required to provide written informed consent prior to enrolling in the study.

Blood, 2018

Leukemia & Lymphoma, 2016

European Journal of Haematology, 2016

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Wiadomości Lekarskie, Feb 1, 2005