Christoph Losem

• Doctor of Medicine
• Head of Department at MVZ Onkologie und Hämatologie Neuss

856 Introduction Promising results have been observed in two phase II studies evaluating the combination of bendamustine plus rituximab (B-R) in patients (pts) with relapsed/refractory follicular, other indolent or mantle cell lymphomas (MCL) (Rummel et al. JCO 2005; Robinson et al. JCO 2008). Fludarabine plus rituximab (F-R) is an established tre...

Background Symptomatic anemia is a frequent and severe complication of chemotherapy that is commonly treated with erythropoiesis-stimulating agents. The primary objective of this study was to assess the change in hemoglobin levels in patients with chemotherapy-induced anemia (CIA) following treatment with biosimilar Retacrit® (epoetin zeta). Second...

On the basis of a preceding phase I study, the current trial explored bendamustine in combination with mitoxantrone and rituximab (BMR) in patients with stage III/IV relapsed or refractory indolent lymphomas and mantle cell lymphoma (MCL) with or without prior rituximab containing chemo-immunotherapy (R-chemo) treatment. Therapy consisted of bendam...

Effective and tolerable regimens are sought specifically in patients who have been pretreated with anthracyclines and taxanes. Gemcitabine and cisplatin demonstrated synergistic activity in vitro and provides a new mechanism of drug interaction. Previously treated patients with metastatic breast cancer (MBC) were enrolled in a multicentre phase II...

Therapy adherence can significantly influence the outcome of cancer patients. The prospective, non-interventional CARO study (NCT02970747) investigated adherence, effectiveness, and safety of carfilzomib in patients with relapsed/refractory multiple myeloma (RRMM) in the German real-world setting. In total, 359 patients were included at 69 sites. D...

Background The BCL-2 inhibitor Venetoclax (V) is approved for the treatment of CLL as continuous monotherapy (VM) and in combination with the anti-CD20 antibody Rituximab (VR). The following prospective non-interventional observational study comprises different study arms for patients treated with VM and VR after treatment with Ibru. Methods Adult...

Introduction CDK4/6 inhibitors (CDKi) plus endocrine therapy (ET) are standard of care in first-line (1L) treatment of hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (ABC). In the pivotal trials the three CDK4/6i (palbociclib, ribociclib and abemaciclib) + ET showed similar progression-free survival (PFS) benefit over...

Venetoclax is active in both frontline and relapsed/refractory settings for the treatment of chronic lymphocytic leukemia (CLL). Although the prevalence and severity of tumor lysis syndrome (TLS) are well characterized in clinical trials, laboratory and clinical TLS remain relatively unexplored in real-world clinical practice. In this prospective,...

Patients with lung cancer under treatment have been associated with a high risk of COVID‐19 infection and potentially worse outcome, but real‐world data on patient‐reported outcomes (PROs) are rare. We assess patients' characteristics and PROs before and during the COVID‐19 pandemic in an advanced non‐small cell lung cancer (NSCLC) cohort in German...

Objective Real-world evidence on the application of the granulocyte colony-stimulating factor lipegfilgrastim for the reduction of chemotherapy-induced neutropenia and febrile neutropenia (FN) is limited. The NADIR study aimed to evaluate effectiveness and safety of lipegfilgrastim as primary or secondary prophylaxis in patients with lung cancer un...

Background: Patients (pts) with lung cancer under treatment have been associated with a high risk of COVID-19 infection and potentially worse outcome, but real-world data on patient-reported outcomes (PRO) are still scarce. We show pts’ characteristics and PRO before and during the COVID-19 pandemic in a representative advanced non-small cell lung...

Objectives An increasing number of treatment-determining biomarkers has been identified in non-small cell lung cancer (NSCLC) and molecular testing is recommended to enable optimal individualized treatment. However, data on implementation of these recommendations in the “real-world” setting are scarce. This study presents comprehensive details on t...

Background Treatment guidelines for metastatic non-small cell lung cancer recommend stratified treatment according to biomarker testing results. Here we used CRISP to evaluate treatment and outcome of patients (pts) with PD-L1-expressing tumors. Methods Currently 163 centers in Germany have recruited over 3700 pts at start of 1st-line who will be...

Aim: To assess outcomes in patients with advanced adenocarcinoma non-small-cell lung cancer who received nintedanib plus docetaxel after progression on prior chemotherapy followed by immune checkpoint inhibitor (ICI) therapy. Patients & methods: VARGADO is a prospective, noninterventional study. We describe initial data from a cohort of 22 patients...

Background: Bevacizumab (Avastin®), a recombinant humanized monoclonal antibody, in combination with platinum-doublet chemotherapy has become a routine treatment for advanced non-small-cell lung cancer (NSCLC). The post-authorization, non-interventional study 'AVAiLABLE' assessed the effectiveness and safety of bevacizumab combined with chemothera...

Objectives: The non-interventional study (NIS) NADIR (DRKS00005711) evaluated the effectiveness and safety of prophylaxis with lipegfilgrastim, a glycopegylated granulocyte-colony stimulating factor, in 2500 patients undergoing chemotherapy in routine clinical practice. Primary objective was the incidence of chemotherapy-induced severe neutropenia,...

Objective The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating factor, in cancer patients with different tumor entities undergoing chemotherapy in routine clinical practice. The primary objective...

Objective Azacitidine (Vidaza®) is the standard treatment for patients with higher‐risk MDS not eligible for allogeneic stem cell transplantation. In the non‐interventional study PIAZA we evaluated the effectiveness and safety of azacitidine‐treatment in 149 patients with higher‐risk MDS, CMML and AML in routine clinical practice. Method Patients...

Lenalidomide (LEN) is an immunomodulatory drug with significant clinical activity against relapsed and refractory multiple myeloma (r/r MM). Based on the pivotal phase 3 trials MM-009 and MM-010, LEN in combination with dexamethasone (DEX) is approved for treatment of patients with MM who have received at least one prior therapy. LEN monotherapy is...

7501 Background: This multicenter, randomized, phase III study compared B-R and CHOP-R as first-line treatment in patients (pts) with indolent lymphomas or mantle cell lymphoma and was first published in The Lancet in 2013. The final analysis demonstrated a significantly prolonged progression-free survival (PFS) in the B-R group compared to the CHO...

Background: Fludarabine-based chemoimmunotherapy with rituximab is frequently used in patients with indolent and mantle-cell lymphomas who relapse after alkylating chemotherapy. We aimed to compare the efficacy and safety of rituximab with bendamustine or fludarabine in patients with relapsed, indolent, non-Hodgkin lymphoma and mantle-cell lymphom...

Chemotherapy-induced anaemia is frequent in cancer patients, with severity depending on the extent of the disease and intensity of treatment. Clinical guidelines recommend erythropoietin therapy to treat or prevent anaemia in some oncology/haematology patients being treated with chemotherapy. The patent expiry of the first-generation erythropoietin...

Acquired angioedema due to C1 inhibitor deficiency (C1-INH-AAE) is characterized by recurrent edema of the subcutaneous and/or submucosal tissue without wheals and negative family history of angioedema. Here, we present the case of a patient with a chronic lymphatic B cell leukemia who suffered from both C1-INH-AAE and chronic spontaneous urticaria...

Bcl-2/IgH-rearrangements can be quantified in follicular lymphoma (FL) from peripheral blood (PB) by PCR. The prognostic value of Bcl-2/IgH levels in FL remains controversial. We therefore prospectively studied PB Bcl-2/IgH levels from 173 first-line FL patients who were consecutively enrolled, randomized and treated within the multicenter phase 3...

The non-interventional study (NIS) NADIR was designed to assess the effectiveness and safety of lipegfilgrastim, a novel glycopegylated granulocyte-colony stimulating factor, in reducing the risk of both febrile and severe neutropenia. Here, the interim analysis of NIS Nadir performed under real-world conditions at 80 oncology practices across Germ...

Background: This multicenter, randomized, phase III study compared B-R and CHOP-R as first-line treatment in patients (pts) with indolent lymphomas or MCL and was presented at ASH 2009, ASCO 2012, and published in The Lancet in 2013. The final published analysis at a median follow-up of 45 months demonstrated a significantly prolonged progression-f...

Introduction: Fludarabine plus rituximab (F-R) is an established treatment option for patients (pts) with relapsed/refractory follicular lymphoma (FL), other indolent lymphoma, or mantle cell lymphoma (MCL). To further improve the treatment in this setting we initiated in 2003 a multicenter, randomized phase III study to compare the efficacy and sa...

Background: Rituximab plus chemotherapy, most often CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), is the first-line standard of care for patients with advanced indolent lymphoma, and for elderly patients with mantle-cell lymphoma. Bendamustine plus rituximab is effective for relapsed or refractory disease. We compared bendamus...

3 Background: This multicenter, randomized, phase III study compared B-R and CHOP-R as first-line treatment in indolent lymphoma and MCL and was presented at ASH 2009 including a comprehensive safety analysis. Here we present an updated analysis with a cut-off date for 31 Oct 2011. Methods: 549 patients (pts) with indolent or MCL were randomized to...

3 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

The efficacy of bendamustine (50 mg/m², days 1-3) plus mitoxantrone (10 mg/m², day 1), every 28 days for up to four courses, was evaluated in a Phase II multicentre trial enrolling 59 patients with relapsed or refractory B-cell chronic lymphocytic leukaemia (CLL). Major toxicities were grade 3/4 leucopenia, thrombocytopenia and infections in 42%, 1...

EXtend and eXjange were prospective, 1-yr, non-interventional, observational, multicentre studies that investigated deferasirox, a once-daily oral iron chelator, in iron-overloaded chelation-naïve and prechelated patients with myelodysplastic syndromes (MDS), respectively, treated in the daily-routine setting of office-based physicians. No inclusio...

441 Introduction By means of standard chemotherapy advanced stage follicular lymphoma (FL) is an incurable disease. Clinical courses are characterized by a continuous tendency to relapse caused by residual neoplastic cells. Quantitative polymerase chain reaction (qPCR) to detect lymphoma cell that carry the t(14;18) translocation is a suitable met...

3805 Poster Board III-741 Background Red blood cell (RBC) transfusions on a regular basis are unavoidable in a variety of chronic anemias. Unfortunately, chronic transfusion therapy leads to iron overload (IOL) since the body cannot actively remove excess iron. Transfusional IOL can cause severe organ damage, as exemplified by thalassemia major pa...

405 Introduction: Promising results have been observed in two phase-II studies evaluating the combination of Bendamustine plus Rituximab (B-R) in patients with relapsed/refractory indolent or mantle cell lymphomas (Rummel et al., JCO 2005; Robinson et al., JCO 2008). In order to further investigate the role of the combination B-R we initiated a mul...

Background: Promising results have been observed in our previous phase-II study evaluating the combination of Bendamustine plus Rituximab (B-R) in patients with relapsed/refractory indolent or mantle cell lymphomas. An overall response rate (ORR) of 90%, including a 60% rate of complete remissions (CR) was documented. Objective: In October 2003 we...

Outcomes in patients with brain metastases undergoing whole-brain radiotherapy (WBRT) are hardly encouraging, and an improvement in results is therefore needed. One possible approach is the addition of chemotherapeutics. However the data presented thus far are also disappointing. A promising substance in this setting could become topotecan, which i...

Purpose: Bendamustine is a new anti-lymphoma agent with promising activity. Based on a preceeding phase I study the current trial explored Bendamustine in combination with Mitoxantrone and Rituximab (BMR) in patients with relapsed or refractory indolent lymphomas. Patients and Methods: Patients with relapsed or refractory symptomatic stage III/IV i...

This study analyses invasive fungal infections in neutropenic patients with haematological malignancies during antifungal prophylaxis with itraconazole. From September 1994 to December 1998 20 patients developed fungal infections. Two patients suffered from disseminated infections by yeasts and 18 patients suffered from pulmonary infections by moul...

This retrospective study was designed to show whether invasive pulmonary aspergillosis, which is often difficult to diagnose by bronchoscopy or serology, can be diagnosed at an early stage by typical radiological findings on conventional radiographs or by CT, specially high resolution CT (HR-CT). In 19 Patients with 20 disease episodes, 20 thorax r...

Purpose: This retrospective study was designed to show whether invasive pulmonary aspergillosis, which is often difficult to diagnose by bronchoscopy or serology, can be diagnosed at an early stage by typical radiological findings on conventional radiographs or by CT, specially high resolution CT (HR-CT). Patients and methods: In 19 Patients wit...

Systemic and regional hemodynamics were assessed in 10 patients with uncomplicated mild to moderate essential hypertension before and during gallopamil therapy. Cardiac output was measured in triplicate with indocyanine dye. Plasma volume and renal blood flow were measured radioisotopically. Immediately following the initial dose of a slow-release...

Ten healthy normotensive volunteers demonstrated a progressive decrease (p < 0.01) in systolic and diastolic pressures during 1 hour of aerobic exercise. Cardiac function and structure were assessed by M-mode echocardiography before exercise and, at the same heart rate, after 5 minutes of exercise and after 60 minutes of exercise. After 5 minutes o...

We studied 11 healthy untrained volunteers (aged 28.9 +/- 4.6 years) during 60 minutes of aerobic ergometric exercise with constant heart rates of 130 to 140 beats/minute. We found a continuous and significant decrease in systolic and diastolic pressure from 175 +/- 18/77 +/- 7 mmHg in the 5th minute to 144 +/- 14/68 +/- 6 mmHg in the 60th minute o...

The hemodynamic and humoral effects and trough-to-peak 24-hour blood pressure responses of 2 nifedipine formulations, capsules and continuous-release once-daily formulation tablets, were evaluated in 10 patients with mild to moderate essential hypertension. Both formulations reduced mean arterial pressure similarly from 120 +/- 3 (baseline) to 107...

The immediate and short-term (2 week) hemodynamic and humoral effects of the beta-1 antagonist, beta-2 agonist, celiprolol, were compared with those of more prolonged atenolol therapy in 12 patients with essential hypertension. Celiprolol produced an immediate dose-dependent decrease in mean arterial pressure (113 +/- 3 to 102 +/- 2 mm Hg; p less t...

Recent studies have documented that arterial hypertension increases cardiovascular morbidity and mortality even in the geriatric population. Some elderly hypertensive patients, like younger patients, can benefit from antihypertensive therapy. Antihypertensive therapy should be carefully adjusted to suit the cardiovascular pathophysiology of elderly...

Left ventricular hypertrophy (LVH) is a common sequela of long-standing essential hypertension. LVH cannot be considered, however, an adaptive process only serving to normalize wall stress but can be considered one that significantly increases the risk of sudden death, myocardial ischemia, congestive heart failure, and other cardiovascular diseases...