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Schulz-Kindermann F.,Universitatsklinikum Hamburg Eppendorf | Schieder H.,Onkologische Schwerpunktpraxis
Onkologe | Year: 2016

Background: Molecular oncological therapies belong to the so-called personalized, targeted or individualized therapies. Whereas the therapeutic benefits for specific indications seem to be promising, an unreflecting accentuation on a personalized or individualized treatment may lead to false expectations and misunderstandings in patient-physician communication, especially in a palliative setting. Method: This article presents the consequences of molecular therapy regarding health-related quality of life and psychosocial issues from the perspective of routine daily psychotherapeutic and oncological practice and illustrates them with case examples. Results and conclusion: As a consequence of different treatment modalities and indications for molecular therapies with mostly unknown long-term toxicity, new challenges in communication and physician-patient relationships will develop. From the psychological point of view emphasis is placed on the definition of “being a person”, which stresses the comprehensive understanding of a holistic (“nondivisible”) individual. Patients who are existentially threatened are especially vulnerable to accepting treatment which promises profound healing. Especially in this situation a critical and authentic communication about evidence-based benefits and unrealistic expectations is needed. © 2016, Springer-Verlag Berlin Heidelberg.


Faehling M.,Klinik fur Kardiologie und Pneumologie | Eckert R.,Onkologische Schwerpunktpraxis | Kamp T.,Onkologische Schwerpunktpraxis | Kuom S.,Klinik fur Kardiologie und Pneumologie | And 4 more authors.
Lung Cancer | Year: 2013

Introduction: Some patients with advanced NSCLC show prolonged disease stabilization on treatment with an EGFR-tyrosine kinase inhibitor (TKI) such as erlotinib. It is not clear how to treat patients who progress after prolonged response to erlotinib. We hypothesized that TKI therapy beyond progression with added chemotherapy, radiotherapy or best supportive care may improve survival. Patients and methods: We retrospectively analyzed all NSCLC patients treated with erlotinib at our institutions since 2004who progressed after at least stable disease on erlotinib for at least 6 months. The first 16 patients did not receive further TKI treatment after progression (controls). The following 25 patients were treated with TKI beyond progression (TKI patients). Overall survival (OS) was analyzed for the whole population, a case-control analysis of pairs matched for gender, smoking status, and histology (n=28), and for patients with known EGFR mutation status (n=23). Results: Treatment with TKI and chemotherapy was well tolerated. TKI-patients had a significantly longer OS from progression on TKI (case-control: median 14.5 vs. 2.0 months, HR 0.154) and longer OS from diagnosis of lung cancer (case-control: median 54.5 vs. 28.3 months, HR 0.474). An activating EGFR mutation was detected in 13 of the 23 patient tested (57%). Both among patients with and without detection of an activating EGFR mutation, those treated with erlotinib beyond progression had a longer survival. Conclusions: In our case-control analysis in long-term erlotinib responders, treatment with TKI beyond progression in addition to chemotherapy or radiotherapy was feasible and lead to prolonged overall survival. © 2013 Elsevier Ireland Ltd.


Siebels M.,Ludwig Maximilians University of Munich | Rohrmann K.,Ludwig Maximilians University of Munich | Oberneder R.,Ludwig Maximilians University of Munich | Stahler M.,Ludwig Maximilians University of Munich | And 6 more authors.
World Journal of Urology | Year: 2011

Purpose: To evaluate the efficacy and safety of WX-G250, a chimeric monoclonal antibody that binds to carboxy anhydrase IX, combined with low-dose interferon-alpha (LD-IFNα) in patients with progressive metastatic renal cell carcinoma (mRCC). Patients and methods: Thirty-one patients, nephrectomized for the primary tumor, clear cell progressive mRCC, were enrolled to receive weekly infusions of WX-G250 (20 mg i. v.; week 2-12) combined with LD-IFNα (3 MIU s. c. 3 times/week; week 1-12). At week 16, patients were evaluated for response and stratified into two groups: (a) responders into the extended treatment group for an additional 6 weeks of treatment or (b) the progressive group with no further study treatment. Results: Of the 31 treated patients, 26 were evaluable for response to treatment. Two patients showed partial remission and 14 patients had stable disease as assessed in week 16. One patient experienced partial remission resulting in a complete remission lasting at least 17 months. Nine patients had durable stable disease of 24 weeks or longer. Clinical benefit was obtained in 42% (11/26) patients. The median overall survival achieved was 30 months and the 2-year survival was 57%. Patients receiving extended treatment showed a significantly longer 2-year survival rate than discontinued patients (79 vs. 30%; P = 0.0083). In general, treatment was well tolerated with little toxicity. Conclusion: Treatment with the antibody WX-G250 in combination with LD-IFNα is safe, well tolerated, led to clinically meaningful disease stabilization and demonstrated clinical benefit in this progressive mRCC patient population. © 2010 Springer-Verlag.


Al-Batran S.-E.,UCT | Geissler M.,Klinik fur Allgemeine Innere Medizin | Seufferlein T.,Universitatsklinikum Ulm | Oettle H.,Onkologische Schwerpunktpraxis
Oncology Research and Treatment | Year: 2014

For almost 15 years there has been stagnation in the systemic treatment of patients with pancreatic ductal adenocarcinoma (PDAC). Recently, several developments seem to indicate clinically relevant improvements in the treatment of patients with metastatic disease. One of these developments is the introduction of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) into the firstline treatment of metastatic disease. In this review, underlying preclinical and clinical data are discussed, with a special focus on mechanisms of action, the potential interaction with albumin and calcium-binding matricellular glycoproteins, such as the secreted protein acidic and rich in cysteine (SPARC), as well as the clinical outcome associated with the use of nab-paclitaxel. © 2014 S. Karger GmbH, Freiburg.


Becker M.,Onkologische Praxis Minden Porta | Tschechne B.,Praxis fur Hamatologie und internistische Onkologie | Reeb M.,Onkologische Schwerpunktpraxis | Schwinger U.,MVZ Leuschnerstr. 1 | And 3 more authors.
Annals of Hematology | Year: 2015

Bendamustine has demonstrated clinical activity and a favorable safety profile as monotherapy or in combination with rituximab in lymphoid malignancies. As interventional trials do not always reflect clinical reality, we were interested in the treatment modalities and the outcome of bendamustine-based first-line therapy in patients with advanced indolent non-Hodgkin lymphoma (NHL) and mantle cell lymphoma (MCL) in routine practice. Between April 2010 and October 2011, 324 patients were enrolled in a prospective non-interventional multicenter study. Choice of the bendamustine regimen was at the treating physician’s discretion. Effectiveness was assessed by best response. Mean age at onset of therapy was 69 years. The majority (94 %) of the patients was treated with bendamustine in combination with rituximab at a median bendamustine dose of 177 mg/m2 per cycle. Most often, bendamustine was administered on days 1 and 2 (87 %) at 4-week intervals over a median of 6 cycles. Two hundred eighty-one patients qualified for evaluation of response. The overall response rate was 86 % (complete response 43 %, partial response 43 %, stable disease 10 %, progressive disease 4 %). Side effects of all grades were documented for 161 of the 323 patients (50 %), most frequently affecting blood/bone marrow (35 %). Fifty-four (17 %) patients experienced side effects of grade 3 (15 %) or grade 4 (2 %), and two patients grade 5 toxicities. Bendamustine-based first-line treatment of patients with advanced indolent NHL and MCL in clinical routine practice was assessed as effective and well tolerated in our study. Response was comparable to results from interventional clinical trials. © 2015, The Author(s).


Jitschin R.,Friedrich - Alexander - University, Erlangen - Nuremberg | Hofmann A.D.,Friedrich - Alexander - University, Erlangen - Nuremberg | Bruns H.,Friedrich - Alexander - University, Erlangen - Nuremberg | Giessl A.,Friedrich - Alexander - University, Erlangen - Nuremberg | And 6 more authors.
Blood | Year: 2014

Alterations of cellular metabolism represent a hallmark of cancer. Numerous metabolic changes are required for malignant transformation, and they render malignant cells more prone to disturbances in the metabolic framework. Despite the high incidence of chronic lymphocytic leukemia (CLL), metabolism of CLL cells remains a relatively unexplored area. The examined untreated CLL patients displayed a metabolic condition known as oxidative stress, which was linked to alterations in their lymphoid compartment. Our studies identified mitochondrial metabolism as the key source for abundant reactive oxygen species (ROS). Unlike in other malignant cells, we found increased oxidative phosphorylation in CLL cells but not increased aerobic glycolysis. Furthermore, CLL cells adapted to intrinsic oxidative stress by upregulating the stress-responsive heme-oxygenase-1 (HO-1). Our data implicate that HO-1 was, beyond its function as an antioxidant, involved in promoting mitochondrial biogenesis. Thus ROS, adaptation to ROS, and mitochondrial biogenesis appear to form a self-amplifying feedback loop inCLL cells. Taking advantage of the altered metabolic profile, we were able to selectively target CLL cells by PK11195. This benzodiazepine derivate blocks the mitochondrial F1F0-ATPase, leads to a surplus production of mitochondrial superoxide, and thereby induces cell death in CLL cells. Taken together, our findinags depict how bioenergetics and redox characteristics could be therapeutically exploited in CLL. (Blood. 2014;123(17):2663-2672) © 2014 by The American Society of Hematology.


Faehling M.,Klinikum Esslingen | Eckert R.,Onkologische Schwerpunktpraxis | Kuom S.,Klinikum Esslingen | Kamp T.,Onkologische Schwerpunktpraxis | And 2 more authors.
Oncology | Year: 2010

Background: Erlotinib is a standard of treatment for metastatic non-small-cell lung cancer after failure of initial therapy. Patient selection based on clinical factors is under discussion. Methods: We analyzed the outcome in relation to clinical factors of 121 consecutive Caucasian patients treated with erlotinib in a routine clinical setting in a comprehensive cancer center and 2 regional oncology centers. Results: For patients with erlotinib treatment at the 1st/2nd/3rd/≥4th line, progression-free survival (PFS) was 4.5/3.5/2.5/3.0 months, and overall survival (OS) was 8.0/8.5/7.8/6.5 months. Patients with adenocarcinoma had an improved PFS, but a similar OS. Never-smokers had longer PFS (7 months) and OS (13 months) than smokers and ex-smokers. Male patients had a slightly longer survival than female patients (PFS 3.0 vs. 2.5 months, OS 8.5 vs. 7.0 months). After adjustment for smoking and histology, the gender difference in OS was significant (adjusted hazard ratio 0.57). Patients with clinically relevant skin toxicity (grade 2, 3) had a significantly prolonged PFS and OS. Patients with partial response on 1st radiological evaluation had a significantly prolonged PFS and OS. Conclusion: Among clinical factors, never-smoking status and male gender predicted a prolonged survival. During treatment, skin toxicity and radiological response were related to better survival. © 2010 S. Karger AG, Basel.


Niederwieser D.,University of Leipzig | Schmitz S.,Onkologische Schwerpunktpraxis
European Journal of Haematology | Year: 2011

The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors have received marketing approval in Europe. This review considers general issues surrounding the introduction of biosimilars and highlights current specific issues pertinent to their use in clinical practice in oncology. Information on marketing approval, extrapolation, labelling, substitution, immunogenicity and traceability of each biosimilar product is important, especially in oncology where patients are treated in repeated therapy courses, often with complicated protocols, and where biosimilars are not used as a unique therapy for replacement of e.g. growth hormone or insulin. While future developments in the regulation of biosimilars will need to address multiple issues, in the interim physicians should remain aware of the inherent differences between biosimilar and innovator products. © 2011 John Wiley & Sons A/S.


Jitschin R.,Friedrich - Alexander - University, Erlangen - Nuremberg | Braun M.,Friedrich - Alexander - University, Erlangen - Nuremberg | Buttner M.,Friedrich - Alexander - University, Erlangen - Nuremberg | Dettmer-Wilde K.,University of Regensburg | And 8 more authors.
Blood | Year: 2014

Myeloid-derived suppressor cells (MDSCs) represent a heterogeneous population that shares certain characteristics including an aberrant myeloid phenotype and the ability to suppress T cells. MDSCs have been predominantly studied in malignant diseases and findings suggest involvement in tumor-associated immune suppression. Chronic lymphocytic leukemia (CLL) is the leukemia with the highest incidence among adults. Immune defects occur already at early disease stages and impact the clinical course. We assessed presence, frequency, association to other immune parameters, and functional properties of circulating CD14+ cells lacking HLA-DR expression (HLA-DR lo) in patients with untreated CLL. These monocytic cells represent one of the best-defined human MDSC subsets. Frequency of CD14 +HLA-DRlo cells was significantly increased in CLL patients. Furthermore, MDSCs suppressed in vitro T-cell activation and induced suppressive regulatory T cells (TRegs). The MDSC-mediated modulation of T cells could be attributed to their increased indoleamine 2,3-dioxygenase (IDO) activity. CLL cells induced IDOhi MDSCs from healthy donor monocytes suggesting bidirectional crosstalk between CLL-cells, MDSCs, and TRegs. Overall, we identified aMDSCpopulation that expands in CLL. The exact mechanisms responsible for such accumulation remain to be elucidated and it will be of interest to test whether antagonizing suppressive functions of CLL MDSCs could represent a mean for enhancing immune responses. © 2014 by The American Society of Hematology.


Link H.,Klinik fur Innere Medizin 1 | Schmitz S.,Onkologische Schwerpunktpraxis
Onkologie(Czech Republic) | Year: 2013

Background: The aim was to re-evaluate the current prevalence and management of cancer-associated anaemia as defined by the World Health Organisation (WHO) and related risk factors. Patients and Methods: This was a prospective, 2-day web-based cross-sectional survey in cancer patients with non-myeloid malignancies in German outpatient clinics. Results: 89 centres collected data from 3,867 patients, of whom 74% received active cancer therapy. The median age was 65 years (range 19-99 years) and almost two-thirds were women; 68% of the patients had solid tumours (breast 34%, colorectal 17%, lung 8%), with 56% of them being metastatic; 73% had a WHO performance score of ≤ 1. The mean haemoglobin level was 12.0 ± 1.7 g/dl (± standard deviation; range 4.3-17.8 g/dl); the prevalence of levels below 12.0 g/dl was 49%. Two-thirds of these patients were not treated for anaemia; one-third received erythropoiesis-stimulating agents (12.6%), iron therapy (8.1%), transfusions (7.5%) or combinations thereof (8.0%) during the 4 weeks before evaluation. Chemotherapy, female sex, age and poor performance status were identified as significant anaemia-associated factors. Conclusions: The prevalence of untreated anaemia and the decreased performance status of cancer patients in Germany have hardly changed since the European Cancer Anaemia Survey (ECAS) in 2001. The treatment practice may not only be driven by guidelines and does not yet reflect new concepts of anaemia management. Copyright © 2013 S. Karger AG, Basel.

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