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Hannover, Germany

Discussion: Most recommendations rely on anecdotal data from specialized centers. The field of supportive therapy lacks a sufficient number of prospective studies which could give answers on the optimal approach to therapy management in the era of molecular therapies.Background: Molecular therapies are a landmark in the landscape of cancer treatment. The often long-term intake and clinical activity comes at the expense of chronic toxicity and renders therapy management a key ingredient for successful application.Aim: This article depicts different aspects of selected adverse events (AE) of molecular therapies and gives guidance for therapy management when using these novel class of agents.Material and methods: A selective literature search was performed in the Pubmed database.Results: Hand-foot syndrome and arterial hypertension are key AEs of vascular endothelial growth factor receptor (VEGFR) inhibitors, whereas oral mucositis and metabolic AEs remain the main aspects during treatment with mTOR inhibitors. Both therapeutic classes require specific therapy management in order to monitor and treat specific AEs. © 2015, Springer-Verlag Berlin Heidelberg. Source

Reimer P.,Klinik fur Hamatologie | Chawla S.,Spectrum Pharmaceuticals
Journal of Hematology and Oncology | Year: 2013

Peripheral T/NK-cell lymphomas (PTCL) are rare malignancies with a poor prognosis. Due to the lack of randomised studies, standard therapy has not been established. First-line treatment with anthracycline-based polychemotherapy followed by consolidation with high-dose therapy and autologous stem cell transplant in responding patients has demonstrated good feasibility with low toxicity in prospective studies and is widely used in eligible patients. In relapsed and refractory patients, who are not candidates for transplant approaches, therapeutic options are limited and are usually palliative. Several new agents are currently under investigation to improve the outcome of PTCL in the first line and salvage settings. Belinostat, a histone deacetylase (HDAC) inhibitor, has demonstrated broad antineoplastic activity in preclinical studies, and promising results in advanced relapsed/refractory lymphomas. Here, we report the case of a 73 year old patient with heavily pre-treated refractory PTCL in complete remission with belinostat for 39 months. © 2013 Reimer and Chawla; licensee BioMed Central Ltd. Source

Reimer P.,Klinik fur Hamatologie
European journal of Clinical and Medical Oncology | Year: 2010

Peripheral T/NK-cell lymphomas (PTCL) comprise a rare and heterogeneous group of malignancies that are characterized by an aggressive course. So far, no standard therapy has been defined. With the exception of anaplastic large cell lymphoma (ALCL) expressing the anaplastic lymphoma kinase (ALK), conventional (anthracycline-based) polychemotherapy leads to dismal outcome, with sustaining complete remissions achievable in only a minority of patients. High-dose therapy supported by autologous stem cell transplantation (HDT-ASCT) is a well-defined and widely used therapeutic approach in different hematological malignancies (e.g., relapsed aggressive B-cell lymphomas, relapsed Hodgkin's disease, multiple myeloma), and has also shown efficacy in relapsed PTCL. However, on account of the lack of randomized PTCL-restricted studies, the impact of HDT-ASCT as first-line therapy in PTCL is unclear. Retrospective studies in this setting have shown good feasibility with a low therapy-associated morbidity and mortality not exceeding toxicity in high-dose studies on aggressive B-cell lymphomas. To date, five larger prospective PTCL-restricted trials have addressed this strategy, varying in terms of inclusion criteria, induction therapy, high-dose protocols, etc. The outcome shows promising results with an overall survival of about 50% at 3 years. Patients achieving complete remission (CR) at transplantation seem to benefit most from this strategy. Therefore, induction therapy needs to be further improved to increase the transplantation rate. With the limited data available, upfront HDT-ASCT seems a reasonable approach in eligible patients, especially in patients achieving CR after induction therapy. This approach should be urgently evaluated in randomized trials, as planned by the German High-Grade Non-Hodgkin Lymphoma Study Group. Source

Gutzmer R.,Klinik fur Dermatologie | Wollenberg A.,Ludwig Maximilians University of Munich | Ugurel S.,Medical University of Graz | Homey B.,Universitatsklinikum Dusseldorf | And 2 more authors.
Deutsches Arzteblatt International | Year: 2012

Background: Many new antitumor drugs have been approved in recent years. Their side-effect profiles are distinct from those of older drugs, and their adverse effects are sometimes highly specific, particularly with respect to the skin. Methods: This article is based on articles retrieved by a selective search in Medline and the database of the American Society of Clinical Oncology (ASCO), as well as on the authors' personal experience. Results: Cutaneous adverse effects are among the more common adverse effects of new antitumor drugs: they occur in up to 34% of patients receiving multikinase inhibitors, up to 90% of those receiving selective tyrosine kinase inhibitors (such as EGFR or mutant BRAF inhibitors), and up to 68% of those receiving immunotherapeutic agents (such as CTLA4 inhibitors). These adverse effects can be correlated with therapeutic benefit, but they can also be treatment-limiting because of their severity or visibility. Conclusion: The recognition and proper management of cutaneous adverse effects is an important part of treatment with new antitumor drugs. Source

The market authorisation or extension of indication for all oncology drugs in Europe is now based on Regulation (EC) No. 726/2004, a centralised procedure of the European Medicines Agency (EMA). Studies in recent years have highlighted deficiencies in pivotal studies. For example, the requirements of the EMA are not always consistently followed and studies are stopped prematurely after only interim analysis that at this time point shows improved efficacy with regard to the comparator arm. Our current analysis of the European Assessment Reports (reporting period: 01/01/2009 to 08/13/2012) on 29 drugs for 39 oncology indications shows that the quality of the trials for market authorisation has improved in several respects. Primary endpoints recommended by the EMA and the Food and Drug Administration (FDA) such as overall survival and progression-free survival are used, and only one study was conducted as a phase II trial with no comparator arm. In contrast, oncology drugs that are approved for the treatment of rare diseases (orphan drugs) are based on small studies which are often carried out without blinding, are not randomised and investigate surrogate endpoints. To answer patient-relevant issues following market authorisation, it is necessary to conduct independent clinical studies. Increased public funding needs to be provided and bureaucratic hurdles have to be reduced. Only this will permit a more efficient use of limited health care resources and allow to improve the quality of care for cancer patients. Copyright © 2013 S. Karger AG, Basel. Source

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