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Jehn C.F.,Charite - Medical University of Berlin | Boning L.,Onkologische Praxis Elisenhof | Kroning H.,Gemeinschaftspraxis fur Hamatologie und Onkologie | Possinger K.,Charite - Medical University of Berlin | Luftner D.,Charite - Medical University of Berlin
British Journal of Cancer | Year: 2012

Background: Clinical trials under-represent patients (pts) >65 years. Non-interventional studies (NISs) help to evaluate therapies in daily practice. This NIS evaluates efficacy and safety of cetuximab in combination with chemotherapy in metastatic colorectal cancer (mCRC) pts aged >65 years vs ≤65 years. Methods: A total of 657 pts were recruited into the NIS and analysed applying descriptive statistics and χ2 or Fisher's exact test. Results: A total of 309 and 305 pts aged ≤65 and >65 years, respectively, were documented; 80% showing a reduced ECOG status of 1-2 and 95% having received at least one palliative treatment. Cetuximab was combined with irinotecan according to approval status. Grade III/IV toxicities occurred in 20% of pts without any difference between age groups although the older pts had significantly more pre-existing comorbidities (P=0.001). A total of 64.2% of the pts developed skin rash, which was strongly related to response (P<0.0002) without any difference between age groups (P=0.34). The objective response rates were 37.9% for ages 18-65 years vs 35.4% for >65 years. Progression-free survival (PFS) did not differ between pts 18-65 years old (6.5 months) in comparison with pts >65 years (7.0 months). In a multivariate analysis only ECOG status had a negative impact on PFS (HR: 0,675; 95% Cl, 0.53-0.87; P=0.0019). Conclusion: This NIS reports one of the largest mCRC collectives >65 years and reduced performance status. Cetuximab has a similar efficacy and safety profile for pts aged ≤65 and >65 years. © 2012 Cancer Research UK All rights reserved. Source

Jehn C.F.,Charite - Medical University of Berlin | Boning L.,Onkologische Praxis Elisenhof | Kroning H.,Gemeinschaftspraxis fur Hamatologie und Onkologie | Pezzutto A.,Charite - Medical University of Berlin | Luftner D.,Charite - Medical University of Berlin
European Journal of Cancer | Year: 2014

Background We investigated the influence of comorbidity, Eastern Cooperative Oncology Group (ECOG) performance status and age on the efficacy and safety profile of cetuximab and irinotecan in elderly irinotecan-pretreated patients with mCRC. Methods 497 patients with mCRC were entered in the database of this non-interventional study (NIS). Comorbid conditions were recorded. Results A total of 247 and 250 patients aged <65 and >65 years, respectively, with a median age of 66 y were documented; 78% of the patients showed a reduced ECOG status. Grade III/IV toxicities occurred in 18% of patients without any difference between age groups although older patients had more comorbidities with a higher Charlson Comorbidity Index (CCI) (p = 0.002). Skin rash was strongly related to response (p = 0.006). Age, line of therapy, ECOG, gender and CCI had no influence on response. The objective response rates were similar: 38.1% for age <65 years versus 36.4% for age >65 years (p = 0.57). Progression-free survival (PFS) did not differ between patients 18-65 years (6.0 months) and patients >65 years (6.2 months; p = 0.99). Only PS had a negative impact on PFS (hazard ratio (HR): 0,499; 95% confidence interval (CI) 0.34-0.72; p = 0.002), whereas the presence of skin toxicity (grade > 1) influenced PFS and response rate (RR) positively (HR: 2.04; 95% CI, 1.6-2.6; p < 0.001). Conclusions Only PS and age had a negative influence on PFS irrespective of CCI or age. There were no significant differences in response rate and safety profile for elderly patients when treated with cetuximab and irinotecan. Comorbidities and age had no influence on efficacy or toxicity. © 2014 Elsevier Ltd. All rights reserved. Source

Sandherr M.,Gemeinschaftspraxis fur Hamatologie und Onkologie | Hentrich M.,Klinik fur Hamatologie | von Lilienfeld-Toal M.,Universitatsklinikum Jena | Massenkeil G.,Medizinischen Klinik II | And 5 more authors.
Annals of Hematology | Year: 2015

Reactivation of viral infections is common in patients with solid tumour or haematological malignancy. Incidence and severity depend on the extent of cellular immunosuppression. Antiviral prophylaxis may be effective to prevent viral reactivation. In 2006, the Infectious Diseases Working Party of German Society for Hematology and Medical Oncology (DGHO) published guidelines for antiviral prophylaxis in these patient populations. Here, we present an update of these guidelines for patients with solid and haematological malignancies undergoing antineoplastic treatment but not allogeneic stem cell transplantation. Relevant literature for reactivation of different viruses (herpes simplex virus (HSV), varicella zoster virus (VZV), hepatitis B virus (HBV) and respiratory viruses) is discussed to provide evidence-based recommendations for clinicians taking care of this patient population. We recommend a risk-adapted approach with (val)acyclovir against HSV and VZV in patients treated with alemtuzumab, bortezomib or purine analogues. Seasonal vaccination against influenza is recommended for all patients with solid or haematological malignancies regardless of antineoplastic therapy. Hepatitis B screening is recommended in lymphoproliferative disorders, acute leukaemia, and breast cancer, and during treatment with monoclonal anti-B-cell antibodies, anthracyclines, steroids and in autologous stem cell transplantation. In those with a history of hepatitis B prophylactic lamivudine, entecavir or nucleotide analogues as adefovir are recommended to prevent reactivation. © 2015, The Author(s). Source

Cornberg M.,Klinik fur Gastroenterologie | Schlevogt B.,Klinik fur Gastroenterologie | Rademacher J.,Klinik fur Pneumologie | Schwarz A.,Klinik fur Nieren und Hochdruckerkrankungen | And 2 more authors.
Internist | Year: 2016

This article is concerned with the important topic of infections associated with organ transplantation and includes a discussion on four subtopics. The first section describes the current options in the prevention and therapy of viral hepatitis in association with liver transplantation. Infections with hepatitis B, C, D (delta) and E are discussed with special emphasis on the interferon-free treatment of hepatitis C with the new antiviral drugs. The second section deals with Pseudomonas aeruginosa (PA) infections following lung transplantation (LuTx), which is one of the most frequently detected pathogens in the airway after LuTx. Patients with cystic fibrosis are particularly affected. This is important because studies have shown a clear correlation between chronic PA infections after LuTx and development of chronic transplant failure. Even if the data are still sparse, recommendations on prevention and therapeutic strategies are given. The theme of the third section is the high importance of viral infections after kidney transplantation. In addition to acquired infections, the transplanted organ as well as the recipient can be the source of the infection. The better the transplanted organ is tolerated under moderate immunosuppression, the less common and severe virus infections are. The focus of this section is on three common pathogens: cytomegalovirus, polyomavirus BK and hepatitis viruses. The final section deals with Aspergillus infections following transplantation of various organs. In this context Aspergillus spp. are one of the most commonly occurring fungal diseases. The epidemiology, risk factors, diagnostics, prophylaxis and therapy of invasive aspergillosis are presented. © 2016, Springer-Verlag Berlin Heidelberg. Source

Ponisch W.,University of Leipzig | Moll B.,University of Leipzig | Bourgeois M.,University of Leipzig | Andrea M.,University of Leipzig | And 19 more authors.
Journal of Cancer Research and Clinical Oncology | Year: 2013

Introduction Serious renal failure represents a severe complication of multiple myeloma (MM), with an estimated 25-50 % of patients being affected. Both bortezomib and bendamustine have been identified as quickly acting, effective and well-tolerated drugs and might therefore constitute an adequate combination regimen for patients presenting with light chain-induced renal failure. Methods Between March 2005 and March 2013, 36 patients with relapsed/refractory MM and light chaininduced renal failure (creatinine clearance \60 ml/min) were treated with bendamustine 60 mg/m2 on days 1 and 2, bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11 and prednisone 100 mg on days 1, 2, 4, 8 and 11 (BPV). Patients were divided according to severity of renal impairment into group A (n = 20) with moderate or severe renal dysfunction (eGFR 15-59 ml/min) and group B (n = 16) with renal failure/dialysis (eGFR\15 ml/min). Results Twenty-four patients (67 %) responded with three CR, three nCR, six VGPR and 12 PR. Six patients had minor response, two stable and four progressive disease. With a median follow-up period of 22 months, median progression-free survival (PFS) and overall survival (OS) for patients of group A were 10 and 25 months, respectively. This outcome was significantly better compared to patients of group B with a median PFS and OS of 3 and 7 months, respectively. Eleven patients showed a CRrenal, five a PRrenal and 15 a MRrenal. Summary These results indicate that this BPV combination is feasible, effective and well tolerated in patients with relapsed/refractory MM and light chain-induced renal failure. © Springer-Verlag Berlin Heidelberg 2013. Source

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