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Knauf W.,Onkologische Gemeinschaftspraxis | Abenhardt W.,Munchner Onkologische Praxis | Aldaoud A.,Dr. Aldaoud Dr. Schwarzer Forschungsgesellschaft mbH | Nusch A.,Praxis fur Hamatologie und internistische Onkologie | And 4 more authors.
Oncology Research and Treatment | Year: 2014

Background: Various treatment options exist for patients with multiple myeloma (MM). Clinical registries provide insight into routine treatment and identify changes in treatment over time. Patients and Methods: The Tumour Registry Lymphatic Neoplasms (TLN) prospectively collects data on the treatment of patients with lymphoid B cell neoplasms as administered by office-based haematologists in Germany. Data on patient and tumour characteristics, comorbidities, systemic treatments and outcome parameters are recorded. Results: 371 non-transplant patients with MM were recruited between 2009 and 2011. At the start of first-line (second-line) treatment, the median age was 73 (75) years; 67% (74%) of the patients had stage III MM (classification of Durie and Salmon) and 19% (28%) had renal insufficiency. In the first line, 40% of the patients received bortezomib + melphalan + prednisone (VMP), 25% received bortezomib ± dexamethasone (V±D) and 8% were treated with melphalan + prednisone + thalidomide (MPT). While use of bortezomib-based regimens increased from 67% (2009) to 85% (2011), use of melphalan-based regimens decreased from 68% to 48%. The overall objective response rate of treatment was 82%. In the second line, 34% of the patients received V±D and 16% lenalidomide + dexamethasone (LD). Conclusion: Bortezomib-based regimens dominate the first- and second-line treatment of MM. Future analyses will investigate outcome data, e.g. effectiveness of bortezomib retherapy compared to other second-line treatments. © 2014 S. Karger GmbH, Freiburg.


PubMed | iOMEDICO, Outpatient Clinic for Interdisciplinary Oncology and Haematology, Oncology Outpatient Clinic and Center for Urology
Type: | Journal: Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners | Year: 2016

Signal transduction inhibitors (STIs) have considerably improved treatment of advanced/metastasized renal cell carcinoma (mRCC). Most safety data for these drugs are derived from clinical trials. The purpose of this study was to evaluate which adverse drug reactions are documented during first-line treatments in routine clinical practice.The ongoing prospective German mRCC clinical registry is recruiting patients in 110 oncology and urology outpatient centers. Data from the first 250 patients who had completed first-line treatment were analyzed regarding adverse drug reactions (ADRs) documented in patients medical records.Patients were older than in clinical trials and had comorbidities. Patients were treated with the STIs sunitinib (61%), temsirolimus (14%), sorafenib (10%), or bevacizumab combined with interferon (6%). About 520 ADRs were documented, of which 29% resulted in treatment modifications. The most frequently affected organ system was the gastrointestinal system. The most frequently documented ADRs were mucositis/stomatitis (14%), fatigue (14%), diarrhea (12%), and nausea (12%).In routine practice, mRCC first-line treatments using STIs frequently lead to ADRs partly necessitating treatment modifications. The pattern of reported ADRs is similar to that reported in clinical trials, but frequencies of events differ, especially for symptoms of multifactorial origin that are not immediately associated with the treatment. These results indicate that perception and documentation of adverse reactions is different between clinical trials and routine practice, and that reviews of patients medical records might not be the best method to assess safety in routine practice.


Welt A.,University of Duisburg - Essen | Marschner N.,The Interdisciplinary Center | Lerchenmueller C.,Oncology Outpatient Center | Decker T.,Oncology Outpatient Center | And 5 more authors.
Breast Cancer Research and Treatment | Year: 2016

The study was designed to evaluate efficacy and superiority of capecitabine/bevacizumab + vinorelbine (CAP/BEV/VIN) compared to CAP/BEV alone. Main purpose was to introduce a taxane-/anthracycline-free first-line treatment in advanced breast cancer (ABC), in order to avoid long-term toxicities. In this open-label, superiority, phase 3 trial, patients with HER2-negative ABC were randomized 1:1 to receive either oral CAP at 1000 mg/m2 [twice daily, days 1–14, q3w] plus intravenous BEV at 15 mg/kg [day 1, q3w] (arm A) or in addition to this protocol intravenous VIN at 25 mg/m2 [days 1 + 8, q3w] (arm B) until disease progression, unacceptable toxicity or withdrawal of consent. Between 26 February 2009 and 26 October 2012, we randomised 600 patients (arm A N = 300; arm B N = 300) from 57 German outpatient-centres and 2 university hospitals. Median progression-free survival (PFS) (primary endpoint) was not improved with VIN (CAP/BEV, 8.8 months; CAP/BEV/VIN, 9.6 months; HR 0.84 [95 % CI 0.70–1.01], P = 0.058). Median overall survival (OS) (secondary endpoint) was 25.1 and 27.2 months for CAP/BEV and CAP/BEV/VIN, respectively, average HR 0.85 [95 % CI 0.70–1.03], P = 0.104). The 1- and 2-year OS rates appeared to be similar (78.0 and 77.0 %; 53.0 and 54.0 %). Toxicity profiles were generally mild and manageable. Adverse events occurred more frequently in arm B. Regarding the balance between clinical efficacy (PFS, OS) and toxicity, the CAP/BEV combination provides a favourable treatment option in first-line ABC avoiding taxane- and/or anthracycline-induced long-term toxicity. Superiority of CAP/BEV/VIN was not met, and side effects were even enhanced. Nevertheless, no safety issues occurred. © 2016, The Author(s).


PubMed | HOPE Practice for Oncology, The Interdisciplinary Center, IOMEDICO, Oncology Outpatient Center and University of Duisburg - Essen
Type: Clinical Trial, Phase III | Journal: Breast cancer research and treatment | Year: 2016

The study was designed to evaluate efficacy and superiority of capecitabine/bevacizumab + vinorelbine (CAP/BEV/VIN) compared to CAP/BEV alone. Main purpose was to introduce a taxane-/anthracycline-free first-line treatment in advanced breast cancer (ABC), in order to avoid long-term toxicities. In this open-label, superiority, phase 3 trial, patients with HER2-negative ABC were randomized 1:1 to receive either oral CAP at 1000 mg/m(2) [twice daily, days 1-14, q3w] plus intravenous BEV at 15 mg/kg [day 1, q3w] (arm A) or in addition to this protocol intravenous VIN at 25 mg/m(2) [days 1 + 8, q3w] (arm B) until disease progression, unacceptable toxicity or withdrawal of consent. Between 26 February 2009 and 26 October 2012, we randomised 600 patients (arm A N = 300; arm B N = 300) from 57 German outpatient-centres and 2 university hospitals. Median progression-free survival (PFS) (primary endpoint) was not improved with VIN (CAP/BEV, 8.8 months; CAP/BEV/VIN, 9.6 months; HR 0.84 [95 % CI 0.70-1.01], P = 0.058). Median overall survival (OS) (secondary endpoint) was 25.1 and 27.2 months for CAP/BEV and CAP/BEV/VIN, respectively, average HR 0.85 [95 % CI 0.70-1.03], P = 0.104). The 1- and 2-year OS rates appeared to be similar (78.0 and 77.0 %; 53.0 and 54.0 %). Toxicity profiles were generally mild and manageable. Adverse events occurred more frequently in arm B. Regarding the balance between clinical efficacy (PFS, OS) and toxicity, the CAP/BEV combination provides a favourable treatment option in first-line ABC avoiding taxane- and/or anthracycline-induced long-term toxicity. Superiority of CAP/BEV/VIN was not met, and side effects were even enhanced. Nevertheless, no safety issues occurred.


Steinmetz T.,Outpatient Clinic for Hematology and Oncology | Schroder J.,Outpatient Clinic for Oncology | Plath M.,Outpatient Clinic for Oncology | Link H.,Westpfalz Klinikum | And 3 more authors.
Anemia | Year: 2016

The aim of this prospective cohort study was to assess current antianemic treatment of cancer patients in German routine practice, including diagnostics, treatments, and quality of life (QoL). 88 study sites recruited 1018 patients at the start of antianemic treatment with hemoglobin (Hb) levels <11 g/dL (females) or <12 g/dL (males). Patients were followed up for 12 weeks. 63% of the patients had inoperable solid tumors, 22% operable solid tumors, and 15% hematological malignancies. Over 85% received chemotherapy. Median age was 67 years; 48% were male. Red blood cell transfusions (RBCTx) were given to 59% of all patients and to 55% of the patients with Hb ≥8 g/dL on day 1 of the observation period (day 1 treatment). Erythropoiesis-stimulating agents (ESAs) were the second most frequently applied day 1 treatment (20%), followed by intravenous (IV) iron (15%) and ESA + IV iron (6%). Only about a third of patients were tested for blood serum iron parameters at the start of treatment. Overall, more than half of the patients had long-term responses to antianemic therapy. Our data suggest that in routine practice diagnostics for treatable causes of anemia are underused. A high proportion of cancer patients receive RBCTx. It should be discussed whether thorough diagnostics and earlier intervention could decrease the need for RBCTx. This trial is registered with NCT01795690. © 2016 Tilman Steinmetz et al.


PubMed | Friedrich - Alexander - University, Erlangen - Nuremberg, iOMEDICO, Hamato Onkologische Gemeinschaftspraxis, Praxis fur interdisziplinare Onkologie und Hamatologie and Practice Hematology Onc
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2017

454 Background: Being overweight is a known risk factor for developing renal cell carcinoma (RCC). On the other hand, overweight patients may harbor a less aggressive type of disease. A recent meta-analysis was able to demonstrate that a high preoperative BMI was an independent prognostic indicator for better overall survival in patients with RCC. We present data on the prognostic impact of the postoperative BMI, at the start of systemic treatment in patients with advanced or metastatic RCC (mRCC).The German RCC registry is a prospective, longitudinal, multicenter study conducted by a network of 133 office-based medical oncologists in Germany to document treatment of unselected patients with mRCC. Based on the inclusion criteria for this analyses we identified 475 prospectively documented patients who received 1The mean age of patients at the start of systemic treatment was 68 years and the median follow-up was 23.8 months. 118 (25%) presented with a BMI < 24, 195 (41%) with a BMI 24 - 28 and 162 (34%) with a BMI > 28. Patient characteristics did not differ between groups, except more patients in the low BMI group had a higher prognostic risk according to Motzer-score (11% vs. 5 % vs. 6 %). Median overall survival was 10.0 month, 16.7 month and 23.4 month in the low, medium and high BMI group, respectively. In a multivariate analysis, BMI (HR 0.94, 95% CI 0.91-0.98, p < .001) and Motzer-Score (HR 1.83, 95% CI 1.59-2.12, p < .001) had a significant impact on overall survival.In addition to Motzers prognostic score, the BMI at the start of palliative treatment may be used to discriminate mRCC patients with good and poor prognosis. Patients with a higher BMI tend to live longer than patients with low or normal BMI supporting evidence from previous meta-analyses on preoperative BMI and outcome.


Knauf W.,Onkologische Gemeinschaftspraxis | Abenhardt W.,Munchner Onkologische Praxis | Dorfel S.,Onkozentrum | Meyer D.,Hamatologisch Onkologische Schwerpunktpraxis | And 4 more authors.
Hematological Oncology | Year: 2015

Various treatment options exist for patients with chronic lymphocytic leukaemia (CLL). Clinical registries provide insight into routine treatment and identify changes in treatment over time. The Tumour Registry Lymphatic Neoplasms prospectively collects data on the treatment of patients with lymphoid B-cell neoplasm as administered by office-based haematologists in Germany. Data on patient and tumour characteristics, co-morbidities, systemic treatments, and outcome parameters are recorded. Eight hundred and six patients with CLL were recruited between May 2009 and August 2013. At the start of first-line treatment, median age was 71years, 64% were male, and 44% had a Binet stage C disease. The most frequently used first-line/second-line regimens were bendamustine+rituximab (BR, 56%/55%), fludarabine+cyclophosphamide+rituximab (FCR, 22%/11%), and bendamustine (B, 5%/9%). Chlorambucil was used in only 7% (first-line) and 6% (second-line) of patients. Patients treated with FCR were younger and healthier than patients treated with BR. Overall, 91% of first-line treatments were successful (40% complete response). Real-life patient populations differ considerably from patients treated in randomized controlled trials. BR and FCR dominate the first-line and second-line treatments of CLL by office-based haematologists in Germany. Future analysis will investigate progression-free and overall survival times. © 2014 The Authors. Hematological Oncology Published by John Wiley & Sons, Ltd. © 2015 John Wiley & Sons, Ltd.


Goebell P.J.,Friedrich - Alexander - University, Erlangen - Nuremberg | Muller L.,Oncology Outpatient Center | Hurtz H.-J.,Group Practice for Oncology | Koska M.,IOMEDICO | And 2 more authors.
Clinical Genitourinary Cancer | Year: 2016

Background The management of symptoms associated with treatment of metastatic renal cell carcinoma (mRCC) is crucial to ensure treatment adherence and outcome. The perception of symptoms can vary between the treating physician and patient, leading to assumptions and subsequent changes in treatment, potentially affecting treatment effectiveness. The aim of the present cross-sectional study was to evaluate the perception of the common symptoms of fatigue, mucositis, hand-foot syndrome, and dysgeusia in patients with mRCC receiving systemic therapies in routine practice. Patients and Methods German patients receiving first-line systemic treatment for mRCC and their physicians were independently queried about the incidence and severity of fatigue, mucositis, hand-foot syndrome, and dysgeusia. Patients also completed the Functional Assessment of Cancer Therapy-General questionnaire to assess their quality of life (QOL). The effect of the 4 symptoms on QOL was analyzed using linear regression modeling. Results A total of 63 matching questionnaires were completed by both physicians and patients with first-line treatment. The incidence and severity of symptoms differed between the patients and physicians. Patients rated the severity of symptoms significantly higher than did the physicians. A greater severity of symptoms correlated with a lower QOL. In multivariate regression analysis, fatigue adversely affected overall QOL. Conclusion Physicians underestimated the severity of common symptoms in patients with mRCC. The incorporation of patient-reported outcome measures into routine practice might increase awareness of patients' overall QOL and thereby potentially improve treatment adherence. A thorough evaluation of fatigue, its potential underlying causes, and active measures to manage fatigue could potentially improve patients' QOL. © 2016 Elsevier Inc. All rights reserved.


PubMed | Friedrich - Alexander - University, Erlangen - Nuremberg, iOMEDICO, Group Practice for Oncology, Oncology Outpatient Center and The Interdisciplinary Center
Type: Journal Article | Journal: Clinical genitourinary cancer | Year: 2016

Treatment of metastatic renal cell carcinoma can be associated with adverse symptoms. The perception of fatigue, mucositis, hand-foot syndrome, and dysgeusia, and quality of life (QOL) was assessed in 63 oncologists and their patients receiving first-line treatment. Physicians underestimated the severity of the symptoms and the severity correlated with a lower QOL. A consistent assessment of symptoms in routine practice might improve QOL, adherence to treatment, and outcome.The management of symptoms associated with treatment of metastatic renal cell carcinoma (mRCC) is crucial to ensure treatment adherence and outcome. The perception of symptoms can vary between the treating physician and patient, leading to assumptions and subsequent changes in treatment, potentially affecting treatment effectiveness. The aim of the present cross-sectional study was to evaluate the perception of the common symptoms of fatigue, mucositis, hand-foot syndrome, and dysgeusia in patients with mRCC receiving systemic therapies in routine practice.German patients receiving first-line systemic treatment for mRCC and their physicians were independently queried about the incidence and severity of fatigue, mucositis, hand-foot syndrome, and dysgeusia. Patients also completed the Functional Assessment of Cancer Therapy-General questionnaire to assess their quality of life (QOL). The effect of the 4 symptoms on QOL was analyzed using linear regression modeling.A total of 63 matching questionnaires were completed by both physicians and patients with first-line treatment. The incidence and severity of symptoms differed between the patients and physicians. Patients rated the severity of symptoms significantly higher than did the physicians. A greater severity of symptoms correlated with a lower QOL. In multivariate regression analysis, fatigue adversely affected overall QOL.Physicians underestimated the severity of common symptoms in patients with mRCC. The incorporation of patient-reported outcome measures into routine practice might increase awareness of patients overall QOL and thereby potentially improve treatment adherence. A thorough evaluation of fatigue, its potential underlying causes, and active measures to manage fatigue could potentially improve patients QOL.


PubMed | Ludwig Maximilians University of Munich, iOMEDICO, Outpatient Center for Haematology and Internistic Oncology, Friedrich - Alexander - University, Erlangen - Nuremberg and 2 more.
Type: | Journal: Clinical genitourinary cancer | Year: 2016

Because real-life patients often do not meet the strict eligibility criteria of clinical trials, we assessed the trial eligibility of patients with advanced or metastatic renal cell carcinoma (mRCC) in routine practice and compared the survival of trial-ineligible and potentially trial-eligible patients.The present prospective, multicenter German cohort study is recruiting patients from 110 oncology/urology outpatient centers and hospitals at initiation of systemic first-line treatment. The demographic, clinical, treatment, and survival data were collected. We defined patients as trial-ineligible when 1 exclusion criterion (Karnofsky performance status< 80%, hemoglobin less than the lower limit of normal, non-clear cell carcinoma histology) was documented. Otherwise, the patients were considered trial-eligible.Of 732 patients included, 57% were classified as trial-ineligible. Overall, the median first-line progression-free survival (PFS) was 7.9 months (95% confidence interval [CI], 6.9-8.9 months). The median first-line PFS of trial-eligible and trial-ineligible patients was 11.0 months (95% CI, 9.6-13.1 months) and 5.3 months (95% CI, 4.6-6.5 months), respectively. The median OS of the trial-eligible and trial-ineligible patients was 26.0 months (95% CI, 22.1-29.7 months) and 12.6 months (95% CI, 10.6-15.8 months), respectively.Our data suggest that patients in routine practice differ from patients treated in clinical trials and that almost 60% of mRCC patients in German routine practice would be ineligible for participation in clinical trials. While their first-line PFS and OS were shorter than those of trial-eligible patients, the PFS and OS of trial-eligible patients were comparable with the results from clinical trials. Physicians should be aware of these differences when discussing treatment options and outcome expectations with patients.

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