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  • 1
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    German Medical Science; Düsseldorf, Köln
    In:  GMS Current Posters in Otorhinolaryngology - Head and Neck Surgery; VOL: 2; DOC005 /20060424/
    Publication Date: 2006-04-24
    Description: Einleitung: In einer vorangegangenen Studie konnte bereits die Wirksamkeit der RF-Chirurgie des Zungengrundes bezüglich der Schnarchsymptomatik in der Therapie der obstruktiven Schlafapnoe dokumentiert werden. Ziel einer ersten prospektiven Fallserie sollte nun sein, die Wirksamkeit der RF-Chirurgie des Zungengrundes bei primären Schnarchen zu untersuchen.Methoden: Eingeschlossen wurden 20 Patienten mit der Diagnose eines primären Schnarchens (AHI/ODI 〈 10/h, Body-Mass-Index (BMI) 〈 32 kg/m²) sowie einer klinisch evidenten isolierten Zungengrundhyperplasie. Es erfolgte eine Sitzung bipolare RF-Chirurgie des Zungengrundes (Celon) mit 12 Läsionen à 7 Watt in Analgosedierung. Prä- und 6 - 8 Wochen postoperativ wurden die Schnarchsymptomatik unter Einbeziehung des Bettpartners (Visuelle Analogskala), die Schläfrigkeitssymptomatik (ESS) und der BMI erfragt.Ergebnisse: Die subjektive Schnarchsymptomatik konnte signifikant von präoperativ 7,5±0,5 Punkten auf 6,1±0,6 Punkte gesenkt werden (p〈0,005). BMI, Tagesschläfrigkeit und ESS-Score wurden durch die Behandlung nicht beeinflusst. Eine subjektive Zufriedenheit mit dem therapeutischen Ergebnis konnte lediglich in 3 von 20 Fällen erzielt werden.Schlussfolgerungen: Trotz statistisch signifikanter Reduktion der Schnarchsymptomatik, konnte keine klinisch relevante Verbesserung erreicht werden. Lediglich 3 von 20 Patienten waren mit dem Behandlungserfolg zufrieden. Aufgrund des intensivierten Therapieschemas mit 12 Läsionen/Sitzung ist eine weitere Steigerung des Therapieeffektes durch zusätzliche Sitzungen nicht zu erwarten. Dies deutet auf eine unterschiedliche Pathogenese der Schnarchsymptomatik bei primärem Schnarchen und obstruktiver Schlafapnoe hin.
    Keywords: ddc: 610
    Type: article
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  • 2
    Abstract: Biomarker-stratified cancer pharmacotherapy was pioneered in the care of breast cancer patients. The utility of agents modulating hormone receptors, synthesis of steroid hormones, or HER2-targeting agents has been greatly enhanced by the detection of predictive biomarkers in diagnostic tumor samples. Based on deeper understanding of breast cancer biology multiple drug candidates have been developed to modulate additional molecular targets which may associate with specific biomarker profiles. Accordingly, exploratory biomarkers are increasingly incorporated in early clinical trials, thus demanding a new process of patient selection. Here, we describe the implementation of preemptive, multiplexed biomarker profiling linked to standard diagnostic algorithms for metastatic breast cancer patients treated at the West German Cancer Center. Profiling for experimental biomarkers was prospectively offered to patients with metastatic breast cancer who met generic clinical trial inclusion criteria. Formalin-fixed, paraffin-embedded tumor samples were retrieved and studied for potentially "actionable" biomarkers related to active clinical trials by immunohistochemistry, amplicon sequencing, and in situ hybridization. The clinical course of those "profiled" patients was closely monitored to offer trial participation whenever applicable. Here, we report results from the first 131 patients enrolled in this program. PIK3CA mutations (23 %) and amplifications (2 %), loss of PTEN expression (13 %), and FGFR1 amplifications (8 %) were detected next to established biomarkers such as estrogen (67 %) and progesterone receptor expression (52 %), and HER2 overexpression or amplification (23 %). So far 16 "profiled" patients (12 %) have been enrolled in biomarker-stratified early clinical trials. Preemptive profiling of investigational biomarkers can be integrated into the diagnostic algorithm of a large Comprehensive Cancer Center. Extensive administrative efforts are required to successfully enroll "profiled" patients with metastatic breast cancer in early clinical trials stratified by exploratory biomarkers.
    Type of Publication: Journal article published
    PubMed ID: 24122392
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  • 3
    Keywords: GROWTH ; CELL LUNG-CANCER ; PATHWAYS ; MUTATIONS ; sensitivity ; FUTURE ; THERAPIES
    Abstract: PURPOSE: Multiple investigational drugs are currently explored in cancer patient populations defined by specific biomarkers. This demands a new process of patient selection for clinical trials. PATIENTS AND METHODS: Starting January 1, 2012, preemptive biomarker profiling was offered at the West German Cancer Center to all patients with advanced non-small-cell lung (NSCLC) or colorectal cancer (CRC), who met generic study inclusion criteria. Tumour specimens were subjected to prespecified profiling algorithms to detect 'actionable biomarkers' by amplicon sequencing, in situ hybridisation and immunohistochemistry. The clinical course was closely monitored to offer trial participation whenever applicable. RESULTS: Within 12 months, 267 patients (188 NSCLC, 79 CRC) were profiled. Estimated additional cost for biomarker profiling was 219615.51 EUR excluding histopathology workup and administration. The most prevalent biomarkers in pulmonary adenocarcinoma were KRAS mutations (29%), loss of PTEN expression (18%), EGFR mutations (9%), HER2 amplification (5%) and BRAF mutations (3%), while the prevalence of ALK translocations and PIK3CA mutations was extremely low. In pulmonary squamous cell carcinoma FGFR1 amplifications were found in 15%, PTEN expression was lost in 20% and DDR2 was mutated in a single case. KRAS mutations (41%) predominated in CRC, followed by loss of PTEN expression (16%), PIK3CA (5%) and BRAF (5%) mutations. So far 13 patients (5%) have entered biomarker-stratified clinical trials. Therapeutic decisions for approved drugs were guided in another 45 patients (17%). CONCLUSION: Preemptive biomarker profiling can be implemented into the diagnostic algorithm of a large Comprehensive Cancer Center. Substantial investments in diagnostics and administration are required.
    Type of Publication: Journal article published
    PubMed ID: 23876834
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  • 4
    Abstract: BACKGROUND: Male breast cancer (MBC) is a rare malignant disease, accounting for 〈1% of all breast cancers (BCs). Treatment of men with early-stage BC is based on standards established in female BC. Prognostic or predictive markers to guide therapeutic decisions, in particular in early-stage male BC, are missing. Here, we explored whether disseminated tumor cells (DTC) in bone marrow (BM) and circulating tumor cells (CTC) in blood could be suitable biomarkers in male BC. PATIENTS AND METHODS: Five male patients (pT2-4, pN0-2, M0) with hormone receptor-positive, HER2-negative, and ductal primary BC (median age 70 years, range 51-73) were enrolled in a prospective study of patients with early-stage breast cancer. Here, we analyze the male subgroup. DTC in BM were analyzed before therapy and identified by immunocytochemistry using the pancytokeratin antibody A45B/B3. Blood samples (10 ml) were analyzed for CTC using the AdnaTest BreastCancer (AdnaGen AG, Langenhagen, Germany). RESULTS: DTC were found in three out of five male patients (60%) with two DTC detected in one patient and one DTC detected in each of the other two patients. This is compared to a detection rate of 25-40% in pooled analyses of female patients. CTC were only found in one of five patients. After a median follow-up time of 3 years (range 1-10 years), all patients were still alive and free of relapse. CONCLUSION: The prevalence of DTC and CTC in male BC seems comparable with female BC. No prognostic relevance could be documented in this small population. A prospective study or at least larger cases series will be required to assess the prognostic or predictive value of DTC and CTC in this rare disease.
    Type of Publication: Journal article published
    PubMed ID: 25108406
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  • 5
    Abstract: BACKGROUND: The randomised phase III TANIA trial demonstrated that continuing bevacizumab with second-line chemotherapy for locally recurrent/metastatic breast cancer (LR/mBC) after progression on first-line bevacizumab-containing therapy significantly improved progression-free survival (PFS) compared with chemotherapy alone [hazard ratio (HR) = 0.75, 95% confidence interval (CI) 0.61-0.93]. We report final results from the TANIA trial, including overall survival (OS) and health-related quality of life (HRQoL). PATIENTS AND METHODS: Patients with HER2-negative LR/mBC that had progressed on or after first-line bevacizumab plus chemotherapy were randomised to receive standard second-line chemotherapy either alone or with bevacizumab. At second progression, patients initially randomised to bevacizumab continued bevacizumab with their third-line chemotherapy, but those randomised to chemotherapy alone were not allowed to cross over to receive third-line bevacizumab. The primary end point was second-line PFS; secondary end points included third-line PFS, combined second- and third-line PFS, OS, HRQoL and safety. RESULTS: Of the 494 patients randomised, 483 received second-line therapy; 234 patients (47% of the randomised population) continued to third-line study treatment. The median duration of follow-up at the final analysis was 32.1 months in the chemotherapy-alone arm and 30.9 months in the bevacizumab plus chemotherapy arm. There was no statistically significant difference between treatment arms in third-line PFS (HR = 0.79, 95% CI 0.59-1.06), combined second- and third-line PFS (HR = 0.85, 95% CI 0.68-1.05) or OS (HR = 0.96, 95% CI 0.76-1.21). Third-line safety results showed increased incidences of proteinuria and hypertension with bevacizumab, consistent with safety results for the second-line treatment phase. No differences in HRQoL were detected. CONCLUSIONS: In this trial, continuing bevacizumab beyond first and second progression of LR/mBC improved second-line PFS, but no improvement in longer term efficacy was observed. The second-line PFS benefit appears to be achieved without detrimentally affecting quality of life. CLINICALTRIALSGOV: NCT01250379.
    Type of Publication: Journal article published
    PubMed ID: 27502725
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  • 6
    Abstract: PURPOSE: Hepatic arterial infusion chemotherapy (HAIC) is an option for patients with liver-predominant metastatic breast cancer (LMBC), when no further systemic treatment is available. But systematic reports are limited. Here we conducted a retrospective analysis of LMBC patients treated at an expert center. METHODS: Individual patient data were retrieved from the clinical data base of the West German Cancer Center. Primary endpoints included hepatic response (RECIST), progression-free survival (PFS), overall survival (OS), and toxicity. A score based on LDH, AST, ALT and bilirubine was developed to estimate the hepatic metastasis load. RESULTS: Data from 70 consecutive patients were included. All patients were heavily pretreated (median 7 treatment lines for LMBC). HAIC protocols included mitomycin/5-FU (70%), mitomycin (14.3%), melphalan (12.9%) and 5-FU (7.1%), with selection based on patient characteristics. Partial hepatic remission was obtained as best response in 14 patients (20.0%), stable disease in 27 patients (38.6%), and progressive disease in 29 patients (41.4%). Median PFS and OS from initiation of HAIC were 2 (range 0-10) and 7 months (range 1-37). Mainly hepatic and hematopoietic HAIC-related toxicities were observed; there was no treatment-related death. The hepatic metastasis score effectively separated two prognostic groups: Patients with a score 〈3 had significantly superior PFS (15 vs 7 weeks, p = 0.017) and OS (12 vs 5 months, p = 0.002). CONCLUSION: HAIC offers a safe and effective salvage treatment strategy in heavily pretreated patients with LMBC and no further treatment options. The hepatic metastasis score may help to identify patients with sustained clinical benefit.
    Type of Publication: Journal article published
    PubMed ID: 28646261
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  • 7
    Keywords: SURVIVAL ; BLOOD ; CELL ; Germany ; THERAPY ; DEATH ; DISEASE ; PATIENT ; CYCLE ; treatment ; LYMPHOMA ; chemotherapy ; PROGNOSTIC-FACTORS ; BONE-MARROW-TRANSPLANTATION ; CYCLOPHOSPHAMIDE ; RANDOMIZED TRIAL ; Hodgkin's lymphoma ; ifosfamide ; ETOPOSIDE ; PHASE-II ; NON-HODGKINS-LYMPHOMA ; HIGH-DOSE CHEMOTHERAPY ; RE ; analysis ; SINGLE-CENTER ; PROGENITOR-CELL ; CONVENTIONAL CHEMOTHERAPY ; 2ND-LINE THERAPY ; aggressive non-Hodgkin's lymphoma ; ARA-C ; POOR-RISK ; salvage treatment
    Abstract: High-dose chemotherapy (HD-CT) with autologous stem cell transplantation is considered to be the treatment of choice for relapsed high-grade non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma (HL) patients, but the optimal treatment has not yet been defined. We evaluated a salvage treatment regimen consisting of conventional cycles with ifosfamide, etoposide, cytarabine, and dexamethasone (IVAD) followed by two cycles of HD-CT consisting of cyclophosphamide, melphalan, and etoposide (CMV) with autologous stem cell support in patients with relapsed or refractory NHL (n = 59) and HL (n = 16). Response to IVAD was complete remission (CR) in 16 patients (21%), partial remission (PR) in 39 patients (52%), stable disease (SD) in 18 patients (24%), and progressive disease (PD) in two patients (2.7%). Of 70 patients treated with HD-CT, 41 patients (59%) showed a CR, 20 patients a PR (29%), eight patients a SD (11%), and one patient a PD (1.4%). The 5-yr overall survival for the entire group of patients was 29%, and for patients with NHL and HL 25%, and 38%, respectively. The respective event-free survival probabilities at 5 yr were 22%, 16%, and 31%. Seven treatment-related deaths due to septicemia (three), cardiac arrhythmia (one), pneumonia (one), pneumonitis (one), and toxic epidermal necrolysis (one) were observed. In multivariate analysis, an International Prognostic Index of 〉= 2 and resistant disease to first-line chemotherapy were poor independent prognostic factors for the subgroup of patients with NHL. In conclusion, these results indicate that IVAD/CMV is feasible as a salvage therapy for lymphoma patients. This treatment is currently evaluated with the addition of rituximab
    Type of Publication: Journal article published
    PubMed ID: 17313557
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  • 8
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    German Medical Science; Düsseldorf, Köln
    In:  77. Jahresversammlung der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e.V.; 20060524-20060528; Mannheim; DOC06hnod632 /20060424/
    Publication Date: 2006-04-25
    Keywords: ddc: 610
    Language: German
    Type: conferenceObject
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  • 9
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    German Medical Science GMS Publishing House; Düsseldorf
    In:  26. Internationaler Kongress der Deutschen Ophthalmochirurgen; 20130613-20130615; Nürnberg; DOCH 3.4 /20131018/
    Publication Date: 2013-10-19
    Keywords: ddc: 610
    Language: German
    Type: conferenceObject
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  • 10
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    German Medical Science; Düsseldorf, Köln
    In:  104. Jahrestagung der Deutschen Ophthalmologischen Gesellschaft (DOG); 20060921-20060924; Berlin; DOC06dogFR.01.02 /20060918/
    Publication Date: 2006-09-19
    Keywords: ddc: 610
    Language: German
    Type: conferenceObject
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