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1.
Biomed Res Int ; 2020: 3432987, 2020.
Article in English | MEDLINE | ID: mdl-33145346

ABSTRACT

INTRODUCTION: Literature shows platelet-rich plasma (PRP) to improve overall outcomes in orthopedics, dermatology, ophthalmology, gynecology, and plastic surgery. Data on oncological patients is very limited. Only one publication is available on PRP in breast cancer patients. This work evaluated PRP in sentinel node biopsy procedures for breast cancer patients in terms of complication rates and oncological short-term follow-up. METHODS: The evaluated PRP was ACP®, i.e., autologous conditioned plasma by Arthrex®. Between 2015 and 2018, 163 patients were offered to receive an ACP®/PRP injection in their lymph node biopsy site. Recruitment resulted in an approximate one-to-one ratio for analysis. Endpoints were major (revision) and minor (seroma, hematoma, and infection) complications rates as well as distant metastases, local recurrence, and overall survival. Median follow-up was 30 months. RESULTS: Complication rates and oncological follow-up showed PRP to be applicable to use in a sentinel node biopsy scenario in breast cancer patients. There were 0 revisions in the ACP®/PRP group and 1.2% revisions in the control group (not significant). Oncological follow-up showed zero (0) distant metastases and local recurrences as well as a 100% 30-month overall survival. CONCLUSIONS: This is the first analysis of ACP®/PRP used in breast cancer patients in a sentinel node biopsy setting worldwide. PRP does not seem to increase rates of local recurrence within this 30-month follow-up time frame. Also, trend towards decreasing complication rates could be shown.


Subject(s)
Breast Neoplasms/surgery , Lymph Node Excision/methods , Neoplasm Recurrence, Local/prevention & control , Platelet-Rich Plasma/physiology , Sentinel Lymph Node/surgery , Adult , Aged , Breast Neoplasms/diagnosis , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Female , Humans , Lymphatic Metastasis/prevention & control , Middle Aged , Sentinel Lymph Node/pathology , Sentinel Lymph Node Biopsy , Survival Analysis
2.
Eur J Cancer ; 96: 82-90, 2018 06.
Article in English | MEDLINE | ID: mdl-29679775

ABSTRACT

BACKGROUND: Endocrine treatment (ET) with an aromatase inhibitor (AI) is the treatment of choice in post-menopausal patients with hormone receptor-positive early breast cancer (EBC). However, adverse events (AEs) often lead to treatment discontinuation. This analysis aimed to identify side-effects that lead to patients failing to persist with letrozole treatment. PATIENTS AND METHODS: Post-menopausal hormone receptor-positive EBC patients starting ET with letrozole were enroled in EvAluate-TM, a non-interventional study. Information regarding treatment compliance and persistence was gathered in months 6 and 12. Persistence was defined as the time from 30 d after the start to the end of treatment. The influence on persistence of musculoskeletal syndrome, menopausal disorder, sleep disorder and other AEs within the first 30 d was analysed using Cox regression analyses. RESULTS: Among 3887 patients analysed, the persistence rate after 12 months was >85%. In all, 568 patients (14.6%) discontinued the treatment, 358 of whom (63.0%) did so only because of side-effects. The main AEs influencing persistence were musculoskeletal symptoms (hazard ratio [HR] 2.55; 95% confidence interval [CI], 1.90-3.42), sleep disorders (HR 1.95; 95% CI, 1.41-2.70) and other AEs (HR 2.03; 95% CI, 1.51-2.73). Menopausal disorder was not associated with non-persistence (HR 1.17; 95% CI, 0.74-1.84). CONCLUSIONS: These results suggest that side-effects of AIs such as musculoskeletal syndrome and sleep disorder lead to ET discontinuation within the first treatment year in significant numbers of EBC patients. Compliance programmes adapted for subgroups that are at risk for early non-persistence might help to ensure the recommended therapy duration. CLINICAL TRIALS NUMBER: CFEM345DDE19.


Subject(s)
Antineoplastic Agents/adverse effects , Aromatase Inhibitors/adverse effects , Breast Neoplasms/drug therapy , Letrozole/adverse effects , Medication Adherence , Postmenopause , Aged , Breast Neoplasms/pathology , Female , Germany , Humans , Middle Aged , Prospective Studies , Risk Factors , Time Factors , Treatment Outcome
3.
Ann Oncol ; 29(1): 186-192, 2018 01 01.
Article in English | MEDLINE | ID: mdl-29045642

ABSTRACT

Background: Patients' compliance and persistence with endocrine treatment has a significant effect on the prognosis in early breast cancer (EBC). The purpose of this analysis was to identify possible reasons for non-persistence, defined as premature cessation of therapy, on the basis of patient and tumor characteristics in individuals receiving adjuvant treatment with letrozole. Patients and methods: The EvAluate-TM study is a prospective, multicenter, noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive EBC in the early therapy phase. Treatment persistence was evaluated at two pre-specified study visits after 6 and 12 months. As a measure of early therapy persistence the time from the start to the end of treatment (TTEOT) was analyzed. Cox regression analyses were carried out to identify patient characteristics and tumor characteristics predicting TTEOT. Results: Out of the total population of 3941 patients with EBC, 540 (13.7%) events involving treatment cessation unrelated to disease progression were observed. This was due to drug-related toxicity in the majority of cases (73.5%). Persistence rates were 92.2%, 86.9%, and 86.3% after 6, 12, and 15 months, respectively. The main factors influencing premature treatment discontinuation were older age [hazard ratio (HR) 1.02/year], comorbidities (HR 1.06 per comorbidity), low body mass index, and lower tumor grade (HR 0.85 per grade unit). Conclusion: These results support the view that older, multimorbid patients with low tumor grade and low body mass index are at the greatest risk for treatment discontinuation and might benefit from compliance and support programs.


Subject(s)
Breast Neoplasms/drug therapy , Letrozole/administration & dosage , Medication Adherence , Aged , Antineoplastic Agents/administration & dosage , Aromatase Inhibitors/administration & dosage , Breast Neoplasms/pathology , Breast Neoplasms/psychology , Chemotherapy, Adjuvant , Female , Humans , Middle Aged , Postmenopause , Prospective Studies
4.
Ann Oncol ; 28(3): 497-504, 2017 03 01.
Article in English | MEDLINE | ID: mdl-27831502

ABSTRACT

Background: The neoadjuvant phase III GeparSepto study showed that substituting nab-paclitaxel for standard solvent-based paclitaxel significantly improved the pathologic complete response (pCR) rate achieved with a sequential neoadjuvant chemotherapy regimen of paclitaxel, epirubicin, and cyclophosphamide for high-risk primary breast cancer. Recent trials demonstrated that in HER2+ breast cancer pCR can be increased by using pertuzumab in addition to trastuzumab and chemotherapy. The present analysis focuses on efficacy and safety data from the subset of patients with HER2+ tumors from the GeparSepto trial (n = 396) in comparison to the HER2- cohort. Patients and methods: Patients with histologically confirmed breast cancer (n = 1206) received four cycles of weekly paclitaxel [either solvent-based (Pac) or nab-paclitaxel (nab-Pac), according to randomization] followed by 4 cycles of epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 q3w, with concurrent trastuzumab and pertuzumab q3w for those with HER2+ tumors. The primary endpoint was pCR defined as ypT0 ypN0. Results: Higher rates of pCR were achieved in HER2+ than in HER2- tumors (57.8% versus 22.0%, P < 0.0001), with the highest rate in the HER2+/HR- cohort (71.0%; 66.7% Pac, 74.6% nab-Pac). In HER2+/HR+ tumors, the pCR rate was 52.9% (49.7% Pac, 56.4% nab-Pac). Grade ≥3 toxic effects were significantly more common in HER2+ than in HER2- patients, with grade 3-4 diarrhea in 7.6% versus 0.9% (P < 0.001) and febrile neutropenia in 6.3% versus 3.3% (P = 0.023) of patients. Left ventricular ejection fraction decreases from baseline were uncommon, with 2.0% versus 0.4% of patients showing decreases to <50% along with a ≥10% decrease from baseline. Conclusion: In HER2+ early breast cancer, a dual HER2-targeted combination of pertuzumab and trastuzumab, together with taxane-epirubicin-cyclophosphamide neoadjuvant chemotherapy, achieved high rates of pCR.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/drug therapy , Receptor, ErbB-2/antagonists & inhibitors , Aged , Albumins/administration & dosage , Anthracyclines/administration & dosage , Antibodies, Monoclonal, Humanized/administration & dosage , Breast Neoplasms/genetics , Breast Neoplasms/pathology , Epirubicin/administration & dosage , Female , Fluorouracil/administration & dosage , Humans , Middle Aged , Neoadjuvant Therapy , Neoplasm Staging , Paclitaxel/administration & dosage , Receptor, ErbB-2/genetics , Trastuzumab/administration & dosage
5.
PLoS One ; 11(2): e0144143, 2016.
Article in English | MEDLINE | ID: mdl-26844890

ABSTRACT

INTRODUCTION: Pectopexy, a laparoscopic method for prolapse surgery, showed promising results in recent literature. Further improving this approach by reducing surgical time may decrease complication rates and patient morbidity. Since laparoscopic suturing is a time consuming task, we propose a single suture /mesh ileo-pectineal ligament fixation as opposed to the commonly used continues approach. METHODS: Evaluation was performed on human non-embalmed, fresh cadaver pelves. A total of 33 trials was performed. Eight female pelves with an average age of 75, were used. This resulted in 16 available ligaments. Recorded parameters were ultimate load, displacement at failure and stiffness. RESULTS: The ultimate load for the mesh + simplified single "interrupted" suture (MIS) group was 35 (± 12) N and 48 (± 7) N for the mesh + continuous suture (MCS) group. There was no significant difference in the ultimate load between both groups (p> 0.05). This was also true for displacement at failure measured at 37 (± 12) mm and 36 (±5) mm respectively. There was also no significant difference in stiffness and failure modes. CONCLUSION: Given the data above we must conclude that a continuous suture is not necessary in laparoscopic mesh / ileo-pectineal ligament fixation during pectopexy. Ultimate load and displacement at failure results clearly indicate that a single suture is not inferior to a continuous approach. The use of two single sutures may improve ligamental fixation. However, overall stability should not benefit since the surgical mesh remains the limiting factor.


Subject(s)
Laparoscopy/methods , Ligaments/surgery , Pelvis/surgery , Suture Techniques , Aged , Biomechanical Phenomena , Cadaver , Female , Humans , Pelvic Organ Prolapse/surgery , Surgical Mesh , Weight-Bearing
6.
Biomed Res Int ; 2015: 630601, 2015.
Article in English | MEDLINE | ID: mdl-25879032

ABSTRACT

INTRODUCTION: Platelet-rich plasma (PRP) is a product widely used in sports medicine, tissue repair, and general surgery. A recent meta-analysis showed this product to be beneficial when introduced into a wound area, be it intra-articular (i.e., joint-injections) or direct introduction onto the wound surface. METHODS: Between the years of 2012 and 2014 a questionnaire evaluating surgical outcome after port (venous access device) removal was answered by 100 patients in the control group and 20 patients in a PRP group, leading to a total of 120 patients in this single center, retrospective, subjective outcome evaluation. RESULTS: No statistical difference was shown in postsurgical complication rates, postsurgical pain, decreased mobility, and overall quality of life. A significant difference was shown in overall patient satisfaction and the desire to further improve port area scarring. Results differed significantly in favor of the PRP group. Interestingly, approximately 40.2% of patients are dissatisfied with the surgical outcome after port removal in the control group. This result, though surprising, may be improved to 10% dissatisfaction when a PRP product is used. CONCLUSION: PRP products such as Arthrex ACP are safe to use and present an additional option in improving surgical outcome.


Subject(s)
Cicatrix/drug therapy , Platelet-Rich Plasma , Postoperative Complications/drug therapy , Veins/drug effects , Arthroscopy/adverse effects , Cicatrix/physiopathology , Humans , Patient Satisfaction , Postoperative Complications/pathology , Retrospective Studies , Surveys and Questionnaires , Treatment Outcome , Veins/injuries , Veins/surgery , Wound Healing/drug effects
7.
Ultraschall Med ; 35(4): 345-9, 2014 Aug.
Article in German | MEDLINE | ID: mdl-24563421

ABSTRACT

PURPOSE: The aim of this study was to evaluate the quality standard of the nationwide breast ultrasound training program of the German Society of Ultrasound in Medicine (DEGUM) through objective parameters. MATERIALS AND METHODS: 10 quality criteria, based on the recommendations of The National Association of Statutory Health Insurance Physicians (KBV), were defined for this study. All training units of the DEGUM received a questionnaire. The questionnaires and training material were analyzed. RESULTS: All units met the required criteria pertaining to the trainer's qualification, duration per training course and the maximum number of participants per ultrasound machine. Only 1 course did not fulfill the required 50 % practical training time. The requirements to participate in the graduate course (200 self-made and documented cases) were not clearly conceived and a defined training log could be improved. CONCLUSION: DEGUM breast ultrasound training offers trainees a high level of education based on the requirements of the KBV. Despite the high quality of training, the content of course announcements could be improved and an official and structured educational index could be meaningful.


Subject(s)
Education, Medical, Continuing/standards , Education, Medical, Graduate/standards , National Health Programs , Societies, Medical , Ultrasonography, Mammary , Clinical Competence/standards , Curriculum/standards , Female , Germany , Humans , Quality Assurance, Health Care/standards , Quality Indicators, Health Care/standards
8.
Geburtshilfe Frauenheilkd ; 74(12): 1137-1143, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25568468

ABSTRACT

Introduction: The EvaluateTM study (Evaluation of therapy management and patient compliance in postmenopausal hormone receptor-positive breast cancer patients receiving letrozole treatment) is a prospective, non-interventional study for the assessment of therapy management and compliance in the routine care of postmenopausal women with invasive hormone receptor-positive breast cancer receiving letrozole. The parameters for inclusion in the study are presented and discussed here. Material and Methods: Between January 2008 and December 2009 a total of 5045 patients in 310 study centers were recruited to the EvaluateTM study. Inclusion criteria were hormone receptor-positive breast cancer and adjuvant treatment or metastasis. 373 patients were excluded from the analysis for various reasons. Results: A total of 4420 patients receiving adjuvant treatment and 252 patients with metastasis receiving palliative treatment were included in the study. For 4181 patients receiving adjuvant treatment, treatment with the aromatase inhibitor letrozole commenced immediately after surgery (upfront). Two hundred patients had initially received tamoxifen and started aromatase inhibitor treatment with letrozole at 1-5 years after diagnosis (switch), und 39 patients only commenced letrozole treatment 5-10 years after diagnosis (extended endocrine therapy). Patient and tumor characteristics were within expected ranges, as were comorbidities and concurrent medication. Conclusion: The data from the EvaluateTM study will offer a good overview of therapy management in the routine care of postmenopausal women with hormone receptor-positive breast cancer. Planned analyses will look at therapy compliance and patient satisfaction with how information is conveyed and the contents of the conveyed information.

9.
Ann Oncol ; 25(1): 75-80, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24356620

ABSTRACT

BACKGROUND: WSG-ARA plus trial evaluated the effect of adjuvant darbepoetin alfa (DA) on outcome in node positive primary breast cancer (BC). PATIENTS AND METHODS: One thousand two hundred thirty-four patients were randomized to chemotherapy either with DA (DA+; n = 615) or without DA (DA-; n = 619). DA (500 µg q3w) was started at hemoglobin (Hb) levels <13.0 g/dl (<12 g/dl after DA label amendment) and stopped at Hb levels ≥14.0 g/dl (12 g/dl after label amendment). Primary efficacy end point was event-free survival (EFS); secondary end points were toxicity, quality of life (QoL) and overall survival (OS). RESULTS: Venous thrombosis (DA+: 3.0%, DA-: 1.0%; P = 0.013) was significantly higher for DA+, but not pulmonary embolism (0.3% in both arms). Median Hb levels were stable in DA+ (12.6 g/dl) and decreased in DA- (11.7 g/dl). Hb levels >15 g/dl were reported in 0.8% of cycles. QoL parameters did not significantly differ between arms. At 39 months, DA had no significant impact on EFS (DA+: 89.3%, DA-: 87.5%; Plog-rank = 0.55) or OS (DA+: 95.5%, DA-: 95.4%; Plog-rank = 0.77). CONCLUSIONS: DA treatment did not impact EFS or OS in routine adjuvant BC treatment.


Subject(s)
Anemia/drug therapy , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Erythropoietin/analogs & derivatives , Hematinics/therapeutic use , Anemia/chemically induced , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Darbepoetin alfa , Disease-Free Survival , Erythropoietin/therapeutic use , Female , Humans , Lymphatic Metastasis , Middle Aged , Proportional Hazards Models , Treatment Outcome
10.
Ann Oncol ; 24(3): 618-24, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23136233

ABSTRACT

BACKGROUND: We carried out a prospective clinical study to evaluate the impact of the Recurrence Score (RS) on treatment decisions in early breast cancer (EBC). PATIENTS AND METHODS: A total of 379 eligible women with estrogen receptor positive (ER+), HER2-negative EBC and 0-3 positive lymph nodes were enrolled. Treatment recommendations, patients' decisional conflict, physicians' confidence before and after knowledge of the RS and actual treatment data were recorded. RESULTS: Of the 366 assessable patients 244 were node negative (N0) and 122 node positive (N+). Treatment recommendations changed in 33% of all patients (N0 30%, N+ 39%). In 38% of all patients (N0 39%, N+ 37%) with an initial recommendation for chemoendocrine therapy, the post-RS recommendation changed to endocrine therapy, in 25% (N0 22%, N+ 39%) with an initial recommendation for endocrine therapy only to combined chemoendocrine therapy, respectively. A patients' decisional conflict score improved by 6% (P = 0.028) and physicians' confidence increased in 45% (P < 0.001) of all cases. Overall, 33% (N0 29%, N+ 38%) of fewer patients actually received chemotherapy as compared with patients recommended chemotherapy pre-test. Using the test was cost-saving versus current clinical practice. CONCLUSION: RS-guided chemotherapy decision-making resulted in a substantial modification of adjuvant chemotherapy usage in node-negative and node-positive ER+ EBC.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/drug therapy , Neoplasm Recurrence, Local/prevention & control , Antineoplastic Agents, Hormonal/economics , Breast Neoplasms/genetics , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Cost-Benefit Analysis , Decision Making , Female , Humans , Lymphatic Metastasis , Markov Chains , Middle Aged , Neoplasm Recurrence, Local/genetics , Neoplasm Staging , Patient Care Planning , Prospective Studies , Receptors, Estrogen/metabolism , Surveys and Questionnaires
11.
J Med Econ ; 16(1): 30-40, 2013.
Article in English | MEDLINE | ID: mdl-22966753

ABSTRACT

OBJECTIVE: The 21-gene assay (Oncotype DX Breast Cancer Test (Genomic Health Inc., Redwood City, CA)) is a well validated test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER+, HER2- early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany. METHODS: A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy, and direct costs for patients with ER+, HER2-, node-negative, or up to 3 node-positive early-stage breast cancer. Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospective, multi-center trial in 366 patients. Transition probabilities and risk adjustment were based on published landmark trials. Costs (2011 Euros (€)) were estimated from a sick fund perspective based on resource use in patients receiving chemotherapy. Future costs and clinical benefits were discounted at 3% annually. RESULTS: The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality-adjusted life expectancy by 0.06 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon. Clinical benefits were driven by optimized allocation of adjuvant chemotherapy. Costs from a healthcare payer perspective were lower with the 21-gene assay by ∼€561 vs standard of care. Probabilistic sensitivity analysis indicated that there was an 87% probability that the 21-gene assay would be dominant (cost and life saving) to standard of care. LIMITATIONS: Country-specific data on the risk of distant recurrence and quality-of-life were not available. CONCLUSIONS: Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival, quality-adjusted life expectancy, and be cost saving vs the current standard of care women with ER+, HER2- early-stage breast cancer.


Subject(s)
Breast Neoplasms/drug therapy , Breast Neoplasms/genetics , Chemotherapy, Adjuvant/economics , Adult , Age Factors , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/economics , Clinical Trials as Topic , Cost-Benefit Analysis , Decision Making , Female , Gene Expression Profiling , Germany , Health Expenditures/statistics & numerical data , Humans , Life Expectancy , Markov Chains , Middle Aged , Models, Econometric , Multicenter Studies as Topic , Neoplasm Recurrence, Local/economics , Neoplasm Recurrence, Local/epidemiology , Quality-Adjusted Life Years , Receptor, ErbB-2/genetics , Reverse Transcriptase Polymerase Chain Reaction
12.
Anticancer Res ; 30(10): 4251-9, 2010 Oct.
Article in English | MEDLINE | ID: mdl-21036749

ABSTRACT

BACKGROUND: The central objective of this study was to determine the predictive impact of several established tumor biological factors (PgR, ER, HER2 and Ki-67) on response to pre-operative chemotherapy in primary breast cancer. PATIENTS AND METHODS: 59 primary M0 breast cancer patients received pre-operative sequential dose-dense epirubicin and cyclophosphamide followed by docetaxel (19 patients at dosage 100 mg/m(2), 40 patients at 75 mg/m(2)). RESULTS: Pathological complete remission (pCR) occurred in 17 patients (29%) and at least partial remission in 42 (71%). Higher proliferation (Ki-67) and lack of hormone receptors (either or both) were significant predictive factors for pCR; moreover, 8/11 (73%) patients with triple-negative tumors (HER2(-)/ER(-)/PgR(-)) had pCR (p=0.001). Breast conserving surgery was achieved in 46/59 patients (78%). Hand-foot syndrome occurred in 12/19 patients treated at the higher docetaxel dosage but only 1/40 of the remaining patients. Higher docetaxel dosage was associated with improved pCR in the non-triple-negative subgroup. CONCLUSION: The tumor biology of hormone receptor-negative, especially triple-negative, and highly proliferating breast cancer is associated with strongly positive response to dose-dense, pre-operative epirubicin/cyclophosphamide/docetaxel chemotherapy.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Adolescent , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/metabolism , Breast Neoplasms/surgery , Cyclophosphamide/administration & dosage , Docetaxel , Dose-Response Relationship, Drug , Drug Administration Schedule , Epirubicin/administration & dosage , Female , Humans , Middle Aged , Multivariate Analysis , Neoadjuvant Therapy , Prospective Studies , Receptor, ErbB-2/biosynthesis , Receptors, Estrogen/biosynthesis , Receptors, Progesterone/biosynthesis , Taxoids/administration & dosage , Young Adult
13.
Clin Pharmacol Ther ; 81(5): 659-68, 2007 May.
Article in English | MEDLINE | ID: mdl-17301739

ABSTRACT

The objective of the study was to assess individual distribution of antineoplastic drugs into the tumor. Twelve advanced-stage primary breast cancer patients with neoadjuvant epirubicin+paclitaxel chemotherapy were studied. Plasma concentrations of epirubicin and paclitaxel were monitored for 24 h. Epirubicin concentrations in subcutaneous and tumor tissues were measured using microdialysis up to 12 h postdose. Epirubicin concentrations were described by a compartmental population pharmacokinetic model (NONMEM). Noncompartmental analysis was used for paclitaxel. Plasma pharmacokinetics corresponded to published data. Mean epirubicin exposure in the tumor and in subcutaneous tissue was very similar, but tissue Cmax and area under the curve values reached only (means) 1% and 11%, respectively, of plasma values. Epirubicin doses were significantly correlated to tumor exposure irrespective of body surface area. There is no specific barrier for epirubicin to reach primary breast cancer tumors.


Subject(s)
Antibiotics, Antineoplastic/pharmacokinetics , Antineoplastic Agents, Phytogenic/pharmacokinetics , Breast Neoplasms/metabolism , Epirubicin/pharmacokinetics , Paclitaxel/pharmacokinetics , Adipose Tissue/metabolism , Antibiotics, Antineoplastic/therapeutic use , Antineoplastic Agents, Phytogenic/therapeutic use , Area Under Curve , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Dose-Response Relationship, Drug , Double-Blind Method , Epirubicin/therapeutic use , Female , Humans , Microdialysis , Paclitaxel/therapeutic use
14.
Rofo ; 178(3): 324-9, 2006 Mar.
Article in German | MEDLINE | ID: mdl-16508841

ABSTRACT

PURPOSE: Retrospective analysis of the success and complication rates of chest port implantation via the lateral subclavian vein. MATERIALS AND METHODS: Between January 2003 and June 2004, the lateral subclavian vein in 271 patients (186 women, 85 men, mean age 53.2 years) was punctured guided by ultrasound. This access was used to insert a port system, and the catheter tip was placed at the cavoatrial junction. The port reservoir was implanted in a subcutaneous infraclavicular pocket and fixed to the fascia of the pectoralis muscle. Indications for port implantation were chemotherapy (n = 239), total parenteral nutrition (n = 2) and intravenous medication (n = 30). The patient follow-up was mainly performed either by the oncology division of the department of gynecology or by the department of internal medicine. RESULTS: A chest port catheter system was successfully implanted in all patients. The catheter remained in place for a mean duration of 269.4 days (SD 192.3 days). No complications occurred during implantation. In the post-interventional period, 6 catheter dysfunctions were found (thrombotic 0.09 per 1000 catheter days; mechanic 0.05 per 1000 catheter days). While one local infection occurred in the early post-interventional period, 3 local and 15 systemic infections were independent of the port catheter placement (0.39 per 1000 catheter days). The rate of port catheter ex-plantation due to dysfunction or infection was 0.07 per 1000 catheter days. CONCLUSION: Ultrasound-guided puncture of the lateral subclavian vein is a safe procedure for the insertion of central venous port catheter systems and had a very low complication rate in our study. For further evaluation of our port placement technique, prospective studies compared to placement through the internal jugular vein are necessary.


Subject(s)
Catheterization, Central Venous/methods , Catheters, Indwelling , Infusion Pumps, Implantable , Subclavian Vein , Catheterization, Central Venous/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Parenteral Nutrition, Total/instrumentation , Punctures , Radiography, Thoracic , Retrospective Studies , Subclavian Vein/diagnostic imaging , Thorax , Time Factors , Ultrasonography
15.
Rofo ; 177(7): 955-61, 2005 Jul.
Article in German | MEDLINE | ID: mdl-15973597

ABSTRACT

PURPOSE: To compare the image quality of digital X-ray mammographies obtained with wet imagers with that of standard dry imaging technology. MATERIAL AND METHODS: Beginning 03/08/2003, 200 X-ray mammographies with a digital fullfield mammography system (Lorad Selenia, Lorad/Hologic) were prospectively and consecutively documented with a wet laser imager (Scopix LR 5200, Agfa), a dry infrared laser imager (DryView 8610, Kodak) and a dry imager using the principle of direct thermography (Drystar 4500M, Agfa, N = 166). One X-ray exposure was systematically chosen from each examination and was presented in an anonymous and randomized form to three radiologists who evaluated the films using a structured questionnaire. RESULTS: The visualization of normal anatomic structures was considered being good to excellent for all imagers with the mean assessments 1.0 - 2.4 for the Drystar 4500M, 1.0 - 2.1 for the DryView 8610 and 1.1 - 2.0 for the Scopix LR 5200. The mean assessments were 0.1 - 0.6 points lower in dense than in normal parenchyma, thus, the parenchymal density is the predominant factor for image quality. CONCLUSION: In view of the comparable image quality obtained with the different imagers used in the study, individual decisions to purchase a specific imager will be based on economics rather than on diagnostic points of view.


Subject(s)
Computer Peripherals , Equipment Failure Analysis , Lasers , Mammography/instrumentation , Printing/instrumentation , Radiographic Image Enhancement/instrumentation , Equipment Design , Humans , Mammography/methods , Paper , Radiographic Image Enhancement/methods , Reproducibility of Results , Sensitivity and Specificity , Thermography/instrumentation
16.
Rofo ; 176(5): 688-93, 2004 May.
Article in German | MEDLINE | ID: mdl-15122467

ABSTRACT

PURPOSE: To evaluate preoperative contrast enhanced MR imaging in clinically, mammographically and/or ultrasonographically established breast cancer. MATERIALS AND METHOD: From September 1998 to August 1999, preoperative contrast-enhanced MR imaging of the breast was performed in 91 patients with lesions highly suggestive of malignancy (BIRADS IV and V) by clinical, mammographic, and/or ultrasonographic criteria. MR imaging findings were postsurgically correlated with other imaging, intraoperative and histopathologic results. RESULTS: Histopathologic analysis revealed 61 (66 %) malignant and 31 (34 %) benign lesions. In 63 (69 %) of the 91 investigated patients, MR mammographies were classified as tumor suspect and in the remaining 28 (31 %) cases as benign. The sensitivity, specificity and accuracy were 90 %, 67 % and 81 % for contrast-enhanced MR imaging. Additional tumor manifestations (multifocal or multicentric disease, contralateral carcinoma) were found by MR imaging alone in 10 patients (11 %). CONCLUSION: Contrast-enhanced MR imaging may reveal unsuspected multifocal, multicentric or contralateral breast carcinoma that changes the surgical therapy if the intention is total tumor removal. The prognostic role of a potentially more radical surgical therapy on the basis of these findings is not clear.


Subject(s)
Breast Neoplasms/diagnosis , Magnetic Resonance Imaging/methods , Mammography , Ultrasonography, Mammary , Breast/pathology , Breast Diseases/diagnosis , Breast Diseases/pathology , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/diagnosis , Carcinoma, Ductal, Breast/pathology , Carcinoma, Intraductal, Noninfiltrating/diagnosis , Carcinoma, Intraductal, Noninfiltrating/pathology , Contrast Media , Diagnosis, Differential , Female , Fibroadenoma/diagnosis , Fibroadenoma/pathology , Fibrocystic Breast Disease/diagnosis , Fibrocystic Breast Disease/pathology , Gadolinium DTPA , Granuloma/diagnosis , Granuloma/pathology , Humans , Lymphatic Metastasis/diagnosis , Mastitis/diagnosis , Mastitis/pathology , Neoplasm Staging , Palpation , Prognosis , Sensitivity and Specificity , Time Factors
17.
Br J Plast Surg ; 56(5): 478-83, 2003 Jul.
Article in English | MEDLINE | ID: mdl-12890461

ABSTRACT

Pedicled TRAM flap surgery is a complex procedure characterised by an extensive wound site. We present two patients with efficient postoperative pain relief by continuous wound instillation of ropivacaine 0.2% via two multilumen catheters. The catheters were placed subcutaneously before the wound closure through the umbilicus into the abdominal wound, and under the autologous flap into the breast. Each multilumen catheter provides even distribution for local anaesthetics over 12.5 cm. At the end of surgery, patients received a single shot dose of local anaesthetic via the pain catheters. After surgery the continuous infusion of ropivacaine 0.2% was commenced at a rate of 10 ml/h per catheter. Pain scores at rest and on coughing were low on the first postoperative day, and later zero. No medication for breakthrough pain was required throughout the recovery period, and the patients experienced no adverse events linked to the analgesia scene. Patient satisfaction was excellent, and quality of recovery score was superior.


Subject(s)
Amides/administration & dosage , Anesthetics, Local/administration & dosage , Breast Neoplasms/surgery , Mastectomy/methods , Pain, Postoperative/prevention & control , Surgical Flaps , Adult , Analgesia/methods , Catheters, Indwelling , Female , Humans , Infusions, Intralesional/instrumentation , Infusions, Intralesional/methods , Middle Aged , Pain Measurement , Ropivacaine , Treatment Outcome
18.
Rofo ; 174(6): 767-75, 2002 Jun.
Article in German | MEDLINE | ID: mdl-12063609

ABSTRACT

BACKGROUND: In 1994, 5 % of a total of 25 718 examinations and 7 % of all 4630 B-mode sonograms performed in the Radiology Department, University of Cologne was classified as not indicated. In light of these results, the health care policy guidelines for sonographic indications have been amended. PURPOSE: The aim of this study was to establish the current rate of non-indicated sonographic examinations performed in routine diagnostics by radiology departments at university hospitals, to determine the reasons for such over-diagnosis and identify which regulatory mechanisms can be implemented to prevent his. METHOD: We counted the number of 1) B-mode and 2) color-flow Doppler ultrasound imaging procedures carried out in patients who had had no change in symptoms within the previous 4 weeks or who were scheduled without reference to an existing sonogram (double examinations). 3) The reasons for over-diagnosis were analyzed. 4) The 1994 survey was repeated in 2000 with an identical protocol and 5) additionally, a modified survey of the diagnostic questions was conducted. RESULTS: 1) Out of 4,119 patients presenting for the first time to receive a B-mode sonogram, 443 prior sonograms (11 %), 305 CT scans (7 %) and 57 MRI scans (1 %) were documented. 2) Double sonograms were carried out in 6 % of the 1,118 patients presenting for the first time for color-flow Doppler ultrasounds and in 16 % of the 651 patients assigned to receive catheter angiographies with arterial color-flow Doppler. 2) 41 out of 55 (75 %) prior sonograms from non-university settings stated by 94 surgery patients were listed in the medical records. 36 out of 43 (84 %) prior sonograms from the university hospital were repeated in the same patients despite the fact that the medical report with the findings was available. None of the 48 sonograms indicated to confirm a plausible finding yielded any information that was additionally relevant to therapy. 4) In the period April - June, 2000, 12 % of all 15,921 tests and interventions, 26 % of 3,569 B-mode sonograms and 58 % of 1,033 abdominal sonograms performed in adults were classified as having not been indicated. 5) Staging and follow-up were stated as the most common reasons that a sonography was carried out in 46 % of the 1,017 adults who were given B-mode sonograms conducted from Jan - Mar, 2000 and comprised 62 % of the 410 sonograms classified as not or probably not medically indicated. CONCLUSION: The results showed that a multidisciplinary consensus was required to establish the diagnostic value of sonographic procedures. Therefore, this research group drafted a hospital-internal interdisciplinary guideline for "abdominal transcutaneous B-mode sonography in oncological questions".


Subject(s)
Health Services Misuse/statistics & numerical data , National Health Programs/statistics & numerical data , Radiology Department, Hospital/statistics & numerical data , Ultrasonography, Doppler, Color/statistics & numerical data , Ultrasonography/statistics & numerical data , Diagnostic Imaging/statistics & numerical data , Female , Germany , Humans , Male , Neoplasm Staging , Neoplasms/diagnostic imaging , Neoplasms/pathology , Practice Guidelines as Topic , Utilization Review
19.
Eur J Obstet Gynecol Reprod Biol ; 99(1): 135-7, 2001 Nov.
Article in English | MEDLINE | ID: mdl-11604205

ABSTRACT

Ectopic pregnancies sited in dehiscent cesarean section scars have a high risk of rupture and bleeding. Attempts at operative therapy frequently end in loss of the uterus. A connection with the cavum uteri justifies an attempt at dilatation and curettage. We describes a patient with combined systemic and local intra-amniotic methotrexate (MTX). The uterus was preserved.


Subject(s)
Abortifacient Agents, Nonsteroidal/therapeutic use , Cesarean Section , Methotrexate/therapeutic use , Pregnancy, Ectopic/drug therapy , Pregnancy, Ectopic/surgery , Adult , Female , Fetal Death , Humans , Pregnancy , Pregnancy, Ectopic/diagnostic imaging , Ultrasonography
20.
Clin Exp Med ; 1(1): 1-8, 2001 Mar.
Article in English | MEDLINE | ID: mdl-11467396

ABSTRACT

Proteinkinase C (PKC) is involved in carcinogenesis, proliferation, and metastatic spread of breast cancer. New anticancer strategies have been developed with PKC as a potential target for therapeutic intervention. However, most of the encouraging preliminary data were observed in breast cancer cell lines only. Insignificant information is available concerning clinical breast cancer cells. Our aim was to investigate the involvement of PKC in clinical breast carcinoma cells. To this end, we set up short-term cultures (3 days) of native tumor cells derived from 12 patients with advanced breast cancer. Addition of commonly used antineoplastics, including both single agents and combinations (tamoxifen, Adriamycin, paclitaxel, Adriamycin plus paclitaxel, epirubicin plus 4-OOH-cyclophosphamide, mitoxantrone, mitoxantrone plus vinorelbin, vinorelbin), simulated the clinical situation. In relation to each control we determined total PKC activity and quantified the PKC-zeta isoform. In 6 patients, no obvious alteration of PKC activities was detected. In the remainder, either inhibition or augmentation of PKC activity in the presence of cytostatics was detected. However, no tendency could be observed concerning the influence of the therapeutics on PKC activity. PKC-zeta expression was much more heterogeneous than activity assays. Although anticancer drugs influenced PKC-zeta expression, the results showed no uniformity with regard to PKC-zeta expression. Moreover, PKC-zeta expression did not correlate with total PKC activity, indicating a differential expression of different PKC isoenzymes. Therefore, we conclude that both PKC activity and PKC-zeta expression differ individually. More data concerning this topic are necessary prior to offering a clinically useful PKC-tailored regimen.


Subject(s)
Antineoplastic Agents/pharmacology , Antineoplastic Combined Chemotherapy Protocols/pharmacology , Breast Neoplasms/enzymology , Breast Neoplasms/pathology , Protein Kinase C/genetics , Protein Kinase C/metabolism , Adult , Aged , Cell Culture Techniques/methods , Enzyme Inhibitors/pharmacology , Female , Gene Expression Regulation, Enzymologic/drug effects , Gene Expression Regulation, Neoplastic/drug effects , Humans , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Phloretin/pharmacology , Tumor Cells, Cultured
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