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Becker-Schiebe M.,Klinik fur Radioonkologie und Strahlentherapie | Bulitta M.,CRM Biometrics GmbH | Hoffmann W.,Klinik fur Radioonkologie und Strahlentherapie
Strahlentherapie und Onkologie | Year: 2011

Purpose: More than 80% of patients with breast cancer undergoing postsurgical radiotherapy (RT) will develop radiodermatitis and approximately 10% of these patients show grade 3 lesions. Side effects may reduce the patient's compliance and can be limiting factors to follow RT protocols. Therefore, there is a high need for more effective prophylactic treatments. In this study, a silymarin-based cream (Leviaderm®) was tested in comparison to our standard of care (SOC) at the involved site. Methods: A total of 101 patients were evaluated after breast-conserving surgery followed by RT with 50.4 Gy plus boost 9-16 Gy. Of these, 51 patients were treated with the silymarin-based cream. In addition, 50 patients were documented receiving a panthenol-containing cream interventionally, if local skin lesions occurred. The acute skin reactions were classified according to the RTOG and VAS (Visual Analogue Scale) scores. Results: The median time to toxicity was prolonged significantly with silymarin-based cream (45 vs. 29 days (SOC), p < 0.0001). Only 9.8% of patients using silymarin-based cream showed grade 2 toxicity in week 5 of RT in comparison to 52% with SOC. At the end of RT, 23.5% of patients in the silymarin-based study group developed no skin reactions vs. 2% with SOC, while grade 3 toxicity occurred only in 2% in the silymarin-based arm compared to 28% (SOC). Conclusions: Silymarin-based cream Leviaderm® may be a promising and effective treatment for the prevention of acute skin lesions caused by RT of breast cancer patients. To confirm the results of this nonrandomized, observational trial, this component should be tested in larger multicenter studies in this setting. © 2011 Urban & Vogel.


Sautter-Bihl M.-L.,Klinik fur Radioonkologie und Strahlentherapie | Sedlmayer F.,Paracelsus Medical University | Budach W.,Heinrich Heine University Düsseldorf | Dunst J.,University of Lübeck | And 9 more authors.
Strahlentherapie und Onkologie | Year: 2014

Aim. The purpose of this work is to update the practical guidelines for adjuvant radiotherapy of the regional lymphatics of breast cancer published in 2008 by the breast cancer expert panel of the German Society of Radiation Oncology (DEGRO). Methods. A comprehensive survey of the literature concerning regional nodal irradiation (RNI) was performed using the following search terms: "breast cancer", "radiotherapy", "regional node irradiation". Recent randomized trials were analyzed for outcome as well as for differences in target definition. Field arrangements in the different studies were reproduced and superimposed on CT slices with individually contoured node areas. Moreover, data from recently published meta-analyses and guidelines of international breast cancer societies, yielding new aspects compared to 2008, provided the basis for defining recommendations according to the criteria of evidence-based medicine. In addition to the more general statements of the German interdisciplinary S3 guidelines updated in 2012, this paper addresses indications, targeting, and techniques of radiotherapy of the lymphatic pathways after surgery for breast cancer. Results. International guidelines reveal substantial differences regarding indications for RNI. Patients with 1-3 positive nodes seem to profit from RNI compared to whole breast (WBI) or chest wall irradiation alone, both with regard to locoregional control and disease-free survival. Irradiation of the regional lymphatics including axillary, supraclavicular, and internal mammary nodes provided a small but significant survival benefit in recent randomized trials and one meta-analysis. Lymph node irradiation yields comparable tumor control in comparison to axillary lymph node dissection (ALND), while reducing the rate of lymph edema. Data concerning the impact of 1-2 macroscopically affected sentinel node (SN) or microscopic metastases on prognosis are conflicting. Conclusion. Recent data suggest that the current restrictive use of RNI should be scrutinized because the risk-benefit relationship appears to shift towards an improvement of outcome. © 2014 Springer-Verlag.


Sedlmayer F.,Paracelsus Medical University | Sautter-Bihl M.-L.,Klinik fur Radioonkologie und Strahlentherapie | Budach W.,Heinrich Heine University Düsseldorf | Dunst J.,University of Lübeck | And 8 more authors.
Strahlentherapie und Onkologie | Year: 2013

Background and purpose: The aim of the present paper is to update the practical guidelines for postoperative adjuvant radiotherapy of breast cancer published in 2007 by the breast cancer expert panel of the German Society for Radiooncology (Deutsche Gesellschaft für Radioonkologie, DEGRO). The present recommendations are based on a revision of the German interdisciplinary S-3 guidelines published in July 2012. Methods: A comprehensive survey of the literature concerning radiotherapy following breast conserving therapy (BCT) was performed using the search terms "breast cancer", "radiotherapy", and "breast conserving therapy". Data from lately published meta-analyses, recent randomized trials, and guidelines of international breast cancer societies, yielding new aspects compared to 2007, provided the basis for defining recommendations according to the criteria of evidence-based medicine. In addition to the more general statements of the DKG (Deutsche Krebsgesellschaft), this paper addresses indications, target definition, dosage, and technique of radiotherapy of the breast after conservative surgery for invasive breast cancer. Results: Among numerous reports on the effect of radiotherapy during BCT published since the last recommendations, the recent EBCTCG report builds the largest meta-analysis so far available. In a 15 year follow-up on 10,801 patients, whole breast irradiation (WBI) halves the average annual rate of disease recurrence (RR 0.52, 0.48-0.56) and reduces the annual breast cancer death rate by about one sixth (RR 0.82, 0.75-0.90), with a similar proportional, but different absolute benefit in prognostic subgroups (EBCTCG 2011). Furthermore, there is growing evidence that risk-adapted dose augmentation strategies to the tumor bed as well as the implementation of high precision RT techniques (e.g., intraoperative radiotherapy) contribute substantially to a further reduction of local relapse rates. A main focus of ongoing research lies in partial breast irradiation strategies as well as WBI hypofractionation schedules. The potential of both in replacing normofractionated WBI has not yet been finally clarified. Conclusion: After breast conserving surgery, no subgroup even in low risk patients has yet been identified for whom radiotherapy can be safely omitted without compromising local control and, hence, cancer-specific survival. In most patients, this translates into an overall survival benefit. © 2013 The Authors.


Sautter-Bihl M.L.,Klinik fur Radioonkologie und Strahlentherapie | Sedlmayer F.,Paracelsus Medical University | Budach W.,Heinrich Heine University Düsseldorf | Dunst J.,University of Lübeck | And 8 more authors.
Strahlentherapie und Onkologie | Year: 2012

Background: Although postoperative radiotherapy (RT) after breast-conserving surgery (BCS) halves the 10-year recurrence rate in breast cancer patients through all age groups, the question of whether RT may be omitted and replaced by endocrine therapy for women aged 70 years and older with low-risk factors has recently become an issue of debate. Methods: Survey of the relevant recent literature (Medline) and international guidelines. Results: Three randomized studies investigating the effect of RT in older women revealed significantly increased local recurrence rates when RT was omitted, and a negative impact on disease-free survival was observed in two of these trials. Despite these findings, in one of the studies omission of RT in women over 70 is recommended, leading to a respective amendment in the guidelines of the American National Comprehensive Cancer Network. Several large retrospective cohort studies analyzing the outcome of patients over 65 years with and without RT have since been published and showed a significantly improved local control in all subgroups of advanced age and stage, which predominantly translated into improved disease-free and overall survival. Conclusion: No subgroup of elderly patients has yet been identified that did not profit from RT in terms of local control. Therefore, chronological age alone is not an appropriate criterion for deciding against or in favor of adjuvant RT. The DEGRO breast cancer expert panel explicitly discourages determination of a certain age for the omission of postoperative RT in healthy elderly women with low-risk breast cancer. For frail elderly women, treatment decisions should be individually decided on the basis of standardized geriatric assessment. © 2012 Urban & Vogel. Zusammenfassung: Hintergrund: Nach brusterhaltender Operation wird die 10-Jahres-Rezidivrate bei Brustkrebspatientinnen sämtlicher Altersgruppen durch eine postoperative Radiotherapie (RT) halbiert. Dennoch ist neuerdings eine Kontroverse darüber entbrannt, ob bei Frauen über 70 Jahre mit niedrigem Risikoprofil auf die RT verzichtet und stattdessen eine endokrine Therapie erfolgen solle. Methoden: Literaturrecherche der kürzlich zu diesem Thema publizierten Studien (Medline) und internationaler Leitlinien. Resultate: In drei randomisierten Studien wurde die Effektivität der RT bei älteren Frauen untersucht und zeigte eine signifikant höhere Lokalrezidivrate bei Nichtbestrahlten sowie in zwei dieser Studien einen negativen Einfluss auf das krankheitsfreie Überleben. Dennoch wurde in einer Publikation der Verzicht auf eine RT bei >70-Jährigen empfohlen, was als Ergänzung in die aktuellen amerikanischen National-Comprehensive- Cancer-Network-Leitline übernommen wurde. Seitdem wurde in mehreren umfangreichen Kohortenstudien der Verlauf von Patientinnen >65 Jahre mit und ohne RT ausgewertet, wobei sich in sämtlichen Alterssubgruppen und Tumorstadien der >65-Jährigen eine signifikant verbesserte lokale Tumorkontrolle nach RT zeigte, die überwiegend auch zu einem verlängerten rezidivfreien und Gesamtüberleben führte. Schussfolgerung: Bislang wurde keine Subgruppe älterer Patientinnen identifiziert, die nicht durch Senkung der Lokalrezidivrate von einer RT profitierten. Die DEGRO-Expertengruppe Mammakarzinom sieht deshalb das kalendarische Alter allein nicht als hinreichendes Entscheidungskriterium gegen eine RT, diese sollte deshalb älteren Patientinnen in gutem Allgemeinzustand nicht vorenthalten werden. Bei gebrechlichen Älteren ist eine individuelle Entscheidung anhand eines standardisierten geriatrischen Assessments zu treffen. © 2012 Urban & Vogel.


Winzer K.-J.,Brustzentrum | Gruber C.,Brustzentrum | Badakhshi H.,Klinik fur Radioonkologie und Strahlentherapie | Hinkelbein M.,Klinik fur Radioonkologie und Strahlentherapie | Denkert C.,Institute For Pathologie
Strahlentherapie und Onkologie | Year: 2012

Background and purpose. In this study, we investigated how often guidelines for radiation therapy in patients with breast cancer are not complied with, which patient group is mostly affected, and how this influences local recurrence.Patients and methods. All patients (n=1,903) diagnosed between November 2003 and December 2008 with primary invasive or intraductal breast cancer in the interdisciplinary breast center of the Charité Hospital Berlin were included and followed for a median 2.18 years.Results. Patients who, in contrast to the recommendation of the interdisciplinary tumor board, did not undergo postoperative radiation experienced a fivefold higher local recurrence rate (p<0.0005), corresponding to a 5-year locoregional recurrence-free survival of 74.5% in this group. The 5-year locoregional recurrence-free survival of patients following the recommendations was 93.3%. Guideline compliance was dependent on age of patients, acceptance of adjuvant hormonal treatment or chemotherapy, and increased diameter of the primary tumor. Multiple logistic regression analysis showed an association between compliance and age or hormonal therapy. Conclusion. In order to avoid local recurrence patients should be motivated to comply with guideline driven therapy. Since a higher number of local recurrences is observed in health services research compared to clinical research, studies on the value of adjuvant treatment following local recurrence should be performed. © Springer-Verlag 2012.


Neu B.,Klinik fur Radioonkologie und Strahlentherapie | Sautter V.,Klinik fur Radioonkologie und Strahlentherapie | Momm F.,University Hospital Freiburg | Melcher U.,Klinik fur Radioonkologie und Strahlentherapie | And 3 more authors.
Strahlentherapie und Onkologie | Year: 2011

Background: Gynecomastia is a frequent side effect of antiandrogen therapy for prostate cancer and may compromise quality of life. Although it has been successfully treated with radiotherapy (RT) for decades, the priority of RT as a preferred treatment option has recently been disputed as tamoxifen was also demonstrated to be effective. The aim of the present paper is to provide an overview of indications, frequency, and technique of RT in daily practice in Germany, Switzerland, and Austria. Patients and Methods: On behalf of the DEGRO-AG GCG-BD (German Cooperative Group on Radiotherapy of Benign Diseases) a standardized questionnaire was sent to 294 RT institutions. The questionnaires inquired about patient numbers, indications, RT technique, dose, and - if available - treatment results. Moreover, the participants were asked whether they were interested in participating in a prospective study. Results: From a total of 294 institutions, 146 replies were received, of which 141 offered RT for gynecomastia. Seven of those reported prophylactic RT only, whereas 129 perform both preventive and symptomatic RT. In 110 of 137departments, a maximum of 20 patients were treated per year. Electron beams (76%) were used most often, while 24% of patients received photon beams or orthovolt x-rays. Total doses were up to 20 Gy for prophylactic and up to 40 Gy for therapeutic RT. Results were reported by 19 departments: prevention of gynecomastia was observed in 60-100% of patients. Only 13 institutions observed side effects. Conclusion: Prophylactic and symptomatic RT is widely used in the German-speaking countries, but patient numbers are small. The clinical results indicate that RT is a highly effective and well-tolerated treatment. © 2011 Urban & Vogel.


Heidenreich A.,Universitatsklinikum Cologne | Bohmer D.,Klinik fur Radioonkologie und Strahlentherapie
Urologe | Year: 2016

Locally advanced prostate cancer (LAPCA) comprises about 5–10 % of all newly diagnosed prostate cancers and is associated with the highest prostate cancer specific mortality (approximately 8–20 %). LAPCA is defined by the presence of extraprostatic extension, seminal vesicle invasion, and bladder neck infiltration of pelvic lymph node metastases. It is evident that prognosis can only be improved by interdisciplinary multimodality treatment strategies. Adequate local staging by multiparametric MRI is one of the cornerstones for an individualized, risk-adapted treatment approach. This might consist of extended radical prostatectomy with an extended pelvic lymphadenectomy or intensity-modulated radiation therapy with androgen deprivation as the primary local therapeutic approach. Both treatment strategies may be combined with neoadjuvant or adjuvant radiation therapy or salvage surgery. Combination with neoadjuvant or adjuvant chemotherapy and new androgen receptor pathway inhibitors might also be possible. This article summarizes the current treatment strategies for LAPCA. © 2016, Springer-Verlag Berlin Heidelberg.


PubMed | Universitatsklinikum Cologne and Klinik fur Radioonkologie und Strahlentherapie
Type: Journal Article | Journal: Der Urologe. Ausg. A | Year: 2016

Locally advanced prostate cancer (LAPCA) comprises about 5-10% of all newly diagnosed prostate cancers and is associated with the highest prostate cancer specific mortality (approximately 8-20%). LAPCA is defined by the presence of extraprostatic extension, seminal vesicle invasion, and bladder neck infiltration of pelvic lymph node metastases. It is evident that prognosis can only be improved by interdisciplinary multimodality treatment strategies. Adequate local staging by multiparametric MRI is one of the cornerstones for an individualized, risk-adapted treatment approach. This might consist of extended radical prostatectomy with an extended pelvic lymphadenectomy or intensity-modulated radiation therapy with androgen deprivation as the primary local therapeutic approach. Both treatment strategies may be combined with neoadjuvant or adjuvant radiation therapy or salvage surgery. Combination with neoadjuvant or adjuvant chemotherapy and new androgen receptor pathway inhibitors might also be possible. This article summarizes the current treatment strategies for LAPCA.


Sautter-Bihl M.-L.,Klinik fur Radioonkologie und Strahlentherapie | Sedlmayer F.,Paracelsus Medical University
Breast Care | Year: 2015

International guidelines reveal substantial differences regarding indications for regional nodal irradiation (RNI). Recently, several randomized studies provided new insights and these are discussed here. Patients with 1-3 positive nodes seem to profit from RNI compared to whole-breast (WBI) or chest-wall irradiation (CWI) alone, both with regard to locoregional control and disease-free survival. Irradiation of the regional lymphatics including axillary, supraclavicular and internal mammary nodes provided a small but significant survival benefit in recent randomized trials and 1 meta-analysis. Lymph node irradiation yields comparable tumor control in comparison to axillary lymph node dissection while reducing the rate of lymph edema. Data concerning the impact of 1-2 macroscopically affected sentinel nodes or microscopic metastases on prognosis are equivocal. Recent data suggest that the current restrictive use of RNI should be scrutinized, as the hazard-benefit relation appears to shift towards an improvement of outcome. © 2015 S. Karger GmbH, Freiburg.


Sautter-Bihl M.L.,Klinik fur Radioonkologie und Strahlentherapie | Hohenberger W.,Friedrich - Alexander - University, Erlangen - Nuremberg | Fietkau R.,Friedrich - Alexander - University, Erlangen - Nuremberg | Rodel C.,Goethe University Frankfurt | And 2 more authors.
Strahlentherapie und Onkologie | Year: 2013

Recently, preliminary results of the OCUM study (optimized surgery and MRI-based multimodal therapy of rectal cancer) were published and raised concern in the scientific community. In this observational study, the circumferential resection margin status assessed in preoperative MRI (mrCRM) was used to decide for either total mesorectal excision (TME) alone or neoadjuvant radiochemotherapy (nRCT). In contrast to current guidelines, neither T3 stage (with negative CRM) nor clinically positive lymph nodes were an indication for nRCT. Pathologically node-positive patients received chemotherapy (ChT). Overall, 230 patients were included, of whom 96 CRM-positive patients received nRCT. The CRM was accurately predicted in MRI, the rate of mesorectal plane resection was high. Recurrence rates have not yet been reported, but an impressive rate of down-staging for both T and N stage after nRCT was observed, while acute side effects were minimal. Nonetheless, the authors conclude that a substantial number of patients could be "spared severe radiation toxicity" and propagate their concept for prospectively replacing current guidelines. This is based on the hypothesis that CRM is a valid surrogate parameter for the risk of local recurrence and in case of a negative CRM, nRCT becomes dispensable. Moreover, it is assumed that lymph node status is no more relevant. Both assumptions are a contradiction to recent data from randomized studies as specified below. As 5-year locoregional recurrence rate (LRR) of only of 5-8% and < 5% in low risk rectal cancer can be achieved by the addition of RT, the noninferiority of surgery alone can not be presumed unless the expected 5-year LRR is ≤ 5-8%, whereas any excess of this range renders the study design inacceptable. Unless a publication explicitly specifies 5-year LRR, results are not exploitable for clinical decisions. © 2012 Springer-Verlag Berlin Heidelberg.

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