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Purpose Radiotherapy (RT) was identified as a risk factor for long-term cardiac effects in breast cancer patients treated until the 1990s. However, modern techniques reduce radiation exposure of the heart, but some exposure remains unavoidable. In a retrospective cohort study, we investigated cardiac mortality and morbidity of breast cancer survivors treated with recent RT in Germany. Methods A total of 11,982 breast cancer patients treated between 1998 and 2008 were included. A mortality follow-up was conducted until 06/2018. In order to assess cardiac morbidity occurring after breast cancer treatment, a questionnaire was sent out in 2014 and 2019. The effect of breast cancer laterality on cardiac mortality and morbidity was investigated as a proxy for radiation exposure. We used Cox Proportional Hazards regression analysis, taking potential confounders into account. Results After a median follow-up time of 11.1 years, there was no significant association of tumor laterality with cardiac mortality in irradiated patients (hazard ratio (HR) for left-sided versus right-sided tumor 1.09; 95% confidence interval (CI) 0.85–1.41). Furthermore, tumor laterality was not identified as a significant risk factor for cardiac morbidity (HR = 1.05; 95%CI 0.88–1.25). Conclusions Even though RT for left-sided breast cancer on average incurs higher radiation dose to the heart than RT for right-sided tumors, we found no evidence that laterality is a strong risk factor for cardiac disease after contemporary RT. However, larger sample sizes, longer follow-up, detailed information on individual risk factors and heart dose are needed to assess clinically manifest late effects of current cancer therapy.

Background The B2 Prognostic Score (B2PS) is a clinical decision-making tool in metastatic breast cancer (MBC) that provides risk classification based on routine parameters. This study validates the B2PS in an independent series of MBC for the whole study group and for each intrinsic subtype. Patients and Methods We analyzed 641 metastasized patients, treated in 17 German certified breast cancer centers between 2001 and 2009. They were classified into low, intermediate, and high-risk groups according to B2PS. Overall survival (OS) curves for the various B2PS groups were compared with Kaplan-Meier method. Results According to the B2PS formula, 42.3% of patients were classified as low risk, 25.4% as intermediate risk and 32.3% as high risk. Intermediate- and high-risk patients had a statistically significant decreased OS compared with B2PS low-risk patients: (intermediate-risk: hazard ratio, 1.36; 95% confidence interval, 1.04-1.77; P = .023; high-risk: hazard ratio, 2.62; 95% confidence interval, 2.06-3.32; P Conclusions This study demonstrates the reproducibility of the B2PS based on routinely assessable parameters and confirms its prognostic value in an independent entire cohort of MBC as well as in the separate intrinsic subtypes. It therefore can help in counseling and individualizing the therapeutic regimens of those patients.

To examine influences on the receptor status of a local cohort of patients with recurrent breast cancer after primary diagnosis of hormone receptor positive breast cancer. We retrospectively analyzed 2078 female patients with primary hormone receptor positive breast cancer treated at the university hospital of Wuerzburg between 2000 and 2013. Main focus was on discordance in receptor status in recurrent disease. 196 patients with the primary diagnosis of hormone receptor positive breast cancer developed recurrent disease. 29.1% of patients revealed discordance in estrogen receptor (ER), progesterone receptor (PgR) or HER2 receptor (ER+ to −: 33.3%; PgR+ to −: 59.6%; HER2+ to −: 8.8%; HER2− to +: 17.5%). Aggressive tumor biology such as low grading or involvement of axillary lymph nodes showed increased risk of receptor conversion in relapse. Premenopausal patients with adjuvant application of tamoxifen and the application of chemotherapy had a significantly lower risk for the development of ER negative recurrent disease. Receptor changes to ER and PgR negativity in recurrent disease showed a trend to worse overall survival (OS). Histological analysis of recurrent disease is indispensable, since one-third of patients with hormone receptor positive breast cancer develop change in the receptor status.

Background Radiotherapy (RT) is of critical importance in the locoregional management of early breast cancer. Although RT is routinely used following breast conserving surgery (BCS), patients may occasionally be effectively treated with BCS alone. Currently, the selection of patients undergoing BCS who do not need breast irradiation is under investigation. With the advancement of personalized medicine, there is an increasing interest in reduction of aggressive treatments especially in older women. The primary objective of this study was to identify elderly patients who may forego breast irradiation after BCS without measurable consequences on local tumor growth and survival. Methods We analyzed 2384 early breast cancer patients aged 70 and older who were treated in 17 German certified breast cancer centers between 2001 and 2009. We compared RT versus no RT after guideline adherent (GA) BCS. The outcomes studied were breast cancer recurrence (RFS) and breast cancer-specific survival (BCSS). Low-risk patients were defined by luminal A, tumor size T1 or T2 and node-negative whereas higher-risk patients were defined by patients with G3 or T3/T4 or node-positive or other than Luminal A tumors. To test if there is a difference between two or more survival curves, we used the Gp family of tests of Harrington and Fleming. Results The median age was 77 yrs (mean 77.6±5.6 y) and the median observation time 46 mths (mean 48.9±24.8 mths). 950 (39.8%) patients were low-risk and 1434 (60.2%) were higher-risk. 1298 (54.4%) patients received GA BCS of which 85.0% (1103) received GA-RT and only 15% (195) did not. For low-risk patients with GA-BCS there were no significant differences in RFS (log rank p = 0.651) and in BCSS (p = 0.573) stratified by GA-RT. 5 years RFS in both groups were > 97%. For higher-risk patients with GA-BCS we found a significant difference (p

In breast cancer patients treated in the 1970s and 1980s, radiation therapy (RT) for left-sided tumors has been associated with an elevated risk of cardiac mortality. In recent years, improved RT techniques have reduced radiation exposure of the heart and major coronary vessels, but some exposure remains unavoidable. In a retrospective cohort study, we investigated the long-term cardiac mortality risk of breast cancer survivors treated with modern RT in Germany.A total of 11,982 women were included who were treated for breast cancer between 1998 and 2008. A systematic mortality follow-up was conducted until December 2012. The effect of breast cancer laterality on cardiac mortality and on overall mortality was investigated as a surrogate measure of exposure. Using Cox regression, we analyzed survival time as the primary outcome measure, taking potential confounding factors into account.We found no evidence for an effect of tumor laterality on mortality in irradiated patients (N = 9058). For cardiac mortality, the hazard ratio was 0.94 (95% CI 0.64-1.38) for left-sided versus right-sided tumors. For all causes of death, the hazard ratio was 0.95 (95% CI 0.85-1.05). A diagnosis of cardiac illness prior to breast cancer treatment increased both cardiac mortality risk and overall mortality risk.Contemporary RT seems not to be associated with an increased risk of cardiac mortality or overall mortality for left-sided breast cancer relative to right-sided RT. However, an extended follow-up period and exact dosimetry might be necessary to confirm this observation.

Background Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia. In healthy and fit individuals, anaemia can be compensated by several mechanisms. Elderly patients, however, have less compensatory mechanisms because of multiple co-morbidities and age-related decline of functional reserves. The purpose of the study is to evaluate whether elderly surgical patients may benefit from a liberal red blood cell (RBC) transfusion strategy compared to a restrictive transfusion strategy. Methods The LIBERAL Trial is a prospective, randomized, multicentre, controlled clinical phase IV trial randomising 2470 elderly (≥ 70 years) patients undergoing intermediate- or high-risk non-cardiac surgery. Registered patients will be randomised only if Haemoglobin (Hb) reaches ≤9 g/dl during surgery or within 3 days after surgery either to the LIBERAL group (transfusion of a single RBC unit when Hb ≤ 9 g/dl with a target range for the post-transfusion Hb level of 9–10.5 g/dl) or the RESTRICTIVE group (transfusion of a single RBC unit when Hb ≤ 7.5 g/dl with a target range for the post-transfusion Hb level of 7.5–9 g/dl). The intervention per patient will be followed until hospital discharge or up to 30 days after surgery, whichever occurs first. The primary efficacy outcome is defined as a composite of all-cause mortality, acute myocardial infarction, acute ischaemic stroke, acute kidney injury (stage III), acute mesenteric ischaemia and acute peripheral vascular ischaemia within 90 days after surgery. Infections requiring iv antibiotics with re-hospitalisation are assessed as important secondary endpoint. The primary endpoint will be analysed by logistic regression adjusting for age, cancer surgery (y/n), type of surgery (intermediate- or high-risk), and incorporating centres as random effect. Discussion The LIBERAL-Trial will evaluate whether a liberal transfusion strategy reduces the occurrence of major adverse events after non-cardiac surgery in the geriatric population compared to a restrictive strategy within 90 days after surgery. Trial registration ClinicalTrials.gov (identifier: NCT03369210). Electronic supplementary material The online version of this article (10.1186/s13063-019-3200-3) contains supplementary material, which is available to authorized users.

Purpose:Our aim was to implement a structured literature search using PICO (patient/intervention/comparison/outcome) questions and a standardized consensus method for the German Guideline ‘Detection, diagnostics, therapy and follow-up of Breast Cancer' using, as an example, the significance of systemic therapy in lymph node recurrent disease (LNRD). Methods: We defined specified PICO questions according to the clinical significance of a recommendation for systemic therapies in locoregional LNRD. A methodologist performed a systematic literature search including randomized controlled trials, systematic reviews and observational studies (2007-2016). In a consensus conference, the level of evidence and consensus was determined and the clinical recommendation was adopted. Results: In total 143 publications were identified according to the search strategy including 14 duplicates, which were excluded. 4 publications were included based on experts' choice. The team excluded 119 publications, leaving 14 that were then screened by a full text search. Finally, 1 publication was found to be of methodologically and clinically reliable content. The conclusion of this publication in favor of systemic therapy for LNRD received strong consent from the consensus conference. Conclusions: The literature search strategy using PICO questions helped to achieve a fast and standardized selection of publications. The recommendation concerning systemic treatment of LNRD was first implemented in the update of the German Breast Cancer guideline.

The current law on the protection of expectant and nursing mothers largely rules out surgical activities during pregnancy for female doctors who perform surgical roles in hospitals. The proportion of female junior staff in gynaecology amounts to 80 %, and, for many of these women, surgical further training is not possible following official notification of an existing pregnancy. In a Germany-wide survey of female gynaecologists and surgeons using a questionnaire, it was determined to what extent female doctors worked in surgery during pregnancy, whether it led to complications in the pregnancy, when the employer was notified about the pregnancy, and what desire for change there is with regard to the law on the protection of expectant and nursing mothers. The data from 164 female doctors, of which 136 are gynaecologists and 28 surgeons, was evaluated. On average, the pregnancy was announced during the 14th week of pregnancy (WOP), and the doctor was not allowed to perform surgical activities in the 21st WOP. Female doctors in higher professional roles tended to announce the pregnancy later and ended their surgical activities later. There was no link between the time of ceasing surgical activities and an increased occurrence of complaints or complications during the pregnancy. In total, only 53 % of respondents had an appraisal during pregnancy and 75 % wanted a change in the law on the protection of expectant and nursing mothers.Das aktuelle Mutterschutzgesetz schließt eine operative Tätigkeit während der Schwangerschaft für in der Klinik operativ tätige Ärztinnen weitestgehend aus. Der Anteil der Berufseinsteigerinnen liegt in der Gynäkologie bei 80 %, für viele dieser Frauen ist die operative Weiterbildung nach offizieller Mitteilung einer bestehenden Schwangerschaft nicht möglich. In einer deutschlandweiten Umfrage unter Gynäkologinnen und Chirurginnen wurde anhand eines Fragebogens u. a. ermittelt, inwieweit Ärztinnen in der Schwangerschaft operativ tätig waren, ob es zu Komplikationen in der Schwangerschaft kam, wann die Schwangerschaft dem Arbeitgeber mitgeteilt wurde und welche Änderungswünsche bez. des Mutterschutzgesetzes bestehen. Die Daten von 164 Ärztinnen, davon 136 Gynäkologinnen und 28 Chirurginnen, wurden ausgewertet. Die Schwangerschaft wurde im Mittel in der 14. Schwangerschaftswoche (SSW) bekanntgegeben, ein Ausschluss aus der operativen Tätigkeit erfolgte in der 21. SSW. Ärztinnen in höheren beruflichen Positionen gaben tendenziell später die Schwangerschaft bekannt und beendeten später die operative Tätigkeit. Es bestand kein Zusammenhang zwischen dem Zeitpunkt des Ausscheidens aus der operativen Tätigkeit und einem vermehrten Auftreten von Beschwerden oder Komplikationen während der Schwangerschaft. Insgesamt führten nur 53 % der Befragten in der Schwangerschaft ein Personalgespräch und 75 % wünschten sich eine Änderung des Mutterschutzgesetzes.

Reconstruction of the vermilion of the upper lip can be very challenging, especially in tumorous relapse conditions, due to the limited local mucosa available. This accounts even more for resections solely involving mucosa or even skin of the upper lip leaving the orbicularis oris muscle intact. In these cases, an aesthetic reconstruction of the red/white border or the white roll is very hard to achieve. Even the color of the reconstructed vermilion is very important. Sometimes an appealing shape of the cupid bow and color of the “vermilion” can only be achieved by a tattoo. We present a case of multiple vermilion and skin resections of the upper lip due to a lentigo maligna melanoma. In the last step, we had to resect even the whole vermilion mucosa of the upper lip, including parts of the oral mucosa of the vestibule leaving a bare orbicularis oris muscle. Due to the fact that we reconstructed the vermilion of the upper lip several times with local tanspositional flaps or even crosswise pedicled mucosa flaps from the vermilion of the lower lip, we now had to harvest mucosa transplants for the reconstruction of the upper vermilion without impairing lip or cheek function. For this purpose, we performed a mucosa-free flap from genital mucosa (labia minora).

There is an increasing demand for accurate preoperative and intraoperative staging of bronchial carcinoma with respect to neoadjuvant therapy protocols and parenchyma-sparing operations. This study prospectively evaluated accuracy of computed tomographic scan and surgical assessment for staging of bronchial carcinoma in 108 consecutive patients. The stage of the primary tumor (T stage) was correctly determined in 85% of the patients, and surgical evaluation correctly determined the T stage in 92%. Invasion of major mediastinal structures posed a major problem for computed tomographic scan. On a node-by-node basis, computed tomographic scan predicted involvement of lymph nodes in 81% (sensitivity 29%, specificity 93%, positive predictive value 49%, negative predictive value 85%). The surgeon correctly determined the lymph node status in 69% of lymph nodes (sensitivity 90%, specificity 63%, positive predictive value 39%, negative predictive value 96%). On a patient-by-patient basis, computed tomographic scan correctly predicted the nodal status in 58% of patients. Accuracy of computed tomographic scan and surgical assessment in determination of the lymph node status strongly depended on tumor type and lymph node region (hilar or mediastinal region) studied. This was partly due to the fact that adenocarcinomas exhibited a high proportion of tumor-positive normal-sized lymph nodes, whereas squamous cell carcinomas showed a high proportion of enlarged tumor-free lymph nodes. In conclusion, computed tomographic scan and surgical assessment are sufficiently accurate for determination of the tumor stage but are insufficient in determining the nodal status. (J T horac C ardiovasc S urg 1992;104:413-20)

Background and Objective: Guidelines for the treatment of early-onset breast cancer have been proposed in several countries, but to date, their impact on outcomes is unverified. The objective of this study was to evaluate the association between guideline-adherent versus nonadherent treatment and recurrence-free survival (RFS) and overall survival (OAS) in early-onset breast cancer patients. Methods: A total of 1,778 patients were included in the study, of whom 111 were 35 years or younger and 1,667 were between 36 and 55 years. RFS and OAS were compared between the two groups, with respect to multiple parameters. All survival data were adjusted for tumor characteristics and analyzed with respect to guideline adherence according to the German Step 3 guidelines. Results: Statistically significant differences between the two groups (Conclusion: Guideline-adherent treatment for early-onset breast cancer patients significantly improves OAS and RFS and should therefore be demanded for all patients.

The objective of this study was to show differences between breast cancer patientsor =35 and35 years with regard to tumor characteristics and to present the patient-relevant outcomes overall survival (OAS) and recurrence-free survival (RFS).We analyzed data from 119 women aged 35 years or younger with breast cancer and compared multiple parameters against breast cancer patients between 36 and 55 (n = 1,097), all pre-menopausal. Data were adjusted for tumor characteristics and therapy.There was no statistically significant difference in tumor size, axillary lymph node involvement, and histological subtypes. On the contrary, grading lymphovascular invasion and receptor negativity showed statistically significant differences. Unadjusted hazard ratio are 2.11 (1.32-3.39) (OAS) and 1.92 (1.35-2.73) (RFS). Multi-adjusted hazard ratio are 2.97 (1.70-5.18) (OAS) and 2.11 (1.42-3.13) (RFS).In conclusion, young breast cancer patients still have a poor prognosis. Even after adjustment of the data, OAS and RFS showed a worse prognosis. Normal prognostic factors like tumor size, axillary lymph node involvement, and grading can therefore be not the explanation for the more aggressive disease progress within early onset breast cancer patients.

Introduction Taste is a hereditary trait and affects eating and dietary behavior. Nearly 70% of the population is sensitive for 6-n-propylthiouracil (PROP) which is typified as moderately-to-extremely bitter by this population group. It has been hypothesized that PROP-tasters are more sensitive to other bitter tastes, sweet taste and the texture of fats. Recently we could show that food preferences in healthy adolescents are associated with the number of the tongue's taste papillae and the sensitivity for PROP. The impact of PROP status in eating disorders is unknown. Aims The aim of the present study was to evaluate the food consumption in PROP-tasters and nontasters of remitted female patients with anorexia nervosa (AN). Methods 20 remitted female patients with AN were included and tested for PROP-sensitivity. 10 patients were PROP-nontaster (aged 22,9 ± 3,0 yrs., BMI 20,5 ± 2,0 kg/m2, remission period 6,7 ± 2,9 yrs.) and 10 patients with AN were PROP-taster (24,9 ± 2,9 yrs., BMI 22,3 ± 3,5 kg/m2, remission period 5,3 ± 2,2 yrs.). Taste perception was evaluated using taste strips (sweet, sour, salty, bitter). Food practice and choice were assessed by self-report. Several blood parameters including hormones and leptin were analyzed. For psychological evaluation SIAB-S, EDI-2 and ASR were used. Results Remitted PROP-taster with AN consume significantly more often ice cream, dumpling, lemonade, potato chips, candies and sweets. Conclusions We hypothesize that PROP status may influence eating behaviour in eating disorders. The sensitivity for PROP possibly improves the course of AN.

ObjectiveRestrictive and selective eating behavior with food preferences and aversions is a characteristic symptom in anorexia nervosa (AN). Typically fat-containing food is avoided. Furthermore, very often patients with AN replace food which is rich in calories by fruits and vegetable. The aim of the present study was to evaluate if there is a relationship between food preferences and taste perception in AN.Methods15 female patients with acute AN (ANacute) (BMI 16.5 ± 1.3 kg/m2, 20.4 ± 4.7 yrs.), 21 remitted female patients with AN (ANrem) (BMI 21.4 ± 2.9 kg/m2, 24.2 ± 3.2 yrs., remission period 6 ± 2.6 yrs.) and 15 female healthy controls (HC) (BMI 21.6 ± 3.1 kg/m2, 24.9 ± 2.7 yrs.) were included. Taste perception was evaluated using taste strips (sweet, sour, salty, bitter). Food practice and choice were assessed by self-report. Several blood parameters including hormones and leptin were analyzed. The number of fungiform papillae was quantified using digital photography and image processing.ResultsIn ANacute bitter tasting foods were significantly consumed more often when compared with ANrem and HC. Sensoric taste perception for salty and bitter was reduced in ANacute (n.s.). Hedonic taste perception for sour, salty and bitter was increased in ANacute (n.s.). The number of fungiform papillae was significantly decreased in ANacute compared with ANrem and HC. Taste perception for bitter tastes within a range of concentrations correlated with serum estrogen and leptin.ConclusionsOur results indicate a relationship between food selection and biological factors which can influence taste perception during the underweight stage of ANacute.

6130 Background: The BRENDA Study network aims to improve quality of care for breast cancer patients by analyses of treatment related outcome within a network of specialized breast cancer centers i...

Purpose: Two pivotal studies by Veronesi and Fisher have established the concept of breast conserving surgery for small breast cancers stage T1 or with size less than 4 cm respectively. The aim of this retrospective study was to validate the current practice of BCS in an unselected cohort of patients within the network of 16 regional breast cancer centres in germany and to quantify the detrimental effect of guideline non-compliant locoregional therapy on recurrence free survival.Methods: 4507 patients who received primary therapy between 1992 and 2005 were recorded. Data on surgery, axillary dissection and postoperative irradiation were used to categorize patients according to adherence to guidelines. The effect of guideline compliant locoregional therapy on recurrence free survival was calculated.Results: Out of 3579 patients (79.4%) who were treated by BCS 3036 (84.8%) received postoperative irradiation as mandated by the guideline. A total of 928 (20.6%) patients underwent mastectomy, out of these a fraction of 344 patients received postoperative irradiation as required by the guideline. No significant difference in recurrence free survival was found between patients who underwent BCS plus postoperative irradiation and those patients who underwent mastectomy (T1: HR=1.08 (95%-CI: 0.70-1.67), p=0.281; T2: HR=1.21 (95%-CI: 0.61 - 2.39), p=0.577). Guideline compliant locoregional therapy resulted in a significant improvement in RFS as shown for patients receiving guideline compliant BCS plus irradiation or guideline compliant mastectomy without irradiation versus patients with any type of non-compliant locoregional therapy (HR=3.53, 95%-CI: 2.97-4.18, p Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4106.

521 Background: Over the past two decades significant progress in treatment of early breast cancer has been accomplished through well designed, clinical trials (CTs). It has been hypothesized that trial participation could also be beneficial for the individual breast cancer patient. The BRENDA study group has been analysing quality of care provided by one university based and 16 regional breast cancer centers in south germany. In this study we investigated the impact of study participation on survival in an unselected clinical cohort of early stage breast cancer patients. Methods: The study population includes 5,966 patients who received primary therapy for early breast cancer between 1992 and 2005. Influence on survival by study participation was calculated by Cox proportional hazard analyses. Model adjustments include prognostic factors, type of treatment, age, risk group and time period. Guideline compliant treatment was assessed based on the St Gallen expert consensus recommendations and the German national S3 Guidelines. Results: A total of 738 patients (12%) received adjuvant (n = 552) or neoadjuvant (n = 186) systemic therapy within one out of 42 registered prospective multicenter phase II or III clinical trials. For patients not receiving neoadjuvant systemic therapy trial participation was associated with improved overall and disease free survival (hazard ratio [HR] = 0.75, 95% confidence interval [CI] 0.57–0.99, HR = 0.78, CI 0.63 - 0.97, respectively). The calculated effect was of similar magnitude after additional adjustment for co-existing morbidity of patients. Descriptional analysis revealed that guideline violations for locoregional or systemic treatment were more frequently found in patients receiving adjuvant treatment outside CTs. No significant effect on survival was calculated for 183 patients receiving neoadjuvant systemic therapy within CT protocols. Conclusions: In our study population participation in prospective clinical trials for adjuvant systemic therapy was associated with improved survival irrespective of treatment actually given. Intrinsic mechanisms within the framework of clinical trials can improve quality of breast cancer patient care. No significant financial relationships to disclose.

Abstract #6109 Background: The non-steroidal aromatase inhibitor (AI) anastrozole is superior to tamoxifen in terms of efficacy and safety in the adjuvant treatment of postmenopausal patients with hormone receptor-positive (HR+) early breast cancer (EBC). The aim of the current study was to evaluate the cost-effectiveness of anastrozole versus tamoxifen from the German health care perspective. Methods: A probabilistic Markov model was developed using data from the published literature and expert opinion to project trial outcomes to 25 years based on a cohort of 1000 postmenopausal women with HR+ EBC. Resource use data and costs were obtained from standard sources and expert opinion. Utility scores for the different heath states were obtained from a patient-based utility study using the standard gamble technique. Results were expressed as incremental cost-effectiveness ratios (ICERs) per quality adjusted life-years (QALYs) gained. Costs and benefits were discounted at 5% annually. Results: Total costs over the 25 year period for anastrozole and tamoxifen were €12,422 and €6,757, respectively. The cost per life year (LY) for anastrozole compared to tamoxifen was €24,822/LY gained. The ICER of anastrozole compared to tamoxifen was €21,050/QALY gained (95% CI €9,841 - €62,344). The result remained robust to all parameters tested in the sensitivity analysis. Cost-effectiveness probability curves indicated a >90% probability that the cost per QALY gained with anastrozole would be Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6109.