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Objectives: The purpose of the current study was to examine the relationship between two forms of religious discrimination (religious prejudice and environmental discrimination) and life satisfaction among a sample of Muslim Americans. Based on the framework of minority stress theory, we also hypothesized that higher levels of religious prejudice as well as environmental discrimination, would significantly relate to higher fear of safety, and in turn, would relate to lower life satisfaction.Method: A total of 192 Muslim American participants (Age M= 27.87) completed an on-line survey about their experiences as Muslim American. Women made up almost 75% of the sample.Results: Findings revealed that higher religious prejudice as well as environmental discrimination were both significantly related to lower life satisfaction and that fear of safety partially mediated both of these relationships.Conclusions: Findings help illustrate that Muslim Americans are not immune to the social-political climate of Islamophobia and can experience religious discrimination in different ways. In addition, women and younger participants expressed higher fear of safety when compared to men and older participants. Professionals who work with individuals from the Muslim community are encouraged to consider the chronic and on-going impact of stress that Muslim Americans face especially within the context of the United States.

Over the last couple of years, the topic of White fragility has garnered a considerable degree of attention. White fragility is considered a state in which even a minimum amount of racial stress can become intolerable and trigger a range of emotional and behavioral reactions intended to restore a sense of racial comfort (DiAngelo, White fragility: Why it's so hard for White people to talk about racism, 2018, Beacon Press). In effort to measure the expression of White fragility, we developed and evaluated the psychometric properties of the 21-item White Fragility Scale (WFS). Data consisted of two independent samples of White participants recruited from M-Turk (327) and a Midwest University's Psychpool (234). Results from exploratory and confirmatory factor analyses provided evidence for a bifactor model consisting of one general White fragility factor and three specific factors of Emotional Defensiveness, Accommodation of Safety, and Exceptionism. Ancillary bifactor indices supported treating the WFS as a unidimensional measure of White fragility yet also revealed meaningful utility of the Accommodation of Safety subscale. Concurrent validity evidence for the WFS was established through significant associations with modern racism, general and specific dimensions of colorblind racial attitudes, and social dominance orientation. In addition, nonsignificant, near-zero correlations with social desirability provided support for divergent validity. Recommendations for future research involving the WFS are provided as well as practical implications for professionals whose work requires a certain degree of racial stamina. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Background COVID-19 is a novel viral disease. Severe courses may present as ARDS. Several publications report a high incidence of coagulation abnormalities in these patients. We aimed to compare coagulation and inflammation parameters in patients with ARDS due to SARS-CoV-2 infection versus patients with ARDS due to other causes. Methods This retrospective study included intubated patients admitted with the diagnosis of ARDS to the ICU at Munich university hospital. 22 patients had confirmed SARS-CoV2-infection (COVID-19 group), 14 patients had bacterial or other viral pneumonia (control group). Demographic, clinical parameters and laboratory tests including coagulation parameters and thromboelastometry were analysed. Results No differences were found in gender ratios, BMI, Horovitz quotients and haemoglobin values. The median SOFA score, serum lactate levels, renal function parameters (creatinine, urea) and all inflammation markers (IL-6, PCT, CRP) were lower in the COVID-19 group (all: p, Highlights • COVID-19 patients presented with higher coagulatory potential than non-COVID-ARDS. • DIC scores were lower in COVID-19 ARDS patients. • An intensified anticoagulation regimen might be advisable. • Use of platelet inhibitors may be considered.

Using survey data from 278 counseling psychology doctoral students, we explored the concept of professional socialization in graduate training and investigated the degree to which a combination of student training factors accounted for (a) greater professional involvement in the Society of Counseling Psychology, (b) endorsement of counseling psychology values, and (c) affiliation with the Society. Results revealed that training programs fostered students’ professional connection to the field by providing faculty models, emphasizing counseling psychology identity, and encouraging student involvement in the Society. Together, these three professional socialization variables accounted for students’ professional activity, counseling psychology values, and Society membership status above and beyond years of enrollment, degree at admission, and membership status in other professional organizations. Implications regarding the influence of early professional socialization in graduate training within the context of establishing a long-term professional pipeline for the Society are discussed.

In this study, we examined the relations between multiple forms of oppressive experiences (i.e., racism, sexism, and sexual objectification) and trauma symptoms among Women of Color (WOC). In addition, self-esteem was explored as a partial mediating variable in these links, and ethnic identity strength was proposed to buffer the negative relationship between multiple forms of oppression and self-esteem, and the positive relationship between oppressive experiences and trauma symptoms. Results suggested that self-esteem partially mediated the positive relationship between racist experiences and trauma symptoms, such that racism was related to lower self-esteem, which was then related to more trauma symptoms. Sexism and sexual objectification were directly linked with trauma symptoms. Moreover, average and high levels of ethnic identity strength buffered the positive link between racism and trauma symptoms. Consistent with an additive intersectionality framework, results demonstrate the importance of attending to multiple forms of oppression as they relate to trauma symptoms among WOC. (PsycINFO Database Record

African American women are often times characterized by stereotypes that can be traced back to slavery. Those stereotypes have been found to affect many outcomes in an array of domains related to work, intimate relationships, and personal well-being. The literature does not address how these stereotypes may affect adolescent African American girls. This study aimed to fill that gap by examining how the endorsement of stereotypes affects the psychological well-being, specifically stress, in 144 African American adolescent girls (N = 144) who ranged from 12–19 years old. This study goes a step further to investigate whether collective self-esteem can serve as a buffer between endorsement of stereotypes and perceived stress. Using combined mediation–moderation model, the analysis showed that there is a significant positive relationship between stereotypic beliefs and perceived stress that is buffered by moderate to high levels of collective self-esteem. Implications for treatment and policy, as well as educa...

Objectives: Telehealth (via videocall) was rapidly implemented by the South Australian Adult Cystic Fibrosis (CF) Service in March 2020 due to the Novel Coronavirus 2019 pandemic. Home spirometers were distributed as part of objective patient assessment. Our aim was to assess patient satisfaction with the telehealth service in CF multidisciplinary clinic via online survey. Methods: All patients of the CF service were invited to complete an online survey designed to assess satisfaction with telehealth, which was undertaken through the consumer organisation Cystic Fibrosis South Australia. A quantitatively driven concurrent mixed-methods design was chosen, with statistical analysis of symmetrical five-point Likert responses using IBM SPSS Statistics for Windows v.26 and coding of unstructured responses for thematic analysis. Results: To date 57/160 patients (35.6%) completed the survey, with some item non-responses. 37/57 (64.9%) participants were aged ≤35 years of age, 42/53 (79.2%) had ≥2 telehealth appointments, and 46/53 (86.7%) found it easy/very easy to access. 18/48 (37.5%) of participants had technical issues. Despite this 48/52 (92.3%) felt satisfied/very satisfied with engagement of CF team via telehealth. 38/50 (76%) found telehealth more convenient with significant time saved. The thematic analysis added depth to quantitative analysis by identification of six key themes: convenience, ease of access, maintaining the therapeutic relationship, comprehensive care, safety, and patient centred care. Conclusion: Most patients reported high satisfaction with telehealth and would like a hybrid clinic with the option of telehealth or in person review for clinics into the future.

Objectives In a sample of transracially adoptive parents, this study examined the moderating role of adoption stigma in the relationship between their colorblind attitudes and their perceptions of different forms of discrimination. Specifically, we hypothesized that parents' colorblind attitudes would be negatively related to their perceptions of their adopted children's experiences with racism and their views toward racial microaggressions and institutional racism. We also hypothesized that perceived adoption stigma would moderate these relationships, such that the inverse association between colorblindness and the 3 outcome variables would be weakened by adoption stigma. Method A total of 172 White parents (Mage = 48.41) with adopted children of color participated in the study by completing questionnaires about their experiences as transracially adoptive parents. Women comprised 74% of participants. Results Results indicated that the relationship between participants' colorblind attitudes and their reports of adoptees' racist experiences was enhanced at nearly all levels perceived adoption stigma. In addition, results revealed that at high levels of perceived adoption stigma (75th and 90th percentiles), the magnitude of the relationships between colorblind attitudes with microaggressions and institutional discrimination was significantly reduced and became nonsignificant for parents with younger adoptees but not older adoptees. Conclusions Findings point to the potential benefits of helping transracially adoptive parents explore different dimensions of their own social-cultural identity as a way to enhance their ability to recognize different forms of discrimination that their adopted children may face. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

This article presents a review of 21 years (1990 to 2011) of multidisciplinary research on nontraditional college students that focuses on determinants of nontraditional student status and research methodology. The purpose is to address the methodological hindrances that have contributed to deficit-based views of nontraditional students in scholarly research. Specifically, the goals of the study are (a) to identify determinants used to classify nontraditional student status beyond older age, and (b) to provide a systematic analysis of methodological and theoretical approaches used to interpret findings on nontraditional students. Study findings are used to draw updated conclusions about conceptualizing nontraditional students and ways that scholars can promote a more accurate depiction of nontraditional students in the research.

This study used a consensual qualitative research method to explore the implications of transnational adoption in the lives of 12 adult Korean adoptees. From the analysis, 6 domains emerged: (a) adoption history and preadoptive memories, (b) meaning of adoption, (c) adoptive family dynamics, (d) racism, (e) identity formation, and (f) counseling experiences. Results highlight the need for more awareness surrounding transnational adoption throughout the life span. Additional suggestions concerning research and practice are discussed. Este estudio uso un metodo de investigacion cualitativa consensual para explorar las implicaciones de la adopcion transnacional en las vidas de 12 adultos coreanos adoptados. A partir del analisis, surgieron 6 parametros: (a) la historia de adopcion y las memorias preadoptivas, (b) el significado de la adopcion, (c) la dinamica de la familia adoptiva, (d) racismo, (e) formacion de la identidad, y (f) experiencias en consejeria. Los resultados destacan la necesidad de prestar mayor atencion a la adopcion transnacional a lo largo de toda la vida. Se discuten sugerencias adicionales relacionadas con la investigacion y la practica.

The purpose of the current study was to test a model of socialization among a sample of adult Korean adoptees. Based on the tenants of homophily and social identity theory, it was hypothesized that participants’ early racial and ethnic socialization experiences would account for their current intragroup friendships as adults, and that this relationship would be mediated by early intragroup contact and moderated by early ethnic identity status. The two ethnic and racial socialization variables (i.e., ethnic heritage activities and racial in-exposure) significantly accounted for participants’ relationships with other Korean adoptees and nonadopted Koreans, and the effects were partially explained by early intragroup contact. Results of multigroup testing indicated the proposed socialization model was non-invariant across groups, such that the effects of ethnic heritage activities on intragroup contact and the effect of racial in-exposure on friendships with Korean adoptees were significantly different based on early ethnic identity status.

OBJECTIVES The purpose of the current study is to test a recently established model of racial-ethnic socialization (Langrehr, 2014) among 2 samples of White transracially adoptive parents and to assess whether the proposed model functions similarly after accounting for adopted child race. METHOD Based on a modified version of the Racial Bias Preparation Scale (Fisher, Wallace, & Fenton, 2000), confirmatory factor analysis was used to test the 3-factor model (i.e., Prejudice Awareness, Racial-Ethnic Pride, and Egalitarianism) among 172 White transracially adoptive parents with Asian children (Mage = 45.72) and 140 White transracially adoptive parents with Black children (Mage = 42.62). In addition, multigroup invariance testing was used to assess whether the proposed model functioned similarly across the 2 groups of parents. RESULTS Results indicate that the proposed 3-factor model demonstrated partial measurement invariance such that the subconstruct of Egalitarianism functioned similarly across groups, whereas Racial-Ethnic Pride and Prejudice Awareness were deemed noninvariant. CONCLUSIONS Findings are intended to help expand the concept of racial-ethnic socialization for transracially adoptive families and address the degree to which current research on racial-ethnic socialization can be applied to different transracially adoptive families. Results are intended to highlight ways that various social-cultural dimensions of family can culminate into different socialization experiences. (PsycINFO Database Record

Gender differences in predicting subjective well-being (SWB) were examined in 168 urban adolescents. School satisfaction predicted life satisfaction for boys; for girls, family satisfaction predicted life satisfaction and neighborhood satisfaction predicted negative affect. Self-esteem predicted positive affect for both genders, but friends satisfaction and ethnic identity failed to predict SWB. Se examinaron las diferencias de genero al predecir el bienestar subjetivo (SWB, por sus siglas en ingles) de 168 adolescentes urbanos. La satisfaccion escolar predijo la satisfaccion vital en los chicos; en las chicas, la satisfaccion familiar predijo la satisfaccion vital, y la satisfaccion en el vecindario predijo los sentimientos negativos. La autoestima predijo sentimientos positivos en ambos generos, pero la satisfaccion con los amigos y la identidad etnica no fueron predictores del SWB.

This study explored relations between culturally relevant stressors (i.e., urban hassles, perceived discrimination) and subjective well-being (SWB; i.e., positive/ negative affect, life satisfaction) to examine whether ethnic identity and/or coping strategies would serve as moderators of the relations between stress and SWB for 157 urban, ethnic minority adolescents. Ethnic identity moderated the relation between perceived discrimination and life satisfaction. Selfdistraction coping moderated the relation between urban hassles and negative affect. This article discusses implications for school counseling prevention and interventions.

This study examined the psychosocial histories of 134 male, juvenile offenders, focusing on race and the probability of being diagnosed with internalizing and/or externalizing psychological disorders at the time of their sentencing to a correctional institution for committing serious and violent crimes as minors. In addition, based on case file information, the author investigated offenders' histories with child maltreatment, court-ordered probation, and counseling services received as part of the child welfare and/or juvenile justice system. RESULTS from logistic regression analyses indicated the probability for White youth to be diagnosed with internalizing disorders was over 19 times that of Black youth; however, rates of externalizing disorders were similar across groups. Although maltreatment histories were comparable based on race, White youth received more counseling services, were significantly older at the time of diagnosis, and were more likely to be diagnosed with internalizing and comorbid disorders. Issues regarding multicultural assessment in the child welfare and juvenile justice system are discussed, specifically highlighting the potential for attributional bias in the diagnostic and treatment recommendation process. Language: en

The authors conducted a 22-year (1988–2009) content analysis of quantitative empirical research that included acculturation and/or enculturation as a study variable(s). A total of 138 studies in 134 articles were systematically evaluated from 5 major American Psychological Association and American Counseling Association journals in counseling and counseling psychology, including Journal of Counseling Psychology, The Counseling Psychologist, Journal of Counseling and Development, Journal of Multicultural Counseling and Development, and Cultural Diversity and Ethnic Minority Psychology. To guide the analysis, the authors conceptualized acculturation/enculturation as a “bilinear” (i.e., developing cultural orientations to both majority and ethnic cultures) and “multidimensional” (i.e., across multiple areas such as behaviors, values, identity, and knowledge) cultural socialization process that occurs in interaction with “social contexts” (e.g., home, school, work, West Coast, Midwest). Findings include the patterns and trends of acculturation/enculturation research in (a) conceptualization and use of acculturation/enculturation variable(s), (b) research designs (e.g., sample characteristics, instruments, data collection, and analysis methods), (c) content areas, and (d) changes in total publications and trends over time. Additionally, meta-analyses were conducted on the relationship of acculturation/enculturation and a few key variables of mental health, adjustment, and well-being. Major findings and directions for future research are discussed.

This study examined the moderating role of transracially adoptive parents' cross-racial friendships in the relationship between their color-blind attitudes and views toward cultural and racial socialization. Using hierarchical multiple regression analyses and the Johnson-Neyman technique, it was hypothesized that parents' color-blind attitudes would significantly account for 3 different dimensions of socialization beliefs (i.e., prejudice awareness, ethnic pride, and egalitarian socialization) and that self-reported cross-racial friendships would moderate the effects of color-blind attitudes. Results suggest that having several cross-racial friendships minimized the effects of participants' color-blind attitudes on their ethnic pride and egalitarian socialization beliefs, whereas having few cross-racial friendships enhanced the effects of color-blind attitudes on both socialization variables. The importance of transracially adoptive families creating diverse and multiracial social networks is discussed.

The duration of postoperative mechanical ventilation and its influence on pulmonary function in liver transplant recipients is still debated controversially.We retrospectively analyzed the incidence of immediate tracheal extubation, prolonged mechanical ventilation (24 h following surgery), and episodes of reintubation in 546 patients who underwent orthotopic liver transplantation (OLT) at our institution.Immediate tracheal extubation in the operating theater was achieved in 18.7% of patients, and prolonged mechanical ventilation was required by 11.2% of patients. In these, median time of extubation was 49.5 h, whereas the remaining 70.1% of patients required ventilation support for a median 5 h after OLT. As risk factors for prolonged mechanical ventilation we identified the indications of acute liver failure and retransplantation, as well as factors such as mechanical ventilation prior to OLT, massive intraoperative bleeding, and severe reperfusion injury of the liver graft. The incidence of reintubation was 8.8% in patients who were immediately extubated following surgery, and 13.1% in patients who underwent extubation within 24 h. The incidence was significantly increased in patients requiring prolonged mechanical ventilation (36.1%).Immediate tracheal extubation was safe and well tolerated. The incidence of reintubation was not increased when compared to patients in whom extubation succeeded later. However, special attention should be given to transplant recipients presenting in reduced clinical condition at the time of OLT, undergoing complicated surgery, or receiving liver allografts with severe reperfusion injury because of an increased risk for prolonged mechanical ventilation.

Summary Background Gemcitabine (Gemzar®) and 5-fluorouracil (5-FU) plus folinic acid (FA) both have proven activity in the treatment of patients with advanced pancreatic cancer. The present study was initiated to investigate the efficacy of gemcitabine in combination with 5-FU-FA. Patients and methods Thirty-eight patients, median age 60 years (range 34–70) with inoperable, stage IV, pancreatic cancer were enrolled into the study and treated on an outpatient basis. All except one patient received at least one cycle of treatment with gemcitabine (1000 mg/m2 followed by FA (200 mg/m2 and 5-FU (750 mg/m2 administered as a 24-hour continuous infusion on days 1, 8, 15 and 22 of a 42-day schedule. No patient had received prior chemotherapy or radiotherapy. All 38 patients were assessed for efficacy, toxicity and time to progressive disease. Results Two patients (5%), achieved a partial response and thirty-four patients (89%) achieved stable disease. There were two early deaths (≤4 weeks). The median time to progression was 7.1 months (range 0.4–18.1+; 95% confidence interval (95% CI): 5.3–7.9 months). Three patients had a progression-free interval of greater than 12 months and 12 of 38 patients (32%) survived longer than 12 months. The median overall survival was 9.3 months (range 0.5–26.5; 95% CI: 7.3–13.0 months). The incidence of grade 3 and 4 toxicities was low. Conclusions The combination of gemcitabine and 5-FU-FA is active and well tolerated and seems to offer an improvement in progression-free interval over both gemcitabine monotherapy and 5-FU-FA therapy.

Zur Uberprufung der Effektivitat und der Toxizitat der Kombination Gemcitabine (1000 mg/m2; 30 min), Folinsaure (200 mg/m2; 2 h) und 5-FU (750 mg/m2; 24 h), fuhrten wie eine ambulante, multizentrische Phase-Il-Studie durch. Behandelt wurde an den Tagen 1, 8, 15 und 22 (2 Wochen Pause) und bis zur Progression der Erkrankung. Wir schlossen 19 konsekutive Patienten im Stadium III/IV (1/18) mit einem medianen Alter von 59 Jahren [46–70] und einem medianen Karnofsky PS von 90% [80–90] ein. Die Kombination wurde gut vertragen, das mediane Progression-freie Uberleben betragt zur Zeit 9+ [2 bis 14+] Monate. Unsere Ergebnisse zeigen, das die Kombination von Gemcitabine, Folinsaure und 5-FU bei der Behandlung des fortgeschrittenen Pankreaskarzinoms sicher und effektiv ist.

Gemcitabine (Gemzar) has a significant impact upon survival and quality of life for patients with pancreatic cancer, compared with 5-fluorouracil (5-FU). This phase I study was initiated to define the recommended dose of 5-FU delivered as a 24 h infusion in combination with gemcitabine (1000 mg/m2) and folinic acid (200 mg/m2) in patients with inoperable pancreatic cancer, treated on an outpatient basis. Drugs were administered weekly for 4 weeks out of 6 weeks. Sixteen chemonaive patients (median age 59 years, range 51-66) were enrolled, 15 had stage IV and one stage III disease. The median Karnofsky performance score (KPS) was 70 (range 60-80). Six patients received 5-FU 750 mg/m2, eight received 5-FU 1000 mg/m2 and two received 5-FU 1250 mg/m2. The maximum tolerated dose of 5-FU was 1000 mg/m2. Hepatotoxicity was dose limiting. One patient who received 5-FU 1250 mg/m2 died as a result of hepatorenal failure. There was one partial response, nine patients had stable disease for more than 3 months and 13 patients had improved KPS. The median time to progressive disease was 31 weeks (range 5-50 weeks). A phase 11 trial is underway to further assess the activity of this combination at the recommended dose of 750 mg/m2 5-FU.

Ischemic-type biliary lesions (ITBL) mainly induce stenoses in liver transplants causing cholestasis thus endangering the allograft. ERC enables distinction of ITBL from other differential diagnosis. From 1988 to 1998, 1,026 liver transplantations had been carried out at our clinic. 2.4% (25 out of 1,026) of liver transplanted patients were afflicted from ITBL. 60% (15 out of 25) of patients were endoscopically treated by means of sphincterotomy and balloon dilation. Furthermore, some patients needed extraction of calculi (n = 3), bile duct sequester (n = 6) or stenting (n = 4), respectively. Three patients suffered from ITBL type 1 (= only extrahepatic lesions) and five other patients were afflicted from ITBL type 2 (= circumscript intrahepatic lesions). 90% of those patients revealed long-term benefit from endoscopic therapy (follow-up to seven years). Another 15 patients elicited ITBL type 3 (= multiple intra- and extrahepatic lesions). Therefrom, nine patients had to be retransplanted directly while eight others were assigned to endoscopic treatment. Follow-up investigations revealed that retransplantation could be avoided in 50% of ITBL patients by means of endoscopic therapy for at least three years. In contrast, only 27% of ITBL patients could survive for more than three years without endoscopic therapy. Endoscopic success depends on localization and severity of ITBL complications in the biliary tract of the liver allograft. Therefore, benefit of endoscopic therapy depends on proper diagnosis as early as possible guiding further therapeutic strategy. Conclusively, endoscopic success enables maintenance of liver function in ITBL afflicted liver grafts and avoids or at least, delays retransplantation.

We report on 48 patients, treated by laparoscopic fundoplication for pronounced gastroesophageal reflux disease. The results show that laparoscopic fundoplication is a very safe, gentle, and successful procedure for the therapy of gastroesophageal reflux disease. We regard laparoscopic fundoplication as a good alternative to long term medical therapy if a careful diagnosis and indication is provided.

Tuberculosis occurred in 5 (1.2%) of 462 liver transplant recipients. De novo infection was assumed in 4 patients and a recurrent infection in 1. The clinical courses varied, from asymptomatic open lung tuberculosis to disseminated disease with cerebral tuberculoma and convulsions. Four patients survived with anti-tuberculous triple-drug therapy. Very few cases of tuberculosis after liver transplantation have been reported (4 patients in the medical literature and 5 patients in this paper). However, the incidence, course of infection, and outcome seem to be similar to those of tuberculosis in renal transplant recipients, approximately 150 cases of which are known.

This study explored relations between culturally relevant stressors (i.e., urban hassles, perceived discrimination) and subjective well-being (SWB; i.e., positive/negative affect, life satisfaction) to examine whether ethnic identity and/or coping strategies would serve as moderators of the relations between stress and SWB for 157 urban, ethnic minority adolescents. Ethnic identity moderated the relation between perceived discrimination and life satisfaction. Self-distraction coping moderated the relation between urban hassles and negative affect. This article discusses implications for school counseling prevention and interventions.

LBA4504 Background: Prognosis of patients (pts) with PC is dismal, even after curatively intended resection. Whereas gemcitabine-based chemotherapy is standard in advanced PC, the role of adjuvant chemotherapy is still under discussion. Methods: CONKO-001, a prospective, open, multicenter, controlled phase 3 study was designed to evaluate the efficacy and toxicity of gemcitabine in PC pts after complete (R0 or R1) resection. After stratification for R0/R1, nodal tumour involvement and tumour stage pts were randomized to receive either gemcitabine (G) (1g/m2 d 1, 8 and 15 every 4 weeks) for 6 months or observation (O). Pts in the observation group received no specific anticancer treatment. Primary study endpoint was disease free survival (DFS), secondary endpoints included OS and toxicity. The study was powered to detect a significant difference in DFS with 90% probability at a significance level of .05 on all eligible patients. Results: Between July 1998 and December 2004 368 pts were randomized and 354 w...

LBA4013 Background: Chemotherapy with Gemcitabine 1 g/m2 given on d 1, 8, 15 every four weeks is standard therapy in inoperable pancreatic cancer. The value of adjuvant therapy has not been clearly defined and no data on randomised trials with Gemcitabine in the adjuvant setting is available. Methods: This study was designed to evaluate the efficacy and toxicity of Gemcitabine in patients with resectable pancreatic cancer. Within 6 weeks after operation, patients were randomised to receive Gemcitabine or observation after stratification for positive or negative resection margins, nodal tumor involvement and tumor stage. Gemcitabine was administered at a dosage of 1g/m2 days 1, 8 and 15 every 4 weeks for 6 months. Patients in the observation arm received no specific postoperative treatment. Primary endpoint was disease free survival (DFS), secondary endpoints included overall survival (OS) and side effects in both groups. The study was powered to detect a significant difference with 90% probability at a si...