Karen Basen-Engquist

Bio: Karen Basen-Engquist is an academic researcher from University of Texas MD Anderson Cancer Center. The author has contributed to research in topics: Population & Cancer. The author has an hindex of 47, co-authored 215 publications receiving 7713 citations.

Bevacizumab and paclitaxel–carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial

Abstract: Summary Background Platinum-based chemotherapy doublets are a standard of care for women with ovarian cancer recurring 6 months after completion of initial therapy. In this study, we aimed to explore the roles of secondary surgical cytoreduction and bevacizumab in this population, and report the results of the bevacizumab component here. Methods The multicentre, open-label, randomised phase 3 GOG-0213 trial was done in 67 predominantly academic centres in the USA (65 centres), Japan (one centre), and South Korea (one centre). Eligible patients were adult women (aged ≥18 years) with recurrent measurable or evaluable epithelial ovarian, primary peritoneal, or fallopian tube cancer, and a clinical complete response to primary platinum-based chemotherapy, who had been disease-free for at least 6 months following last infused cycle of platinum. Patients were randomly assigned (1:1) to standard chemotherapy (six 3-weekly cycles of paclitaxel [175 mg/m 2 of body surface area] and carboplatin [area under the curve 5]) or the same chemotherapy regimen plus bevacizumab (15 mg/kg of bodyweight) every 3 weeks and continued as maintenance every 3 weeks until disease progression or unacceptable toxicity. Individuals who participated in both the bevacizumab objective and surgical objective (which is ongoing) were randomly assigned (1:1:1:1) to receive either of these two chemotherapy regimens with or without prior secondary cytoreductive surgery. Randomisation for the bevacizumab objective was stratified by treatment-free interval and participation in the surgical objective. The primary endpoint was overall survival, analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00565851. Findings Between Dec 10, 2007, and Aug 26, 2011, 674 women were enrolled and randomly assigned to standard chemotherapy (n=337) or chemotherapy plus bevacizumab (n=377). Median follow-up at the end of the trial on Nov 5, 2014, was 49·6 months in each treatment group (IQR 41·5–62·2 for chemotherapy plus bevacizumab; IQR 40·8–59·3 for chemotherapy), at which point 415 patients had died (214 in the chemotherapy group and 201 in the chemotherapy plus bevacizumab group). Based on pretreatment stratification data, median overall survival in the chemotherapy plus bevacizumab group was 42·2 months (95% CI 37·7–46·2) versus 37·3 months (32·6–39·7) in the chemotherapy group (hazard ratio [HR] 0·829; 95% CI 0·683–1·005; p=0·056). We identified incorrect treatment-free interval stratification data for 45 (7%) patients (equally balanced between treatment groups); a sensitivity analysis of overall survival based on the audited treatment-free interval stratification data gave an adjusted HR of 0·823 (95% CI 0·680–0·996; p=0·0447). In the safety population (all patients who initiated treatment), 317 (96%) of 325 patients in the chemotherapy plus bevacizumab group had at least one grade 3 or worse adverse event compared with 282 (86%) of 332 in the chemotherapy group; the most frequently reported of these in the chemotherapy plus bevacizumab group compared with the chemotherapy group were hypertension (39 [12%] vs two [1%]), fatigue (27 [8%] vs eight [2%]), and proteinuria (27 [8%] vs none). Two (1%) treatment-related deaths occurred in the chemotherapy group (infection [n=1] and myelodysplastic syndrome [n=1]) compared with nine (3%) in the chemotherapy plus bevacizumab group (infection [n=1], febrile neutropenia [n=1], myelodysplastic syndrome [n=1], secondary malignancy [n=1]; deaths not classified with CTCAE terms: disease progression [n=3], sudden death [n=1], and not specified [n=1]). Interpretation The addition of bevacizumab to standard chemotherapy, followed by maintenance therapy until progression, improved the median overall survival in patients with platinum-sensitive recurrent ovarian cancer. Although the intention-to-treat analysis for overall survival was not significant, our sensitivity analysis based on corrected treatment-free interval stratification indicates that this strategy might be an important addition to the therapeutic armamentarium in these patients. Funding National Cancer Institute and Genentech.

Obesity and cancer risk: recent review and evidence.

Abstract: The prevalence of overweight and obesity is increasing worldwide, and the evidence base for a link between obesity and cancer is growing. In the United States, approximately 85,000 new cancer cases per year are related to obesity. Recent research has found that as the body mass index increases by 5 kg/m2, cancer mortality increases by 10%. Additionally, studies of patients who have had bariatric surgery for weight loss report reductions in cancer incidence and mortality, particularly for women. The goal of this review is to provide an update of recent research, with a focus on epidemiologic studies on the link between obesity and cancer. In addition, we will briefly review hypothesized mechanisms underlying the relationship between obesity and cancer. High priorities for future research involve additional work on the underlying mechanisms, and trials to examine the effect of lifestyle behavior change and weight loss interventions on cancer and intermediate biomarkers.

Short-Term and Long-Term Psychosocial Adjustment and Quality of Life in Women Undergoing Different Surgical Procedures for Breast Cancer

Abstract: The various surgical procedures for early-stage breast cancer are equivalent in terms of survival. Therefore, other factors, such as the procedures’ effect on psychosocial adjustment and quality of life (QOL), take on great importance. The aim of the current study was to prospectively examine the short- and long-term effects of mastectomy with reconstruction, mastectomy without reconstruction, and breast conservation therapy on aspects of psychosocial adjustment and QOL in a sample of 258 women with breast cancer. Participants completed questionnaires before surgery and then again 1, 6, 12, and 24 months after surgery. Questionnaires assessed depressive symptoms, anxiety, body image, sexual functioning, and QOL. Adjustment patterns differed throughout the 2-year period after surgery. Some short-term changes in adjustment (less anxiety, less overall body satisfaction) were similar across surgery groups, whereas others (satisfaction with chest appearance, QOL in physical health domain) were higher for women who had breast conservation therapy. However, women who had mastectomy with reconstruction reported greater satisfaction with their abdominal area. During the long-term follow-up period (6 months to 2 years after surgery), women in all three groups experienced marked improvements in psychosocial adjustment (depressive symptoms, satisfaction with chest appearance, sexual functioning) and QOL in physical and mental health domains. In fact, the level for most variables returned to baseline levels or higher. Overall, the general patterns of psychosocial adjustment and QOL are similar among the three surgery groups.

Implementation Matters: A Review of Research on the Influence of Implementation on Program Outcomes and the Factors Affecting Implementation

Abstract: The first purpose of this review was to assess the impact of implementation on program outcomes, and the second purpose was to identify factors affecting the implementation process. Results from over quantitative 500 studies offered strong empirical support to the conclusion that the level of implementation affects the outcomes obtained in promotion and prevention programs. Findings from 81 additional reports indicate there are at least 23 contextual factors that influence implementation. The implementation process is affected by variables related to communities, providers and innovations, and aspects of the prevention delivery system (i.e., organizational functioning) and the prevention support system (i.e., training and technical assistance). The collection of implementation data is an essential feature of program evaluations, and more information is needed on which and how various factors influence implementation in different community settings.

Standards for educational and psychological testing

Abstract: Pedagosko i psiholosko testiranje i procjenjivanje spadaju među najvažnije doprinose znanosti o ponasanju nasem drustvu i pružaju temeljna i znacajna poboljsanja u odnosu na ranije postupke. Iako se ne može ustvrditi da su svi testovi dovoljno usavrseni niti da su sva testiranja razborita i korisna, postoji velika kolicina informacija koje ukazuju na ucinkovitost kvalitetnih instrumenata u onim situacijama u kojima je njihovo koristenje potkrijepljeno validacijskim podacima. Pravilna upotreba testova može dovesti do boljih odluka o pojedincima i programima nego sto bi to bio slucaj bez njihovog koristenja, a također i ukazati na put za siri i pravedniji pristup obrazovanju i zaposljavanju. Međutim, losa upotreba testova može dovesti do zamjetne stete nanesene ispitanicima i drugim sudionicima u procesu donosenja odluka na temelju testovnih podataka. Cilj Standarda je promoviranje kvalitetne i eticne upotrebe testova te uspostavljanje osnovice za ocjenu kvalitete postupaka testiranja. Svrha objavljivanja Standarda je uspostavljanje kriterija za evaluaciju testova, provedbe testiranja i posljedica upotrebe testova. Iako bi evaluacija prikladnosti testa ili njegove primjene trebala ovisiti prvenstveno o strucnim misljenjima, Standardi pružaju okvir koji osigurava obuhvacanje svih relevantnih pitanja. Bilo bi poželjno da svi autori, sponzori, nakladnici i korisnici profesionalnih testova usvoje Standarde te da poticu druge da ih također prihvate.

Multiple Imputation for Nonresponse in Surveys

Abstract: 25. Multiple Imputation for Nonresponse in Surveys. By D. B. Rubin. ISBN 0 471 08705 X. Wiley, Chichester, 1987. 258 pp. £30.25.