Influence of side-effects on early therapy persistence with letrozole in post-menopausal patients with early breast cancer: Results of the prospective EvAluate-TM study.

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

Influence of patient and tumor characteristics on early therapy persistence with letrozole in postmenopausal women with early breast cancer: results of the prospective Evaluate-TM study with 3941 patients.

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

Breast reconstruction and revision surgery for implant-associated breast deformities using porcine acellular dermal matrix: a multicenter study of 156 cases.

BACKGROUND: Acellular dermal matrix is increasingly used as caudolateral coverage for breast implants in immediate breast reconstruction after skin-sparing mastectomy or in the correction of implant-associated breast deformities. Matrices of human, bovine, and porcine origin are available. The purpose of this retrospective multicenter study was to report experiences with porcine acellular dermal matrices, as only limited data can be found in the literature. METHODS: In the hospital databases of five institutions, 127 patients were identified who underwent breast reconstructions in 156 breasts using an acellular porcine dermal matrix. Medical records were reviewed. Patients were divided into three groups: immediate expander-implant or direct to implant reconstructions (n = 98), delayed expander-implant reconstructions (n = 14), and revision surgery for implant-associated breast deformities (n = 44). RESULTS: With a mean follow-up of 19.6 months, total major complication rate was 7.1 %: implant loss (3.2 %), skin flap necrosis (2.6 %), delayed skin healing (2.6 %), hematoma (1.9 %), seroma (1.3 %), infection (0.6 %), and capsular contracture (0.6 %). Total minor complication rate was 22.9 %, with seroma being the most frequent complication (19.2 %). In the group of immediate breast reconstructions, 20.4 % of the breasts had received radiotherapy in the past. These patients exhibited a significantly higher rate of seroma than patients without prior radiotherapy (35.0 vs. 14.9 %, p = 0.031). CONCLUSIONS: Complication rates using porcine acellular dermal matrix in breast reconstruction are comparable to complication rates reported in studies using human acellular dermal matrices. Thus, porcine acellular dermal matrices can safely be applied in breast reconstructive surgery.

Evaluation of Therapy Management and Patient Compliance in Postmenopausal Patients with Hormone Receptor-positive Breast Cancer Receiving Letrozole Treatment: The EvaluateTM Study.

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

[Quality of life by limited vision in old age: the example of age-related macula degeneration]. / Lebensqualität bei Seheinschränkung im Alter: Das Beispiel altersabhängige Makuladegeneration.

Age-related macula degeneration (AMD) is accompanied by considerable consequences regarding the psychosocial quality of life. A considerable body of research literature now indicates, for instance, an increased rate of depression and substantial loss of everyday capabilities in AMD patients. However, inter-individual differences are large and part of the explanation lies in differences in the ability to cope with and detach oneself from aims in life. The negative impact of AMD on the qualify of life is associated with a need for psychosocial support, but this need is barely met at present. A series of studies nevertheless supports the view that successful intervention is possible even with very old patients. In this respect the problems at present have less to do with recognition than with application and implementation.

[Friendships in middle and older adulthood: the long arm of early childhood experiences]. / Freundschaften im mittleren und höheren Erwachsenenalter: Der lange Arm frühkindlicher Erfahrungen.

In this study, direct associations between recalled parent-child relations and adult friendships and a mediation of this relationship by personality characteristics were examined. Furthermore, the contribution of the personality characteristics openness and agreeableness to friendship involvement in different phases of life was investigated. Data from 392 middle aged (43-46 years) and 345 older participants (61-64 years) in the first wave of the Interdisciplinary Longitudinal Study of Adult Development (ILSE) were used for structural equation modeling. Results show that the relation between recalled mother-child relationship and friendship involvement in old adults is mediated by agreeableness. Recalled father-child relationship was associated with friendships in both age groups, independent of personality characteristics. Data support the hypothesis that openness contributes to friendship involvement in middle age, while agreeableness contributes to friendship involvement in old age.

Psychosocial consequences of age-related visual impairment: comparison with mobility-impaired older adults and long-term outcome.

Indices of behavioral competence (activities of daily living [ADLs], instrumental activities of daily living [IADLs], use of outdoor resources, leisure activity level) as well as emotional adaptation (subjective well-being, future orientation) were used to investigate the psychosocial consequences of age-related vision impairment in a threefold manner: (a) comparison of visually impaired and unimpaired elders, (b) comparison of visually impaired and mobility-impaired elders, and (c) long-term adaptation across 5 years. The research design used (a) 42 severely visually impaired elders, (b) 42 blind elders, (c) 42 mobility-impaired elders, and (d) 42 unimpaired elders. Compared with the mobility impaired, the visually impaired demonstrated lower IADL competence but no difference in emotional adaptation. The long-term adjustment of the visually impaired remained relatively stable in the behavioral domain, although lower compared with the unimpaired elders. Emotional adaptation decreased over the 5-year longitudinal interval in the visually impaired and the unimpaired group, but the decrease was generally higher in the visually impaired group. Conceptual ideas from environmental gerontology as well as psychological resilience are used to interpret these results.

[Deteriorating vision in the elderly: double stress?]. / Sehbeeinträchtigung im Alter: eine doppelte Belastung?

BACKGROUND: Epidemiologic studies have provided clear evidence that the majority of people affected by severe visual impairment are adults above the age of 60 years. The goal of this psychological research was to analyze the emotional and behavioral consequences of age-related visual impairment in three steps: descriptive data concerned with subjective well-being, depression, everyday competence, and leisure as well as explanations of interindividual variability based on individual and environmental variables are presented (study I). Also, the impact of the time of onset (early versus late in life) is addressed (study II). Finally, the role of the living accomodation (institutional versus private household) was the main target of another study (study III). MATERIALS AND METHODS: Study I was based on 84 elderly adults who experienced an irreversible visual loss after age 55 years; a control group of unimpaired elderly adults is also included (mean age 75.8, range 59 to 92). In study II, 18 elderly adults who had been blind since their early childhood were compared to nine matched elderly adults who experienced blindness in their later life as well as nine matched unimpaired elderly adults (mean age 71.7, range 63 to 83). The data for study III came from 15 visually impaired institutional residents who were compared to 15 matched unimpaired residents and 15 matched visually impaired and 15 unimpaired older adults living in private households (mean age 87.0, range 78 to 93). All subjects underwent an intensive psychological measurement program. RESULTS: The findings of study I emphasize that age-related visual impairment is associated with lower subjective well-being, greater depression, reduced everyday competence, and lowered leisure activity level. A significant portion of interindividual variability in these outcomes can be explained by addressing individual variables (e.g., comorbidity) as well as environmental variables (e.g., quality of the dwelling unit). Study II data offer evidence that older adults suffering from blindness since their early childhood are better adapted than older adults who experienced blindness only in their later years. Study III shows that visually impaired institutional residents reveal deficits in everyday competence and social contacts as contrasted with their unimpaired counterparts, whereas no difference is observed in the domain of subjective well-being. CONCLUSIONS: All three studies point to the negative impact of age-related visual impairment on emotional and behavioral adaptation in later life. This highlights the need for a whole range of rehabilitative efforts, including psychosocial elements, which are described in the final part of this article.

[Open laparoscopy in patients at risk]. / Die offene Laparoskopie bei Risikopatientinnen.

A variant of the technique of open laparoscopy is reported. The principal feature of this technique is that creation of a pneumoperitoneum is simplified. No additional instruments are required, nor sharp instruments, except for the skin incision and splitting of the fascia. The modified open laparoscopy technique was used on 23 high-risk patients in a group of 224 patients on whom laparoscopy was performed at Ludwigshafen Gynecological Clinic. The technique is discussed with reference to the literature.