The GISS trial: a phase II prevention trial of screening plus goserelin, ibandronate, versus screening alone in premenopausal women at increased risk of breast cancer.

BACKGROUND: Genetic testing for inherited mutations in breast cancer genes provides valuable information for disease prevention. Today, premenopausal women with increased risk for breast cancer have only limited nonsurgical options to reduce their risk. METHODS: The GISS trial, a randomized, multicenter, open-label phase II trial, assessed the feasibility of a preventive treatment with goserelin and ibandronate for premenopausal women at increased risk for breast cancer. The primary endpoints were refusal to undergo randomization and discontinuation of treatment. Safety and quality of life were also evaluated. RESULTS: Between the years 2001 and 2003, 31 of 322 eligible women participated in the trial; 15 received goserelin/ibandronate plus screening, 15 screening only, and 1 withdrew her consent after randomization. The treatment duration was 24 months. Here, mainly the results from the first 12 months were evaluated because of the low compliance thereafter. Hot flushes, headache, and vaginal dryness/discharge occurred more often in the goserelin arm. No difference was observed between the two arms in the agreement to randomization, compliance, or any other endpoints. CONCLUSIONS: Acceptance of chemoprevention with goserelin and ibandronate was low. Premenopausal women at increased risk for breast cancer should be better informed about chemoprevention through physician counseling and a more feasible study design (e.g., oral medication) should be provided. IMPACT: This is the first chemoprevention trial in premenopausal women at increased risk for breast cancer.

The burden of pain of inpatients undergoing radiotherapy--discrepancies in the ratings of physicians and nurses.

BACKGROUND: The aim of this study was to rate the burden of pain of cancer patients receiving radiotherapy from the point of view of the patients themselves as well as the physicians and nurses caring for the patient, and to examine possible differences in the ratings. PATIENTS AND METHODS: 68 cancer patients received a pain questionnaire about pain intensity and subjective well-being. At the same time, physicians and nurses answered 7 pain-related questions about each patient. RESULTS: 34% of the patients reported strong or very strong pain in the past week, 8% even unbearable pain. 66% felt psychologically distressed, 70% developed anxiety because of pain. 74% believed that pain is an essential part of the disease. Nurses and physicians often underestimate patients' burden of pain. Nevertheless, the rating of the nurses is more accurate than that of the physicians. CONCLUSION: Physicians and nurses often underestimate pain intensity. It seems that several patients are unable or unwilling to express their pain or that therapists lack adequate methods of pain assessment. To optimize pain treatment, communication between patients, physicians and nurses needs to be improved.

Religious belief as a coping strategy: an explorative trial in patients irradiated for head-and-neck cancer.

PURPOSE: To explore the role of religious belief in coping with disease symptoms and treatment-related side effects in patients with head-and-neck cancer under radiotherapy. PATIENTS AND METHODS: Prospectively collected data were used with a cohort of head-and-neck cancer patients treated by radiotherapy and epoetin beta or placebo within a double-blind multicenter trial. All patients were divided into believers and nonbelievers. Answers to a quality of life questionnaire at four points in time during radiotherapy were analyzed according to both groups. Clinical parameters and therapy side effects were controlled regularly. RESULTS: 62.1% of the patients (66/105) sent back a baseline questionnaire discriminating between believers and nonbelievers. For 34.2% (40/105) data of all four measures could be obtained. On average, believers felt better in all categories of side effects at all points of time before, during and directly after therapy. CONCLUSION: Religious faith seems to play an important role in coping strategies of radiotherapy patients. More research in this area would be worthwhile.

Retrospective analysis of the superior vena cava syndrome in irradiated cancer patients.

BACKGROUND: A carcinoma is the underlying cause of superior vena cava syndrome (SVCS) in 95-97% of patients. The aim of our study is to retrospectively analyse the outcome of patients after local radiotherapy compared to literature data. PATIENTS AND METHODS: In 35 consecutively registered patients, irradiated because of SVCS, different primary carcinomas (lung, breast, head-and-neck, Non-Hodgkin's lymphoma) were ascertained. Distant metastases had already been diagnosed in 33 patients. Chemotherapy had previously been given in seven patients. RESULTS: In 30 patients, radiotherapy obtained a reduction of symptoms within 5-9 days. However, in seven patients, radiotherapy had to be stopped early because of local progress and tumor induced complications. Local recurrences were observed in six patients. The 1-year overall survival rate was 15.6%. Survival rate depended significantly on the performance status (p < 0.004). CONCLUSION: Based on literature data our results are comparable regarding the incidence, the radio-oncological procedure and the response to treatment. These data confirm that radiotherapy is the standard treatment in most patients suffering from SVCS. However, it should be determined if endovascular stenting, which is more frequently considered in the last few years in patients with a tumor induced SVCS, may be a useful option as a simultaneous or sequentially given treatment to optimize the palliative effect.

Cancer of the uterine cervix is susceptible to anti-EGF-R antibody EMD 55,900 therapy.

BACKGROUND: Among a variety of cancer therapeutics targeting the epidermal growth factor receptor (EGF-R), monoclonal antibodies have shown some therapeutic potential in the treatment of various tumours of different entities. Nevertheless, several high EGF-R-expression carcinomas show no response to this treatment. Tumours of the uterine cervix represent a group, in which the response to anti-EGF-R treatment is hardly predictable, despite a relatively high expression of the receptor. MATERIALS AND METHODS: To assess the antitumour activity of anti-EGF-R monoclonal antibody EMD 55,900 in vivo, a series of experiments were performed in the nude mouse model using xenotransplanted primary carcinomas of the uterine cervix. RESULTS AND CONCLUSION: EMD 55,900 was found to be capable of inhibiting the growth of primary carcinomas of the uterine cervix at different stages of tumour development. The therapeutic response was not dependent on EGF-R expression solely, but also on the pre-treatment microvessel density.

EGF-R and Her2/neu overexpressing tumors: independent collectives for treatment of breast cancer by specific monoclonal antibody-therapy.

PURPOSE: In our recent studies, we demonstrated that breast cancer treatment by anti-EGF-R antibody resulted in a significant therapeutic effect in vivo. Furthermore, we were able to elucidate histopathologic parameters with an impact on therapy success. The aim of this study was the evaluation of EGF-R and Her2/neu protein expression on a large series of primary breast cancer, to elucidate if anti-EGF-R antibody therapy is a new therapeutic option for patients who are Her2/neu negative and where, therefore, anti-Her2/neu antibody treatment is not applicable. METHODS: We analyzed EGF-R and Her2/neu protein expression of 149 consecutive primary breast cancer specimens by fully quantitative enzyme-linked immunosorbent assay. For evaluation of stochastic independence, we used chi(2)-test as goodness-of-fit test. RESULTS: We found EGF-R and Her2/neu expression as stochastically independent in primary breast cancer. CONCLUSIONS: Anti-EGF-R antibody treatment is a potential therapeutic option for patients with Her2/neu negative breast cancer.

[Self-esteem and partner relationships of patients with bipolar affective disorder: a study of the interval personality with the Giessen-test]. / Selbstwertgefühl und Partnerbeziehungen von Patienten mit bipolaren affektiven Störungen: Untersuchung zur Intervallpersönlichkeit mit dem Giessen-Test.

The self-concept and the partner relationships of patients with bipolar affective disorder in remission were investigated with the Giessen-Test (GT, Beckmann et al. ) comparing the bipolar patients with unipolar depressive patients, a control group of orthopedic patients and the standard sample of the Giessen-Test. The new dimensions "self-esteem" and "near-to-object" were developed by means of the Giessen-Test items. Self-esteem was significantly lower in bipolar patients in remission than in the controls. The bipolar patients also described themselves as "more distant to others" than the controls. Bipolar and unipolar-depressive patients had a similar self-concept and view of their partner relationships. The results underline the importance of the regulation of self-esteem and the interpersonal dimension in the long-term course of bipolar affective disorder. Therapeutic implications are discussed.