COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy.

5 Office-based Professional Association Gynecologic Oncologists e.V. in Germany (BNGO e.V.), Berlin; 6 Background: This prospective study evaluated the relationship between arthralgia and compliance during the first year of adjuvant anastrozole therapy in postmenopausal women with hormone receptor-positive early breast cancer. Patients and methods: COMPliance and Arthralgia in Clinical Therapy (COMPACT) was an open-label, multicenter, noninterventional study conducted in Germany. Patients had started adjuvant anastrozole 3-6 months before the study start. The primary end points were arthralgia, compliance, and the relationship between compliance and arthralgia, assessed at specific time poi…

Magnetresonanztomographie in der Diagnostik des Kollumkarzinoms. Computertomographische und histologische Korrelation

The value of magnetic resonance tomography in the diagnosis of carcinoma of the cervix was studied in a prospective series of 20 patients. The results were compared with those of computed tomography and with the clinical findings. The diagnosis depended on the postoperative histology. Gynaecological examination proved superior to imaging methods in determining the extent of local tumour spread. Tumour involvement of the regional lymphatic system was better demonstrated by MRT than by CT. Exact staging proved inadequate with both these methods and the new imaging methods have not produced any changes in operative planning or technique.

Basic and Clinical Relevance of Hormonal Influence in Breast Cancer

In the Federal Republic of Germany breast cancer has a leading place among malignant tumors in women. Genital and breast cancers account for 32% of all female deaths from malignant neoplasias. The distribution of types of cancer is as follows: breast 52%, uterine cervix 9%, corpus uteri 4.5%, adnexae 19%, and other sex organs 15.5% (Maas and Sachs 1972; Schmidt-Matthiesen 1975, Vorherr 1980). Besides general epidemiological factors such as geographical distribution, dietary factors, age distribution, familial disposition, and socioeconomic influences, possible hormonal components are discussed in connection with the etiology of breast cancer (Fischedick and Lux 1977; Henderson et al. 1974; …

Zum Problem des prätherapeutischen Staging des Carcinoma Colli Uteri

In a prospective study of 20 cases, the importance of nuclear magnetic resonance as a diagnostic tool in cervix carcinoma was investigated. The results were compared with those of the Computer tomography as well as with those of the clinical examinations. The histology served as "Standard". In the evaluation of the local tumor invasion the gynecological examination appeared to be the most important. The involvement of regional lymph nodes was detected more accurately by the NMR as compared to CT. The exact clinical staging was not achieved by either method; thus these new diagnostic methods do not alter the planning and the technique of the operation.

Neoadjuvant bevacizumab and anthracycline-taxane-based chemotherapy in 678 triple-negative primary breast cancers; results from the geparquinto study (GBG 44).

Abstract Background We evaluated the pathological complete response (pCR) rate after neoadjuvant epirubicin, (E) cyclophosphamide (C) and docetaxel containing chemotherapy with and without the addition of bevacizumab in patients with triple-negative breast cancer (TNBC). Patients and methods Patients with untreated cT1c-4d TNBC represented a stratified subset of the 1948 participants of the HER2-negative part of the GeparQuinto trial. Patients were randomized to receive four cycles EC (90/600 mg/m2; q3w) followed by four cycles docetaxel (100 mg/m2; q3w) each with or without bevacizumab (15 mg/kg; q3w) added to chemotherapy. Results TNBC patients were randomized to chemotherapy without (n =…

Standard treatment of female patients with breast cancer decreases substantially for women aged 70 years and older: a German clinical cohort study

Standard treatment of patients with breast cancer decreases with age and older persons are mostly excluded from clinical trials. We hypothesized that non-adherence to treatment guidelines occurs for women agedor =70 years and changes overall survival (OAS) and disease-free survival (DFS).We enrolled 1922 women agedor =50 years with histologically confirmed invasive breast cancer treated at the University of Ulm from 1992 to 2005. Adherence to guidelines and effects on OAS and DFS for women agedor =70 years was compared with that for younger women (50-69 years).Women70 years less often received recommended breast-conserving therapy (70-79 years: 74%-83%;79 years: 54%) than women agedor =69 y…

Morphological, immunohistochemical and biochemical characterization of 6 newly established human ovarian carcinoma cell lines

Six permanent human tumor cell lines (OV-MZ-1 to 6) were established from 6 patients with serous adenocarcinomas of the ovary. These cell lines were derived from both solid tumors and ascites, from pre-treated and untreated patients, and are available over a range of in vitro passage numbers. The tumor cells grow its monolayers and develop foci of “piled-up” cells in confluent cultures. Flow cytophotometry showed that all the lines exhibited DNA hyperdiploidy with DNA tetraploidy in one cell line and DNA aneuploidy in the other cell lines. The mean population doubling time ranged from 24 to 52 hr. Transmission electron microscopy demonstrated that the tumor cells of all cell lines exhibited…

Participation in adjuvant clinical breast cancer trials: does study participation improve survival compared to guideline adherent adjuvant treatment? A retrospective multi-centre cohort study of 9,433 patients.

Abstract Adjuvant clinical trials (CTs) usually compare a standard treatment regime versus an innovative new substance or regimen. Participation in CT however, is available for only few patients and exclusion criteria are usually very strict. Therefore we used an unselected patient cohort to investigate the following questions: (1) Is participation in adjuvant CT associated with improved survival in breast cancer (BC)? (2) What is the impact of guideline conform therapy on survival in BC compared to that of participants in CT? Does guideline-conform adjuvant treatment provide an equal impact? Material and methods This German retrospective multi-centre cohort study included 9433 patients wit…

Die perkutane Harnleiterokklusion

One hundred and nineteen transrenal occlusions of 77 ureters were carried out in 71 patients. Thirty-one ureters were occluded by means of glue and in 21 Gianturco coils were introduced at the same time. Forty-six ureters were occluded by means of disposable silicone-filled latex balloons. Seventeen out of 31 ureters treated with glue (55%) and 32 out of 46 ureters with balloons (70%) were permanently occluded. On 42 occasions, re-occlusions had to be carried out, the average period from the initial occlusion being 2.5 weeks for glue and 19.5 weeks for balloons. In nine out of the 119 ureteric occlusions (7.5%), there were mild complications; these were easily treated and were of no consequ…

Das Qualitätssicherungsprogramm der Deutschen Krebsgesellschaft

3H-estradiol and3H-R5020 binding in cytosols of normal and neoplastic human ovarian tissue

High-affinity cytoplasmic estrogen and progesterone receptors in normal and abnormal ovarian tissues were studied. Estradiol receptor was detectable in 65% and progesterone receptor in 36% of the malignant tumors; 39% of all malignant ovarian tissues were estradiol- as well as progesterone-receptor-positive. Tumors were said to be receptor-positive when the receptors bound greater than 5 fM steroid/mg cytosol protein. No correlations were found between receptor status and histopathological diagnosis. In normal ovarian tissues collected at various phases of the menstrual cycle no changes in [3H]-estradiol and [3H]-R5020 binding could be detected. Analysis of the receptor concentration for bo…

Medroxyprogesterone acetate: steady-state pharmacokinetics bioequivalence of two oral formulations

Two micronized oral formulations of medroxyprogesterone acetate (MPA) (Farlutal and Clinovir) were compared in order to evaluate their relative bioavailability. Sixteen female patients with metastatic breast cancer were entered in a randomized cross-over study on 500-mg MPA tablets repeatedly administered (twice daily for 20 days). At the steady state, similar mean +/- SD serum levels of MPA were obtained (131 +/- 44 ng/ml for Farlutal and 136 +/- 45 ng/ml for Clinovir) and the two formulations proved to be bioequivalent (confidence interval at a significance level of 0.95 = 93%-107%).

The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer.

BACKGROUND Compliance and persistence are often overlooked in adjuvant breast cancer treatment. PATIENTS AND METHODS PACT was a prospective, multicenter, randomized, open, parallel-group study assessing whether educational materials (EMs) enhanced compliance with aromatase inhibitor (AI) therapy in postmenopausal women with early, hormone-receptor-positive (HR+) breast cancer. The primary end points were compliance (proportion taking ≥ 80% anastrozole) at 12 months and persistence (proportion reporting anastrozole intake during the study period). RESULTS Four thousand eight hundred and forty-four patients were randomly assigned 1:1 to receive standard therapy or standard therapy with EMs. T…

Therapeutische Möglichkeiten beim Rezidiv des Zervixkarzinoms

Rezidive von Zervixkarzinomen nach Operation und adjuvanter Strahlentherapie oder nach alleiniger primarer Strahlenbehandlung haben eine extrem schlechte Prognose und stellen eine Herausforderung fur den gynakologischen Onkologen dar. Bei ca. 35% der Patientinnen mit invasivem Zervixkarzinom zeigt sich im weiteren Krankheitsverlauf ein solches Rezidiv. Die Lokalisation dieser Rezidive betreffen in etwa einem Drittel der Falle ausschlieslich den Scheidenstumpf (27%) und den unteren Teil der Vagina (6%), uber 40% der Rezidive sind uberwiegend im Parametrium und an der Beckenwand lokalisiert. Nur ca. 20% der Patientinnen weisen Fernmetastasen auf [10, 27, 32, 33]. Treten solche Rezidive nach a…

Intron variants of the p53 gene are associated with increased risk for ovarian cancer but not in carriers of BRCA1 or BRCA2 germline mutations

Two biallelic polymorphisms in introns 3 and 6 of the p53 gene were analysed for a possible risk-modifying effect for ovarian cancer. Germline DNA was genotyped from 310 German Caucasian ovarian cancer patients and 364 healthy controls. We also typed 124 affected and 276 unaffected female carriers with known deleterious BRCA1 or BRCA2 germline mutation from high-risk breast-ovarian cancer families. Genotyping was based on PCR and high-resolution gel electrophoresis. German ovarian cancer patients who carried the rare allele of the MspI restriction fragment length polymorphism (RELP) in intron 6 were found to have an overall 1.93-fold increased risk (95% confidence internal (CI) 1.27–2.91) w…

17 beta-carboxamide steroids: highly effective inhibitors of the phytohaemagglutinin mediated blastogenesis of normal human peripheral lymphocytes.

Several novel 17 beta-carboxamide analogues of dexamethasone were synthesized. The common precursor, 9-fluoro-16 alpha-methyl-11 beta,17-dihydroxy-3-oxo-1,4-androstadiene-17 beta-carboxylic acid, did not bind to the glucocorticoid receptors of rat liver and human spleen tumours. In addition, no inhibition of the mitogen-induced blastogenesis of cultured human peripheral lymphocytes was observed. The 17 beta-carboxamide analogues, however, bound with similar affinities to the glucocorticoid receptors of both tissues. They inhibited the mitogen-induced blastogenesis of peripheral lymphocytes, showing the same potency and same order of binding affinity as the natural glucocorticoids.

Randomisierte Tamoxifen-Loading dose-Studie: Bestimmung der Serumspiegel von Tamoxifen und 5 Hauptmetaboliten mit einer neuen HOPLC-Methode

Je 20 Patientinnen mit Ostrogen- und/oder Progesteron-Rezeptor-positiven Mammakarzinomen oder Patientinnen mit unbekanntem Rezeptorstatus aber gunstigen Prognosekriterien wurden mit Tamofen® (Fa. Rhone-Poulence) einem der folgenden Therapieschemata unterworfen: 1.) 160 mg/Tag fur eine Woche, dann Umsetzen auf eine Dauerdosis von 20 mg/Tag; 2.) 80 mg/Tag fur eine Woche, Erhaltungsdosis 20 mg/Tag; 3.) 80 mg/Tag fur eine Woche, Erhaltungsdosis 40 mg/Tag; 4.) Dauerdosis 30 mg/Tag.

An International Proficiency Study with the Tumor Marker CA 125

A strict and adequate quality assurance program is the only real guarantee of the reliability of laboratory test results. Such proficiency testing was carried out for the CA 125 test system in five university laboratories over a period of three years (1984 - 1987) using five different reference materials (BIOREF, FRG). A concentration-dependent performance profile could thus be established evaluating a total of 301 assays. Intra-assay precision of the test ranged between 4.8 and 11.5%, and interassay precision between 13.6 and 19.1%. Laboratory specific average values of the individual reference materials ranged between 26 and 32 U/ml for reference 1, 51 and 59 U/ml for reference 2, 109 an…

Ergebnisse pathohistologischer und differentialdiagnostischer Untersuchungen an 4000 Probeexcisionen der Mamma

Supplementary Material for: Assessment of Quality of Life in Postmenopausal Women with Early Breast Cancer Participating in the PACT Trial: The Impact of Additional Patient Information Material Packages and Patient Compliance

Background: Breast cancer patients’ self-understanding of their disease can impact their quality of life (QoL); the relationship between compliance and QoL is poorly understood. Patients and Methods: The Patient’s Anastrozole Compliance to Therapy (PACT) program, a prospective, randomized study, investigated the effect of additional patient information material (IM) packages on compliance with adjuvant aromatase inhibitor (AI) therapy in postmenopausal women with hormone receptor-positive early breast cancer. The QoL subanalysis presented here examined the impact of IM packages on QoL and the association between QoL and compliance. European Organization for Research and Treatment of Cancer …