Prognostic impact of circulating tumor cells assessed with the CellSearch System? and AdnaTest Breast? in metastatic breast cancer patients: the DETECT study

Introduction

There is a multitude of assays for the detection of circulating tumor cells (CTCs) but a very limited number of studies comparing the clinical relevance of results obtained with different test methods. The DETECT trial for metastatic breast cancer patients was designed to directly compare the prognostic impact of two commercially available CTC assays that are prominent representatives of immunocytochemical and RT-PCR based technologies.

Methods

In total, 254 metastatic breast cancer patients were enrolled in this prospective multicenter trial. CTCs were assessed using both the AdnaTest Breast Cancer and the CellSearch system according to the manufacturers' instructions.

Results

With the CellSearch system, 116 of 221 (50%) evaluable patients were CTC-positive based on a cut-off level at 5 or more CTCs. The median overall survival (OS) was 18.1 months in CTC-positive patients. (95%-CI: 15.1-22.1 months) compared to 27 months in CTC-negative patients (23.5-30.7 months; p<0.001). This prognostic impact for OS was also significant in the subgroups of patients with triple negative, HER2-positive and hormone receptor-positive/HER2-negative primary tumors. The progression free survival (PFS) was not correlated with CTC status in our cohort receiving different types and lines of systemic treatment (p = 0.197). In multivariate analysis, the presence of CTCs was an independent predictor for OS (HR: 2.7, 95%-CI: 1.6-4.2). When the AdnaTest Breast was performed, 88 of 221 (40%) patients were CTC-positive. CTC-positivity assessed by the AdnaTest Breast had no association with PFS or OS.

Conclusions

The prognostic relevance of CTC detection in metastatic breast cancer patients depends on the test method. The present results indicate that the CellSearch system is superior to the AdnaTest Breast Cancer in predicting clinical outcome in advanced breast cancer.

Trial registration

Current Controlled Trials Registry number ISRCTN59722891.     

Temporal changes in key maternal and fetal factors affecting birth outcomes: A 32-year population-based study in an industrial city

Background

In Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies as well as decreased fertility; and significant resource implications. Randomised controlled trials (RCTs) of continuity of midwifery care have reported reduced caesareans and other interventions in labour, as well as increased maternal satisfaction, with no statistically significant differences in perinatal morbidity or mortality. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6–12 midwives) with very few testing caseload (one-to-one) midwifery care. This study aims to determine whether caseload (one-to-one) midwifery care for women at low risk of medical complications decreases the proportion of women delivering by caesarean section compared with women receiving 'standard' care. This paper presents the trial protocol in detail.

Methods/design

A two-arm RCT design will be used. Women who are identified at low medical risk will be recruited from the antenatal booking clinics of a tertiary women's hospital in Melbourne, Australia. Baseline data will be collected, then women randomised to caseload midwifery or standard low risk care. Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a designated primary midwife with one or two antenatal visits conducted by a 'back-up' midwife. The midwives will collaborate with obstetricians and other health professionals as necessary. If the woman has an extended labour, or if the primary midwife is unavailable, care will be provided by the back-up midwife. For women allocated to standard care, options include midwifery-led care with varying levels of continuity, junior obstetric care and community based general medical practitioner care. Data will be collected at recruitment (self administered survey) and at 2 and 6 months postpartum by postal survey. Medical/obstetric outcomes will be abstracted from the medical record. The sample size of 2008 was calculated to identify a decrease in caesarean birth from 19 to 14% and detect a range of other significant clinical differences. Comprehensive process and economic evaluations will be conducted.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN012607000073404.     

Fluorescenzspektroskopische Untersuchungen an Mucoproteinen des Serums bei malignen Erkrankungen

Zusammenfassung In weiterer Verfolgung bereits früher beobachteter Unterschiede in der Fluorescenz pathologischer und gesunder Seren wurde ein spektroskopischer Ca.-Serumtest zu erarbeiten versucht. Wegen der beobachteten Vermehrung dieser Fraktion bei Ca., der leichten Darstellbarkeit sowie der distinkten Unterschiede zu anderen Eiweißfraktionen wurden die Mucoproteine zum Ausgangspunkt der Untersuchung gemacht.Die bisher erzielten Ergebnisse zeigen hinsichtlich Genauigkeit Über-einstimmung mit gebräuchlichen neueren Serumtests.Die Verfasser danken ihren Lehrkanzelvorständen Prof. Dr. L. Flamm und Prof. Dr. L. Schönbauer, die die Durchführung der Arbeit ermöglichten, und Herrn Prof. Dr. F. Regler für die Überlassung des Spektrographen. Weiter sind sie den Herren H. Ellbogen und F. Malek für wertvolle experimentelle Hilfe zu Dank verpflichtet.     

Das Kolloid der Schilddrüse und Hypophyse des Menschen

Ohne ZusammenfassungHierzu Tafel III und 1 Textfigur.     

Therapie

Ohne Zusammenfassung     

Syphilis. Symptomatologie

Ohne Zusammenfassung     

Hautkrankheiten

Ohne Zusammenfassung     

Hautkrankheiten

Ohne Zusammenfassung