Pegase 03: a prospective randomized phase III trial of FEC with or without high-dose thiotepa, cyclophosphamide and autologous stem cell transplantation in first-line treatment of metastatic breast cancer.

Pegase 03 is a multicenter prospective randomized phase III trial evaluating the impact of first-line high-dose chemotherapy (HDC) with stem cell support on overall survival (OS), disease-free survival (DFS) and response rate in 308 patients with histologically proven metastatic breast cancer responding to induction therapy. Eligible patients received four induction cycles with FEC 100 (5-fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), cyclophosphamide 500 mg/m(2)). Patients with objective response (N=179) were randomized to one cycle of HDC (cyclophosphamide 6000 mg/m(2) and thiotepa 800 mg/m(2) (CHUT)) and stem cell support (N=88), or no further treatment (N=91). All patients were observed until disease progression or death. One toxic death occurred after CHUT. Other toxicities were manageable. The response rate at 3 months was higher in the intensification arm: 82.7% (25.3% complete response (CR)) versus 59.2% (14.1% CR) (P=0.0002). Median follow-up was 48 months. Median DFS was 11 and 6.6 months in the intensification and the observation arms, respectively (P=0.0001). There was no survival difference: 33.6 versus 27.3% OS at 3 years (P=0.8) and 22.9 versus 22.3 months median time to relapse in the intensification and observation arms, respectively. In this randomized trial, HDC with CHUT improved DFS but not OS, corroborating findings from earlier trials.

[Contribution of bacterial detachment by enzymatic or physical methods to the diagnosis of foreign material infections and chronic osteomyelitis]. / Apport des méthodes de décrochage enzymatique ou physique des bactéries au diagnostic des infections sur matériel étranger et des ostéomyélites chroniques.

Bacterial adhesion is a crucial factor in the pathogenicity of numerous bacterial species. This property plays such a great role in infections of foreign material that removal of the material is the only effective therapy. The electron microscopy studies performed by Christensen have demonstrated that infected foreign material harbors bacteria which are often coated with slime and therefore escape detection by conventional microbiological methods. in view of these properties, enzymatic or physical detachment of adherent bacteria was attempted. 231 specimens from a variety of materials (catheters, heart valves, drains, bone biopsies) which yielded negative results after 15 days culture in Schaedler medium were either exposed to trypsin or sonicated. Among catheter specimens, 44.7% yielded positive bacteriologic results; pathogens recovered included 8.3% micrococci, 5.1% nongroupable streptococci, 1.7% group D streptococci, 2.9% Enterobacteria, and 23.3% coagulase-negative staphylococci. Among the bone specimens, the improvement in yield was 64.7%; except in one case, the pathogens recovered were consistent with previously initiated treatments. This bacterial detachment method should be studied in a larger number of specimens to determine its diagnostic value as compared with conventional techniques.

[Protection and reperfusion of the myocardium by cardioplegia with blood enriched in aspartate and glutamate. Technique and initial results. Report of 60 cases]. / Protection et reperfusion du myocarde par cardioplégie au sang enrichie en aspartate et glutamate. Technique et résultats préliminaires. A propos de soixante patients.

From 1st November 1987 to 30th September 1988, 27 patients with recent myocardial infarction and 33 patients at high risk of postoperative circulatory failure were operated according to the same protocol. In each case, myocardial protection, at the time of aortic clamping, consisted of an intra-coronary injection of a cardioplegic solution of blood enriched with aspartate and glutamate, administered in 3 phases (normothermic induction, hypothermic induction, normothermic reperfusion) according to the protocol described by Buckberg et al. The operative mortality was 11.6% (7/60) and 46.6% (28/60) of patients did not develop any postoperative complications. It is difficult to draw any conclusions concerning the superiority of the method on the basis of a non-comparative clinical study, but its simple application and its safety appear to be clearly demonstrated.

[Use of the Cerebral Function Monitor in cardiac surgery]. / Utilisation du Moniteur de Fonction Cérébrale en chirurgie cardiaque.

Having employed routinely the monitor of cerebral function in cardiac surgery operations for about a year, the authors now present an analysis of the variations in the traces of a group of 57 patients. They have found, when there is no major haemodynamic consequence associated with the induction of anaesthesia, and when there are no difficulties of a surgical or a technical nature accompanying the artificial extra-corporeal circulation, that the monitor curve stays perfectly stable. On the other hand, all sudden haemodynamic changes result in hypotension (haemorrhage, dysrhythmia, and a fall in flow in the extracorporeal circulation) that is reflected in the level of the monitor curve which also falls. They conclude, using examples of certain variations, that the monitor curve is a supplementary form of surveillance and that the trace recorded simultaneously with the anaesthetic sheet allows retrospective analysis of the haemodynamic events to be performed for each operation.