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Animal Welfare↗
Biomedical subjects
M Bergmans
Publications and source records attributed to M Bergmans.
Cyclophosphamide, epirubicin and cisplatin (CEP) versus epirubicin plus cisplatin (EP) in stage Ic-IV ovarian cancer: a randomized phase III trial of the Gynecologic Oncology Group of the Comprehensive Cancer Center Limburg.
Cisplatin is the most important drug in the treatment of advanced ovarian cancer. The role of anthracyclines is controversial. We compared a combination of epirubicin plus cisplatin (EP) with a regimen of cyclophosphamide, epirubicin and cisplatin (CEP). Patients with stage Ic-IV ovarian cancer were randomized to receive either epirubicin 100 mg/m2 plus cisplatin 75 mg/m2 q 4 weeks or cyclophosphamide 500 mg/m2 plus epirubicin 75 mg/m2 plus cisplatin 50 mg/m2 q 4 weeks, which we considered the reference treatment based on our previous experience. Patients were initially debulked, followed by six cycles of chemotherapy, or in case primary debulking was insufficient or considered inappropriate, secondary debulking was attempted in selected cases after sufficient chemotherapy-induced regression. Optimal debulking was defined as residual lesions < or = 2 cm. A total of 210 patients (191 eligible) were randomized. Results did not show significant differences in all major endpoints (pathologically documented complete response and survival). The median survival for all patients was 34 months, for patients with stage III 26 months, for patients with stage IV 20 months and it has not been reached for patients with stage Ic-II. As no significant differences between an equitoxic regimen of EP and CEP were detected, it might be more useful to look again at the anthracyclines as part of combination chemotherapy instead of the alkylating agents.
Antineoplastic Combined Chemotherapy Protocols↗
Study on causes and prevention of electrostatic charge build-up during extracorporeal circulation.
For many years it has been known that roller pumps interfere regularly with the electrocardiogram (ECG) signal. This electrical activity is also considered responsible for the electrostatic charge build-up in some oxygenators with a plastic heat exchanger. During use of such an oxygenator, an electrical shock can be felt when touching the device. In the absence of a provoked discharge, a spontaneous discharge may occur. The construction of the heat exchanger and the use of nonconductive materials enable some devices to function as a capacitor. If the voltage difference across the fibre wall is too high, an electrostatic discharge may occur. In 1997, four blood-to-water leaks in Maxima Forté oxygenators were reported on a worldwide basis. After thorough research by Medtronic Cardiac Surgery (Cardiopulmonary Division), the cause of the leaks was found to be an electrothermal event across the fibre wall of one single fibre. No patient injuries were reported in any of the events. Medtronic patented a number of US Food and Drug Administration-approved and patient-safe solutions to prevent this electrostatic charge build-up. We studied the electrostatic phenomenon in order to clarify the clinical aspects. The in vitro part of the study is related to the behaviour of the Medtronic Biopump and the Stockert Shiley roller pump--in combination with the use of a PVC or silicone pumpheader. Subsequently, we have investigated the influence of the rotation or flow of both types of blood pumps and occlusion settings on the roller pump. Furthermore, we tried to capture the electrical charge generated by the roller pumps in a capacitor and in some oxygenators with different types of heat exchanger. Finally, we tested the external CEL (Charge Equalization Line) and the internal 'Gold Wire' charge equalization systems, both patented by Medtronic. In the in vivo part of the study, 15 patients were divided into three groups of five patients each. In the first group a roller pump with a PVC pumpheader was evaluated and, in the second group, a roller pump with a silicone pumpheader. The third group consisted of the Medtronic Biopump. In all the groups, a Maxima Forté oxygenator with the external CEL protection was used. Owing to the fact that, at the time, the Maxima Forté 'Gold Wire' oxygenator was not available for clinical use, only the external CEL could be evaluated.
Electric Injuries↗