Phase II trial of sagopilone, a novel epothilone analog in metastatic melanoma.

BACKGROUND: Sagopilone is a novel fully synthetic epothilone with promising preclinical activity and a favourable toxicity profile in phase I testing. METHODS: A phase II pharmacokinetic and efficacy trial was conducted in patients with metastatic melanoma. Patients had measurable disease, Eastern Cooperative Oncology Group performance status 0-2, adequate haematological, and organ function, with up to 2 previous chemotherapy and any previous immunotherapy regimens. Sagopilone, 16 mg m⁻², was administered intravenously over 3 h every 21 days until progression or unacceptable toxicity. RESULTS: Thirty-five patients were treated. Sagopilone showed multi-exponential kinetics with a mean terminal half-life of 64 h and a volume of distribution of 4361 l m⁻² indicating extensive tissue/tubulin binding. Only grade 2 or lower toxicity was observed: these included sensory neuropathy (66%), leukopenia (46%), fatigue (34%), and neutropenia (31%). The objective response rate was 11.4% (one confirmed complete response, two confirmed partial responses, and one unconfirmed partial response). Stable disease for at least 12 weeks was seen in an additional eight patients (clinical benefit rate 36.4%). CONCLUSION: Sagopilone was well tolerated with mild haematological toxicity and sensory neuropathy. Unlike other epothilones, it shows activity against melanoma even in pretreated patients. Further clinical testing is warranted.

[Image tracking system. A new technique for safe and cost-saving laparoscopic operation]. / Image Tracking System. Eine neue Technik für die sichere und kostensparende laparoskopische Operation.

The potential for improvement of the results of laparoscopic operations as well as necessity of enhanced efficiency in the health-care systems are the main reasons for development and practical use of robotic systems in the field of laparoscopic surgery. While robotic systems imitate the human camera-holder the Image Tracking System (ImagTrac, Olympus, Tokio) is based on another principle: A voice-activated zoom function allows change between overview and detailed view. In the zoom-in position it is possible to select four different fields of view. The results of a clinical trial with control group show that the system: 1. Makes it possible to dispense with the human camera-holder without compromising patient safety, sometimes at greater convenience to the surgeon. 2. Makes it possible for routine laparoscopic operations such as laparoscopic cholecystectomy and laparoscopic hernia repair to be performed (as solo surgery) by a team of a surgeon and a nurse only. 3. Is more cost-effective than robotic systems with a similar range of features.

[Routine ultrasound in diagnosis of acute appendicitis]. / Routine-Sonographie in der Diagnostik der akuten Appendizitis.

A prospective trial reveals that routine ultrasound in suspected appendicitis in the hands of experts can lead to a specificity of 94% and a sensitivity of 90% in opposite to 82% and 78% for clinical findings alone. The rate of "negative laparotomies" has decreased from 22% to 11%.

[Antegrade scrotal phlebography of the v. spermatica in left-sided testicular varicocele--are retrograde phlebographic classifications suitable for typing?]. / Die antegrade skrotale Phlebographie der V. spermatica bei linksseitiger Varikozele testis--sind retrograde Phlebographie-Klassifikationen für die Typisierung geeignet?

PURPOSE: The study was conducted to clarify whether the use of classifications in base of retrograde phlebography would be sufficiently suitable for typifying the findings of antegrade phlebography examinations of the internal spermatic vein with regard to antegrade sclerotherapy. SUBJECTS AND METHODS: In course of antegrade sclerotherapy in 236 patients with previously untreated idiopathic left-sided varicocele, phlebography via scrotal approach was performed. The results were compared with the relevant findings of the pre-existing classifications of the retrograde exams. RESULTS: Comparison with the classifications of Bähren and Braedel showed distinct discrepancies. In 28.8% (Bähren) respectively 36.4% (Braedel) of our findings, typification was unsuccessful. Correspondence was found with the Riedl-classification. Collateral vessels however, are not sufficiently differentiated. CONCLUSION: Retrograde classifications proved insufficient in typifying the findings of antegrade phlebography of the internal spermatic vein. A more subtle classification is required. This has been worked out and presented.