WorldCare Limited provides a broad range of telemedicine and teleradiology services on a global scale. The company's technology division which was set up three years ago, will start to operate independently from now on. Under the name of WorldCare Technologies, it will concentrate on leading-edge telemedicine applications via the Internet and advanced clinical information management solutions for electronic health care delivery. As a second but fully owned subsidiary of the same company, WorldCare Clinical Trials offers digital image management assistance in a clinical trial that was organized to obtain an accelerated US Food and Drug Administration (FDA) approval for Hoffmann-La Roche's newly developed oral, chemotherapeutic agent, Xeloda. Measurements of the medical images showed a less by half tumour size reduction in one out of four Xeloda-tested patients.
Some tumours in metastatic breast cancer are difficult to treat with conventional chemotherapy, since they are not responding anymore to standard drugs, such as paclitaxel (Taxol) and an anthracycline-containing regimen (Adramycin, doxorubicin). After the pivotal phase II clinical trial, Xeloda (capecitabine) has received accelerated FDA approval on April 30th 1998, as the first oral anticancer drugs for patients with otherwise resistant tumours. The FDA fiat has only been granted on the criterion of successful tumour shrinkage. More profound research is currently being undertaken to assess Xeloda's impact on the positive or negative development of the cancer symptoms and on average patient survival.
The interim decision by the FDA is based on a study that involved 43 hard-to-treat patients. The outcome showed a positive response rate to the Xeloda drug of 25.6 percent, or 11 cases with a substantial tumour size reduction. These encouraging results were supported by the overall patient population (n=135). Here, the tumour shrinkage of at least less by half showed an 18.5 percentage. One of the patients even experienced a complete remission. The major role of WorldCare Clinical Trials in the study consisted in providing a severe quality control for the tumour response rates by means of a blinded, independent review of tumour scans from different investigators. In this capacity, WorldCare took charge of the image management, over-reads as well as digital measurements of diagnosed chest and abdominal lesions for 101 patients suffering from metastatic breast cancer.
The company digitized over 2500 images, produced with Ultrasound, X-ray, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) in order to import the data into high resolution workstations by means of proprietary intelligent software. As a result, the images could safely be captured, stored, displayed and analysed. Two-dimensional measurements were made of the chest and abdominal lesion boundaries to enable evaluation of the tumour reduction or arrest in regular intervals of six weeks. A team of well-trained technicians was responsible for the quantitative analysis of more than 800 measurements. Expert radiologists from Harvard Medical School and the Massachusetts General Hospital double-checked the outcome. Overall turn around time for the over-reads was set on two weeks.
WorldCare will carry on to support medical image analysis in the remaining phases of the Xeloda research programme. It seems the new oral anticancer drug can mean a breakthrough in breast cancer treatment if dangerous and unpleasant side effects can be kept under control by adapting the dosages to the patient's physical condition. The Clinical Trials subsidiary has unlimited access to WorldCare's Global Telemedicine Network which interconnects a huge range of carefully protected patient information and image capture and review stations. For this multi-specialty information management system that WorldCare has set up to coordinate the creation, referral, transmission, storage and review of patients' Electronic Telemedicine Records (ETRs), the new spin-off company, WorldCare Technologies, will provide fully integrated telemedicine network solutions.
These solutions can be delivered via the intranet of health care institutions, through a local or regional health care extranet, or by means of a national or international Internet service. The entire telemedicine product assortment has been clinically validated in co-operation with the company's partnering hospitals. The telemedicine applications can be transmitted over a variety of communication systems, from ordinary telephone lines to sophisticated ATM (Asynchronous Transfer Mode) networks. Wavelet image compression with a 30:1 ratio is used to facilitate and speed up the transfer of medical images. In this way, WorldCare Technologies can offer its telemedicine technology platform services via an international network, operating in twelve countries all over the world.