ABSTRACT
We evaluated the impact of an evaluation committee (EC) on patients' overall response status in a large multicenter trial in oncology. We identified reasons for disagreements between investigators and the EC. The Cancer Renal Cytokine (CRECY) study was a French multicenter trial that tested cytokine therapy in 489 patients with metastatic renal cell carcinoma. Objective response (OR) evaluation included medical imaging and was studied according to international guidelines. A blinded peer review of all responders and litigious cases was performed by an EC. Major disagreements occurred in 43% and minor disagreements in 10.5% of the reviewed files. The number of significant tumor responses was reduced by 23.2% after review by the EC. Reasons for disagreements included errors in tumor measurements, errors in selection of measurable targets, intercurrent diseases, and radiologic technical problems. These reasons for disagreements are analyzed and discussed. We conclude that all therapeutic trial results should be reviewed by peer analysis of all presumed responders by an EC. International guidelines for response evaluation should be updated by including more reliable methods of measurements and definition of minimal imaging procedures.
Subject(s)
Interferon-alpha/therapeutic use , Interleukin-2/therapeutic use , Neoplasms/drug therapy , Antineoplastic Agents/therapeutic use , Humans , Multicenter Studies as Topic , Neoplasms/diagnostic imaging , Neoplasms/pathology , Professional Staff Committees , Randomized Controlled Trials as Topic , Reproducibility of Results , Tomography, X-Ray Computed , Treatment OutcomeABSTRACT
PURPOSE: We evaluated the impact of an evaluation committee (EC) on patients' overall response status in a large multicenter trial in oncology. We identified reasons for disagreements between investigators and the EC. MATERIALS AND METHODS: The Cancer Renal Cytokine (CRECY) study was a French multicenter trial that tested cytokine therapy in 489 patients with metastatic renal cell carcinoma. Objective response (OR) evaluation included medical imaging and was studied according to international guidelines. A blinded peer review of all responders and litigious cases was performed by an EC. RESULTS: Major disagreements occurred in 40% and minor disagreements in 10.5% of the reviewed files. The number of significant tumor responses was reduced by 23.2% after review by the EC. Reasons for disagreements included errors in tumor measurements, errors in selection of measurable targets, intercurrent diseases, and radiologic technical problems. These reasons for disagreements are analyzed and discussed. CONCLUSION: We conclude that all therapeutic trial results should be reviewed by peer analysis of all presumed responders by an EC. International guidelines for response evaluation should be updated by including more reliable methods of measurements and definition of minimal imaging procedures.
Subject(s)
Clinical Trials as Topic , Medical Oncology/methods , Observer Variation , Treatment Outcome , Humans , Multicenter Studies as Topic , Neoplasm Metastasis , Neoplasms/therapy , Practice Guidelines as Topic , Survival Analysis , Tomography, X-Ray ComputedABSTRACT
Periprosthetic false aneurysm due to dehiscence of a suture line represents a serious postoperative complications after Bentall's procedure, because of its asymptomatic presentation and spontaneous course towards progressive increase in size with high risk of sudden rupture. This type of complication justifies systematic radiologic follow-up. Magnetic Resonance Imaging, as proved by our two cases, is a reliable technique in the diagnosis of this complication requiring reoperation.
Subject(s)
Aortic Aneurysm/etiology , Magnetic Resonance Imaging , Suture Techniques/adverse effects , Adult , Aorta, Thoracic , Aortic Aneurysm/diagnosis , Aortic Diseases/surgery , Diagnosis, Differential , Female , Humans , Male , Middle Aged , ReoperationABSTRACT
The accuracy of Magnetic Resonance Imaging in cervical carcinoma staging for clinical stages superior to IB was studied retrospectively in 27 patients. The MRI results were then correlated with operative findings in 12 cases and with examination carried out under general anesthesia in 15 cases for myometrial, bladder, rectal, parametrial, parietal and vaginal extension. The accuracy of MRI was 81.5% for bladder, 92.5% for rectal, 87% for parametrial and 73% for vaginal extension. The accuracy of staging by MRI was 59%. The contribution of MRI in pre-operative studies for cervical carcinomas has not been properly defined until now. Nevertheless it is a particularly valuable technique due to its non invasive nature.
Subject(s)
Magnetic Resonance Imaging , Uterine Cervical Neoplasms/pathology , Adult , Aged , Evaluation Studies as Topic , Female , Humans , Middle Aged , Neoplasm Staging , Retrospective StudiesABSTRACT
Twenty three patients suffering from severe chronic ischemia of the lower limbs were explored by conventional and digital angiography. A comparative study of these 2 angiographic techniques was carried out to appreciate the pre-operative distal vascular tree and the surgical indications. In all cases, digital angiography was never found to be less informative than conventional angiography. In 14 cases, the surgical approach was changed as a result of digital angiography in 4 cases the method of revascularization and in 10 cases the surgical indication itself (distal bypass instead of amputation). The authors consider digital angiography to be essential in this surgical indication.
Subject(s)
Angiography, Digital Subtraction , Ischemia/diagnostic imaging , Leg/blood supply , Adult , Aged , Aged, 80 and over , Angiography , Female , Humans , Male , Middle Aged , Retrospective StudiesABSTRACT
The authors report a case of pseudocoarctation of the aorta associated with a retro-aortic left brachiocephalic vein. This exceptional congenital malformation, never described before, was studied by aortography, computed tomography and magnetic resonance imaging.