Massimo Gion

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Despite years of research and hundreds of reports on tumor markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the(More)
Lisa M. McShane, Biometric Research Branch, National Cancer Institute, Bethesda, MD Douglas G. Altman, Medical Statistics Group, Cancer Research UK, Centre for Statistics in Medicine, Wolfson College, Oxford, UK Willi Sauerbrei, Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, Freiburg, Germany Sheila E.(More)
BACKGROUND The clinical outcome is generally positive for patients with node-negative breast carcinoma (i.e., those who do not have detectable metastases in the lymph nodes) who have been treated with surgery or surgery plus radiation therapy. In about 30% of the patients, however, the disease recurs, and they are at risk of death. Determination of valid(More)
Elevated circulating chromogranin A (CgA) levels are found in neuroendocrine tumors (NETs), but the diagnostic usefulness of this marker is still debatable. To assess the role of CgA for the diagnosis of gastroenteropancreatic (GEP) NETs and the identification of metastatic patients, an Italian multicenter observational study has been performed. CgA was(More)
A randomized Phase II study evaluated the activity of weekly paclitaxel versus its combination with trastuzumab for treatment of patients with advanced breast cancer overexpressing HER-2. Among 124 patients randomized, 123 are assessable for toxicity and 118 for response. Patients received weekly paclitaxel single agent (80 mg/m2) or combined with(More)
The monoclonal antibody (MAb) b12 raised against human breast cancer cell lines was found to identify an epitope of a mucinous-like carcinoma associated antigen (MCA) that is strongly represented on breast tumor cells. The b12 MAb was used to develop an enzyme immunoassay (EIA) kit. MCA levels were measured with the EIA method in the cytosol of both breast(More)
LM McShane*, DG Altman, W Sauerbrei, SE Taube, M Gion and GM Clark for the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics US National Cancer Institute, Bethesda, MD 20892, USA; Cancer Research UK Medical Statistics Group, Centre for Statistics in Medicine, Wolfson College, Oxford OX2 6UD, UK; Institut fuer Medizinische(More)
Recommendations are presented for the routine clinical use of serum and tissue-based markers in the diagnosis and management of patients with breast cancer. Their low sensitivity and specificity preclude the use of serum markers such as the MUC-1 mucin glycoproteins (CA 15.3, BR 27.29) and carcinoembryonic antigen in the diagnosis of early breast cancer.(More)
We studied the diagnostic accuracy of carcinoembryonic antigen (CEA) and cancer antigen 15.3 (CA 15.3) in detecting breast cancer recurrence. Biomarker follow-up determinations, made over 900 patients, were related to local-regional or distant recurrence using statistical models for longitudinal data. The diagnostic accuracy was quantified in terms of(More)