Research papers: Breast CancerEfficacy and safety of direct and frontal macrobiopsies in breast cancerCornelis, Anna; Verjans, Marcela; Van den Bosch, Thierrya; Wouters, Katrienb; Van Robaeys, Johanc; Janssens, Jaak Ph.dWorking Group on Hormone Dependent Cancers, The European Cancer Prevention OrganizationAuthor Information aDepartment of Pathology and Gynaecology, H. Hartziekenhuis, Tienen bDepartment of Pathology, Salvatorziekenhuis, Hasselt cDepartment of Pathology, Ziekenhuis Oost-Limburg, Genk dLimburg University Centre, University of Hasselt, Hasselt, Limburg, Belgium Correspondence to Professor Jaak Ph. Janssens, MD, PhD, European Cancer Prevention Organization, Klein Hilststraat 5, Hasselt, Limburg 3500, Belgium Tel: +32 11 275734; fax: +32 11 283677; e-mail: firstname.lastname@example.org Received 31 January 2009 Accepted 31 January 2009 European Journal of Cancer Prevention: August 2009 - Volume 18 - Issue 4 - p 280-284 doi: 10.1097/CEJ.0b013e328329d885 Buy Metrics Abstract Recent innovations in tissue acquisition from the human breast have led to the development of unique direct frontal systems. We intend to evaluate efficacy and safety in a multicenter clinical study. Efficacy was considered optimal if the diagnosis by transcutaneous biopsy was identical to the surgical specimen in case of malignancy or in line with clinical follow-up when benign. One hundred and seventy-three women (aged 22–95 years) with a suspect lesion in the breast were eligible for transdermal biopsy. One hundred and seventeen biopsies were performed with the Spirotome and 56 with the Coramate under radiological or ultrasound guidance. Sample quality was evaluated by comparing the pathology results of the samples with definitive pathology at subsequent surgery or follow-up in case of benign lesions. An average of 1.66 biopsies per procedure were obtained. All patients had sufficient sample size (up to 5 mm diameter/20 mm length) to make a reliable diagnosis. The average length was 1.39 cm and the average diameter 3.72 mm. There were three false-negative diagnoses, leaving a correct diagnosis in 170 patients. None of the patients suffered from a serious complication, and the procedure was generally well tolerated. The new direct frontal transdermal tissue acquisition approach gives adequate diagnostic results through high-quality tissue samples. No major patient discomfort was noted. © 2009 Lippincott Williams & Wilkins, Inc.