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6 results on '"Gallwas, Julia"'

5. Immunoreactivity of the fully humanized therapeutic antibody PankoMab-GEX™ is an independent prognostic marker for breast cancer patients

Author

Heublein, Sabine, Mayr, Doris, Egger, Markus, Karsten, Uwe, Goletz, Steffen, Angele, Martin, Gallwas, Julia, Jeschke, Udo, and Ditsch, Nina

Subjects
Adult, Mucin-1, MUC1, Antineoplastic Agents, Breast Neoplasms, TA-MUC1, Middle Aged, Prognosis, Antibodies, Monoclonal, Humanized, Immunohistochemistry, Survival Analysis, PankoMab-GEX™, Epitopes, Breast cancer, Antigens, Neoplasm, Biomarkers, Tumor, Humans, Female, Neoplasm Grading, skin and connective tissue diseases, Research Article, Aged
Abstract

Background Mucin-1 (MUC1, CD227), more widely known as CA15-3, is an abundantly expressed epithelial cell surface antigen and has evolved to be the most predictive serum tumour marker in breast cancer. PankoMab-GEX™, which is currently being evaluated for its therapeutic efficacy in a phase IIb clinical trial, is a glyco-optimized anti-MUC1 antibody specifically recognizing a tumour-associated MUC1 epitope (TA-MUC1). The current study aimed to analyse the immunoreactivity of PankoMabGEX™ and its correlation with established clinico-pathological variables including 10-year and overall survival in a large cohort of breast cancer patients. Methods Breast cancer tissue sections (n = 227) underwent a standardized immunohistochemical staining protocol for TA-MUC1 by using PankoMab-GEX™ as a primary antibody. The staining was evaluated by two independent observers and quantified by applying the IR-score. Results TA-MUC1 as detected by PankoMab-GEX™ was identified in 74.9% of breast cancer tissue sections. Patients were subdivided according to the subcellular localisation of TA-MUC1 and cases classified as mem-PankoMab-GEX™ (solely membranous) positive, cyt-PankoMab-GEX™ (solely cytoplasmic) positive, double positive or as completely negative were compared regarding their survival. Herein mem-PankoMab-GEX™-positive patients performed best, while double-negative ones presented with a significantly shortened survival. Positivity for mem-PankoMab-GEX™ as well as a double-negative immunophenotype turned out to be independent prognosticators for survival. Conclusions This is the first study to report on PankoMab-GEX™ in a large panel of breast cancer patients. The PankoMab-GEX™ epitope TA-MUC1 could be identified in the majority of cases and was found to be an independent prognosticator depending on its subcellular localisation. Since TA-MUC1 is known to be highly immunogenic cancers staining positive for PankoMab-GEX™ might be more compromised by host anti-tumour immune defence. Further, the observations reported here might be fundamental for selecting patients to undergo PankoMab-GEX™-containing chemotherapy protocols. Electronic supplementary material The online version of this article (doi:10.1186/s13046-015-0152-7) contains supplementary material, which is available to authorized users.

Published
2015

6. Comparison of two surgical methods for the treatment of CIN: classical LLETZ (large-loop excision of the transformation zone) versus isolated resection of the colposcopic apparent lesion -- study protocol for a randomized controlled trial.

Author

Schwarz, Theresa M., Kolben, Thomas, Gallwas, Julia, Crispin, Alexander, and Dannecker, Christian

Subjects
CERVICAL cancer treatment, TREATMENT of cervical intraepithelial neoplasia, LOOP electrosurgical excision procedure, HIGH-risk pregnancy, PAPILLOMAVIRUSES
Abstract

Background: In compliance with national and international guidelines, non-pregnant women with cervical intraepithelial neoplasia grade 3 should be treated by cervical conization. According to the definition of the large loop excision of the transformation zone (LLETZ) operation, the lesion needs to be resected, including the transformation zone. It is well known from the literature that the cone size directly correlates with the risk of preterm delivery in the course of a future pregnancy. Thus, it would be highly desirable to keep the cone dimension as small as possible while maintaining the same level of oncological safety. Methods/Design: The aim of this study is to analyze whether resection of the lesion only, without additional excision of the transformation zone, is equally as effective as the classical LLETZ operation regarding oncological outcome. We are performing this prospective, patient-blinded multicenter trial by randomly assigning women who need to undergo a LLETZ operation for cervical intraepithelial neoplasia grade 3 to either of the following two groups at a ratio of 1:1: (1) additional resection of the transformation zone or (2) resection of the lesion only. To evaluate equal oncological outcome, we are performing human papillomavirus (HPV) tests 6 and 12 months postoperatively. The study is designed to consider the lesion-only operation as oncologically not inferior if the rate of HPV high-risk test results is not higher than 5% compared with the HPV high-risk rate of women undergoing the classical LLETZ operation. Discussion: In case that non-inferiority of the "lesion-only" method can be demonstrated, this operation should eventually become standard treatment for all women at childbearing age due to the reduction in risk of preterm delivery. Trial registration: German Clinical Trials Register (DRKS) Identifier: DRKS00006169. Date of registration: 30 July 2014. [ABSTRACT FROM AUTHOR]

Published
2015
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