{"title":"Molecular Profiling - Challenges and Perspectives","authors":"C. Dittrich, Kaiser Franz Josef-Spital","doi":"10.17925/EOH.2014.10.2.102","DOIUrl":"https://doi.org/10.17925/EOH.2014.10.2.102","url":null,"abstract":"Molecular profiling is today’s answer to the eternal unmet need of personalising anticancer therapy. We have never reached such a level of rationality before, based on new technologies, knowledge of systems biology and insights into patho-mechanisms. Whereas we actually focus mainly on mutations of a limited number of cancer genes, we will also have to integrate epigenetic, transcriptional and post-transcriptional changes into our future therapeutic considerations. Overall, we have reached an advanced level of stratified medicine, but are still on the way of targeting the holy grail of real personalisation.","PeriodicalId":38554,"journal":{"name":"European Oncology and Haematology","volume":"55 1","pages":"102"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84483410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Neoadjuvant Chemotherapeutic and Targeted Therapies for Early-stage, High-risk Breast Cancer","authors":"C. Chung, Rosetta Lee","doi":"10.17925/EOH.2014.10.1.28","DOIUrl":"https://doi.org/10.17925/EOH.2014.10.1.28","url":null,"abstract":"Neoadjuvant or preoperative chemotherapy is the preferred treatment for locally advanced, inflammatory and early-stage high-risk breast cancers. Patients with locally advanced breast cancers are candidates for neoadjuvant therapy because their tumours are often not amenable to resection. On the other hand, patients are candidates for neoadjuvant chemotherapy if the breast-conserving surgery is not possible. At present, anthracycline- and taxane-based chemotherapy regimens remain as the cornerstone for neoadjuvant therapy in early breast cancer, but there is a clear need for effective therapies in high-risk, early-stage patients. A number of chemotherapeutic and targeted therapies have been evaluated in clinical trials with varying results. The US Food and Drug Administration (FDA) has recently approved pertuzumab in combination with trastuzumab and cytotoxic chemotherapy as a neoadjuvant therapy option for HER2-positive breast cancer. This article reviews the neoadjuvant chemotherapeutic and targeted therapies options for early-stage, high-risk breast cancer. Possible role of molecular subtyping in triple-negative breast cancer is also described.","PeriodicalId":38554,"journal":{"name":"European Oncology and Haematology","volume":"52 1","pages":"28"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90490155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
B. Jilma, A. Jagiełło-Gruszfeld, P. Tomczak, H. Gadgil, G. Orlik, Kalpna Desai, Tina Catalano, Jason Dowd, M. Skłodowska-Curie
{"title":"Demonstration of Clinical Comparability of the Biosimilar Filgrastim to Neupogen, in Terms of Safety and Efficacy, in Healthy Volunteers and Patients Receiving Myelosuppressive Chemotherapy","authors":"B. Jilma, A. Jagiełło-Gruszfeld, P. Tomczak, H. Gadgil, G. Orlik, Kalpna Desai, Tina Catalano, Jason Dowd, M. Skłodowska-Curie","doi":"10.17925/EOH.2014.10.2.107","DOIUrl":"https://doi.org/10.17925/EOH.2014.10.2.107","url":null,"abstract":"Aim: To demonstrate biosimilarity as evidenced by the pharmacokinetic (PK), pharmacodynamics (PD), efficacy and safety comparability of Accofil ® /Grastofil ® (filgrastim), a recombinant human granulocyte colony-stimulating factor, and the reference product, Neupogen ® . Patients and methods: Four phase I studies were conducted to demonstrate the comparative efficacy of Accofil/Grastofil and Neupogen. PD and PK parameters of Accofil/Grastofil (filgrastim) at and around the main clinical dose (5 μg/kg), using both the intravenous (IV) and subcutaneous (SC) routes of administration, were compared with Neupogen (EU) in healthy volunteers in three phase I clinical studies in a single-dose setting and following multiple-dose administration. An additional phase I PK/PD study was performed to compare Accofil/ Grastofil (filgrastim) to both EU-approved Neupogen and US-licensed Neupogen following the administration of a fixed SC dose of 300 μg. The efficacy and safety of Accofil/Grastofil was also evaluated in chemotherapy-naive women with stage IIA, IIB and IIIA breast cancer receiving docetaxel, doxorubicin, cyclophosphamide (TAC) chemotherapy. No comparator arm was included in this study so the efficacy and safety comparison was made with published data for the reference product, Neupogen. Results: A total of 235 healthy subjects were enrolled in the phase I studies and 120 patients in the phase III study. The PK and PD data demonstrated high comparability of the Accofil/ Grastofil and Neupogen products, with the 90 % confidence interval (CI) for primary PK parameters and 95 % CI for primary PD parameters falling within the pre-defined equivalence limits. In the phase III study, Accofil/Grastofil (filgrastim) demonstrated a safety and efficacy profile that was similar to the published data for the reference product Neupogen for the reduction of the duration of neutropenia in patients with breast cancer who were undergoing chemotherapy. Conclusion: Lack of clinically meaningful differences was convincingly demonstrated between Accofil/Grastofil (filgrastim) and the reference product, Neupogen.","PeriodicalId":38554,"journal":{"name":"European Oncology and Haematology","volume":"12 3","pages":"107"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72463436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}