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Neu Isenburg, Germany

Loibl S.,GBG Forschungs GmbH
Current Opinion in Obstetrics and Gynecology | Year: 2015

PURPOSE OF REVIEW: Neoadjuvant therapy is very often an adequate alternative to adjuvant therapy. This review summarizes the recent advances made in the area of neoadjuvant therapy in breast cancer. The focus will lie on recently published clinical trials, but will not further highlight surgical, imaging and radio-oncological issues related to neoadjuvant therapy. RECENT FINDINGS: Within the past year, it has been discussed if neoadjuvant treatment can be used as a faster way to get access to new therapies, based on new data in HER2+ breast cancer, suggesting a higher pathological complete response rate when a dual anti-HER2 therapy was used. Nevertheless, this higher pathological complete response rate does not necessarily always translate into a better survival. In triple negative breast cancer, carboplatin could be identified as an asset for patients, especially in patients with gBRCA mutations. However, mature long-term data are still missing. The neoadjuvant approach is ideal to identify new biomarkers which predict response or resistance to the given treatment. Tumour-infiltrating lymphocytes and PIK3CA mutations are amongst the most promising markers. SUMMARY: Neoadjuvant treatment should be considered for all patients with HER2-positive or triple negative breast cancer. Clinical trials in this setting are currently investigating new approaches. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. Source


Massey Skatulla L.,Klinikum Hanau GmbH | Loibl S.,GBG Forschungs GmbH | Schauf B.,Chefarzt Frauenklinik | Muller T.,Klinikum Hanau GmbH
Archives of Gynecology and Obstetrics | Year: 2012

Purpose There has been some discussion about the eVect of antineoplastic agents on the trophoblast, and whether this is associated with abnormal placental function such as an increased risk of pre-eclampsia/eclampsia. We discuss a possible causal relationship between chemotherapy for breast cancer during pregnancy and the development of pre-eclampsia based on the occurrence of both in a recent pregnancy. Methods We report the case of a 34-year-old gravida 4, para 1 with unilateral ductal invasive breast cancer, treated by surgery and subsequent chemotherapy during pregnancy. At 36 + 2 weeks of gestation a growth restricted male infant (1,680 g, <5th percentile) was born by urgent caesarean section because of acute pre-eclampsia, pathologic CTG and umbilical end-diastolic reverse Xow. This case is reported in detail, and literature and databases reviewed. Results So far there have been no reports suggesting an increased risk of pre-eclampsia following chemotherapy for breast cancer in pregnancy from the second trimester onwards, and the most probable is an accidental occurrence from pre-eclampsia and chemotherapy. Conclusions Whenever possible, pregnant patients with breast cancer should receive the same treatment as those who are not pregnant. Should chemotherapy for breast cancer be indicated in pregnancy from the second trimester onwards only, contraindications would be other risks for pre-eclampsia and intrauterine growth restriction, such as smoking and gestational diabetes. © 2012 Springer-Verlag. Source


Jackisch C.,Breast Cancer Center | Scappaticci F.A.,Genentech | Heinzmann D.,Hoffmann-La Roche | Bisordi F.,Hoffmann-La Roche | And 3 more authors.
Future Oncology | Year: 2015

Identify sensitive end points and populations for similarity studies of trastuzumab and biosimilar monoclonal antibodies. Methods: We performed meta-analyses of trastuzumab clinical trials data: overall response rate (ORR) and progression-free survival in metastatic breast cancer (MBC), and total pathologic complete response (tpCR) and event-free survival in the neoadjuvant setting. Fitted models predicted the maximum loss in long-term efficacy for different similarity trial designs. Immunogenicity rates were investigated in different early breast cancer (EBC) study phases. Results: Using the same equivalence margins for ORR (MBC) and tpCR (EBC), the predicted maximum loss in long-term efficacy with a biosimilar candidate versus the reference product is smaller for tpCR than for ORR. In EBC this predicted loss could be controlled with feasible patient numbers for a typical clinical trial. Analyses suggested that a treatment-free follow-up phase is preferable for immunogenicity characterization. Conclusion: Treatment of patients with neoadjuvant breast cancer represents a sensitive setting for establishing biosimilarity of efficacy and immunogenicity. tpCR is a sensitive end point in this setting to establish biosimilarity between a biosimilar candidate and its reference product. © 2015 Future Medicine Ltd. Source


Von Minckwitz G.,GBG Forschungs GmbH
Breast Cancer | Year: 2012

New insights into neoadjuvant treatment of breast cancer have shown that the prognostic value of pathological complete response has to be rated differently according to subtype. Whereas in triple-negative, HER2-positive (non-luminal) and luminal B (HER2-negative) patients with a pCR after neoadjuvant chemotherapy show a significantly better outcome than patients without a pCR, this prognostic impact cannot be seen in patients with luminal A or luminal B (HER2-positive) tumors. Patients can therefore only avoid an initially high-risk prognosis if they have a pCR of these first mentioned subtypes. For patients with those tumors or with high Ki-67 levels in residual disease, new treatment options have to be found. Contrarily, response-guided chemotherapy, i.e., changing the regimen in case of no early response or intensification in case of early response, showed significant survival advantages only in the latter group. Strategies are currently being developed on how locoregional treatment can be reduced in patients with a pathological complete response. These aim to reduce the extent of surgery or even avoid surgery completely. © 2012 The Japanese Breast Cancer Society. Source


von Minckwitz G.,GBG Forschungs GmbH | Martin M.,Complutense University of Madrid
Annals of Oncology | Year: 2012

Neoadjuvant chemotherapy provides a means both of improving subsequent surgical intervention and of testing novel therapies or combinations. Historically, triple-negative breast cancer (TNBC) has responded well in the neoadjuvant setting, with rates of pathological complete response (pCR) commonly higher than for other breast tumour types. However, more than half of TNBC patients do not achieve a pCR and have a very poor prognosis. The lack of drug-targetable receptors on TNBC tumours has made improving the available interventions in TNBC an area of important medical need. The routine use of neoadjuvant anthracycline/taxane combinations in TNBC is currently being supplemented by ongoing investigations of their use with other types of agent. In particular, the substantial proportion of TNBC tumours associated with BRCA1 mutations is driving clinical research into the use of DNA-damaging agents such as platinums, as well as of potentiators of DNA damage such as the investigational agent iniparib and inhibitors of poly-ADP ribose polymerase such as olaparib. Tyrosine kinase receptor inhibitors and microtubule-targeting inhibitors of cell cycling are also under active investigation. The use of neoadjuvant treatment with pCR as a surrogate of overall survival will allow the rapid evaluation and comparison of these and other much-needed new treatments for TNBC. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

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