CHMP recommends EU approval of Roche ’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment

Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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Conclusions: NAC may have an adverse effect on breast cancer prognosis among patients with grade 2 tumors. These patients need not receive NAC, except when the patient has a strong desire for breast conservation, and this is unlikely to be achieved in the absence of NAC.
Source: Journal of Cancer - Category: Cancer & Oncology Authors: Tags: Research Paper Source Type: research
CONCLUSION: Application of the subtype-guided 18F-FDG PET/CT could accurately predict nodal response and aid in tailoring axillary surgery among patients with node-positive breast cancer after NAC, which includes identifying candidates appropriate for TAD or directly proceeding to ALND. This approach might help to avoid false-negative events in TAD. IMPLICATIONS FOR PRACTICE: This feasibility study showed that 18[F]-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) could accurately predict nodal response after neoadjuvant chemotherapy (NAC) among patients with breast cancer with in...
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Oncologist Source Type: research
Conclusion.Pathological response in locally advanced tumors is related to the molecular subtype of breast cancer, finding higher pCR rates in pure HER2 and triple‐negative tumors. A direct relationship was found between disease recurrences and the pathological response, evidencing greater tumor recurrence in patients who did not respond to NACT (Chevallier 3 and 4). EFS and OS were greater in patients with pCR, with statistical significance only in triple‐negative tumors.Implications for Practice.This research article is of scientific interest, because it describes the clinical and pathological features and analyzes th...
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Breast Cancer, Global Health and Cancer Source Type: research
Authors: Abduyev Z, Altundag K PMID: 31786900 [PubMed - in process]
Source: Journal of B.U.ON. - Category: Cancer & Oncology Tags: J BUON Source Type: research
AbstractPurpose of ReviewThis review will discuss recent important trials for the treatment of HER2-positive breast cancer, emphasize ongoing areas of development, and highlight areas of unmet need.Recent FindingsAdvances for early-stage treatment have been driven by key clinical trials with pertuzumab, neratinib, and TDM-1. In the adjuvant setting, dual HER2 targeting with trastuzumab and pertuzumab has demonstrated modest improvement in disease-free survival. Neratinib also showed modest benefit in the extended adjuvant setting after prior trastuzumab. Finally, for patients who did not achieve pathologic complete respons...
Source: Current Breast Cancer Reports - Category: Cancer & Oncology Source Type: research
Authors: Takeshita T, Asaoka M, Katsuta E, Photiadis SJ, Narayanan S, Yan L, Takabe K Abstract Polo-like kinase 1 (PLK1), the most investigated member of the PLK family, plays a pivotal role both in the p53-mediated regulation of DNA damage repair and in mitosis, especially in the G2/M phase. However, the evidence on the clinical and prognostic relevance of PLK1 is limited to triple negative subtype among breast cancer (BC). We hypothesized that high expression of PLK1 is associated with TP53 inactivation, DNA repair deficiency, and worse prognosis in ER positive in BC in a large-scale cohort should clarify its cli...
Source: American Journal of Translational Research - Category: Research Tags: Am J Transl Res Source Type: research
The objective of this study is to determine factors related with axillary downstaging and complete pathological response (CPR), and how CPR influences the decision to perform bilateral mastectomy with immediate reduction. METHODS: A retrospective analysis of breast cancer patients who had undergone neoadjuvant chemotherapy and bilateral mastectomy with immediate reduction between 2000-2018 was performed. Two groups were compared:1) CPR and 2) non-CPR. Descriptive and comparative statistical analyses are provided. RESULTS: 69 patients; 26 (37.68%) reached CPR and 43 (62.32%) non-CPR. Median follow-up of 45.3 month...
Source: Cirugia eEspanola - Category: Surgery Authors: Tags: Cir Esp Source Type: research
AbstractBackgroundCharacterization of breast cancer phenotypes has improved our ability to predict breast cancer behavior. Triple-negative (TN) breast cancers have higher and earlier rates of distant events. It has been suggested that this behavior necessitates treating TNs faster than others, including use of neoadjuvant chemotherapy (NACT) if time to surgery is not rapid.MethodsA review of women diagnosed with non-inflammatory, invasive breast cancer was conducted using the National Cancer Database for patients not having NACT, diagnosed between 2010 and 2014. Changes in overall survival due to delay were measured by phe...
Source: Annals of Surgical Oncology - Category: Cancer & Oncology Source Type: research
CONCLUSIONS: We have identified the TAF/FGF5/FGFR2/c-Src/HER2 axis as an escape pathway responsible for HER2 targeted therapies resistance in breast cancer which can be reversed by FGFR inhibitors. PMID: 31699826 [PubMed - as supplied by publisher]
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
CONCLUSION: Most mastectomies are advised for large tumour to breast size ratio, but there is an inconsistency in the use of NST to downsize tumours in patients with large ER+ or HER2+ cancers. The application of standardized recommendations for NST could reduce the number of mastectomies advised by MDTs. PMID: 31691270 [PubMed - as supplied by publisher]
Source: The British Journal of Surgery - Category: Surgery Authors: Tags: Br J Surg Source Type: research
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