FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers
Roche today announced that the US Food and Drug Administration (FDA) has approved Herceptin Hylecta ™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metast atic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease.
AbstractIntroductionPrediction models are useful to guide decision making. Our goal was to compare three published nomograms predicting axillary response to neoadjuvant chemotherapy (NAC), clinically node-positive breast cancer.MethodsPatients with cT1 –T4, cN1–N3 breast cancer treated with NAC and surgery from 2008 to 2019 were reviewed. The predicted probability of pathologic node-negative (ypN0) status was estimated for each nomogram. Area under the curve (AUC) was compared across models, overall and by biologic subtype.ResultsOf 581 patients, 253 (43.5%) were ypN0. ypN0 status varied by subtype: 23.9% for e...
We reported nodal and breast downstaging rates with NET, and compared axillary response rates following NET and neoadjuvant chemotherapy (NAC).MethodsConsecutive stage I –III breast cancer patients treated with NET and surgery from January 2009 to December 2019 were identified from a prospectively maintained database. Nodal pCR rates were compared between biopsy-proven node-positive patients treated with NET, and HR+/HER2- patients treated with NAC from November 2 013 to July 2019.Results127 cancers treated with NET and 338 with NAC were included. NET recipients were older, more likely to have lobular and lower-grade...
CONCLUSION: The probability of nodal positivity after neoadjuvant chemotherapy was less than 3 per cent in patients with TNBC or HER2-positive disease who achieved a breast rCR on MRI. These patients could be included in trials investigating the omission of sentinel node biopsy after neoadjuvant chemotherapy. PMID: 33031572 [PubMed - as supplied by publisher]
CONCLUSIONS: The newly developed and validated NGS-based multigene assay can predict the distant recurrence risk in ER-positive, HER2-negative breast cancer. PMID: 33028590 [PubMed - as supplied by publisher]
Conditions: HER2-negative Breast Cancer; Neoadjuvant Chemotherapy Interventions: Drug: Epirubicin; Drug: Cyclophosphamid; Drug: Docetaxel; Drug: Paclitaxel Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
ConclusionsThis retrospective study demonstrated that age at diagnosis was independently associated with IBTR-free survival. Special caution is needed when clinical trials analyzing omission of breast surgery after NAC are enrolling younger patients (UMIN-CTR No. UMIN000037067).
Abstract Breast cancer is the second most common cancer in the world based on incidence, reaching more than 2 million new cases in 2018, while continuing to increase. Invasive ductal carcinoma is the most common type of this cancer, making up approximately 70-80% of all breast cancer diagnoses. In particular, the type of breast cancer overexpressing human epidermal growth factor receptor 2 (HER2) has potential of strong proliferation, migration and invasion and early treatment is necessary. The authors identified and studied a single patient displaying complete therapeutic resistance to monoclonal anti-HER2 antibo...
Background: Breast cancer molecular subtypes (Luminal A and B, Triple negative, Her2-enriched) together with histology-based parameters (i.e. grading) are pivotal in understanding how tumor response is related to relapse risk and would help clinicians make decisions about additional treatment options after neoadjuvant chemotherapy (NCT). Different methods can be used to assess ER/PR status (Allred score, H score, semiquantitative score). Mitotic index (MI) can be performed on conventional histology or by using immunohistochemistry for phosphohistone H3 (PHH3).
Background: PIK3CA mutations are known to be associated with a reduced pathological complete response (pCR) rate in HER2+ breast cancer, but the relationship between PIK3CA mutations and the therapeutic effects of neoadjuvant chemotherapy in hormone receptor (HR) -positive or HR −/HER2− breast cancer is not clear. We herein analyzed PIK3CA mutations in primary breast cancers of patients who had undergone neoadjuvant chemotherapy. We also investigated the associations of these mutations with the therapeutic effects of neoadjuvant chemotherapy.