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.
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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ConclusionsThe present study demonstrates that, in plasma-derived exosomes, high  baseline CDK4 mRNA levels are associated with response to palbociclib plus hormonal therapy, while the increase in TK1 and CDK9 mRNA copies/ml is associated with clinical resistance.
Source: Breast Cancer Research and Treatment - Category: Cancer & Oncology Source Type: research
Conclusion: Despite the low pCR rate, the tumor response and BCS conversion rates after NAC of luminal HER2- breast cancer were similar to those of other subtypes. NAC has the potential benefit of reducing the size of breast cancer, thereby increasing the BCS conversion rate in luminal HER2- breast cancer. PMID: 31598341 [PubMed]
Source: Journal of Breast Cancer - Category: Cancer & Oncology Tags: J Breast Cancer Source Type: research
ConclusionOne year of trastuzumab increases the risk of cardiac events, though most consist of asymptomatic or mildly symptomatic LVEF drops. Adjuvant trastuzumab should be considered a safe treatment from a cardiac standpoint for most patients. Trastuzumab-associated cardiotoxicity is the main cause of discontinuation and further research is needed to individualize prevention and management.
Source: Breast Cancer Research and Treatment - Category: Cancer & Oncology Source Type: research
In conclusion, high-risk early stage breast cancer patients should be treated with (neo)adjuvant dose-dense anthracycline-based chemotherapy followed by paclitaxel. In the era of trastuzumab, the benefit of dose-dense chemotherapy is still unclear for patients with HER2-positive breast cancer.
Source: Current Opinion in Oncology - Category: Cancer & Oncology Tags: BREAST CANCER: Edited by Giuseppe Curigliano Source Type: research
The addition of the PARP inhibitor veliparib to carboplatin  and paclitaxel offered significant improvement to patients with HER2-negative breast cancer.
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news
In conclusion, luminal subtypes and the 21-gene RS were found to be associated with chemotherapy recommendation for HR+/HER2- patients. For patients with a discordant luminal subtype and 21-gene RS risk, the 21-gene RS score was found to be the most important factor that influences chemotherapy decision, which warrants further clinical evaluation. PMID: 31579428 [PubMed]
Source: Oncology Letters - Category: Cancer & Oncology Tags: Oncol Lett Source Type: research
Abstract Efficacy data from the KATHERINE clinical trial comparing ado-trastuzumab emtansine (T-DM1) to trastuzumab in patients with early-stage human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer with residual disease after neoadjuvant therapy (hazard ratio for invasive disease or death, 0.50; P
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
Authors: Skálová H, Hájková N, Majerová B, Bártů M, Povýšil C, Tichá I Abstract The importance of the expression profile of claudins in the molecular classification of breast cancer (BC) is currently under investigation. Claudins, together with cadherins, serve an important role in the epithelial-mesenchymal transition and influence the chemosensitivity of cancer cells. Adjuvant chemotherapy is administered following surgical resection in selected cases of BC. Previous neoadjuvant chemotherapy may change the molecular profile of a tumour and subsequent...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
In this study we aimed to examine the independent effect of baseline QoL and persistent CRT among pts with early BC.MethodsWe included data stage I-III BC pts treated with chemotherapy who were included in the CANTO prospective cohort study (NCT-01993498) from 03/2012 to 12/2014. The primary outcome was CRT defined as the presence at 3-6 months after the end of treatment, of any of the following toxicities (NCI-CTC-AE): infection, venous or arterial thrombosis, neurological G2-4, digestive G3-4 or pulmonary toxicities G3-4). Treatment deliver including chemotherapy dose reductions were also examined. The independent variab...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research
AbstractBackgroundApproximately 40% of pts with HR+, HER2 – ABC have mutations (mut) in PIK3CA, which encodes α-PI3K and leads to PI3K pathway hyperactivation and potentially ET resistance. ALP is a selective inhibitor of α-PI3K that, in combination with fulvestrant (FUL), significantly improved median progression-free survival (PFS) vs placebo + FUL i n pts with PIK3CA-mut, HR+ HER2– ABC in the phase 3 SOLAR-1 trial (11.0 vs 5.7 mo, respectively; HR 0.65; 95% CI, 0.50-0.85; P 
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research
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