Did you know that 18 pathologists only had 26% concordance on whether a HER2 IHC stain was 0 or 1+? This study, done back in 2022, collected 170 biopsies from Yale and sent the scanned slides to 18 different pathologists. Of those 170 biopsies, 92 were read as IHC 0 by at least one of the 18 pathologists. 17 of 18 pathologists agreed on 24/92 of these cases (26%), meaning that you have a good chance of turning an IHC 0 patient into an IHC 1 patient simply by sending the biopsy slides to another pathologist. That would qualify a breast cancer patient for fam-trastuzumab deruxtecan - no repeat biopsy needed! Differences in HER2 testing before and after fixation have also been noted in our national guidelines (https://lnkd.in/eA8qKshR). This is why central HER2 testing is very important in studies that look at HER2-directed agents, especially in "low" and "ultralow" patients, because it eliminates variation between institutions. New HER2 testing methodologies are needed (and being studied), but then the question is, how would that impact fam-trastuzumab deruxtecan? The current FDA approval may need to be re-validated for any new testing methodology, not to mention all the clinical trials that currently use HER2 IHC testing. #breastcancer #enhertu https://lnkd.in/eJh5XeCA
Ming-Hei Tai, PharmD, BCOP’s Post
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This content is for US audiences only. The relentless pace of oncology innovation never slows down – even after AstraZeneca’s thrilling ASCO appearance just a few weeks ago. Today, we announced positive high-level results from the NIAGARA Phase 3 study with our IO medicine demonstrating clinically meaningful and statistically significant benefits in muscle-invasive bladder cancer (MIBC). Administering our IO therapy plus chemo as neoadjuvant treatment, then as adjuvant monotherapy after surgery led to improved event-free survival in patients with MIBC. This cancer is hard to treat and likely to spread, so we see the promise for a more effective options in this patient population. Pushing the boundaries of science has allowed us to begin realizing the potential of IO treatments in new tumor areas like bladder cancer. And today’s positive readout means that we’re starting to see the impact on the patients we serve. We look forward to sharing the full results of the NIAGARA trial at a future medical conference. Read more about the announcement: https://bit.ly/4eFKaW2 #USOnly #AstraZenecaUS
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🚀 Exciting Advancement in the Liquid Biopsy Market! 🚀 Earlier this month the FDA has approved AKEEGA® (niraparib and abiraterone acetate) specifically for patients with BRCA-positive metastatic castration-resistant prostate cancer. This approval is coupled with the use of FoundationOne®Liquid CDx, a revolutionary liquid biopsy test from Foundation Medicine, which now enables identification of suitable patients for AKEEGA®. This cutting-edge liquid biopsy offers a less invasive alternative to traditional tissue biopsies, making the testing process more comfortable and accessible for patients. Key Highlights: FDA Approval Date: July 1, 2024 Indication: BRCA-positive metastatic castration-resistant prostate cancer Diagnostic Tool: FoundationOne®Liquid CDx liquid biopsy test This advancement underscores the significant strides we are making in precision medicine and personalized treatment plans. The integration of AKEEGA® with FoundationOne®Liquid CDx marks a pivotal step forward in providing tailored, effective treatments while reducing the physical burden on patients. #Oncology #FDAApproval #LiquidBiopsy #CancerResearch #PrecisionMedicine #FoundationMedicine #HealthcareInnovation #AKEEGA #ProstateCancer
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The #ESMO2024 author's list is now available and this is my list of sessions not to be missed in #sarcoma. 🔸Desmoid-type Fibromatosis: To treat or not to treat? Bernd Kasper Alessandro Gronchi 🔸New developments in the treatment of bone sarcomas Sandra Strauss 🔸 Landmark trials in immunotherapy Breelyn Wilky, MD 🔸Landmark trials in bone and joint sarcomas (incl. LPS/LMS) Silvia Stacchiotti 🔸New Developments in the treatment of soft tissue sarcomas Kjetil Boye 🔸Landmark Trials in soft tissue sarcoma Robin Jones 🔸 1726MO - Updated efficacy and safety of botensilimab plus balstilimab in patients with refractory metastatic sarcoma from an expanded phase 1 study Breelyn Wilky, MD 🔸1718O - EREMISS Trial: A double-blind placebo-controlled randomized trial assessing efficacy/safety of Regorafenib as maintenance therapy after 1st line doxorubicin-based chemotherapy in advanced soft-tissue sarcoma patients Nicolas Penel 🔸 1720MO - A phase II study of palbociclib combined with the PD-1 inhibitor retifanlimab in patients with advanced dedifferentiated liposarcoma Evan Rosenbaum #ESMO2024 #sarcoma #oncology #sarcomaresearch ESMO - European Society for Medical Oncology OncoDaily
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Online! 🌈 Identification of #circulatingtumorcells captured by the FDA-cleared Parsortix® PC1 system from the peripheral blood of metastatic #breastcancer patients using immunofluorescence and cytopathological evaluations ---------- Circulating Tumor Cells (CTCs) may serve as a non-invasive source of tumor material to investigate an individual’s disease in real-time. The Parsortix® PC1 System, the first FDA-cleared medical device for the capture and harvest of CTCs from peripheral blood of metastatic breast cancer (MBC) patients for use in subsequent user-validated downstream analyses, enables the epitope-independent capture of CTCs with diverse phenotypes based on cell size and deformability. The aim of this study by Mariacristina Ciccioli et al was to determine the proportion of MBC patients and self-declared female healthy volunteers (HVs) that had CTCs identified using immunofluorescence (IF) or Wright-Giemsa (WG) staining. Look here👇 https://lnkd.in/daPqxtJW #LiquidBiopsy IFO - Istituto Nazionale Tumori Regina Elena - Istituto Dermatologico San Gallicano
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The authors analyzed HER2 expression of ≃1000 breast tumors before and after neoadjuvant treatment, finding that nearly 30% changed HER2 status after treatment. This led to worse prognosis if a HER2+ tumor became HER2- after neoadjuvant treatment. Reassuring to see consistency with similar prior analyses. Clinical trials testing new anti-HER2 drugs (particularly ADCs) in the early setting will need to take into account the extremely high rate of HER2 changes. #personaloncologia #oncologiadeprecisão #oncologia #câncerdemama #her2 https://lnkd.in/dxzb_kgK
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This post is intended for a US audience. Following AstraZeneca's first FDA approval of #immunotherapy in endometrial cancer last week, today, we announced another positive milestone, with high-level results from the NIAGARA Phase 3 study for patients with muscle-invasive #BladderCancer (#MIBC). Patients who received our immunotherapy plus chemo as neoadjuvant treatment, and later as adjuvant monotherapy after surgery, saw a clinically meaningful and statistically significant improvement in event-free survival. This is the first immunotherapy regimen before and after surgery to extend patient survival in bladder cancer. We know that genitourinary cancers are challenging to treat and many patients continue to be underserved, so we are committed to advancing the science that will give these individuals more options and a better future. Today’s positive readout in bladder cancer shows how we’re driving innovation in oncology and unlocking what science can do for patients in this setting. Read more about the announcement: https://bit.ly/4eFKaW2 #USOnly #AstraZenecaUS
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You can't have one without the other… To me, theranostics is one of the most impressive and intriguing medical applications. As flashy and "hip" as the therapeutic may be -- Ac-225's alphas or Lu-177's betas -- this administration is nothing without diagnostic procedures. Therefore, it would only make sense to advance the diagnostic processes in conjunction with the therapeutic processes. Check out this study by Regina Munter-Young et al. on how FES-PET scans can drastically shape the diagnostic funnel for women with Estrogen Receptor + Breast Cancer (~70% of all diagnoses of breast cancer). In comparison with biopsies, FDG-PET scans, and immunohistochemistry, FES-PET has the likelihood to not only be more sensitive but also save a lot of unnecessary expenditures -- more than $140 million! Read more about it here: https://lnkd.in/erxR5AaA
Clinical and economic outcomes of adding [18F]FES PET/CT in estrogen receptor status identification in metastatic and recurrent breast cancer in the US
journals.plos.org
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Did you know that Superficial Radio Therapy (SRT) is a powerful treatment option for non-melanoma skin cancer including basal cell and squamous cell carcinoma? Superficial Radio Therapy (SRT) technology provides versatility beyond traditional surgical techniques to fit your unique needs. Ask your dermatologist if Superficial Radio Therapy (SRT) is an option for your skin cancer treatment. #nonmelanomaskincancer #sensus #SRT
Aug 24, Post 3
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Breaking #cryoablation news! The final #ICE3 trial results on cryoablation of small, low-risk #breastcancer have been published in a renowned peer-review journal. Read our press release for more info and to find a link to the open-access article.
IceCure Medical’s ICE3 5-Year Trial Results Published in the Peer Reviewed Annals of Surgical Oncology Journal: ProSense® #Cryoablation Without Excision for Early-Stage, Low-Risk #BreastCancer Demonstrates 96.3% Recurrence Free Rate ❄ Publication comes ahead of the FDA Advisory Panel Meeting for Marketing Authorization of ProSense® in Early-Stage Low Risk Breast Cancer scheduled for November 7, 2024 ❄96.3% recurrence free rate for women treated with ProSense® cryoablation and endocrine therapy; 100% of patients and treating physicians were satisfied with the cosmetic outcome ❄Lead study author, Dr. Richard Fine, is an ICE3 investigator and winner of the 2024 American Society of Breast Surgeons’ Scientific Impact Award for his presentation of the ICE3 trial data Read the full #pressrelease for details and link to the open access article: https://lnkd.in/epRcXvrW Eyal Shamir Ronen Tsimerman Tlalit Bussi Tel-Tzure Shay Levav Naum Muchnik Galit (Bar) Malik Merav Nir Dotan Shad Good Hilla Debby Rotem Edgar Ronit Lipson Stav Edgar Kenneth Tomkovich MD
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