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  • buttonsmachine
    buttonsmachine Member Posts: 339
    edited August 2020

    Lumpie, thank you for all your posts. I hope the liquid biopsy becomes more mainstream soon.

    As for milk consumption and breast cancer risk, I hope this topic gets more investigation. As BSandra pointed out, milk has been a staple food source for many cultures for hundreds of years. However, modern milk production is not done in the same way it was done historically, and that could be a factor too.

    I am not a huge consumer of dairy, but I do have a little bit almost every day. I use a small amount of milk in my coffee, and I find that plain yogurt is sometimes helpful for my stomach during chemo and Ibrance.

  • Lumpie
    Lumpie Member Posts: 1,553
    edited August 2020

    buttonsmachine: I had wondered about hormones, antibiotics... anything that might be added to the situation. Another forum I read raised the issue of BLV (Bovine leukemia virus) DNA. This was something I knew nothing about. If you want to read more on the topic, I will paste a citation below.

    Bovine leukemia virus DNA associated with breast cancer in women from South Brazil

    Nature - Published: 27 February 2019

    https://www.nature.com/articles/s41598-019-39834-7?fbclid=IwAR2thHnEPjDBeNCBIUbizQe23AsWvcmHoEJOb91HYaLLH1w_4YUijaey18c

    Schwingel, D., Andreolla, A.P., Erpen, L.M.S. et al. Bovine leukemia virus DNA associated with breast cancer in women from South Brazil. Sci Rep 9, 2949 (2019). https://doi.org/10.1038/s41598-019-39834-7


  • BlueGirlRedState
    BlueGirlRedState Member Posts: 900
    edited August 2020

    Lumpie, thank you for your posts on dairy. Very disturbing. I consume dairy daily, milk, unflavored yogurt, cheese, and a wee bit of ice-cream. Maybe organic is not enough. Nutrition is so hard to pin down, advice changes all the time, lots of disagreement. Was it something else in their lifestyle ? At one time eggs were considered evil incarnate because of cholesteral, but now it seems like they have been redeemed as far as cholesterol is concerned.

  • buttonsmachine
    buttonsmachine Member Posts: 339
    edited August 2020

    Wow, the bovine leukemia connection just goes to show how far-reaching cause and effect can be - like the butterfly effect I suppose. That is definitely concerning.

    I had another thought: is it possible that populations who traditionally consume more milk products are also at statistically higher risk for breast cancer anyway?

    In statistics, we must always remember that "correlation is not causation" as they say.

    I don't know the answers, but this is an interesting topic.

  • moth
    moth Member Posts: 3,293
    edited August 2020
    This specific study was talking about north American women.

    & Actually, I believe we have not been consuming tons of cow milk for generations. Before refrigeration, milk spoiled quickly and thus our predecessors consumed dairy as fermented buttermilk, kefir or cheese. Even being able to consume milk & other dairy after weaning from human milk is geographically limited & linked to European genetic populations - most people become lactose intolerant around age 6 yr.

    Also, all mammals produce milk to feed their babies so excess production didn't become common until humans started preferentially breeding animals for it.

    The study mentioned here was done on north American women. I didn't see a race breakdown at first glance - will go have another look later.

    Bias disclosure - ethical vegan; human lactation consultant :)
  • dread2020
    dread2020 Member Posts: 36
    edited August 2020

    Re the milk study, I take some comfort in this: "No important associations were noted with cheese and yogurt."

    Consistent with moth's point about how we have evolved to consume dairy, and great news for Olma61.


  • Lumpie
    Lumpie Member Posts: 1,553
    edited August 2020

    Bovine leukemia virus DNA associated with breast cancer in women from South Brazil

    Nature, Scientific Reports, Published: 27 February 2019

    Abstract

    Breast cancer is a neoplastic condition with a high morbidity and mortality amongst women worldwide. Recent data linking bovine leukemia virus (BLV) with breast cancer has been contested already. Our study investigated the presence of BLV genome in healthy (n = 72) and cancerous (n = 72) paraffin-embedded samples of breast tissues from women in south Brazil. BLV DNA was found most frequently (30.5%) in breast cancer tissue than in healthy breast (13.9%) (Odds ratio = 2.73; confidence interval = 1.18–6.29; p = 0.027). In contrast, antibodies to BLV were found in a very small percentage of healthy blood donors. There was no association between BLV DNA and other tumor prognostic biological markers such as hormonal receptors, HER2 oncoprotein, proliferation index, metastasis in sentinels lymph nodes, and tumor grade and size. Our findings suggest that BLV should be considered a potential predisposing factor to breast cancer in women.

    https://www.nature.com/articles/s41598-019-39834-7?fbclid=IwAR2thHnEPjDBeNCBIUbizQe23AsWvcmHoEJOb91HYaLLH1w_4YUijaey18c#citeas

    Schwingel, D., Andreolla, A.P., Erpen, L.M.S. et al. Bovine leukemia virus DNA associated with breast cancer in women from South Brazil. Sci Rep 9, 2949 (2019). https://doi.org/10.1038/s41598-019-39834-7

    {Posting this abstract for those disinclined or unable to click through. Full article is open access. I didn't find the reference to yogurt or cheese, but if those are not implicated, I am relieved!}

  • Lumpie
    Lumpie Member Posts: 1,553
    edited August 2020

    A Roadmap for Developing Study Endpoints in Real-World Settings

    August 28, 2020

    EXECUTIVE SUMMARY

    With growing interest in using real-world data (RWD) and real-world evidence (RWE) to support regulatory decision-making, stakeholders are considering how to develop robust real-world study endpoints to evaluate medical product effectiveness when fit-for-use data and valid methods are available. Despite extensive literature and guidance for developing clinical trial endpoints, few resources support real-world endpoint development. Some principles can be carried over from the clinical trial setting, but differences in patient populations, care settings, and data collection in the real-world setting result in unique considerations for endpoint development. Additionally, studies conducted in the realworld setting have the potential to capture outcomes that are more relevant to patients than outcomes captured in clinical trials. This paper explores how key differences in study settings influence a researcher's considerations for developing study endpoints in the real world. First, because stakeholders involved in the realworld endpoint development process have multidisciplinary backgrounds, this paper details the current landscape of endpoint development, provides standardized definitions of key concepts, and introduces existing frameworks. Second, this paper presents a roadmap for endpoint development, beginning with selection of a concept of interest and study outcome that reflect the research question. Within this roadmap, the paper details how real-world settings impact selection of a concept of interest, outcome, and endpoint components, raising challenges for researchers to consider when developing real-world endpoints. Third, this paper addresses key considerations for the validation of real-world endpoints. Finally, this paper examines opportunities to enhance the use of real-world endpoints through stakeholder collaboration.

    The paper contains disclosures about drug company funding of and participation in the preparation of the paper.

    The full paper is available here without charge (but you may have to register): https://healthpolicy.duke.edu/sites/default/files/2020-08/Real-World%20Endpoints.pdf



  • karenfizedbo15
    karenfizedbo15 Member Posts: 719
    edited September 2020

    Came across this article - it summarises MBC and some of the current clinical trials and may have already been posted here.

    https://www.oncozine.com/new-therapies-may-offer-hope-for-patients-with-metastatic-breast-cancer/


  • morrigan2575
    morrigan2575 Member Posts: 805
    edited September 2020
    Very early study with a long ways to go but, it's very interesting/cool none the less.

    https://www.abc.net.au/news/2020-09-01/new-aus-research-finds-honey-bee-venom-kills-breast-cancer-cells/12618064
  • norcals
    norcals Member Posts: 214
    edited September 2020

    Morrison,

    Thanks for the article. Very interesting indeed. Hopefully, they get it to the human clinical trials stage soon

  • BevJen
    BevJen Member Posts: 2,341
    edited September 2020

    Here's a wild one -- talking about the venom of the honey bee wiping out breast cancer cells. The ingredient that does is can be synthetically created, so perhaps some drug company will jump on this.

    http://dx.doi.org/10.1038/s41698-020-00129-0


  • bsandra
    bsandra Member Posts: 1,031
    edited September 2020

    Dear Bev, just read the article - honeybees saving humans - I like this idea:)> Just like Pacific yew tree (taxanes), another organic chemotherapy! Saulius

  • BevJen
    BevJen Member Posts: 2,341
    edited September 2020

    Saulius,

    Yes, to me, this honey bee stuff sounds very promising -- and also makes me wonder why the heck we haven't found a "cure" for cancer. My pessimistic self says it is because lots of things could "cure" cancer, or at least some types of cancer. But they are not commercially viable, meaning that some company can't make a lot of money in developing it. The good thing about the honey bee story is that the thing that they take from the honey bee can be synthetically created -- so -- maybe commercially viable?

    I did have to laugh when I read the article, though. I am seriously allergic to certain bee venoms, and in fact, years ago, had to go through treatments to desensitize me to bee stings because it could be life threatening for me. However, honeybees were not among my list of bees and wasps to which I would react, so bring on the honeybees!

  • Lumpie
    Lumpie Member Posts: 1,553
    edited September 2020

    Aug 30, 2020

    Clinical implications of HER2 mRNA expression and intrinsic subtype in refractory HER2-positive metastatic breast cancer treated with pan-HER inhibitor, poziotinib

    Breast Cancer Research And Treatment

    Abstract

    We explored clinical implication of intrinsic molecular subtype in human epidermal growth factor receptor 2 (HER2) + metastatic breast cancer (BC) with pan-HER inhibitor from a phase II clinical trial of poziotinib in refractory HER2+BC patients. For this translational research correlated with phase II clinical trial, we performed an nCounter expression assay, using gene panel including 50 genes for PAM50 prediction and targeted deep sequencing. From 106 participants, we obtained 97 tumor tissues and analyzed gene expression in 91 of these samples. Of 91 HER2+BCs, 40 (44.0%) were HER2-enriched (E) intrinsic molecular subtype, 17 (18.7%) of Luminal A, 16 (17.6%) of Basal-like, 14 (15.4%) of Luminal B and 4 (4.4%) of Normal-like. HER2-E subtype was associated with hormone receptor negativity (odds ratio [OR] 2.93; p = 0.019), 3 + of HER2 immunohistochemistry(IHC) (OR 5.64; p = 0.001), high mRNA expression of HER2 (OR 14.43; p = 0.001) and copy number(CN) amplification of HER2 (OR 12.80; p = 0.005). In genetic alterations, alteration was more frequently observed in HER2-E subtype (OR 3.84; p = 0.022) but there was no association between PIK3CA alteration and HER2-E subtype (p = 0.655). In terms of drug efficacy, high mRNA expression of HER2 was the most powerful predictor of poziotinib response (median progression-free survival [PFS): 4.63 months [high] vs. 2.56 [low]; p < .001). In a combination prediction model, median PFS of intrinsic subtypes except Her2-E with high HER2 mRNA expression without PIK3CA genetic alteration was 6.83 months and that of the remaining group was 1.74 months (p < .001). HER2-E subtype was associated with hormone receptor status, HER2 IHC, CN and mRNA expression and TP53 mutation. In survival analysis, the information of level of HER2 mRNA expression, intrinsic molecular subtype and PI3K pathway alteration would be independent predictors to poziotinib treatment. ClinicalTrials.gov identifier: NCT02418689.

    https://www.meta.org/papers/clinical-implications-of-her2-mrna-expression-and/32860168?utm_medium=email&utm_source=transactional&utm_campaign=digests%40meta.org

    DOI: 10.1007/S10549-020-05891-0


  • Lumpie
    Lumpie Member Posts: 1,553
    edited September 2020

    Published in Oncology

    September 01, 2020

    Surgery at Primary and Metastatic Sites for Stage IV Breast Cancer

    • The authors of this National Cancer Database study of 54,871 patients with stage IV breast cancer found longer overall survival to be associated with lumpectomy or mastectomy compared with no surgery. There was also a survival benefit associated with liver, lung, and brain metastasectomy.
    • These findings add to previous retrospective studies suggesting improved survival with surgical management in the setting of metastatic breast cancer but are in contrast to various prospective studies which have failed to demonstrate a survival benefit with the addition of local management to systemic treatment, including the updated results from E2108 presented at ASCO 2020.
    {Access to full article requires a fee or subscription.}
  • [Deleted User]
    [Deleted User] Member Posts: 760
    edited September 2020

    Anyone hear of this drug that should perform better than fulvestrant?

    Arvinas is developing ARV-471, an oral estrogen receptor (ER)-targeting PROTAC® protein degrader for the potential treatment of patients with locally advanced or metastatic ER positive / HER2 negative breast cancer.

    Trial NCT04072952
    I am going to check it out when I go to Sarah Cannon next week


    Dee

  • ShetlandPony
    ShetlandPony Member Posts: 3,063
    edited September 2020

    Lumpie, in the article about surgery for stage iv, do they mean stage iv in the technical sense of de novo stage iv, or as many use the term to mean metastatic whether de novo or distant recurrence? (I have not subscribed so could not access the articles.)

  • ShetlandPony
    ShetlandPony Member Posts: 3,063
    edited September 2020

    Dee, I see that is a phase I study with ARV-471. On the Ibrance thread Cure-ious recently posted about the current status of oral SERD trials. Apparently there are only three that are beyond phase 1 right now.

  • Lumpie
    Lumpie Member Posts: 1,553
    edited September 2020

    ShetlandPony: Good question. The full article may go more explicitly into methodology. Reviewing the info available to us, it says they were only looking at women classified as stage 4 in the "National Cancer Database," by which I assume that they mean the SEER database in the US. (The authors are all associated with the Cleveland Clinic.) We all know that there are problems with classification in SEER. (Link below to the MBCN discussion of these issues.) Since the database only counts those diagnosed de novo's as stage 4, it would seem that they are only looking at the case histories of de novo diagnoses for this study. It would be interesting to parse more complex histories to try to identify patterns. Someday, someone will take on that project.

    http://mbcn.org/statistics-for-metastatic-breast-cancer/

  • ShetlandPony
    ShetlandPony Member Posts: 3,063
    edited September 2020

    Thanks, Lumpie. That’s what I figured.

  • lilych
    lilych Member Posts: 176
    edited September 2020

    Harry Perkins Institute of Medical Research study finds honeybee venom rapidly kills aggressive breast cancer cells:

    https://www.abc.net.au/news/2020-09-01/new-aus-research-finds-honey-bee-venom-kills-breast-cancer-cells/12618064

  • bsandra
    bsandra Member Posts: 1,031
    edited September 2020

    Dear Bev, I am not allergic to bees but I love nature, spend lot's of time by lakes and get stung once in a while, so... it hurts:) Cannot imagine being stung by 100 bees but if that'd be a cure for C, I'd take it:) Sure the are looking into commercializing this compound (melittin), and therefore it will take years to get it to the market if all stars align:/ Saulius

  • moth
    moth Member Posts: 3,293
    edited September 2020
    For HER2+/ERBB2- MBC adding Keytruda/pembrolizumab to eribulin doesn't improve PFS

    "The results do not support the use of pembrolizumab in combination with eribulin for patients with hormone receptor–positive/ERBB2-negative metastatic breast cancer, independent of programmed cell death ligand 1 status."

    https://jamanetwork.com/journals/jamaoncology/article-abstract/2769923?utm_source=twitter&utm_campaign=content-shareicons&utm_content=article_engagement&utm_medium=social&utm_term=090320#.X1E_Ap9GuxA.twitter
  • Lumpie
    Lumpie Member Posts: 1,553
    edited September 2020

    September 03, 2020

    Blood test detects common cancer types 4 years before current screening methods

    A novel blood-based assay demonstrated the ability to detect five cancer types up to 4 years earlier than current screening methods, according to study results published in Nature Communications.

    The noninvasive PanSeer test (Singlera Genomics), which is based on DNA methylation, detected stomach, esophageal, colorectal, lung and liver cancer in 91% of asymptomatic individuals who were diagnosed with cancer 1 to 4 years later using standard detection methods.

    "The ultimate goal would be performing blood tests like this routinely during annual health checkups,"..."But the immediate focus is to test people at higher risk, based on family history, age or other known risk factors."

    ...the current study, researchers analyzed plasma samples of 605 asymptomatic individuals, of whom 191 were diagnosed with stomach, esophageal, colorectal, lung or liver cancer up to 4 years after plasma collection.

    With a specificity of 96% (95% CI, 93-98), the test detected cancer accurately in 88% (95% CI, 80-93) of post-diagnosis samples....it detected cancer in 95% (95% CI, 89-98) of asymptomatic individuals who were later diagnosed with cancer, although researchers noted that this result needs to be confirmed in larger studies.

    we hope to proceed with a large prospective study of healthy individuals to determine if noninvasive cancer screening can reduce cancer deaths in a cost-effective manner."

    {Not BC specific, but more encouraging news about blood-based assays.}

    https://www.healio.com/news/hematology-oncology/20...


  • Lumpie
    Lumpie Member Posts: 1,553
    edited September 2020

    I Was Right — How one doctor learned the importance of advocacy

    Podcast {audio} episode called Infectious and {section on patient advocacy} starts at 12:10 on the podcast. It's from Brita Lundberg, MD, patient advocate and founder of Lundberg Health Associates in Boston.

    https://www.medpagetoday.com/podcasts/anamnesis/87...

    {Really interesting commentary - by a physician - on the importance of patient advocacy (she was advocating for her mom). Not BC specific. Relevant segment is about 15 minutes long. No charge to access but you may need to subscribe/sign in.}

  • Lumpie
    Lumpie Member Posts: 1,553
    edited September 2020

    Oncologists Were Paid To Prescribe Generic Chemotherapy (Here's Why It Didn't Change A Thing)

    Forbes.com Aug 27, 2020,07:00am EDT

    Peter Ubel (@peterubel) writes in Forbes about the challenges of increasing use of generic drugs, which could save cancer patients' out-of-pocket costs, because of incentives in the payment system. Even when an insurer offered an additional payment to oncologists to offset the loss of revenue of prescribing a generic drug, compared to a name-brand drug, the program failed to increase generic prescribing.

    For many medicines... oncologists receive a 6% markup, meaning when they infuse a patient with a $10,000 monthly course of chemotherapy, their practice yields an extra $600. By contrast, if the practice treated that patient with a generic chemotherapy, they'd be out most of that extra money.

    "We shouldn't simultaneously burden patients with high out-of-pocket costs while incentivizing physicians to prescribe unnecessarily expensive medications."

    {Note on author perspective: In his book, Sick to Debt, Peter Ubel argues for a middle path between a market-based and a completely free system, Ubel envisions more transparent, smarter healthcare plans that tie the prices of treatments to the value they provide so that people can afford to receive the care they deserve.}

    https://www.forbes.com/sites/peterubel/2020/08/27/...

    {Obviously, this pertains to the U.S. only. I doubt other developed countries allow such perverse incentive schemes. But please let us know if yours does. In the meantime, I'd like more info on that "completely free" system.}

  • morrigan2575
    morrigan2575 Member Posts: 805
    edited September 2020
    Our health care system is so screwed up 😡
  • Lumpie
    Lumpie Member Posts: 1,553
    edited September 2020

    morrigan_257: I concur! Sad.

  • Lumpie
    Lumpie Member Posts: 1,553
    edited September 2020

    ASCO 2020: Immune Profiling of Tumor Microenvironment Predicts Overall Survival in Breast Cancer Brain Metastases

    The findings may help identify which patients could potentially benefit from immunotherapy

    September 01, 2020

    "Brain metastases represent one of the major unmet needs in metastatic breast cancer," lead author Gaia Griguolo, MD, of the University of Padova in Italy, told Elsevier's PracticeUpdate. "Brain involvement is frequent in breast cancer and usually carries a poor prognosis. Even if the central nervous system has been traditionally considered an immune-privileged sanctuary for cancers, recent data from patients with other solid tumors treated with immunotherapy have challenged this dogma by showing intracranial activity of immunotherapy agents."

    Dr. Griguolo went on to explain that an "understanding of the biological processes, and more specifically immune interactions, sustaining breast cancer brain metastases is still limited, as only a small number of studies have tested the role of the immune system in brain metastasis, and the majority of them included patients with a variety of solid tumors, not just breast cancer. Our effort [was] to generate biological knowledge regarding the immune microenvironment of brain metastases, … in order to understand if these immunological interactions are or are not subtype-specific, and to identify potential biomarkers."

    Of the 60 brain metastases samples included in the study, 18 (31.0%) were classified as triple-negative breast cancer, 19 (32.8%) were HR-positive/HER2-negative, and 21 (36.2%) were HER2-positive.

    After a median follow-up of 42.6 months, 35 patients (58.3%) had died. Median OS was 33.4 months (95% confidence interval 22.2–not reached). Breast cancer subtype was the only clinical variable associated with OS. Median OS was 9.4 months for triple-negative breast cancer patients, 33.4 months for HR-positive/HER2-negative patients, and 53.0 months for HER2-positive patients (P = .01).

    ...we have identified two immune characteristics with relevant prognostic impact: CD4/CD8 and FOXP3/CD8 ratio in the stroma and density of granzyme B+CD8+ cells in the tumor area in triple-negative breast cancer. These observations support, from a biological point of view, the inclusion at least of triple-negative breast cancer patients with brain metastases in clinical trials evaluating immunotherapy agents," concluded Dr. Griguolo.

    "Our next step will be to assess, using a specifically designed [multiplex immunofluorescence] panel, the expression of immune checkpoints in these same samples, in order to identify therapeutically actionable targets," she added.

    https://www.practiceupdate.com/c/101957/67/13/?els...

    {No charge to access but may require registration/sign in.}