Topic: Breaking Research News from sources other than Breastcancer.org

Aug 28, 2020 03:36AM - edited Aug 28, 2020 04:16PM by Lumpie

Saulius: You are right... there are lots of trade-offs and lots of questions remain unanswered. I believe that the studied population was adult only, so we don't know about childhood vs adult consumption and weather that makes a difference. As an adult, I really don't drink milk, but I put half-n-half in my coffee and I do enjoy cheese occasionally. I also like yogurt... but it can be digested differently because of the live and active cultures. Does this matter? More research to be done....

Edit: Big one: it does not indicate whether milk consumption impacts recurrence or prognosis for those with MBC.

Aug 28, 2020 09:55AM BevJen wrote:

Re liquid biopsies - as someone who just had one:

I recently had my blood pulled for the F1 liquid biopsy and my MO just sent me the report. This is about 14 months after my tissue biopsy. I haven't met with my MO about it yet (that's on Sept. 8) but I will say that just reading it over and trying to piece it all together, I am ambivalent on whether or not it is that helpful in comparison to a tissue biopsy. For me, the tissue biopsy had a bit more info. The blood biopsy did, however, identify another mutation that hadn't shown up in the tissue biopsy -- TP53. At first I freaked out when I saw that, but then did a little bit of research, and for NON-TNBC folks, it can indicate a sensitivity to immunotherapy (Yay!) which is good for me bc I also have a high tumor mutational burden.

Of interest to me was the fact that on my tissue biopsy, I had 2-3 ERBB2 mutations. On the blood one, it said "not detected." Very interesting. Waiting to find out if my doc thinks that's because of current I/F treatment.

Aug 28, 2020 11:16AM Lumpie wrote:

BevJen: Thanks for sharing your experience with the liquid biopsy. It is my understanding that TP53 is a very common mutation. Please keep us posted on how it informs your treatment.

And thanks to others on dairy insights.

Aug 28, 2020 04:29PM Lumpie wrote:

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.

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

Aug 28, 2020 06:36PM - edited Aug 28, 2020 06:44PM by buttonsmachine

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.

Aug 28, 2020 08:23PM - edited Aug 28, 2020 08:30PM by dread2020

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.

Aug 31, 2020 11:33AM - edited Aug 31, 2020 11:35AM by Lumpie

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

Sep 1, 2020 04:19PM morrigan_2575 wrote:

Sep 1, 2020 08:20PM BevJen wrote:

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

Sep 2, 2020 09:21AM BevJen wrote:

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!

Sep 2, 2020 02:00PM Lumpie wrote:

Published in Oncology

September 01, 2020

• 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.

Sep 2, 2020 04:41PM ShetlandPony wrote:

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.)

Sep 2, 2020 05:03PM Lumpie wrote:

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/

Sep 2, 2020 11:10PM LilyCh wrote:

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

Sep 3, 2020 05:12PM moth wrote: