Breaking Research News from sources other than Breastcancer.org
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This courtesy of Ingerp (I don't think it is already posted...)
STUDY: UNHEALTHY GUT PROMOTES SPREAD OF BREAST CANCER
An unhealthy, inflamed gut causes breast cancer to become much more invasive and spread more quickly to other parts of the body, new research from the University of Virginia Cancer Center suggests.
...a research faculty ...found that disrupting the microbiome of mice caused hormone receptor-positive breast cancer to become more aggressive. Altering the microbiome, the collection of microorganisms that live in the gut and elsewhere, had dramatic effects in the body, priming the cancer to spread.
https://news.virginia.edu/content/study-unhealthy-gut-promotes-spread-breast-cancer?
http://cancerres.aacrjournals.org/content/early/2019/05/07/0008-5472.CAN-18-3464
DOI: 10.1158/0008-5472.CAN-18-3464
(access to full journal article requires subscription)
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Here's a little more about Marijen's article... sounds promising....
Drug to replace chemotherapy may reshape cancer care
A class of drugs is emerging that can attack cancer cells in the body without damaging surrounding healthy ones. They have the potential to replace chemotherapy and its disruptive side effects, reshaping the future of cancer care.
The complex biological medicines, called antibody drug conjugates (ADCs), have been in development for decades, and are now generating renewed excitement because of the success of one ADC in late-stage testing, a breast cancer treatment called DS-8201.
"DS-8201 may become one of the largest cancer biologic drugs,''
Analysts say DS-8201 could triple the number of patients who get powerful targeted treatment for breast cancer, the most common tumor in women that kills more than half a million annually. As importantly, its ability to target cancer cells without affecting normal cells is a key advantage over the take-no-prisoners approach of chemotherapy.
Daiichi's treatment has been seen to double survival time for advanced breast cancer patients ... patients using DS-8201 experienced less nausea and hair loss compared with chemotherapy.
DS-8201's full potential is still years away, as it will take time for data to validate the drug's efficacy in a wide range of patients....About 56 pharmaceutical companies are developing ADC candidates..."ADCs are being positioned as a chemo replacement,''
The concept behind ADCs was envisioned in 1900 by German Nobel laureate Paul Ehrlich, who formed the idea of a "magic bullet" in which a single toxic molecule would be delivered to attack a diseased cell without damaging surrounding healthy cells.
The actual use of ADCs began in 2000, but the interest in the sector cooled down as many failed to live up to expectations. The therapies belong to a broader category of cancer immunotherapies that include Merck & Co.'s Keytruda and Novartis AG's CAR T-cell therapy Kymriah that harness the immune system to kill tumors.
Daiichi Sankyo's drug takes ADCs to another level. Its advantage is that it carries eight payloads stably to cancer cells, double the number of the industry standard..."Currently available ADCs are far from being perfect technically because the payload linked to antibodies aren't properly delivered to cancer cells,''... "We wanted to challenge and improve that.
{For HER2 BC}...their first treatment is chemotherapy alongside Roche's Herceptin and Perjeta, a related drug. While DS-8201 is currently in testing for later-stage cancer, the plan is to go up against the first-line treatment *in the next two years.* {emphasis added}
"It would be transformative" if the drug were to become the sole first-line treatment...."If we can eliminate the side effects associated with chemotherapy, that would be a tremendous benefit for women."
"...my gut feeling is that DS-8201 is the most effective among existing medicines targeting HER2 positive patients, including Herceptin and chemotherapy,'' said Shunji Takahashi, deputy director at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research, who took a part in an early-stage DS-8201 trial. He noted that interstitial pneumonia is a concern as a side effect, and needs to be monitored.
https://www.bnnbloomberg.ca/drug-to-replace-chemotherapy-may-reshape-cancer-care-1.1271773
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On this: "STUDY: UNHEALTHY GUT PROMOTES SPREAD OF BREAST CANCER" interesting concept and study. It would be more useful if we could define better what really IS a healthy gut and how to get it. Yes, eating a varied, high-fiber, high-vegetation diet and getting plenty of sleep, and having low stress, all probably helps. I think it's hard for many people to grasp that as any prescription for living, achieving a healthy gut, low inflammation, and lower risk of cancer.
Not meaning to shoot the messenger here... Thanks as always for posting these.
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Very good question Mountain Mia. You can do a search and find bits and pieces or here is a best seller. Doctors don’t know much about healthy eating unfortunately.
The Microbiome Solution: A Radical New Way to Heal Your Body from the Inside Out Paperback – August 9, 2016
by Dr. Robynne Chutkan M.D. (Author)
4.5 out of 5 stars 217 customer reviews#1 Best Sellerin Gastroenterology
ISBN-13: 978-0399573507 ISBN-10: 039957350X Edition: Reprint
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MountainMi: true. I think that this is still an evolving area of knowledge. There are at least a couple of ongoing studies. If you are interested, I have posted info on those in this thread:
https://community.breastcancer.org/forum/73/topics/871909?page=1#idx_13
See entries regarding The American Gut Project and the British Gut and The Persephone Biome study.
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Oh this is very interesting, hope you don’t mind lumpie!
Can an Airport Scanner Detect a Tumor or Medical Issue? - YouTube
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Regarding Vit D testing--previous MO required, new MO requires it. It's easy to do within the CBC panel labs that I have done before each check up, so (so far) my Vit D is still being monitored. I take Vit D liquid supps (4000 IUs) and when I hike, or walk the dog (nearly every day) I don't use sunblock and try to expose arms and legs for 30 min. My levels are so far above 60, mostly hover around mid 70s. Both MOs wanted levels at 70+, Naturopath wants at least that. MOs get concerned when it rises above 80 since it can skew blood calcium on labs, so 4000 IUs plus exposure seems right to me. At any rate, Vit D testing and supplementing doesn't seem to cause me any harm.
Claire in AZ
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Sounds promising:
Tumor cells that spread cancer via the bloodstream face a new foe: a laser beam, shined from outside the skin, that finds and kills these metastatic little demons on the spot.
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Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer
- This prospective trial involved 9427 women with HR-positive, HER2-negative, axillary node–negative breast cancer in whom an assay of 21 genes had been performed. Their clinical risk of recurrence of breast cancer was classified as low or high on the basis of the tumor size and histologic grade.
- The authors found that clinical-risk stratification provided prognostic information that facilitated the identification of premenopausal women who could benefit from more effective therapy when this prognostic information was combined with the 21-gene recurrence score.
DOI: 10.1056/NEJMoa19048190 -
This op-ed piece may be of interest to some:
New Program Will Offer Unapproved Drugs to Dying Cancer Patients
Kevin Campbell looks at the pros and cons of this controversial FDA decision
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Lazer Beam.... what took them so long?
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Great if the Airport Scanners give you a heads up, but don't count on them for diagnostics. An editorial word of caution about those "health scans" provided by some "virtual physical" centers, also. My impression is that they may be pretty good for cardiac issues but they are not very good for cancer detection. Some market themselves as providing early detection of cancer but if you question the providers, they will tell you what most of us know which is that you are not likely to see anything cancerous without contract - which they do no provide. So.... have realistic expectations.
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Well I worry about how much radiation we are getting from the airport scanners that they can see into our bodies. That’s not nice. Intrusion of privacy.
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I just found this one, not sure if it's already been posted. I don't particularly understand it, but sounds promising at least.
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If you are interested in business start-ups doing cancer research and development, you may be interested in this "blast" that came out from Angel List (angel.co)
Cancer sucks, but there are some exciting developments on the research front. In the last month alone, we've seen regulators consider a CRISPR therapy that directly targets tumor cells—a first for the U.S.—as well as a laser that zaps tumor cells from patients bloodstreams without damaging healthy tissues.
And it's not just the research around new cancer therapies that's exciting. There's a host of startups attempting to tackle other parts of the cancer treatment puzzle, from diagnostics, to emotional support, to medical record logistics.
In the world of diagnostics and early detection, we have startups like:
- Freenome, backed by a16z, using unique blood tests and AI to detect early signs of cancer.
- Ezra, using full-body MRIs and machine learning to detect 11 kinds of cancer in men and 13 in women.
On the logistical side of treatment, there are startups like:
- Flatiron Health, a collaborative platform for doctors, academics, regulators, and more.
- Embleema, a blockchain company for patient health data, which has partnered with Europe's leading cancer center.
And then there are other cancer-focused startups that are tougher to categorize, like Belong.life. A platform for cancer patients, it offers a social network where users can connect with other patients, explore a clinical trial matching service, leverage oncologist-staffed support chat, and use a file storage system for medical records.
The number of people diagnosed with cancer makes the potential for impact huge, while the difficulty of the market's core problems makes the barrier to entry for companies high. For a startup looking to innovate and affect as many individuals as possible, there might not be a more exciting space. If you're interested in joining such a startup, search AngelList here.
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Re: DS-8201 and the hope that it will someday replace chemo and its toxic side effects - it's important for people to know that based on Phase I and II trials of DS-8201, the rate of Grade 3 and higher Adverse Events was 50+% (50% for breast cancer, 64% for gastric cancer), 22.9% had a "serious" AE (ie life-threatening, Grade 5 is death), the rate of interstitial lung disease (ILD) has been so high that they now have an independent outside agency monitoring it during the Phase III trials, and the drug was directly responsible for the death of 2 out of the original 12 breast cancer patients in the Phase I trial. Despite those horrific stats, they claim that maximum toxicity was never achieved in Phase I and the drug is "well tolerated". The rate of AEs in Phase II was similar to the rate in Phase I. Other than the ILD, the most common all-grade AEs were "nausea (79.4 percent), decreased appetite (54.1 percent), alopecia (46.5 percent), vomiting (45.9 percent), fatigue (42.4 percent), anemia (40.0 percent), constipation (38.2 percent) and diarrhea (38.2 percent)", so how is this any better than chemo for early stage patients?
Since I'm HER2+ I pay close attention to HER2+ trials and do a lot of research to see what the media doesn't talk about (thank you Vinay Prasad for teaching me how deceptive these media releases for "ground-breaking miracle drugs" can be). With a $7 billion investment riding on this drug I guess it's easy for them to try to convince people that a rate of 50+% Grade 3 and higher AEs is acceptable so they can fast track drug approval, but as someone who is Stage IV and acutely aware of the Quality of Life vs Quantity of Life spectrum and as someone who has already experienced a Grade 3/4 AE that made me wish I was dead, it's not a risk I'd be willing to take in exchange for the possibility of a few extra months of life. It just blows my mind that this is considered an acceptable level of toxicity; I've seen several research oncologists say that a rate of Grade 3 and higher above 10% should be unacceptable and this drug is more than 5x that. It's bad enough that Stage IV patients will be tempted to try something this toxic, but I can't even wrap my mind around the fact that people are talking about possibly using DS-8201 for early stage patients instead of chemo.
I'll be watching the Phase III DESTINY trials closely, but after reviewing the Phase I and Phase II data, I do not share in the excitement about this drug.
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LBBC has posted a page of links to some highlights on presentations made at the American Society of Clinical Oncology annual meeting. You can access those here: https://www.lbbc.org/news-opinion/updates-2019-asco
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LoriCA, thanks for summarizing and putting in perspective the results from the DS-8201 studies. I also have been following the development of that drug but I hadn't seen the adverse effects numbers that you shared. Do you have a link to the full report on results that you could share? I've had trouble finding anything but the glowing press reports on its efficacy. Thanks!
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Margi a lot of the info was shared directly by the drug company itself, Daiichi Sankyo, in their press releases. The media just seems to gloss over it, maybe because it's always near the bottom of the article. The numbers cited in this press release are the updated Phase I results, it mentions the 50% Grade 3 and higher AEs -
https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006943.html
From Targeted Oncology May 2019 (Phase II) - "Fifty percent of patients experienced a grade ≥3 AE and 19% had a serious AE; this included 2 earlier reported cases of grade 5 treatment-related pneumonitis. Additionally, reported cases of interstitial lung disease or pneumonitis in the clinical development program for this agent are evaluated by an independent adjudication committee. A formal monitoring and management program is also in place to help determine the risk of these toxicities." https://www.targetedonc.com/news/fam-trastuzumab-deruxtecan-demonstrates-encouraging-responses-in-advanced-her2-breast-cancer
This article in Oncozine discussing the results for colorectal cancers says there were five Grade 5 (death) cases of ILD attributable to the drug - https://oncozine.com/encouraging-results-for-fam-trastuzumab-deruxtecan-in-her2-expressing-advanced-colorectal-cancer/
So I originally said there were two deaths attributable to the drug and it looks like that number is now 5.
After they released the Phase II trial results I started doing some digging, found the early published Phase I results (not the "updated" results cited above) and some interesting articles posted in other countries that don't have the same marketing spin we often see in the US. Since the first trials including several different types of cancer including breast, gastric, and colorectal, you sometimes have to dig to find the sub-group analyses. Anyway, the links I posted should be a good start for you to get an idea of the safety profile of the drug.
Lori
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Mountain Mia here’s your answer.
http://www.bbc.com/future/story/20190121-what-we-do-and-dont-know-about-gut-health
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Breast Cancer Subtypes Among Eastern-African–Born Black Women and Other Black Women in the United States
Although triple-negative breast cancer disproportionately affects black women in the U.S., the risk varies according to where they were born.
CONCLUSIONS: The prevalence of triple-negative breast cancer among black women in the United States varied significantly by birthplace, particularly among Eastern-African–born black women. These findings underscore the importance of considering geographic origin in studies characterizing breast cancer among women of African descent in the United States and elsewhere.
Cancer 2019;0:1-11.
DOI: 10.1002/cncr.32293
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Novel Treatment Turns Tumors Into 'Cancer Vaccine Factories'
In-situ vaccine may enhance immunotherapy response in resistant cancers, study shows
A novel approach to cancer immunotherapy injects immune stimulants directly into a tumor to "teach," induce the immune system to destroy the cancer and other tumor cells throughout the body. The three-step approach works as an in-situ cancer vaccine, researchers said.
A preliminary study could point to a new way of making immunotherapy more effective in cancers that have proven to be resistant to treatment and also enhance the effects of checkpoint blockade.
A clinical trial for lymphoma, breast, and head and neck cancer patients opened in March 2019 to test the vaccine with checkpoint blockade. The in-situ vaccine is also being tested in the laboratory in liver and ovarian cancers.
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Clinical Challenges: Avoiding Chemotherapy in Breast Ca
The associated toxicity has breast cancer researchers investigating non-chemotherapeutic approaches
{This article starts out with a discussion of the TAILORx study which studied avoiding chemotherapy in patients with estrogen receptor (ER)-positive, HER2-negative, lymph node-negative breast cancer. It goes on to discuss a less reported study on the possibility of treating HER2+ BC without chemotherapy.}
A recent study adds another potential method of identifying patients who can benefit from certain treatments, while avoiding chemotherapy. Researchers from Johns Hopkins Kimmel Cancer Center in Baltimore identified a positron emission tomography (PET) scan biomarker that may be able to identify patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer who might benefit from targeted therapy alone, without chemotherapy.
Study CONCLUSION: Early changes in SULmax predict response to four cycles of PT in estrogen receptor–negative, HER2-positive breast cancer. Once optimized, this quantitative imaging strategy may facilitate a more tailored approach to therapy in this setting.
https://ascopubs.org/doi/abs/10.1200/JCO.2018.78.7986?journalCode=jco
DOI: 10.1200/JCO.2018.78.7986 Journal of Clinical Oncology 37, no. 9 (March 20 2019) 714-722.
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Cannabinoids in Oncology: A Growing Role
Mellar Davis, MD, on the pros and cons, benefits of cannabis in cancer patients
{Interesting video, + transcription, op-ed on cannabis in palliation. Discussion of history of medicinal use in the U.S., challenges related to dosing and risk for drug interactions.}
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The Arc of Therapy: From Cure to Humbling Legacy
{This is not research, but is a very insightful reflection on the experience of long term survivorship. The physician-author has a history of Hodgkin lymphoma, radiation therapy, breast cancer, a thyroid nodule, and lung cancer. It acknowledges the uncertainty of living with long term survivorship in ways that may speak to others similarly situated.}
https://ascopubs.org/doi/full/10.1200/JCO.19.00666
In a similar vein, here is a commentary on the frustration physicians experience as a result of "not having a crystal ball."
https://connection.asco.org/blogs/modern-day-cassandras-reflections-asco19
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ASCO 2019: SOPHIA Trial Shows Promise for Margetuximab in HER2-Positive Breast Cancer
This is the first trial to use CD16A genotype as a predictor of response
The HER2-targeted antibody margetuximab was associated with better progression-free survival (PFS) rates than trastuzumab for the treatment of HER-2 positive breast cancer, particularly among carriers of the low-affinity CD16A-158F allele, in the SOPHIA trial, presented here at the Annual Meeting of the American Society of Clinical Oncology, which took place from May 31 to June 4.
The primary endpoints of the trial were central blinded PFS and overall survival (OS), assessed sequentially. Objective response rate (ORR) was a secondary endpoint.
Among 524 patients with baseline measurable disease, the ORR was higher with margetuximab versus trastuzumab.
Safety profiles were comparable in 529 patients who received study therapy.
"This is the first prospective analysis of a CD16A genotype as a predictor of efficacy from anti-HER2 therapy. said Dr. Rugo, "and we demonstrated that an enhanced PFS benefit with margetuximab in patients carrying the low-affinity CD16A-158F allele."
Interim survival analyses did not yield significant differences between the two treatment groups. A second interim OS analysis will be available late in 2019.
https://www.practiceupdate.com/C/85100/56?elsca1=emc_enews_topic-alert
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Pyrotinib Plus Capecitabine for HER2+ Metastatic Breast Cancer
- Interview with Lee S. Schwartzberg MD, FACP Interview by Farzanna S Haffizulla MD, FACP, FAMWA
- one of the key studies presented this year looks at the novel compound pyrotinib for HER2+ breast cancer.
- Double-blinded, double randomized controlled study in patients who were HER2+, metastatic breast cancer, had previously been exposed to taxane and trastuzumab, and the results of the study showed that the progression-free survival, the primary endpoint was more than doubled, to about 11 months, from four months, with the addition of pyrotinib. That was quite good, and has a ratio of less than 0.2, so more than 80% improvement overall, highly statistically significant, and that was a very positive result, I think, we can say.
- Not a very large study, under 300 patients, so by phase III standards it was somewhat small, but the results are very strong
- Pyrotinib, like other ERBB inhibitors, tend to have diarrhea as a common side effect, and that was also seen here as the most common toxicity, and of course capecitabine, of course, is hand-foot syndrome, which was the other common toxicity here.
- ... this will be, potentially, the third small molecule TKI that would come to market, potentially. What we don't know, though is the relative benefit of one versus the other{s}. ...where does pyrotinib fit? I don't think we know ....It has attractive biochemical properties and it could potentially find a place in the armamentarium of HER2 therapy.
- https://www.practiceupdate.com/C/84876/56?elsca1=emc_enews_topic-alert
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Lori, thanks for the follow-up information on the DS-8201 study results.
And Lumpie, thanks so much for all the interesting information that you post.
This is really helpful!
Margi
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Three Cheers for Lumpie!!
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!Hip hip hooray! 0
