Breaking Research News from sources other than Breastcancer.org
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HER2-Positive Breast Cancer
FDA Approval Sought for Neratinib Combo in HER2+ Breast Cancer
An application has been submitted to the FDA for neratinib for use in combination with capecitabine for the third-line treatment of patients with HER2-positive metastatic breast cancer.
Expert Explains Evolution of De-Escalating Therapies in HER2+ Breast Cancer
Keerthi Gogineni, MD, MSHP, discusses several trials in the breast cancer field, specifically looking at de-escalation approaches with therapy.
Key Trials Showcase the Utility of Neratinib in HER2+ Breast Cancer
Michel Velez, MD, provides perspective on the clinical experience with neratinib in patients with early-stage HER2-positive breast cancer as well as promising data that may lead to an indication in the metastatic setting.
Incorporating Neoadjuvant and Adjuvant Data in Early-Stage HER2+ Breast Cancer
Yee Chung Cheng, MD, discusses the importance of integrating neoadjuvant and adjuvant trial data into practice in order to optimize outcomes for patients with early-stage HER2-positive breast cancer.
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Where Do Your Med School Tuition Dollars Go?
'Our debt is an amount of money that schools might not actually need'
Daniel Barron, MD, a resident at Yale, detailed his quest to learn How are medical school tuition dollars actually spent? in a Scientific American post. Barron talked to Robert Grossman, MD, dean of NYU School of Medicine and CEO of NYU Langone Health, who famously nixed tuition for the school's medical students last year. Grossman said the $25 million in tuition that students used to pay largely went to supporting "unproductive faculty" -- those who don't get grants, teach, or see patients. Grossman also said this amount could effectively be considered a "rounding error" in the university's $10 billion annual budget. "What's frustrating is the idea that even though we've sacrificed so much already, our debt is an amount of money that schools might not actually need," Budde said in the post. Each year, thousands of new physicians graduate with an average of $195,000 in debt. We ought to be able to know where our tuition dollars are going and what we're buying with our money.
{Troubling....}
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Predicting Breast Cancer Response With 'High' TMB
'Desperately seeking better biomarkers and an understanding of their relationship to one another'
The recent approval of nab-paclitaxel plus atezolizumab in patients with PD-L1 immune cell-positive triple-negative breast cancer, based on results from the Impassion130 study, has led to an explosion in the number of clinical trials in search of other biomarkers to enrich for responding breast cancer patients.
Discussion re TAPUR is a single-arm nonrandomized study. Patients eligible for TAPUR have advanced cancer and no standard treatment options.
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Certain Breast Implants, Tissue Expanders Recalled Due to Cancer Link
Steve DuffyAllergan is recalling BIOCELL textured breast implants and tissue expanders due to the potential risk for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The move to recall was based on an analysis of medical device reports submitted to the Food and Drug Administration (FDA) related to BIA-ALCL and BIA-ALCL-related deaths associated with these devices. "Once the evidence indicated that a specific manufacturer's product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women's health," said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD.
In a press release, Allergan said that "Effective immediately, healthcare providers should no longer implant new BIOCELL textured breast implants and tissue expanders." The recall includes the following products: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants, Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. A complete list can be found here.
As of July 6, the FDA lists 573 unique cases of BIA-ALCL globally, of which 481 are attributed to Allergan implants. Thirty-three deaths have been reported; 12 of the 13 deaths in which the manufacturer was known were confirmed to have an Allergan breast implant at the time of BIA-ALCL diagnosis.
"The recall of these textured implants is a big deal in protecting women from the potential risks of developing, and dying from, this rare type of aggressive lymphoma," said Joshua Brody, MD, Director of the Lymphoma Immunotherapy Program at Mount Sinai. "While case reports have suggested a potential link between some types of breast implants and this disease for over 20 years, it has taken time to gain sufficient evidence to suggest, and understand, the causality."
At this time, the FDA recommends that healthcare providers do not remove these or other types of breast implants in patients who have no symptoms due to the low risk of developing BIA-ALCL, however patients should be informed of the risk. In patients with late onset, peri-implant changes, providers should consider the possibility of BIA-ALCL; in some cases, patients presented with a seroma, mass, hardening adjacent to the breast implant.
Additional recommendations for providers and patients can be found here.
Related Articles
- FDA: Breast Implants Linked to Cancer Can Still Be Sold in US
- Long-Term Outcomes of Breast Implants Explored
- FDA: Number of U.S. Women With Breast Implant-Caused Cancer Has Increased
"Many cases of implant-associated lymphoma have developed mutations and expression of immune-suppressive proteins which prevent anti-tumor immune cells from clearing the cancer, and these chances likely begin with the inflammation induced by some implants," added Brody. "By preventing further use of these implants, the FDA is helping women to protect themselves from the medically serious and emotionally exhausting effects of these risks."
The FDA also announced today that additional actions are being considered to help inform women on the benefits and risks of breast implants. These may include changes to the labeling for breast implants to include a Boxed Warning and a patient decision checklist.
For more information visit FDA.gov.
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PLEASE read this article with care - not just the headline. BCO had posted extensively about this issue and the posts have been very accurate & informative.
Note: The risk is 6x as high - not 60% as stated on the television today. The craziness has officially started. As Marijen quoted, there have only been 33 deaths out of 573 cases sited. That is 6% - a relatively small number.
Note: The FDA is NOT advocating for the removal ('explant') of these products if you aren't having any problems. If you have questions or are having symptoms, by all means make an appointment with your plastic surgeon. Perhaps he/she will recommend an MRI as the next step. But this is not a call for mass panic.
I had an out of town friend call me so upset because I was going to die. Well..... I love my 410s. They have been in place for 9 years. At this point, I don't have any problems. I will see my PS just to discuss the issue, but at this point I certainly don't plan to have them pulled out.
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Cellular soldiers created using the body's own defenses can track down and kill escaping cancer cells during surgeries, preventing metastasis and saving lives, a Vanderbilt University biomedical engineer has discovered, particularly in cases of triple negative breast cancer...
"We've tested this both in the bloodstream and in hundreds of blood samples from cancer patients being treated in clinics across the country. In all cases, within two hours, the viable cancer cells are cleared out. This has worked with breast, prostate, ovarian, colorectal and lung cancer cells."
Not only can the method work during surgeries, King said, but potentially with patients who already suffer metastatic cancer in multiple sites and who have no worthwhile treatment options...
The group's past experiments with TRAIL-coated leukocytes were effective in blocking metastasis, but required multiple repeated injections to sustain their beneficial effect. King said this new breakthrough overcomes those issues by designing three simple doses to coincide with the surgical procedure.
https://medicalxpress.com/news/2019-07-cellular-soldiers-cancer-cells-loose.html
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Ah, so the cancer cells do escape during surgery! Of course they do
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A new way to stop cancer cells from killing their healthy neighbors
Moreno and his team discovered that neighbouring cells in the body are constantly evaluating each other's fitness level by using special markers that each cell exhibits on its surface...
Next, to observe whether the fitness fingerprints impact cancer growth, the team analysed the expression of these four types in different types of tissues: malignant cancer (breast and colon), benign tumors (breast and colon), tissue adjacent to the tumour and normal tissue.
Their analysis revealed several striking findings: in normal tissue, the expression of Win was overall quite sparse, and expression of Lose was even lower. In contrast, the expression of Win was significantly increased in all tumors, with higher levels in malignant tumors than in benign...
Next, to test the full therapeutic potential of this approach, the team decided to combine blocking fitness fingerprints expression with chemotherapy. This two-pronged approach was very successful: "we were able to further reduce, and in some cases completely eliminate, tumorigenesis!", says Gogna.
https://medicalxpress.com/news/2019-07-cancer-cells-healthy-neighbors.html
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Somebody finally admits it! "Surgical intervention in breast cancer is a known cause of metastatic growth and accelerated tumor relapse, either because of cancer cells shed during the process, inflammation at the wound site or a combination of the two factors. Chemotherapy is the most widely used treatment for the resulting metastasis, but still, the five-year survival rate for triple negative breast cancer sits well below 30 percent."
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Beverly Hills Plastic Surgeons React to Breast Implant Recall: "Don't Panic" | Hollywood Reporter
https://www.hollywoodreporter.com/news/beverly-hil...0 -
Too Many Medicines Simply Don't Work
A pair of new studies sheds light on an old problem: Some things doctors do are useless. Some are even harmful.
ByPeter Coy
https://www.bloomberg.com/news/articles/2019-05-30...0 -
Pilot Study of Five-Hour Molecular Test Accurately Distinguishes Malignant and Benign Breast Tumors
Novel technology based on epigenetic alterations could shorten wait for a definitive diagnosis in resource-poor settings
A team led by Johns Hopkins Kimmel Cancer Center investigators reports that a new laboratory test they developed to identify chemical changes to a group of cancer-related genes can accurately detect which breast tumors are cancerous or benign, and do it in far less time than gold-standard tests on biopsied breast tissue.
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New technology targets cancer, other diseases, and hidden elements that allow those diseases to thrive
A Purdue University-affiliated startup has created a platform aimed at treating relapse patients for cancers and other diseases by taking a holistic approach of not only seeking to impede the main cause but also to stop other elements that help that disease thrive. ...a platform that makes complex drug molecules rapidly using bioinformatics, multi-component compound synthesis and the understanding of disease biology. what KinaRx is doing is developing drugs that hit not only the main disease drivers but also the collaborative players that allow the disease to progress." "Kinases basically signal so many processes in a cell. So they are drug targets for many diseases," ... "We have developed a technology that is so powerful that we will be able to target many diseases associated with kinases."
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FDA: Allergan Should Pull Some Breast Implants
Risk of rare lymphoma six times more common with company's textured implants
The FDA called on Allergan to pull certain textured breast implants from the U.S. market due to the risk of breast implant-associated anaplastic large cell lymphoma (ALCL).
Allergan said it would comply and that it was moving forward with a worldwide recall of six products in its Natrelle line of implants and tissue expanders...
https://www.medpagetoday.com/publichealthpolicy/fdageneral/81194
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Share Triumph Conference
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{free pass to this online event here:} https://conference.sharetriumph.com/?utm_campaign=16&utm_content=SlC8Z_G0vbKQGsWqnu1tM5xKZ1E&utm_medium=email&utm_source=newsletter&utm_term=campaign-16
{I don't know much about this online conference but I am getting loads of email blasts about it. Seems to have lots of corporate backers and an extensive list of presenters. Dates Aug 5-15, 2019.}
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First-Line T-DM1 for Patients With HER2+ Advanced Breast Cancer Who Are Unsuitable for Taxane-Based Therapy
- In the randomized, phase III, MARIANNE trial, the authors evaluated the efficacy of trastuzumab emtansine (T-DM1), T-DM1 plus pertuzumab, and trastuzumab plus a taxane in 1095 patients with HER2-positive breast cancer and no prior therapy for advanced disease. This post hoc, landmark analysis compared overall survival (OS) among the groups. Median OS was similar across all three groups. Toxicity was less in the T-DM1 arms compared with the trastuzumab plus taxane arm.
- Although the control group of trastuzumab plus taxane has since been superseded by the combination of trastuzumab, pertuzumab, and a taxane for first-line treatment, the authors conclude that these findings still offer support for T-DM1 as first-line treatment in patients with HER2-positive metastatic breast cancer deemed unsuitable for taxane-based therapy.
Interesting commentary/observations by Lee S. Schwartzberg MD, FACP0 -
Predictive and Prognostic Value of Stromal TILs Before and After Neoadjuvant Therapy in Triple-Negative and HER2-Positive Breast Cancer
- This retrospective analysis was designed to evaluate the predictive and prognostic value of stromal tumor-infiltrating lymphocytes (TILs) before and after neoadjuvant therapy (NAT) for patients with triple-negative and HER2-positive breast cancer. Low levels of TILs prior to neoadjuvant therapy were associated with a lower pathologic complete response rate in both triple-negative and HER2-positive disease.
- Low levels of pre–neoadjuvant therapy TILs were associated with a poor overall prognosis in patients with triple-negative breast cancer.
- CONCLUSION: In TN and HER2+ BCs, low pre-NAT TILs tumours had a low likelihood of achieving pathological complete response (pCR). In TNBC with residual disease (RD), both low pre- and post-NAT TILs were associated with shorter (relapse-free survival) RFS. These results suggest that TILs information should be taken into account when additional therapies may be given in the post-neoadjuvant setting.
https://www.practiceupdate.com/C/86600/56?elsca1=emc_enews_topic-alert
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Michael Lisanti and antibiotics: the next cancer revolution
https://www.healtheuropa.eu/michael-lisanti-antibiotics/88900/0 -
New discovery could open up PARP inhibitors to more cancer patients
PARP inhibitors have transformed treatment for breast and ovarian cancers, but their use has been limited to the small proportion of patients who have BRCA mutations. New research out of UT Southwestern Medical Center has uncovered a mechanism by which the drugs attack cancer, suggesting they could be put to use in many more patients.
https://www.fiercebiotech.com/research/new-pathway-could-open-up-parp-inhibitors-to-more-patients
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On this article above: Predictive and Prognostic Value of Stromal TILs
Does anyone actually measure our stromal TILs? Would we or our docs know and adjust our treatments or expectations based on that?
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A new therapeutic treatment uses engineered stem cells to target and kill cancer bone metastases while preserving the bone, a study with mice shows.
"This is a safe and almost nontoxic treatment compared to chemotherapy, which often leaves patients with lifelong issues."
Sandra Spivey, an Orange County patient advocate who has been living with metastatic breast cancer since 1997, has experienced firsthand the ravages of traditional treatment.
"Chemotherapy can kill both cancer cells and normal cells and create drastic side effects," she says. "I have lost my hair; I have lost sensation in my hands and feet. Most of all, chemotherapy really robs you of your time. This new targeted approach could improve quality of life both during and after treatment."
https://www.futurity.org/bone-metastases-cancer-chemotherapy-2115512/
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MM, I asked my MO if my stromal TILs had been tested on my biopsy... and they were not.
I think with TNBC the first line chemos are basically the same for anyone. That probably needs more refinement as these various markers are identified.
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... our recent live webinar, Precision Medicine in Oncology: No Two Tumors Alike.
Please feel free to view the event on demand, on your schedule.
Thank you,
The Scientist Webinars Team
https://globalmeet.webcasts.com/viewer/event.jsp?ei=1249185&tp_key=ab4b574682
{Hope this link works for others. It works for me. Interesting web presentation.}
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Cancer Trials Often Hinge on Fragile Data
Handful of outcomes represent difference between positive, negative results
Major positive clinical trials in oncology frequently hung by a statistical thread representing a handful of outcomes, according to a statistical fragility analysis.
Publication of the study followed a recent call to "retire statistical significance" in favor of confidence intervals. Acknowledging that confidence intervals are no panacea, the authors argued that eliminating P values as a kind of Holy Grail of clinical trial outcomes would help put an end to unfounded hype and dismissal of potentially crucial effects.
{A brief, rather technical, but interesting discussion of the data behind clinical trials and drug approval.}
Primary Source
The Lancet Oncology
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China's Churning Out Revolutionary Cancer Drugs Much Cheaper Than the U.S.
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Just a wee note, ACE’s also refer to “adverse childhood experiences, which is a high profile trauma informed approach to working with children. There may be some cross referencing!
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marijen...will keep looking at the China options as promising. Thanks
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New cause of cell aging discovered
Findings have huge implications for cancer and age-related health conditions
- Date:
- July 25, 2019
- Source:
- University of Southern California
- Summary:
- New research could be key to our understanding of how the aging process works. The findings potentially pave the way for better cancer treatments and revolutionary new drugs that could vastly improve human health in the twilight years.
https://www.sciencedaily.com/releases/2019/07/190725151018.htm
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MRI Screening Finds More Breast Cancers, but at What Cost?
Even breast cancer survivors may find it tough to sort out benefits and harms
Use of MRI to follow women with a previous history of breast cancer detected more cancers than mammography, but at a cost of significantly more biopsies, researchers reported.
While the cancer detection rate was higher for breast MRI compared with mammography alone (10.8 vs 8.2 per 1,000 examinations), the breast MRI biopsy rate was more than two-fold greater (10.1% vs 4.0%)
For women with a personal history of breast cancer, "the potential benefits and harms, specifically the effect of increased biopsies, should be carefully considered when incorporating breast MRI into surveillance imaging strategies,"
National recommendations lack consensus...
"...the radiologic interpretation of mammography does not appear to miss more second cancer events that would become clinically detectable during the screening interval of 12 months compared with the radiologic interpretation of breast MRI,"
"...it's really important when policymakers are thinking about new surveillance strategies that they consider how these comparisons are made, and that while it might be appropriate for some women to get a breast MRI, we must also consider how often to use mammography in finding second breast cancers," Wernli said. "Right now women are recommended to get a mammogram annually after the diagnosis of breast cancer," adding that, when looking at surveillance strategies, it may be appropriate to start thinking about shortening surveillance intervals for these women, rather than adding additional tests.
{The article includes an interesting discussion of study methodologies.}
Primary Source: Radiology
Source Reference: Wernli K, et al "Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Breast Cancer" Radiology 2019; DOI: 10.1148/radiol.2019182475.Secondary Source: Radiology
Source Reference: Newell MS "Risk versus Benefit of Surveillance MRI: A Sticky Wicket" Radiology 2019;292:319-320.
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I am pro-choice on breast cancer screening! Let me decide, it’s my body.
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