Breaking Research News from sources other than Breastcancer.org
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Long‐Term Survival of De Novo Stage IV Human Epidermal Growth Receptor 2 (HER2) Positive Breast Cancers Treated with HER2‐Targeted Therapy
Background.
An increasing proportion of human epidermal growth receptor 2 (HER2) positive (HER2+) metastatic breast cancer (MBC) is diagnosed as de novo stage IV disease. We hypothesize that a subset of these patients who achieve no evidence of disease (NED) status after multimodality HER2‐targeted treatments may have prolonged progression‐free survival (PFS) and overall survival (OS).
Materials and Methods.
Patients with de novo stage IV, HER2+ MBC (n = 483) diagnosed between 1998 and 2015 were identified at two institutions (Yale and MD Anderson Cancer Centers). Clinical variables, treatment details, and survival outcomes were compared between those who achieved NED and those who did not.
Results.
All patients received trastuzumab, and 20% also received pertuzumab as first‐line therapy. The median OS was 5.5 years. Sixty‐three patients (13.0%) achieved NED; their PFS and OS rates were 100% and 98%, respectively, at 5 years and remained the same at 10 years. For patients with no NED (n = 420), the PFS and OS rates were 12% and 45% at 5 years and 0% and 4% at 10 years, respectively. NED patients more frequently had solitary metastasis and surgery to resect cancer . In multivariate analysis, NED status and estrogen receptor positive status were associated with prolonged OS.
Conclusion.
Among patients with de novo stage IV, HER2+ MBC, those who achieve NED status have a very high PFS and OS. Further randomized studies are required to fully understand the impact of systemic or locoregional therapy on achieving these excellent long‐term outcomes.
Implications for Practice.
In this retrospective review at two institutions, it was demonstrated that 13% of patients with de novo stage IV, human epidermal growth receptor 2 positive metastatic breast cancer achieved no evidence of disease (NED) status with trastuzumab‐based therapy plus/minus local therapies, and these patients had a very high progression‐free survival (100%) and overall survival (98%) at both the 5‐ and 10‐year time points. Achieving NED status may be an important therapeutic goal. However, further randomized studies are required to fully understand the impact of systemic or locoregional therapy on achieving these excellent long‐term outcomes.
Published online before print August 23, 2018. The Oncologist
http://theoncologist.alphamedpress.org/content/ear...
doi: 10.1634/theoncologist.2018-0213
{Confidence intervals and hazard ratios were deleted for readability. Please see abstract or full article for more details.}0 -
Debbew: That is interesting about development moving to China. If true, it seems sad for our talented and experienced researchers here. Development has to be distinguished from production, but given recent safety and quality issues with drugs - not to mention supply chains - it raises questions about quality assurance and and the supply of critical medications.
There is no doubt that therapies that are not likely to be quite profitable are often not researched. Some of that, for better and/or worse, has been addressed by the orphan drug act. Other research needs to be publicly funded. There are a few organizations out there working to distribute low margin drug through public service or low profit corporations/organizations. I'll see if I can find some coverage. It's an interesting model.
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I was reading a report that marijen posted yesterday. IMHO, this is knock-your-socks-off news. This type of test could allow earlier, non-invasive, accurate diagnoses which can be extremely difficult with certain types of cancer. The post was very thorough but I wanted to post a link in case anyone is interested in that or needs it later:
New blood test capable of detecting multiple types of cancer
- Date:
- September 28, 2019
- Source:
- Dana-Farber Cancer Institute
- Summary:
- A new blood test in development has shown ability to screen for numerous types of cancer with a high degree of accuracy, a trial of the test shows.
- https://www.sciencedaily.com/releases/2019/09/1909...
- Dana-Farber Cancer Institute. (2019, September 28). New blood test capable of detecting multiple types of cancer. ScienceDaily. Retrieved September 28, 2019 from www.sciencedaily.com/releases/2019/09/190928082724...
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A Superstar Team of Hospitals Is Sick of High Drug Prices—And Launching a Nonprofit Drug Company to Fight Them
By Sy MukherjeeSeptember 6, 2018
...a number of leading U.S. health systems announced an ambitious project: They would be banding together to create a non-profit generic drug company in the hopes of combating sky high drug prices and shortages regularly faced by American patients.
Civica Rx is a joint effort by big names like Catholic Health Initiatives, HCA Healthcare, Intermountain Healthcare, Providence St. Joseph Health, the Mayo Clinic, SSM Health, and Trinity Health. Those seven massive systems encompass about 500 American hospitals and will comprise the initial governing board of the group, which says it has attracted the interest of "more than 120 health organizations representing about a third of the nation's hospitals."
https://fortune.com/2018/09/06/civica-rx-nonprofit...
This article is considerably older:
Nonprofit vows to lower generic drug costs
By Robert Weisman {Boston} Globe Staff,December 13, 2015
https://www.bostonglobe.com/business/2015/12/13/no...
{May require subscription to access}
Also reported upon here:
A U.S. nonprofit says it has a better way to make generic drugs
by EJ Lane | Oct 7, 2015
https://www.fiercepharma.com/manufacturing/a-u-s-n...
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'Out here, it's just me': In the medical desert of rural America, one doctor for 11,000 square miles
He was the only working doctor left to care for three remote counties east of El Paso, an area similar in size to the entire state of Maryland, home to far-flung oil encampments, a desolate stretch of interstate, communities of drifters living off the electric grid, and highway towns made up of truck stops and budget motels. "A wild place of last resort," was how Garner described parts of his territory, and for every person in every kind of medical trouble, the true last resort was him.
In the medical desert that has become rural America, nothing is more basic or more essential than access to doctors, but they are increasingly difficult to find. The federal government now designates nearly 80 percent of rural America as "medically underserved." It is home to 20 percent of the U.S. population but fewer than 10 percent of its doctors, and that ratio is worsening each year because of what health experts refer to as "the gray wave." Rural doctors are three years older than urban doctors on average, with half over 50 and more than a quarter beyond 60. Health officials predict the number of rural doctors will decline by 23 percent over the next decade as the number of urban doctors remains flat.
https://www.washingtonpost.com/national/out-here-i...
{Article addresses lack of access to medical care in rural areas of the U.S. WaPo may limit access without a subscription.}
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Second generation antihistamines after breast cancer diagnosis to improve prognosis both in patients with ER+ and ER- breast cancer.
Background: Subgroups of patients with breast cancer (BC) could be candidates for immunological interventions. In the present investigation the role of antihistamines on prognosis of breast cancer has been studied, especially comparing first and second generation H-1 receptor antagonists due to their possible different effects on cytokines.
Methods: The study includes all women with BC diagnosed in Sweden 2000 through 2008 (n = 54406). Dates of birth, BC diagnosis and TNM-stage were directly extracted from the cancer registry. Therapy with antihistamines was gathered from the Swedish Prescription Registry. Other registries utilised were the Cause of Death Registry, Population Registry, and the in patient or out patient registries. BC and overall survival was compared between users of antihistamines and non users. Analyses were adjusted for TNM-stage, receptor status and age at diagnosis. A late entry model was used for different types of antihistamines.
Results: The HR for BC specific survival for the combined group of antihistamine users (n = 9777) was 0.70 (0.66-0.75). All the effect was seen for use after BC diagnosis. Results remained after adjusting for out or in patient diagnoses of allergy. In late entry models women using desloratadine (n = 1895) had a HR of 0.69 (0.52-0.91). Loratadine users (n = 2132) HR of 0.74 (0.60-0.93). Cetirizine users (n = 3001) HR of 1.13 (0.96-1.33) and Klemastine users (n = 2278) had a HR of 0.98 (0.80-1.19). Ebastin users (n = 326) had a HR of 0.50 (0.22-1.12) and Fenofexadine users (n = 145) had a HR of 0.73 (0.30–1.76). The analyses was also stratified for ER-status, but the results did not differ noticeably. Results were similar when overall survival was analysed.
Conclusions: This population based registry study shows that women treated with second generation antihistamines have a better overall and BC specific survival compared with non users regardless of age, history of allergy, ER status and tumor stage. The results are strongest for desloratadine use and use after BC diagnosis. Second generation antihistamines could offer a nontoxic therapy for both receptor positive and negative BC. The mechanism behind this effect is presently unknown.
https://ascopubs.org/doi/abs/10.1200/jco.2015.33.1...
DOI: 10.1200/jco.2015.33.15_suppl.3062 Journal of Clinical Oncology 33, no. 15_suppl (May 20, 2015) 3062-3062.
Published online January 31, 2017.
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Report Back from ASCO on Metastatic Breast Cancer
Dr. Linda Vahdat, medical oncologist at Memorial Sloan Kettering Cancer Center and Chief of Medical Oncology and Clinical Director of Cancer Services at Norwalk Hospital, will summarize research presented at ASCO 2019 focusing on metastatic breast cancer. Dr. Vahdat will also discuss her current research in triple negative metastatic breast cancer.
@{@ 1 hour video/webinar presentation}
https://www.sharecancersupport.org/report-back-from-asco-on-metastatic-breast-cancer-3/
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Great variety of articles Lumpie. Thank you
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Lumpie, thanks for the info on Civica Rx. I hope it succeeds and provides drugs to individuals as well as hospitals!
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Ultrasound breakthrough 'can spot cancer earlier'
A new ultrasound technique is being hailed as the biggest breakthrough in the technology for more than 60 years.
Developed at Heriot-Watt University in Edinburgh, it produces images that are 10 times better than current scans.
Researchers believe its ability to precisely pinpoint tumours could one day replace biopsies in investigating suspected cancer cases.
The method, which is about to begin trials in human patients, uses existing scanning equipment... The innovation has come in physics, statistics [,artificial intelligence] - and bubbles...
Dr Lu says it helps to think of each microbubble as a car in traffic. He used artificial intelligence to create a powerful algorithm that can track each one, and reveal the busiest routes...
If they go somewhere unexpected, it could be a sign of cancer - and one detectable much earlier than before.
These are super-resolution images showing details far beyond the physical limitations of the scanner...
Trials on human patients are expected to begin before the end of 2019 at the Western General Hospital in Edinburgh.
https://www.bbc.com/news/uk-scotland-edinburgh-east-fife-49870017
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As Karen said, great variety of articles. Thanks for all the research you do. I save lots of these posts for future needs. I especially liked the one on antihistamine use being good for breast cancer. I have bad allergies and take lots of antihistamines. I've had MBC for almost four years now and I'm stable or NED after Ibrance for only 16 months and Letrozole alone since then. Wonder if the antihistamines are helping to keep the cancer in check.
Faith (in the future)
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Interesting article about diet and its effect on breast cancer cells (as well as other cancer cells)
https://scienmag.com/dietary-vulnerability-found-i...
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This provides interesting insights into post-neoadjuvant treatment pathology:
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This reports a secondary analysis of the TAILORx trial that focused on outcomes for women with scores of 26-100, including a break down of results by chemo regimen.
As a reminder - none of this applies to node-positive cases.
https://www.medscape.com/viewarticle/919336?src=wnl_edit_tpal&uac=153476CT&impID=2117707&faf=1#vp_1
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Risk Factors for Triple-Negative Breast Cancer among Latina Women
Laura Rey-Vargas, María Carolina Sanabria-Salas, Laura Fejerman and Silvia J. Serrano-GómezDOI: 10.1158/1055-9965.EPI-19-0035Abstract
Breast cancer is the most common cancer in Latina women. Although they have a lower incidence of the disease when compared with other population groups such as non-Hispanic white and African-American women, some studies have shown that Latina women have a higher risk of mortality when compared with non-Hispanic white women. This phenomenon can be explained in part by the higher prevalence of aggressive subtypes in Latina women, particularly the triple negative. Such differences in breast cancer–intrinsic subtype distribution between population groups might be a consequence of a variety of risk factors differentially present among population groups. Here, we provide a full description of risk factors that might be associated with the high prevalence of the triple-negative subtype in Latina women. We assessed demographic (socioeconomic status), modifiable (reproductive patterns, obesity, and physical activity), and nonmodifiable (family history, germline BRCA mutations, and genetic ancestry) risk factors. The observed inconsistencies among different epidemiologic studies in Latinas warrant further research focused on breast cancer subtype–specific risk factors in this population.
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BevJen, to make your link live, all you have to do is hit return after the link.
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Marjen,
Thanks. A techie I am not!
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You’re welcome BevJen. I’ll say I used to be a techie, but now I only care about a few good years of quality life that I have left and keeping up techwise, well, I just don’t care too much anymore.
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An essential approach in integrative healthcare involves the strategic combination of targeted modalities that work together to increase benefits of conventional therapies. This is particularly essential when addressing cellular health.
A 2017 preclinical study published in BMC Complementary and Alternative Medicine demonstrates that a breast health dietary supplement offers significant support in this area, specifically against the growth of aggressive breast cells.
Performed at the Methodist Research Institute, Indiana University Health, this study highlights the ability of the breast formula to boost the effects of tamoxifen—a hormonal protocol used for cellular breast health—against estrogen receptor-positive (ER-positive) breast cells. This is the fourth published study on this physician-formulated supplement, and the first using ER-positive cells, to demonstrate the vital breast health benefits of this unique formula.*
These outstanding results were also presented June 2019, at the ICCR-2019.Breastdefend Enhances Effect of Tamoxifen in Estrogen ReceptorPositive Human Breast Cancer in Vitro and in Vivo
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- Patient Selection Key When De-Escalating Radiation in Breast Cancer
- Duke Cancer Institute Faculty Describe Latest Efforts in Breast Cancer Research
- Positive Abemaciclib Data Emerge for Chinese Women With HR+ Breast Cancer
- PD-L1 Assays Demonstrate <70% Concordance in Advanced TNBC
- Abemaciclib/Fulvestrant Improves Survival in HR+ Advanced Breast Cancer
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Anti-evolution drug may help treat resistant breast cancers
Many cancer treatments work very well in the beginning only to fail later as tumours evolve resistance. But a new generation of therapies are being developed to prevent this.
One, called BOS172722, has been shown in animal studies to restore the effectiveness of paclitaxel, the main chemotherapy used to treat so-called triple-negative breast cancer...
[BOS172722] binds to and blocks a protein called MPS1 that plays a key role in division. The combination of the two drugs together causes such severe chromosomal abnormalities that none of the cancer cells survive. And if no cells survive, there can be no resistance.
There are some side effects, and the initial aim of the trial is to establish the maximum safe dose.
Also, Breast cancer drug trial raises hopes
The drug - known as BOS172722 - works by forcing cancer cells through cell division too quickly.
Spiros Linardopoulos, professor of cancer biology and therapeutics at the ICR, who led the study, said: "We have discovered a brand new type of cancer treatment that uses cancer's rapid growth against it, by forcing cells through cell division so quickly that they accumulate fatal errors...
According to the study published in the journal Molecular Cancer Therapeutics, cancer cells in dishes treated with the MPS1 inhibitor went through cell division in just 11 minutes, compared with 52 minutes without the drug.
And fast-dividing cells, from triple-negative breast cancers, ovarian and lung cancers, were especially sensitive to the effects of blocking MPS1.
Article: https://www.newscientist.com/article/2218935-anti-...
Study: https://mct.aacrjournals.org/content/18/10/1696.abstract
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Earlier Diagnosis and Treatment Are Next Steps in TNBC Paradigm
There is an unprecedented array of therapeutic options for patients with triple-negative breast cancer, with more approaches on the horizon.
Immunotherapy for Breast Cancer: What's New and What's on the Horizon?
Immunotherapy may finally be taking center stage in breast cancer, although much work remains to be done.
Rugo Highlights Latest Advances in TNBC Treatment
Hope S. Rugo, MD, discusses the latest advancements and clinical trial data in triple-negative breast cancer treatment.
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Short Courses of Antibiotics Can Cause Big Problems for Dental Patients
Unnecessary antibiotics linked with cases of C. diff, anaphylaxis
Some dental patients who were inappropriately given antibiotics prior to procedures suffered adverse events potentially connected to the drugs, such as anaphylaxis and Clostridioides difficile infection, researchers said here. Of patients inappropriately prescribed antibiotic prophylaxis prior to a dental procedure, almost 4% had adverse events ranging from new allergies and emergency department visits to anaphylaxis and C. difficile infection... Dentists prescribe 10% of antibiotics in the U.S., and are the largest specialty prescriber....o put that into perspective, she added, pediatricians and internists prescribe 10%-12% of all antibiotics in the U.S.
https://www.medpagetoday.com/meetingcoverage/idwee...
{Many of us face dental issues while being treated for b.c. so this article seemed uniquely relevant.}
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Novel CDK 4/6 Inhibitor Fails in Triple Negative Breast Cancer
Misses primary endpoints but has unexpected key benefit
Attempting to limit adverse events with the investigational cyclin-dependent kinase (CDK) 4/6 inhibitor trilaciclib in triple-negative breast cancer failed to do what investigators theorized, missing both primary and secondary endpoints, researchers reported here. Nevertheless, treatment was still associated with improved overall survival relative to a standard chemotherapy regimen. Median overall survival was 12.6 months for women who were treated with gemcitabine plus carboplatin vs 20.1 months for those who had trilaciclib added twice during each 21-day treatment cycle with the chemotherapy doublet (P=0.0023), and 17.8 months for those who received trilaciclib four times per cycle... treatment was still associated with improved overall survival relative to a standard chemotherapy regimen.
"Patients who didn't receive trilaciclib were able to handle four cycles of chemotherapy, and those who received one of the two trilaciclib administration schedules were about to handle seven or eight cycles of gemcitabine-carboplatin, which translated to receiving 50% more chemotherapy in the trilaciclib arms. But there were no differences between the groups in side effects." ...that suggests some degree of bone marrow protection, because we were able to give more chemotherapy without having any statistically greater adverse events,"
"There is definitely interest in going ahead with a Phase III trial with gemcitabine and carboplatin plus or minus trilaciclib."
https://www.medpagetoday.com/meetingcoverage/esmo/...
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MedPage Today's coverage from the 2019 European Society for Medical Oncology (ESMO) congress is a wrap -- check out the latest practice-informing news here.
https://www.medpagetoday.com/meetingcoverage/esmo
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OIG Report: Ambulatory Surgery Center Inspections Lag
Report says states failed to inspect 147 facilities for 6 years, violating Medicare rules
Dozens of states, some of them very large, didn't meet Medicare's requirement that they survey their ambulatory surgery centers (ASCs) at required intervals to assure they met safety protocols, such as infection control or anesthesia administration, and many facilities went without any state survey for at least 6 years.
That's the finding of a recent report from the U.S. Department of Health and Human Services' Office of Inspector General (OIG). The agency took some states to task for not following two rules during fiscal years 2013-2017 -- made more imperative now that Medicare and commercial insurers reimburse ASCs for increasingly risky procedures.
https://www.medpagetoday.com/publichealthpolicy/he...
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Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis
BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5221 (Published 18 September 2019) Cite this as: BMJ 2019;366:l5221Objective To examine the design characteristics, risk of bias, and reporting adequacy of pivotal randomised controlled trials of cancer drugs approved by the European Medicines Agency (EMA).
Design Cross sectional analysis.
Setting European regulatory documents, clinical trial registry records, protocols, journal publications, and supplementary appendices.
Eligibility criteria Pivotal randomised controlled trials of new cancer drugs approved by the EMA between 2014 and 2016.
Main outcome measures Study design characteristics (randomisation, comparators, and endpoints); risk of bias using the revised Cochrane tool (bias arising from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result); and reporting adequacy (completeness and consistency of information in trial protocols, publications, supplementary appendices, clinical trial registry records, and regulatory documents).
Results Between 2014 and 2016, the EMA approved 32 new cancer drugs on the basis of 54 pivotal studies. Of these, 41 (76%) were randomised controlled trials and 13 (24%) were either non-randomised studies or single arm studies. 39/41 randomised controlled trials had available publications and were included in our study. Only 10 randomised controlled trials (26%) measured overall survival as either a primary or coprimary endpoint, with the remaining trials evaluating surrogate measures such as progression free survival and response rates. Overall, 19 randomised controlled trials (49%) were judged to be at high risk of bias for their primary outcome. Concerns about missing outcome data (n=10) and measurement of the outcome (n=7) were the most common domains leading to high risk of bias judgments. Fewer randomised controlled trials that evaluated overall survival as the primary endpoint were at high risk of bias than those that evaluated surrogate efficacy endpoints (2/10 (20%) v 16/29 (55%), respectively). When information available in regulatory documents and the scientific literature was considered separately, overall risk of bias judgments differed for eight randomised controlled trials (21%), which reflects reporting inadequacies in both sources of information. Regulators identified additional deficits beyond the domains captured in risk of bias assessments for 10 drugs (31%). These deficits included magnitude of clinical benefit, inappropriate comparators, and non-preferred study endpoints, which were not disclosed as limitations in scientific publications.
Conclusions Most pivotal studies forming the basis of EMA approval of new cancer drugs between 2014 and 2016 were randomised controlled trials. However, almost half of these were judged to be at high risk of bias based on their design, conduct, or analysis, some of which might be unavoidable because of the complexity of cancer trials. Regulatory documents and the scientific literature had gaps in their reporting. Journal publications did not acknowledge the key limitations of the available evidence identified in regulatory documents.
https://www.bmj.com/content/366/bmj.l5221
{entire article is available for review}
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Why the Women Most Likely to Die of Breast Cancer Have Gotten the Least Attention
https://time.com/5689570/metastatic-breast-cancer-...
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Thanks Marijen, good article
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Hormone Therapy Has a Bigger Impact Than Chemotherapy on Women's Quality of Life [for early stage breast cancer]
Analysis of the CANTO cohort published in the journal Annals of Oncology will upset received wisdom on the effects that hormone therapy and chemotherapy have on the quality of life in women with breast cancer. Contrary to the commonly held view, 2 years after diagnosis, hormone therapy, a highly effective breast cancer treatment worsens quality of life to a greater extent and for a longer time, especially in menopausal patients. The deleterious effects of chemotherapy are more transient. Given that current international guidelines recommend the prescription of hormone therapy for 5 to 10 years, it is important to offer treatment to women who develop severe symptoms due to hormone antagonist medication and to identify those who might benefit from less prolonged or intensive treatment strategies.
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