Breaking Research News from sources other than Breastcancer.org
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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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debbew (and others,) I am ignorant on the issue of hormonal therapy, as I was diagnosed with triple negative cancer. Is there some either-or treatment for hormone positive treatments, like, you can do chemo OR you can do hormonal therapy? I'm thinking of the often used either-or of mastectomy OR lumpectomy with rads.
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debbew, great post. I failed letrozole after 24 months. Makes me feel a little better about it.
Mountain Mia, hormonal therapy is usually an ‘addition to’ treatment. But it can be used alone without surgery, radiation or chemo.
Thanks Karen. Good luck to you, 11 years cancer free - congrats. How were your lung mets found?
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MountainMia, as marijen noted, (anti)hormonal treatment is often offered for ER positive bc in conjunction with other possible treatments. I've read that about half of women prescribed hormonal treatment are non-compliant (and guessing the actual percentage is even higher, since I'm sure many women don't inform their doctors that they have stopped or reduced their dosage).
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Course and predictors of post‐traumatic stress disorder in a cohort of psychologically distressed patients with cancer: A 4‐year follow‐up study
BACKGROUND
Scant evidence exists on the long‐term course of cancer‐related post‐traumatic stress disorder (PTSD). This is among the few studies worldwide, and the first in the South‐East Asian region, to prospectively evaluate PTSD in patients with cancer using gold‐standard clinical interviews. The objective of the study was to assess the course and predictors of PTSD in adult patients with cancer in a South‐East Asian population.
METHODS
A prospective, longitudinal study was conducted in a cohort of 469 consecutively recruited patients (aged ≥18 years) with various cancer types within 1 month of diagnosis at a single oncology referral center. Only patients who had significant psychological distress (Hospital Anxiety and Depression Scale total cutoff score ≥16) underwent the PTSD module of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (SCID) at at 6‐months follow‐up. All patients completed the SCID at the 4‐year follow‐up assessment regardless of their initial Hospital Anxiety and Depression Scale score.
RESULTS
In an analysis combining patients who had both full and subsyndromal PTSD, there was a 21.7% incidence of PTSD at the 6‐month follow‐up assessment (n = 44 of 203 SCID‐interviewed patients), with rates dropping to 6.1% at the 4‐year follow‐up assessment (n = 15 of 245 SCID‐interviewed patients). Patients with breast cancer (compared with those who had other types of cancer) were 3.68 times less likely to develop PTSD at 6‐months, but not at 4‐years follow‐up.
CONCLUSIONS
The overall rates of PTSD decreased with time, but one‐third of patients (34.1%) who were initially diagnosed had persistent or worsening PTSD 4 years later. There is a need for early identification of this subset of patients who have cancer with PTSD to design risk‐targeted interventions. Cancer 2018;124:406‐16. © 2017 American Cancer Society.
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I found the following article very frustrating for its lack of details about the vaccine/studies; I believe they must be referring to the study in this announcement for a HER2/neu-targeted breast cancer vaccine, TPIV110.
New cancer vaccine shows promise, helped kill cancer cells in patient
A vaccine undergoing testing at the Mayo Clinic has reportedly removed cancer cells in a breast cancer patient. Florida resident Lee Mercker became the first patient to participate in a clinical trial for a new vaccine after being diagnosed in March with early-stages of the disease [DCIS].
Dr. Saranya Chumsri says the vaccine helps the body fight cancer cells.
"It's supposed to stimulate a patient's own immune response so that the immune cells like t-cells would go in and attack the cancer," Chumsri said.
For Mercker, it worked. She says it was just a 12-week process...
[Chumsri] says eventually, they hope it can be used to prevent cancer entirely.
Chumsri says they've made such incredible strides because of people who participate in the clinical trials. She says they've got trials for all stages of cancer, even having Stage 4 cancer patients showing positive results.
If you'd like to learn more about how to join a clinical trial at Mayo Clinic, call 1-855-776-0015.
Edited to add: Here's a more informative article:
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Imaging tumor stiffness could help enhance treatment for breast and pancreatic cancer
Magnetic resonance elastography was able to visualise and measure how stiff and dense tumours are in mice. The technique, which can be implemented on conventional clinical MRI scanners, may help select the best treatment course for some cancer patients.
Scientists at The Institute of Cancer Research, London, found that using their new type of scan could assess the contribution of collagen to relative stiffness across a number of different tumour types.
This in turn could identify tumours in which there is the potential to use new drugs designed to 'weaken' the structure holding together tumours—thereby giving other drugs access to cancer cells in the centre of the tumour...
Initial studies established that collagen was key to keeping breast and pancreatic cancers stiff and inaccessible to treatments. In contrast, tumours arising from the nervous system, such as some forms of childhood cancer and brain tumours, were relatively soft and lacking in collagen.
The study, published in the journal Cancer Research today, was largely funded by the European Union, Cancer Research UK and the Rosetrees Trust...
the researchers found that the administration of collagenase resulted in a clear overall reduction in the elasticity and viscosity of breast tumours in mice—both of which fell by around a fifth.
The ICR researchers found that MR elastography provided extra details about tumour structure and density in addition to the information about growth and size given by standard MRI scans.
https://medicalxpress.com/news/2019-10-imaging-tumor-stiffness-treatment-breast.html
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Jane McClelland posted this today on my Repurposed Drugs FB group:
The drug Repertaxin may be a way of targeting this rogue CXCR2 receptor in breast cancer. I was recently investigating this drug for prostate cancer. Here is some info on its use in combination with chemo for gastric cancer: https://www.ncbi.nlm.nih.gov/m/pubmed/26847910/
https://www.sciencedaily.com/releases/2019/10/191007123245.htm
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Clinical Challenges: Brain Mets in HER2-Positive Breast Cancer
Multidisciplinary approach key as patients with brain metastases live longer
Over the last decade, there has also been a shift in the treatment of breast cancer with brain metastases, with clinicians now considering the use of systemic therapy in place of or in addition to local therapy, according to Jane Meisel, MD, of Winship Cancer Institute in Atlanta.
"In the past a lot of trials excluded these patients, but now more and more are including them, particularly patients with stable metastases after radiation," Meisel said. "Getting this type of real-world data, in this rapidly changing field, is more important than ever."
"... we ... see patients living 5 years or longer with brain metastases," Lin said.
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This is not breaking but very informative.
Neuropathy in the Cancer Patient: Causes and Cures
Identifying the causes of neuropathy in cancer patients can be difficult. This review looks at the common causes of neuropathy in cancer patients, as well as effective therapies—and even preventions.
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Breast Cancer Brain Metastases: New Initial Therapy Options
September 17, 2019
https://www.medscape.com/viewarticle/917894?src=mk...
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'How Long Do I Have?' Tackling Oncology's Most Difficult Question
It's a question that cuts to the heart of patients' concerns.
Even with the help of big data and online prognostic tools, immunotherapies and targeted treatments have made this question very difficult to answer. This is where prognosticating becomes more of an art than a science, and one that requires a careful, step-by-step approach based on clinical experience and intuition.
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Concordance of Genomic Variants in Matched Primary Breast Cancer, Metastatic Tumor, and Circulating Tumor DNA
The MIRROR Study
Purpose: Genetic heterogeneity between primary tumors and their metastatic lesions has been documented in several breast cancer studies. However, the selection of therapy for patients with metastatic breast cancer and the search for biomarkers for targeted therapy are often based on findings from the primary tumor, mainly because of the difficulty of distant metastasis core biopsies. New methods for monitoring genomic changes in metastatic breast cancer are needed (ie, circulating tumor DNA [ctDNA] genomic analysis). The objectives of this study were to assess the concordance of genomic variants between primary and metastatic tumor tissues and the sensitivity of plasma ctDNA analysis to identify variants detected in tumor biopsies.
Patients and Methods: Next-generation sequencing technology was used to assess the genomic mutation profile of a panel of 54 cancer genes in matched samples of primary tumor, metastatic tumor, and plasma from 40 patients with metastatic breast cancer.
Results: Using Ion Torrent technology (ThermoFisher Scientific, Waltham, MA), we identified 110 variants that were common to the primary and metastatic tumors. ctDNA analysis had a sensitivity of 0.972 in detecting variants present in both primary and metastatic tissues. In addition, we identified 13 variants in metastatic tissue and ctDNA not present in primary tumor.
Conclusion: We identified genomic variants present in metastatic biopsies and plasma ctDNA that were not present in the primary tumor. Deep sequencing of plasma ctDNA detected most DNA variants previously identified in matched primary and metastatic tissues. ctDNA might aid in therapy selection and in the search for biomarkers for drug development in metastatic breast cancer.
August 15, 2019
https://www.medscape.com/viewarticle/916337?src=mk...
JCO Precis Oncol. 2019;2019(3)
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On-treatment Biomarkers Can Improve Prediction of Response to Neoadjuvant Chemotherapy in Breast Cancer
Breast Cancer Research August 09, 2019
Background: Neoadjuvant chemotherapy is increasingly given preoperatively to shrink breast tumours prior to surgery. This approach also provides the opportunity to study the molecular changes associated with treatment and evaluate whether on-treatment sequential samples can improve response and outcome predictions over diagnostic or excision samples alone.
Conclusion: Changes in gene expression measured in sequential samples from breast cancer patients receiving neoadjuvant chemotherapy resulted in the identification of a potentially novel on-treatment biomarker and suggest that established prognostic tests may have greater prediction accuracy on than before treatment. These results support the potential use and further evaluation of on-treatment testing in breast cancer to improve the accuracy of tumour response prediction.
https://www.medscape.com/viewarticle/915855?src=mk...
Breast Cancer Res. 2019;21(73)
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Sunday Is Metastatic Breast Cancer Awareness Day
October 13, 20198:00 AM ET
Heard on NPR's Weekend Edition Sunday
NPR's Lulu Garcia Navarro talks to Dr. Filipa Lynce, a medical oncologist, and Julia Maues, a woman living with metastatic breast cancer, about what more can be done to fight the deadly disease.
{Quick listen: 6:45 in length}
https://www.npr.org/2019/10/13/769848661/sunday-is...
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MacroGenics looks to future with breast cancer drug margetuximab
June 3, 2019
A small biotech, MacroGenics, took the market by surprise earlier this year with some surprising data from its margetuximab – essentially a tweaked version of Roche's Herceptin (trastuzumab) where a few amino acid mutations are enough to produce a stronger cellular response to cancer.
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New Cancer Vaccine Shows Shows Early Promise In Human Clinical Trials
Doctors say a new vaccine undergoing clinical trials at the Mayo Clinic has effectively removed cancer cells, providing new hope for cancer survivors.
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'Unacceptable' delays in diagnosing secondary {metastatic} breast cancer
One in four patients with secondary {metastatic} breast cancer had to visit their GP three or more times before they got a diagnosis, a survey suggests.
A breast cancer charity said there should be more awareness that the disease can spread to other parts of the body.
Breast Cancer Now said it was "unacceptable" that some people whose cancer had spread were not getting early access to treatments which could alleviate symptoms and improve their quality of life.
https://www.bbc.com/news/health-49999404?ocid=soci...
{Kudos to Breast Cancer Now for this advocacy work!}
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Multigene Testing for All Patients With Breast Cancer Is Cost-Effective
- JAMA Oncology Published online October 3, 2019. The authors of this cost-effectiveness microsimulation modeling study estimated the incremental lifetime effects, costs, and cost-effectiveness of multigene testing for all patients with breast cancer. The authors found unselected, high-risk multigene testing to be cost-effective compared with testing based on family history or clinical criteria for both the UK and US healthcare systems. This study provides evidence to support the expansion of genetic testing to all women with breast cancer.https://www.practiceupdate.com/C/90665/56?elsca1=e...https://jamanetwork.com/journals/jamaoncology/full...doi:10.1001/jamaoncol.2019.3323
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Unraveling the Mystery of What Gives Exceptional Responders Their Superpower
A Conversation With Isaac S. Kohane, MD, PhD
{About a year old but an interesting discussion about Exceptional Responders.}
https://www.ascopost.com/issues/august-25-2018/unr...
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Following NCCN Guidelines for Metastatic Breast Cancer Results in Lower Costs for Patients, According to New Study
Guideline Discordance and Patient Cost Responsibility in Medicare Beneficiaries With Metastatic Breast Cancer
A new study from the O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham (UAB), published in the October 2019 issue of JNCCN—Journal of the National Comprehensive Cancer Network, finds that direct costs for metastatic breast cancer (MBC) patients increase dramatically when their treatment differs from recommendations in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Previous studies have found that guideline discordant care results in higher health care costs overall[1], but this is the first study to look specifically at the cost burden for patients.
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Talking about Toxicity — "What We've Got Here Is a Failure to Communicate"
Improving communication with patients about treatment risks and benefits has long been recognized as a critical priority. But perhaps a necessary first step is for investigators to communicate with clinicians openly and specifically about the toxic effects of treatment.October 10, 2019
N Engl J Med 2019; 381:1406-1408
DOI: 10.1056/NEJMp1908310https://www.nejm.org/doi/full/10.1056/NEJMp1908310...
{NEJM allows access to two articles per month without subscription.} -
I'm sorry: Why I lost my love for medicine
Anonymous | Physician | July 31, 2019
{A physician reflects on his/her disillusion with the practice of medicine and commitment to redeem a sane existence in the wake of a broken system. Link provided by a physician friend.}
https://www.kevinmd.com/blog/2019/07/im-sorry-why-...
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Lumpie, I registered and read the Talking about Toxicity — "What We've Got Here Is a Failure to Communicate" article. Thank you so much for sharing that one. Very, very helpful.
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