Breaking Research News from sources other than Breastcancer.org
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Thanks Moth and MinusTwo I'll keep my eye out. I'm also going in for Booster #2 next week so I'll ask them if they have any information as well.
The study is still on going so they were only supposed to present interim findings and, maybe some stuff on Phase 1.
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Healthcare cost of HER2-positive and negative breast tumors in the United States (2012–2035)
The approach to advanced breast cancer has been revolutionized by targeted agents.
•The total cost of HER2-positive patients was estimated for $2,719,542,347 in 2012.•The total estimated cost for HER2-negative patients in 2012 was $8,376,028,459.•In 2035, we estimated a cost of $3.6 and $11.2 bilions for HER2+ and HER2− tumors.•The cost of HER2-negative tumors should be carefully evaluated in the coming years."...our data strongly suggest that cost-analyses should be carefully evaluated in the coming years, aimed to improve the cost-effectiveness of targeted approaches for advanced BC, in particular in patients with HER2-negative tumors. This will be crucial to guarantee the access to cure for all cancer patients and the future economic sustainability of health system."
https://www-sciencedirect-com.ezproxy.liberty.edu/...
https://doi.org/10.1016/j.ctrv.2017.08.005
{This article was evidently published in 2017, but I only recently located a link. It is a bit cringeworthy because the implication seems to me to be that we are not worth the high cost. Of course, it is mostly the drugs.... which, thankfully, are often effective, but which we know to be astronomically unaffordable. The costs/prices they cite are dramatically higher than my shocking EOB's. I can't quite make sense of that. Access to full article seems to be free.}
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Found this interesting from Loma Linda.
Blood Test Finds 50 Types of Cancer
We reported in our August BOB Tales about this test that was invented by Grail, a biotechnology company in Menlo Park, CA. Mayo Clinic has partnered with Grail in the development of the test, which is known as "Galleri." This new test looks for signals in the blood stream that are associated with specific cancers. Cancer-specific information is carried in bloodstream DNA. According to a recent article in Health Care, "The Galleri test uses next generation sequencing and machine-learning algorithms to analyze methylation patterns of cell-free DNA," which helps identify specific cancers. Cells regulate gene expression using DNA methylation. The Galleri test can also pinpoint the location of the disease allowing doctors to select appropriate treatments to target and destroy the cancer.
Having access to a single blood test that can detect 50 types of cancer is significant. The Health Care report states, "Currently recommended cancer screenings in the U.S. cover only five types of cancer and can screen for only one type at a time." Yet, 71 percent of cancer deaths are caused by cancers that are not commonly screened for, according to Grail. False positives with the Galleri test are low, according to researchers, at about one in 200 people tested.
The test is recommended for adults, typically over 50 with an elevated risk for cancer. It should not be a substitute for currently approved tests, such as colonoscopies or mammograms.
Galleri and Mayo Clinic have not received FDA approval for this new test, and insurers do not cover the $949 cost. This blood test is, however, available to the general public and must be administered by a licensed health care provider.
FDA approval for this breakthrough blood test is expected soon and we will report here when that happens.
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The FDA has granted emergency use authorization to an antibody combination called Evusheld that is highly effective at preventing COVID-19 infection in immune compromised patients. Press release here.
https://www.astrazeneca.com/media-centre/press-rel...
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Perhaps some readers of this forum listen to NPR and their Morning Edition newscast. If so, you have probably heard reporting by journalist Ina Jaffe. She disclosed over the summer that she has been diagnosed with MBC. Below are links to a couple of articles she has published on the topic. While this news is very sad and disappointing to hear, perhaps it will lead to more meaningful coverage of MBC in the media. It amazes me how many people think that breast cancer has been "cured."
https://www.npr.org/2021/06/22/1009065462/breast-c...
https://www.npr.org/sections/health-shots/2021/12/...
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Most Oncologists Discuss Drug Side Effects, Open to Reduce Doses
Roxanne Nelson, RN, BSN
December 15, 2021
Many patients with metastatic breast cancer (MBC) experience distressing toxicity related to treatment.
According to a new survey, all oncologists reported talking to their patients about side effects at every visit and nearly all (97%) were open to lowering medication doses.
The findings, presented during a poster session at the 2021 San Antonio Breast Cancer Symposium (SABCS), were encouraging to Charles Shapiro, MD, of the Icahn School of Medicine at Mount Sinai in New York City.
"I think this survey confirms that a lot of oncologists are willing to reduce the dose if patients have side effects, and a high percentage discuss side effects with their patients," said Shapiro, who was not involved in the study.
Anne L. Loeser, who has MBC and is co-author of the survey alongside a team of oncologists, agreed that it is vitally important for doctors to discuss toxicity and take patients' quality of life into consideration.
"Patients with MBC are incurable — albeit treatable — and the majority will remain on therapy for the rest of their lives," Loeser, founder of the Patient-Centered Dosing Initiative (PCDI), told Medscape Medical News. "Understandably, we want to make the most of the time we have left."
When patients begin treatment, oncologists often prescribe the recommended starting dose, which is based on the clinical trial results used to approve the drug. However, patient tolerance for this dose in the real-world setting often differs from that of clinical trial participants, the survey authors note.
In fact, Loeser said, "this dose generally precipitates the most, and worst, side effects."
In a previous survey, the team of researchers found that, among 1221 patients with MBC, 86% experienced at least one significant treatment-related side effect and almost all were willing to discuss individualized dosing with their physicians. The current study expands on that research, highlighting responses about treatment side effects and dosing options from medical oncologists.
In the new study, a confidential, 28-question online survey was sent to US medical oncologists identified via professional organizations, social media, and email lists. The objective of the survey was to gain a better understanding of oncologists' perspectives regarding the prevalence and severity of treatment-related toxicity, increase recognition of the impact of dosage-related mitigation strategies on clinical outcomes, and determine their willingness to discuss flexible dosing options.
A total of 119 medical oncologists participated in the survey. Of this group, 85% specialized in breast cancer, 66% worked in an academic setting, and 82% had been in practice for more than 5 years.
Overall, respondents estimated that nearly half of their patients had reported a distressing treatment-related side effect, 15% visited the emergency department or hospital for this reason, and 37% required a break from treatment. The most common mitigation strategies included prescribing supportive medication, offering suggestions for palliation, and lowering the medication dose.
All respondents reported reducing medication doses as a means of alleviating side effects; 74% reported that dose reduction helped relieve side effects; and 71% indicated that efficacy of the reduced dose was similar to that of the standard dose.
Notably, 60% of oncologists indicated that patients felt better when therapy began with a lower starting dose rather than the standard dose, and 59% indicated that treatment efficacy was similar to the standard dose. The drugs, or drug classes, most commonly prescribed at lower initial doses were capecitabine (91%), taxanes (60%), and palbociclib (50%).
The authors concluded that "these patient-centered dosing discussions should be part of routine care and may consequently improve [quality of life] for patients with MBC."
In the past, quality of life and quantity of life were perceived as an "either/or" proposition, but that mentality is changing, Loeser said. "In fact, the [US Food and Drug Administration] is moving away from the concept of maximum tolerated dose in favor of identifying the optimal dose with regard to safety and efficacy."
Loeser also noted that toxicity-related side effects not only affect quality of life, they also affect treatment options. These side effects "may force some patients to stop a working treatment prematurely," she said. In addition, "cumulative side effects that build up over successive treatments may preclude patients from [using] the full list of therapies available to them because they can no longer withstand the toxicities from further drugs."
Some survey participants also posted comments in the survey, elaborating on how they communicate with patients and manage treatment-related toxicities.
One oncologist emphasized the need for an individualized approach to dose adjustments: "Like other decisions, this requires good communication and an effort to understand patients' preferences and expectations, so that an informed decision can be made."
Another participant noted that "it is critical to be able to vary dose based on the individual, as well as the biology of their cancer. It is quite likely that lower doses are less effective in some cases, but this can be sorted out as treatment is ongoing."
For certain patients, dose reduction may not be the best option, one respondent said. "In some cases, it may be prudent to go a step further and move to best supportive care rather than reduce dose, particularly for late line therapy or indolent disease."
For Shapiro, establishing a strong partnership between physician and patient is critical to ensuring patients get the best care possible.
"You rely on patients to tell you what's working and what isn't with the drug, and we can make adjustments," he said. "It can be the greatest drug in the world, but if your patient can't tolerate it, then it isn't going to do much good."
The survey was conducted by PCDI. Loeser is the founder of the PCDI.
SABCS 2021. Abstract P4-10-09. Presented December 9, 2021
https://www.medscape.com/viewarticle/964899?uac=21...
{Free access.}
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Oncolytic Virus Clinical Trial Opens for Patients With Advanced [TN] Breast Cancer
City of Hope recently announced the opening of a phase 1 clinical trial for an investigational therapy in patients with metastatic triple-negative breast cancer. The trial is a first-in-human analysis of using an oncolytic virus, which is a cancer-killing virus, to treat patients.
The researchers at City of Hope created a genetically engineered therapy, CF33-hNIS-antiPDL1, from the naturally occurring oncolytic virus. The therapy is intended to infect, replicate and kill cancer cells while leaving healthy cells untouched...
"It is an exciting time in immuno-oncology. Preclinical research has shown that this oncolytic virus can direct the killing of cancers and stimulate the immune system to enable further killing of cancers," said Dr. Yuman Fong, the Sangiacomo Family Chair in Surgical Oncology at City of Hope who developed CF33, in a news release. "This trial is an important step forward."
https://www.curetoday.com/view/oncolytic-virus-cli...
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Great article Lumpie, as one who has required dosage reductions on every treatment so far and had to tolerate significant side effects to get to that point.
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ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer
October 2021
https://www.annalsofoncology.org/article/S0923-7534(21)04498-7/fulltext
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Moth,
Thanks so much for posting the ESMO link. Great information.
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Agreed, moth. That was wonderful information. I am reading and re-reading and highlighting. Thanks!
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https://www.cancer.gov/news-events/cancer-currents...
on the relationship between stress and the return of cancer
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This trial is for triple negative advanced breast cancer.
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BevJen,
Thanks for the link to the reporting on the link between stress and cancer. Ugh! Just what we don't need. We mostly focus on our own cancers and those of family and friends, but that could have all kinds of crazy implications for public health.
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Lumpie,
It just caught my eye. After many years (8-9 years) when my cancer was quiet, I ran into a few years where my life was extremely stressful in an uncontrollable way -- illness and death of a sibling, illness and death of a parent, several other issues -- and boom, major recurrence. Perhaps stress is not the cause of all recurrence, but to me, the article just makes sense.
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BevJen, Yes, my life was very stressful in the years leading up to my becoming sick and eventually being diagnosed. I have often wondered to what extent this contributed to the cancer's development and progression. Thx again.
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In the midst of covid, are you tired of wandering around in a fog trying to figure out what activities are risky and which are less so? Aren't we all! I thought I would share this risk calculator from the Canadian National Institute on Aging. It seems pretty good. to use it, you need to answer several questions about anticpated circumstances. The information/assessment is available in both English and French.
https://covidvisitrisk.com/riskscore-english.html
If you want a more abbreviated descriptive tool, the Virginia Department of Health has an info graphic that is useful here:
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'First Reliable Estimate' of Breast Cancer Metastasis
For the first time, there are now 'reliable' data to show what proportion of women with breast cancer go on to develop metastatic disease.
The data come from a massive meta-analysis of more than 400 studies conducted around the world, involving tens of thousands of women.
It found that the overall risk of metastasis is between 6% and 22%, with younger women having a higher risk.
While women aged 50 years or older when they were diagnosed with breast cancer have a risk of developing metastasis that ranged from 3.7% to 28.6%, women diagnosed with breast cancer before age 35 had a higher risk — 12.7% to 38%. The investigators speculate that this may be because younger women have a more aggressive form of breast cancer or because they are diagnosed at a later stage.
The risk of metastasis also varies by tumor type, with luminal B cancers having a 4.2% to 35.5% risk of metastasis vs a 2.3% to 11.8% risk with luminal A tumors.
"The quantification of recurrence and disease progression is important to assess the effectiveness of treatment, evaluate prognosis, and allocate resources," commented lead investigator Eileen Morgan, PhD, of the International Agency for Research on Cancer.
Morgan and colleagues presented the new meta-analysis at the virtual Advanced Breast Cancer Sixth International Consensus Conference.
She added that this information has not been available until now "because cancer registries have not been routinely collecting this data."
In fact, the US National Cancer Institute began a project earlier this year to track this information, after 48 years of not doing so.
Reacting to the findings, Shani Paluch-Shimon, MBBS, director of the Breast Unit at Hadassah University Hospital, Jerusalem, Israel, commented that this work "provides the first reliable estimate of how many breast cancer patients go on to develop advanced disease in contemporary cohorts."
"This information is, of course, important for patients who want to understand their prognosis," she continued.
"But it's also vital at a public health level for those of us working to treat and prevent advanced breast cancer to help us understand the scale of the disease around the world," she said. "It will help us identify at-risk groups across different populations and demonstrate how disease course is changing with contemporary treatments.
"It will also help us understand what resources are needed and where, to ensure we can collect and analyze quality data in real-time as this is key for resource allocation and planning future studies."
The work was funded by a grant from the Susan G. Komen Foundation.
Advanced Breast Cancer Sixth International Consensus Conference: Abstract Abstract OR91. Presented October 15, 2021.
Source: https://www.medscape.com/viewarticle/962289?uac=21...
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Which Fully Vaccinated Adults Are Most at Risk of Severe COVID?
— Study examines which factors did, and didn't, play a role in risk
A significant proportion of all fully vaccinated adults who died of COVID-19 had at least four risk factors associated with severe outcomes, researchers found.
In addition to older age (65 and up) and being immunosuppressed, having chronic kidney, cardiac, pulmonary, neurologic, or liver diseases, as well as diabetes, were all associated with higher odds of severe COVID outcomes, and 77.8% of fully vaccinated adults who died had at least four of these risk factors, reported Sameer Kadri, MD, of the NIH Clinical Center in Bethesda, Maryland, and colleagues in the Morbidity and Mortality Weekly Report.
However, there were no increased odds of severe outcomes associated with sex, race/ethnicity, time since primary vaccination, or whether the infection occurred during the Delta variant wave.
Kadri and team examined data from 465 U.S. healthcare facilities in the Premier Healthcare Database Special COVID-19 Release from December 2020 to October 2021, which included adults who were either fully vaccinated, received a third dose as part of their primary series, or received a booster dose after their primary series. Severe outcomes were defined as hospitalization with acute respiratory failure, non-invasive ventilation, ICU admission, and death.
Overall, 1,228,664 adults completed a primary vaccination series, and of those, 2,246 contracted COVID-19. Of these, 327 were hospitalized, 189 had a severe outcome, and 36 had a COVID-related death.
Not surprisingly, older age was associated with a higher risk of death (adjusted OR [aOR] 3.22, 95% CI 1.81-5.74), as was immunosuppression (aOR 1.91, 95% CI 1.37-2.66).
Of the six conditions, chronic pulmonary disease (aOR 1.69, 95% CI 1.31-2.18), liver disease (aOR 1.68, 95% CI 1.12-2.52), and kidney disease (aOR 1.61, 95% CI 1.19-2.19) were associated with the highest odds of severe outcomes.
Interestingly, Pfizer vaccine recipients had comparable risks of severe outcomes to those who received the Johnson & Johnson vaccine (aOR 0.70, 95% CI 0.39-1.26), while these risks were lower for those who received Moderna (aOR 0.56, 95% CI 0.32-0.98).
Kadri and colleagues noted that all adults with severe COVID outcomes had at least one of the eight risk factors. Only 19% of all adults with four or more risk factors had non-severe outcomes, while 57% had respiratory failure or were admitted to an ICU.
Among 36 adults who died, 15 had do-not-resuscitate orders at the time of hospital admission, and nine were discharged to hospice.
The authors noted that these results may not be applicable to time periods when other variants were predominant in the U.S.
Source: https://www.medpagetoday.com/infectiousdisease/cov...
Primary Source
Morbidity and Mortality Weekly Report
{Strangely, this article actually made me feel a little better. Of the over 1.2 million people diagnosed with covid, few actually died. Those who did tended to have multiple co-morbidities.}
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Risk for Breast Cancer Recurrence Persists Past 30 Years
For the first time, new data show that risk for breast cancer recurrence extends past 30 years.
The data come from a Danish study involving 20,315 women who were treated for early operable breast cancer between 1987 and 2004, and all of whom were disease-free at 10 years.
Further follow-up showed that 2595 women had a breast cancer recurrence more than 10 years after their primary diagnosis.
The cumulative incidence of recurrence was 8.5% at 15 years; 12.5% at 20 years; 15.2% at 25 years, and 16.6% at 32 years.
Recurrence risk was greatest early in the study period.
Women who had primary tumors larger than 20 mm, lymph node-positive disease, and estrogen receptor-positive tumors were at higher risk for late recurrence.
"Such patients may warrant extended surveillance, more aggressive treatment, or new therapy approaches," said the investigators, led by Rikke Pedersen, MD, a PhD candidate in epidemiology at Aarhus University Hospital in Denmark.
"Our observed high cumulative incidence of late breast cancer recurrence is a concern given the increasing prevalence of long-term survivors." Among other things, a new model to better select women for prolonged surveillance is needed, they said.
The new findings were published online November 8 in the Journal of the National Cancer Institute (NCI).
This study confirms previous investigations, but it is the first to report that breast cancer can recur more than 30 years after diagnosis, note the authors of an accompanying editorial, Serban Negoita, MD, DrPH, and Esmeralda Ramirez-Peña, PhD, MPH, both from the National Cancer Institute.
The caveat is that treatment has evolved considerably since the women in the study were diagnosed, so the prognostic value of the findings with current treatment regimens is uncertain, they note. Some studies haven't found a recurrence benefit for aggressive upfront treatment, but those studies had shorter follow-ups.
Research into the issue is "increasingly important" to guide clinical management and counsel women who are living longer after their primary diagnosis, they comment.
Further Details from the Study
Data for the study came from the Danish Breast Cancer Group clinical database and other national databases. The researchers focussed on women who were disease-free at 10 years after their primary diagnosis, which was stage I or II disease. Median age was 55 years.
Cumulative incidence for breast cancer recurrence was highest for grade 1 tumors with four or more positive lymph nodes (37.9% 10-25 years after the primary diagnosis) and was lowest for patients with grade 3 disease and no involved lymph nodes (7.5%).
The finding of higher recurrence incidence with lower grade tumors goes against some previous reports, the researchers commented. It may be that some tumors considered lower risk decades ago, and treated accordingly, would be considered higher risk in more recent times.
The cumulative incidence of late recurrence was also higher in younger patients and those treated with breast-conserving surgery instead of mastectomy, the team reported.
Adjusted hazard ratios followed the incidence trends, with higher hazards of recurrence for women diagnosed before age 40 as well as those who had breast-conserving surgery, four or more positive lymph nodes, and primary tumors 20 mm or more across.
The work was funded by the Danish Cancer Society and Aarhus University. Lead author Pedersen reports no disclosures, but co-authors report ties to Amgen, Novo Nordisk, Roche, and other companies. The editorialists have disclosed no relevant financial relationships.
J Natl Cancer Inst. Published online November 8, 2021. Abstract, Editorial
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GnRHa Therapy Protects the Ovaries of Young Women With Breast Cancer Having Chemo
NEW YORK (Reuters Health) - Treatment with a gonadotropin-releasing hormone analog (GnRHa) during chemotherapy in premenopausal women with breast cancer reduces ovarian impairment, according to a randomized controlled trial conducted in China.
Studies on the use of GnRHa therapy to protect ovarian function have shown "mixed results" for a variety of reasons, Dr. Xiangyun Zong of Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital and colleagues note in JAMA Oncology.
To investigate, they did an open-label trial involving 330 women aged 18 to 49 years with operable breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.
Half underwent chemotherapy without and half with GnRHa therapy, which consisted of 3.6 mg of goserelin or 3.75 mg of leuprorelin by subcutaneous injection once every 28 days from one to two weeks before the first cycle of chemotherapy to four weeks after the last cycle of chemotherapy.
At 12 months after the completion of chemotherapy, the rate of premature ovarian insufficiency was significantly lower in the GnRHa group than the control group (10.3% vs. 44.5%; odds ratio, 0.23; P<0.001). Premature ovarian insufficiency was defined as anti-Muellerian hormone levels of less than 0.5 ng/mL.
Anti-Muellerian hormone resumption at 12 months was significantly more common in the GnRHa group than in the control group (15 of 25 vs. six of 44; odds ratio, 4.40; P<0.001).
After a median follow-up of 49 months, there were no between-group differences in four-year overall survival and tumor-free survival (secondary endpoints). However, a post hoc analysis indicated that GnRHa was associated with improved tumor-free survival in patients younger than 35 years.
Based on their findings, the researchers say GnRHa therapy "should be used to protect ovarian function in premenopausal women who are receiving chemotherapy for breast cancer."
This study had no commercial funding, and the authors report no conflicts of interest.
SOURCE: https://bit.ly/32K0yEf JAMA Oncology, online December 30, 2021.
Reporting at: https://www.medscape.com/viewarticle/965865?uac=21...
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Wow, what a clinical trial and results for mTNBC with trilaciclib!!!
https://clincancerres.aacrjournals.org/content/ear...
Saulius
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Early (but interesting-- a new approach) research...
Researchers reduce breast cancer metastasis in animal models by modifying tumor electrical properties [using drugs]
Amiodarone, an ion channel blocker approved for other diseases, significantly inhibits tumor cell invasion
In normal cells, electrical voltage patterns provide a blueprint for orderly growth. But with cancer, the opposite happens. Marked by a breakdown in the normal electrical patterns generated by the cells, they lose their specialized functions, start expanding into a tumor and spreading into and disrupting the function of other tissues -- metastasis. As of yet, there are no clinically available treatments that specifically target the process of metastasis, which remains the leading cause of death in cancer patients.
Now researchers at Tufts University have found that manipulating voltage patterns in tumor cells using ion channel blockers already FDA-approved as treatments for other diseases can in fact significantly reduce tumor cell invasion in a dish and metastasis in an animal model of breast cancer...
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RE the trilaciclib!!! trial,
does that mean that TNMBC people got a year or more out of this drug and then they went to to chemo?
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2019whatayear - one arm just got chemo, the other arms were getting chemo and the trilaciclib either on same day or the trilo a day ahead.
" 34 to group 1 (GCb on days 1 and 8), 33 to group 2 (trilaciclib and GCb on days 1 and 8), and 35 to group 3 (trilaciclib days 1 and 8, and trilaciclib and GCb on days 2 and 9). "
GCb = gemcitabine plus carboplatin
full text is here https://clincancerres.aacrjournals.org/content/cli...
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thanks moth. Damn
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Yes 2019whatayear, chemo, but still... another promising combo/line for mTNBC, and we always want more of them! The plots (group 2: OS not reached!!!) are simply "music to my ears". Saulius
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Oh Saulius so not reached in this case means participants in group 2 are still out there living life?
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Gene expression profiles of breast cancer metastasis according to organ site
https://febs.onlinelibrary.wiley.com/doi/10.1002/1...
this study looked at the genes in various metastatic sites to determine if expression was same or different. Lots of interesting tidbits but also pretty familiar results regarding OS
"Median OS was 63.8 months in patients with HR+/HER2-negative disease, 35.5 months in patients with HER2+ disease, and 22.1 months in patients with TNBC"
"Median OS was 99.7 months for luminal A, 63.6 for luminal B, 34.7 months for HER2-enriched, and 22.4 months for basal-like."
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Thought I would post this here in case anyone is interested:
The eReach Study: A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients.
The University of Pennsylvania is conducting the eReach Study to look at how to best help cancer patients understand and get genetic testing.
If you live in the United States and have metastatic breast cancer, metastatic prostate cancer, advanced pancreatic cancer, or advanced ovarian cancer, and you haven't had genetic testing for a hereditary cancer syndrome, you may be eligible to receive free genetic counseling by participating in the eReach Study.
Read more here:
https://redcap.med.upenn.edu/surveys/?s=MY7H37TM7W...
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