Breaking Research News from sources other than Breastcancer.org
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Covering COVID-19 Vaccines
The Centers for Medicare & Medicaid Services (CMS) released its fourth COVID-19 interim final rule with comment period. This rule requires U.S. Food and Drug Administration-approved COVID-19 vaccines to be provided at no-cost to beneficiaries enrolled in Medicare and Medicare Advantage. Medicaid beneficiaries can receive the vaccine at no cost only during the public health emergency (PHE), and most private payors will also be required to provide the vaccine at no cost. While codes to bill vaccines will not be available until the vaccines have been approved, CMS has set reimbursement rates for single and multiple vaccine doses. Additionally, CMS is continuing efforts around transparency by requiring any provider who performs a COVID-19 diagnostic test to post their prices online.
Learn more about the fourth COVID-19 interim final rule.
Source: ASCO Advocacy News & Action
https://www.asco.org/practice-policy/policy-issues...
Links are to CMS webpage and should not involve a charge.
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Healthcare Price Transparency
On October 28, the U.S. Department of Health and Human Services (HHS), the U.S. Department of Labor, and the U.S. Department of the Treasury released the coverage transparency final rule. Building on earlier administration actions requiring hospitals to disclose standard charges and negotiated rates with third-party payers, this new rule includes two requirements aimed at increasing healthcare price transparency in the commercial market.
First, health plans and payers will be required to provide participants, beneficiaries, and enrollees with personalized out-of-pocket cost information, and the underlying negotiated rates, for all covered health care items, services, and prescription drugs. Plans and payers must provide cost-sharing information through an internet-based self-service tool or in paper form upon request. An initial list of 500 services as determined by the departments must also be available for plans on January 1, 2023. The remainder are required to be available for plans on January 1, 2024.
Second, the rule requires payers and plans to post three data files for public use: 1) negotiated rates for all covered items and services between the plan or payer and in-network providers; 2) historical payments to, and billed charges from, out-of-network providers; and 3) in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level. These files are required to be made public for plan years that begin on or after January 1, 2022.
Learn more about the coverage transparency rule.
Source: ASCO Advocacy News & Action
https://www.asco.org/practice-policy/policy-issues...
Links are to CMS webpage and should not involve a charge/should be fully accessible.
{That is pretty huge if we can see what they are charging whom for services. Too bad it is so far off in the future.}
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FDA Approves Liquid Biopsy NGS Companion Diagnostic Test For Multiple Cancers And Biomarkers
November 9, 2020On October 26 and November 6, 2020, the Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens.The companion diagnostic indications in the October 26 approval are 1) to identify mutations in BRCA1 and BRCA2 genes in patients with ovarian cancer eligible for treatment with rucaparib (RUBRACA, Clovis Oncology, Inc.), 2) to identify ALK rearrangements in patients with non-small cell lung cancer (NSCLC) eligible for treatment with alectinib (ALECENSA, Genentech USA, Inc). and 3) to identify mutations in the PIK3CA gene in patients with breast cancer eligible for treatment with alpelisib (PIQRAY, Novartis Pharmaceutical Corporation).On November 6, FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to identify mutations in BRCA1, BRCA2 and ATM genes in patients with metastatic castration resistance prostate cancer (mCRPC) eligible for treatment with olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP).FoundationOne Liquid CDx approval as a companion diagnostic for rucaparib, alpelisib, alectinib, and olaparib was based on the retrospective testing with FoundationOne Liquid CDx of available plasma samples from patients enrolled in four clinical trials that supported the approval of associated therapeutics. Efficacy for rucaparib, alpelisib, alectinib, and olaparib was shown to be maintained in patients with confirmed BRCA1 and/or BRCA2 gene alterations, PIK3CA mutations, ALK rearrangement, and BRCA1, BRCA2, and/or ATM gene alterations, respectively, by FoundationOne Liquid CDx. If the specific mutations and alterations associated with these approvals are not detected in the blood, then a tumor biopsy should be performed to determine if the specific mutations and alterations are present.View the Summary of Safety and Effectiveness for the FoundationOne® Liquid CDx test (P200006 and P200016).The FoundationOne Liquid CDx test was granted Breakthrough Device designation, in which the FDA provides intensive interaction and guidance to the company on efficient device development.A description of the FDA Breakthrough Device program can be found at Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff.Source: ASCO Advocacy News & Action
https://www.asco.org/practice-policy/policy-issues... -
Copay Accumulator Programs Block Access to Necessary Cancer Treatments
October 27, 2020Beginning January 1, UnitedHealthcare (UHC) will ask physicians to provide information on the copay assistance funds patients receive for their treatments. UHC would then enforce a copay accumulator, which would ensure that no copay assistance funds are applied toward patients' deductibles or out of pocket maximum payments.In response, the Association for Clinical Oncology (ASCO), along with a dozen other medical specialty societies sent a letter to UHC urging the organization to not move forward with its proposed copay accumulator initiative or physician reporting on copay assistance."Our organizations oppose this change as it would endanger patients' access to care and undermine the doctor-patient relationship," the organizations said in the letter. "We urge UHC to explore other pathways to rein in drug costs without jeopardizing patients' health."The letter acknowledges that the specialty drugs targeted by this policy are expensive; however, they are also vitally important for patients with serious illnesses such as cancer. Additionally, most of the targeted drugs have no generic equivalents or therapeutic alternatives, meaning patients do not have lower-cost options.Copay assistance programs allow patients to access potentially life-extending medications with less concern for their personal finances. Blocking copay assistance funds from being applied toward patient deductibles could result in patients facing thousands of dollars in unexpected medical bills and the discontinuation of treatment with disastrous consequences.Read the full letter.Lean more about copay accumulatorsSource: ASCO Advocacy News & Actionhttps://www.asco.org/practice-policy/policy-issues...
{Login may be required for links. Sorry - not sure.} -
More than 100 Organizations Endorse ASCO-Backed Senate Bill to Improve Clinical Trial Access
October 13, 2020The Association for Clinical Oncology (ASCO) joined more than 110 organizations representing patients, medical researchers, providers, cancer survivors and their families in signing an endorsement letter for S. 4742, the CLINICAL TREATMENT Act. This bipartisan legislation, which was recently introduced by Senators Richard Burr (R-NC) and Ben Cardin (D-MD), would expand access to clinical trials and improve the quality of cancer research by requiring Medicaid to guarantee coverage of the routine care costs of clinical trial participation for Medicaid enrollees with a life-threatening condition. The House version of the bill, H.R. 913, currently has 55 cosponsors representing both parties.In a support letter to Senators Burr and Cardin, the organizations write, "Robust clinical trial participation improves the quality of medical research. Medicaid serves many demographics, including ethnic minorities and women, that are underrepresented in current clinical trial enrollment. Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research. Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country."Tell your Senators to cosponsor S. 4742.Read the full letter.Source: ASCO Advocacy News & Action
https://www.asco.org/advocacy-policy/asco-in-actio...{Login may be required for links. Sorry - not sure.}
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Executive Order Would Tie U.S. Drug Prices to What Other Countries Pay
September 15, 2020On September 13, President Trump signed an executive order (EO) aiming to address high prescription drug prices by tying payments for certain Medicare drugs to the costs the treatments sell for outside the United States (U.S.). According to the EO, prices for provider-administered drugs would be linked to a "most-favored-nation price" drawn from the lowest price among countries that have a similar per-capita gross domestic product.The EO grants authority to the Secretary of the U.S. Department of Health and Human Services (HHS) to implement a demonstration project to test a "most favored nation" policy for some drugs or biologicals under Medicare Part B or Part D. The details of the demonstration are unclear, but it could begin more quickly than the typical rulemaking process.The Association for Clinical Oncology (ASCO) is also concerned about the escalating price of prescription drug treatments—particularly cancer therapies. However, as the economic crisis in the U.S. deepens, ASCO believes it is critical that any solution to this complex problem be thoroughly tested before it is implemented to ensure it does not impede patient access to care or stifle innovation in drug development.Source: ASCO Advocacy News & Action
https://www.asco.org/practice-policy/policy-issues...{In-text link is to a government site and should be freely available. Login to this article may be required for links. Sorry - not sure. Who knows what will happen to this Executive Order post-election, but it is interesting.} -
FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer - eff Nov 13
https://www.fda.gov/drugs/drug-approvals-and-datab...
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Lumpie you seem to be on a roll....thank you!
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I did get on a bit of a roll. These were non-scientific but may affect access to care for many in the US, so thought I would share. Hope these help....
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Existing antidepressant helps to inhibit growth of cancer cells in lab animals
New research has shown that the antidepressant sertraline helps to inhibit the growth of cancer cells...
Cancer cells use different biological mechanisms to stimulate their growth. In certain types of breast cancer, leukaemia, skin cancer, brain tumours and lung cancer, among others, the malignant cells produce large amounts of serine and glycine, two amino acids. This production stimulates the growth of cancer cells to such an extent that they become addicted to serine and glycine.
[A screening process involving 1600 yeast trials] showed that the antidepressant sertraline was the most effective substance. "Other studies had already indicated that sertraline has a certain anti-cancer activity, but there was no explanation for this yet", mention researchers Shauni Geeraerts (LDMC and CMPG) and Kim Kampen (LDMC). "In this study, we've been able to demonstrate that sertraline inhibits the production of serine and glycine, causing decreased growth of cancer cells. We also found that this substance is most effective in combination with other therapeutic agents. In studies with mice we saw that sertraline in combination with another therapy strongly inhibits the growth of breast cancer cells."
https://www.eurekalert.org/pub_releases/2020-11/kl...
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I've been a baby aspirin taker for years since dx. I thought this article was interesting. Aspirin may be beneficial in patients who are not BRCA+ but harmful in BRCA + patients.
https://www.upi.com/Health_News/2019/08/12/Aspirin...
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Another interesting post that someone made in another thread:
https://journals.lww.com/oncology-times/fulltext/2...
https://www.biorxiv.org/content/10.1101/2020.01.21...
Metformin may be helpful when metastasis is happening but harmful when BC cells are dormant and the patient is on and AI
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One more interesting study - not breaking - but a small study to look at iodine either alone or in conjunction with chemo.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC66829...
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Eating more fruits and vegetables may help breast cancer survivors live longer
We examined data on nearly 9,000 women with breast cancer who were followed for up to 30 years, and observed that those who consumed higher amounts of fruits and vegetables after their diagnosis were less likely to die during the study period than those with lower amounts of fruits and vegetables in their diets. High fruit and vegetable consumption, and high consumption of just vegetables, was associated with lower mortality from all causes—most women with breast cancer die from other causes. Some subgroups of fruits and vegetables were also associated with lower all-cause mortality, including leafy green vegetables, cruciferous vegetables such as broccoli, fruits and vegetables high in vitamin C, and vegetables high in beta-carotene.
We also observed that eating high amounts of blueberries was significantly associated with lower breast cancer-specific mortality, as well as all-cause mortality. This may be because blueberries contain bioactive components that may prevent or slow breast tumors from growing or spreading.
https://www.hsph.harvard.edu/news/features/breast-cancer-survival-fruits-vegetables/
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Fertility Preservation Boosts Live Births after Breast Cancer
— Also associated with better survival
Fertility preservation (FP) appeared successful for women undergoing breast cancer treatment, data from a Swedish cohort showed.
About 23% of women who underwent FP had one or more live births after treatment for breast cancer, as compared with 9% of those going without it. FP was associated with 5- and 10-year cumulative incidences of post-breast cancer live births that were more than twice as high as rates for women who did not have FP.
https://www.medpagetoday.com/hematologyoncology/br...
Primary Source: JAMA Oncology
Source Reference: Marklund A, et al "Reproductive outcomes after breast cancer in women with vs without fertility preservation" JAMA Oncol 2020; DOI: 10.1001/jamaoncol.2020.5957.
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repurposing drugs for triple negative breast cancer
https://www.researchgate.net/publication/342904316...
proton pump inhibitors like Prilosec look like they might be helpful along with chemo
very small study of 42 patients: https://meetinglibrary.asco.org/record/190369/abst...
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pembrolizumab (Keytruda) for leptomeningeal mets - not just in triple neg breast pt. Pts in this study weren't even all breast ca pts
"Pembrolizumab (Keytruda) led to a 38% central nervous system (CNS) response rate and was well tolerated in patients with leptomeningeal metastasis (LMM) from solid tumors, according to phase 2 results" https://www.onclive.com/view/pembrolizumab-shows-i...
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I'll be watching this one closely. There are currently no targeted treatments for p53 mutations and lots of cancers develop these mutations especially in late stage.
FDA Grants Fast Track to PC14586, Potential Therapy for Specific p53 Mutation
https://breastcancer-news.com/2020/10/29/fda-grant...
Here's the trial info. It's in San Antonio, TX.
https://clinicaltrials.gov/ct2/show/NCT04585750
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techtonicshift
That is an interesting trial. I have genomic TP53 c.847C>T (Arg 283Cys) VUS. It is common in breast cancer but an “unknown significance” for now.
Dee
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Covid & cancer - additional determinants of mortality
https://www.nature.com/articles/s43018-020-00129-w...
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I am not sure if this is the place to post foods and supplements to avoid while in AI:
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[CRISPR used to treat cancer in mice]
..."There are no side effects, and we believe that a cancer cell treated in this way will never become active again." Peer told the news outlet, adding, "This technology can extend the life expectancy of cancer patients and we hope, one day, cure the disease..."
The scientists used the technique on hundreds of mice – and Peer said the method could potentially be used on humans within two years.
The study focused on two types of cancers — glioblastoma, an aggressive type of cancer that can occur in the brain or spinal cord, and metastatic ovarian cancer.
Researchers found that mice with cancer who received the treatment had double the life expectancy of the control group, and their survival rate was 30 percent higher, the [Times of Israel] reported.
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Thank you for sharing! CRISPR is so facinating. I would love to see more about this from a better news source than the NY Post! I do often look to CRISPR editing as the hope to end BRCA1 and BRCA2 mutations :-)
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Interesting article from National Cancer Institute about treating bone mets with radiation
https://www.cancer.gov/news-events/cancer-currents...
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Practicing Oncologists Debate New Tactics for Brain Metastases in HER2+ Breast Cancer
October 21, 2020OncologyLive
New approaches for treating patients with HER2-positive metastatic breast cancer are showing signs of efficacy against brain metastases, generating excitement about the potential to make critical advances and sparking questions about optimal sequencing.
Interview format article
https://www.onclive.com/view/practicing-oncologist...
{No charge for access but sign in may be required.}
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NCI-MATCH Trial Identifies Actionable Alterations in More Than One-Third of Patients With Cancer
December 3, 2020
As part of the National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH) trial conducted at more 1000 study sites, researchers have identified actionable alterations in nearly 38% of patients with cancer, and almost 18% of patients were assigned to treatments based on their molecular profiling results.1 The patient population included a large proportion of patients with less common cancers, including gastroesophageal cancer, sarcoma, and kidney cancer, in addition to patients with the most common cancers — colorectal, breast, and prostate cancers, as well as non-small-cell lung carcinoma (NSCLC).
https://www.cancertherapyadvisor.com/home/cancer-t...
{Free access, registration may be required.}
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Increased Overall Survival in Patients With MBC and Liver or Lung Metastases Treated With Eribulin
December 03, 2020
- In this retrospective study of 443 patients with metastatic breast cancer and liver or lung metastases who received third-line treatment with eribulin (n = 229), gemcitabine (n = 134), or capecitabine (n = 80), the authors evaluated overall survival in real-world clinical practice. A larger proportion of patients who received eribulin were alive at 6, 12, 24, and 36 months compared with those receiving gemcitabine, and more eribulin-treated patients were alive until 36 months compared with capecitabine-treated patients. Overall survival and survival among patients with TNBC and HR+/HER2− disease was numerically increased among patients who received eribulin.
- These real-world data support data from randomized clinical trials regarding the consistent effects of eribulin in this patient population.
{Free access}
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