Breaking Research News from sources other than Breastcancer.org
Comments
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olms61 - I hope you slept well!
This article is scary about COVID-19 and cancer. “Patients with cancer and COVID-19 have a higher risk of severe disease and mortality, researchers reported.“
“If the patient was neutropenic, the mortality was very high -- six of nine died.”😳
I have been slightly neutropenic for a year. I also was planning to have all the kids for Thanksgiving. COVID +Cancer sucks.
https://www.medpagetoday.com/meetingcoverage/chest...Dee
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Dee, thank you, I slept pretty well and had to get up early for my infusion today. All good.
Yes, COVID just makes our already complicated lives exponentially more complicated. Praying for a resolution to this and soon.0 -
yeah it's never a good time to get Cancer but, Cancer+COVID sucks.
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Thank you for posting that, Dee. I have sent the article along to a few people in my life who need to know that information. :-)
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Shetland the recommendation I got was 1. to black out all lights in bedroom, 2. to take 20mg (--work up to this slowly!) of melatonin at roughly the same time each night, and 3. to keep my BR cold. You can have all the blankets you want but the room itself should be cold (under 68 ideally). I believe the cold promotes the production of brown (metabolically active) fat.
Circadian rhythms govern the 'wake/sleep' cycles of cancer cells, too, and this can influence when the drugs are the most effectively administered. ('Chronomodulation')
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Accuray announces ClearRT Helical kVCT Imaging For #Radixact - 510(k) pending
Note: this is a marketing piece. Long on images, short on details.
Provides some information on improved imaging soon to be available from Accuray, U.S. based makers of CyberKnife, one of the frequently used tools for SRS (Stereotactic radiosurgery).
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Efficacy and Safety of Chloroquine in Combination With Taxanes for Advanced or Metastatic Anthracycline-Refractory Breast Cancer
October 24, 2020
Published in Clinical Breast Cnacer
- The authors of this small phase II study evaluated combination treatment with chloroquine and taxane or taxane-like chemotherapy in women with locally advanced or metastatic breast cancer refractory to anthracycline-based chemotherapy. The overall response rate of 45% exceeded the expected benchmark of 30%, and the median progression-free and overall survivals were 12 and 25 months, respectively. The combination was well-tolerated, with a rate of 13% of grade 3+ adverse events.
- Larger studies are warranted to evaluate this combination.
https://www.practiceupdate.com/C/107842/56?elsca1=...
https://linkinghub.elsevier.com/retrieve/pii/S1526...
DOI:https://doi.org/10.1016/j.clbc.2020.09.015
{Free access to practice update. Registration may be required. Free access to abstract. Fee or subscription for access to full article.}
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Chloroquine is gaining some recognition in combo with taxanes: https://www.practiceupdate.com/content/efficacy-an...
Saulius
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Thought this was interesting.
High-Dose SBRT More Effective for Painful Spine Metastases
— Roughly one-third of patients had a complete pain response at 3 and 6 months
AlsoMDACC has a trial for
Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Participants With Estrogen Receptor Positive, HER2 Negative Breast Cancer
https://clinicaltrials.gov/ct2/show/NCT03774472
Dee0 -
Article for clinicians on various treatments options for bone mets. Very interesting, if technical:
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good article,Joyner. I printed it out to save. Thanks
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Lynn,
That was a great article about bone metastases. I had seen bits and pieces of the info in there in different articles, but not in such a consistent, complete way. I did note that this was a study headed up by the Europeans -- confirms my belief that we should look at what docs in other countries are doing as well as info about US progress in treating MBC.
I think I'm going to send this one to my MO. Maybe then she won't think I'm crazy when I ask her about local treatment for bone metastases -- the standard American protocol seems to be treatment for pain, only. This article goes beyond that.
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Stereotactic radiosurgery may be new standard of care for four or more brain metastases
October 27, 2020
Stereotactic radiosurgery conferred equivalent OS as whole-brain radiation but with less cognitive decline in patients with four or more nonmelanoma brain metastases, according to study results presented at the virtual ASTRO Annual Meeting.
"Up to 30% of [patients with cancer] develop brain metastases at some point during the disease process and these patients typically do not do well with current treatment modalities, including radiation and surgery,"... "Whole-brain radiation has been around for some time now; however, it is associated with significant side effects, which is why within the past decade there have been tremendous efforts to minimize the cognitive side effects of brain radiation."
At median follow-up of 6.6 months, results showed patients in the stereotactic radiosurgery group scored higher on memory function compared with baseline, whereas patients in the whole-brain radiation group scored worse compared with baseline. Researchers observed a clinically meaningful and statistically significant benefit with radiosurgery at 1 month and 6 months.
Moreover, half of patients in the whole-brain radiation group experienced a clinically meaningful decline in cognitive function 4 months after treatment compared with only 6% of patients in the stereotactic radiosurgery group.
The radiosurgery and whole-brain radiotherapy groups had similar local control rates at 4 months, median OS and median time to distant brain failure. However, patients assigned radiosurgery experienced shorter interruptions of systemic therapy, with time to systemic therapy of 1.7 weeks vs. 4.1 weeks with whole-brain radiation.
"This is particularly important because patients with brain metastases often have metastases outside of the brain, as well," Li said. "When these patients receive whole-brain radiation, we typically hold chemotherapy for 2 weeks and we continue to hold systemic therapy for up to 4 weeks for them to wash out before they can return to systemic therapy. These patients often need systemic therapy to control extracranial disease."
Radiation necrosis occurred in 17% of patients in the radiosurgery group and in 4% of all treated lesions. Grade 3 or higher toxicities occurred among 8% of patients (n = 2) in the radiosurgery group and 15% of patients (n = 4) in the whole-brain radiation group.
"Despite early termination of the study and the use of memantine in the whole-brain radiation therapy arm, we were able to show that stereotactic radiosurgery was associated with reduced risk [for] cognitive deterioration compared with whole-brain radiation as demonstrated by a constellation of neurocognitive tests, individually or by composite scores," Li said. "The results from this randomized, phase 3 trial strongly support the use of stereotactic radiosurgery in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising OS."
Stephanie E. Weiss, MD, FASTRO
Fox Chase Cancer Center
https://www.healio.com/news/hematology-oncology/20...
Source: Li J, et al. Abstract 41. Presented at: American Society for Radiation Oncology Annual Meeting (virtual); Oct. 25-28, 2020.
{Reporting available w/o charge, registration may be required.}
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Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination–Related Genes
November 05, 2020 Journal of Clinical Oncology
- The authors of this phase II trial evaluated the PARP inhibitor olaparib in the treatment of 54 patients with metastatic breast cancer (76% ER-positive/HER2-negative) and either germline mutations in non-BRCA1/2 homologous recombination–related DNA repair genes (cohort 1) or somatic mutations in BRCA1/2 or other non-BRCA1/2 homologous recombination–related genes (cohort 2). The objective response rate (ORR) in cohort 1 and cohort 2 were similar (33% and 31%), but confirmed responses were only observed in patients with germline PALB2 (ORR, 82%; PFS, 13.3 months) and somatic BRCA1/2 (ORR 50%; PFS, 6.3 months) mutations.
- These findings appear to expand the patient population likely benefit from PARP inhibitors to include those with somatic BRCA1/2 and germline PALB2 mutations, in addition to germline BRCA1/2 mutation carriers.
DOI: 10.1200/JCO.20.02151 Journal of Clinical Oncology{Free access to reporting and abstract. There appears to be a fee for access to the ASCO full article.}0 -
Breast Cancer–Specific Mortality in Small-Sized Tumor With Stage IV Breast Cancer
October 28, 2020 The Oncologist
- This authors of this SEER database study evaluated breast cancer–specific mortality (BCSM) according to primary breast tumor size in over 5300 patients with metastatic breast cancer. Tumor size was not associated with BCSM. In patients with tumors <50 mm, the BCSM rate did not decline in association with decreasing tumor size. Among patients with triple-negative breast cancer, the BCSM rate was worst among patients in the T1a/T1bN2+ group.
- The authors hypothesize that T1a/T1b triple-negative breast cancers with regional lymph node metastases may be a surrogate for biologically aggressive disease.
{Free access to reporting and full article.}0 -
Re: Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination–Related Genes November 05, 2020 Journal of Clinical Oncology
This is disappointing news for ATM or CHEK2 mutations. No response to treatment. I was hoping to have Olaparib as a future treatment option. Although I'm glad to hear the drug helps others..
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Tinkerbell107: I note that it was a small study - only 54 patients. I hope that maybe they will look at larger pools before relying too heavily on what seems like it should be starting point info. (Hope you have lots of options - and don't need any of them for a long time!)
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Santabarbarian, re chronomodulation — I try to get the 13-hour overnight fast, and take my pills so they reach peak levels during the night when, I believe, cancer cells are more active.
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Lumpie: Thanks for the encouragement. Appreciate all your efforts in bringing forth the research studies.
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Hi lumpie and tinkerbell
just anecdotal evidence but after 7 lines of chemo and being told i was out of options I privately financed a foundation one test, found somatic PALB2 and was put on olaparib. my 11cm li ver tumor is at 5,6 after 3 months../amy
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Thanks for all, Lumpie. So important. WOW, Arolsson, and good luck, Tinkerbell-that does sound like a small study.
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arolsson: That is great news! Just goes to show... there is still so much we don't know. I know that a lot of us think that figuring out how to effectively personalize medicine is really important to so many people's effective treatment. We are all still lab rats... but in a good way, a way that contributes to health and future treatments, I hope.
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(I also posted this on reducing dose, AIs) . Reducing dosage. Reading "The Cheating Cell" Athena Aktipis https://press.princeton.edu/books/hardcover/9780691163840/the-cheating-cell . She explores looking at cancer from an evolutionary view. Rather than trying to eradicate/kill cancer which might actually select for cells which resist treatment, she suggests "managing" the cancer which might select for cancer that is less prone to develop resistance. One approach is "adaptive therapy" where the cancer is kept at an "acceptable" size without too much harm/risk to the patient. She also suggests "faking" described in her book and here. the cancer https://chemoth.com/metronomic/adaptive-chemotherapy... This article suggests that while a nice idea, we are not there yet. https://www.oncozine.com/personalizing-cancer-treatment-why-adaptive-therapy-isnt-there-yet/ . In some sense, adaptive therapy makes sense, can we really expect to eradicate? At the same time I want it gone gone gone, not just "manageable". She also describes, briefly, how we are abe to successfully treat and eradicate some types of cancer. I wish and hope the same for breast cancer. She is an evolutionary biologist at Arizona State University.
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Tinkerbell107, I was on the small TBB Trial of Talzenna (another PARP inhibitor) for patients with BRACA-like mutations for almost a year. I have CHEK2 and FANCA germline mutations. The Olaparib Expanded trial evaluated similar BRACA-like mutations, and I was very sad when it did not show a response with many of the mutations (with exception of PALB2 and somatic BRACA1/2). However, as many have said, it was a very small trial. One on my friends who has a germline CHEK2 and somatic BRACA1 mutation responded well for a year on that trial, but was counted in the somatic BRACA mutation arm. I hope that further research will be done... I hope that women who might benefit from PARP inhibitors will have access to them. Despite my durable response to Talzenna, PARP inhibitors would probably not be recommended to me today...
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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...0 -
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.}0 -
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.}0
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