Breaking Research News from sources other than Breastcancer.org
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CMS to make some pandemic telehealth waivers permanent
CMS Administrator Seema Verma said use of telehealth has grown dramatically during the pandemic, and some provisions that temporarily expanded access to telehealth during the pandemic will be made permanent. She said the agency is working on rulemaking now.
FDA: Some COVID-19 policies could be here to stay
FDA Commissioner Stephen Hahn said the agency is considering permanently implementing some of the policies and processes adopted in response to the COVID-19 pandemic. Most of the changes "represent an acceleration of where we were headed before," including increased use of telemedicine in clinical trials, support for decentralized clinical studies and work on laboratory-developed tests, Hahn said.
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Interesting article on how cancers mutate to get around targeted treatments --
https://scienmag.com/revealed-how-cancer-develops-...
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BevJen, thanks for sharing that article on bc cell mutation and resistance. Very interesting.
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New Clue to Anti-PD-L1 Activity in Breast Cancer?
— Survival benefit with durvalumab in patients with PDL1 copy number alteration
A novel biomarker identified a large subgroup of metastatic breast cancer patients who benefited from an immune checkpoint inhibitor, according to an exploratory analysis of a prospective clinical trial.
Almost a fourth of patients with no identified actionable mutations had copy number alteration (CNA) in the PD-L1 gene. Patients without PD-L1 CNA had a median progression-free survival (PFS) of 9 months when treated with the PD-L1 inhibitor durvalumab (Imfinzi), whereas median PFS had yet to be reached in patients whose tumors had copy number gain (three or four copies) or amplification (more than four).
"This exploratory translational analysis suggested a higher efficacy of durvalumab as maintenance treatment for patients with PD-L1 copy gain or amplification," Bachelot said in a statement. "PD-L1 copy number alteration could be an important predictive marker for PD-L1 inhibitor efficacy. If confirmed in larger series, this could have important implications for the development of immunotherapy in patients with metastatic breast cancer, enabling us to better identify patients that are sensitive to PD-L1 inhibitors than current testing for PD-L1 positivity on immune cells."
Link to the clinical trial:
https://clinicaltrials.gov/ct2/show/NCT02299999
Primary Source: ESMO Breast Cancer Conference
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TRAIN-2 Highlights Questions Around the Use of Anthracycline-Based Neoadjuvant Chemotherapy in HER2-Positive Breast Cancer
Long-term follow-up of a phase 3 study showed that anthracycline-based neoadjuvant chemotherapy did not improve event-free survival (EFS) or overall survival (OS) in patients with HER2-positive, nonmetastatic breast cancer compared with a taxane-platinum regimen when trastuzumab and pertuzumab were coadministered with chemotherapy. These findings were presented during the ASCO20 Virtual Scientific Program.
At a median follow-up of 19 months, a previously published analysis of results from 418 patients in this trial showed no difference in the primary study end point of pathologic complete response (pCR) rate when patients treated with an anthracycline (67%) and without an anthracycline (68%) were compared (P =.95).In addition, a significantly higher rate of at least grade 3 febrile neutropenia were observed in the anthracycline-containing arm (10%) compared with the anthracycline-free arm (1%; P =.0001).
References
- Van der Voort A, van Ramshorst MS, van Werkhoven ED, et al. Three-year follow-up of neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2-blockade for HER2-positive breast cancer (TRAIN-2): A randomized phase III trial. ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 501.
- van Ramshorst MS, van der Voort A, van Werkhoven ED, et al. Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): A multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018;19:1630-1640.
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Cancer Care Costs in the United States Are Projected to Exceed $245 Billion by 2030
The national healthcare bill for cancer will exceed $245 billion a year by 2030, a 30% increase from 2015. (American Association for Cancer Research)
The national cancer-attributable costs in the United States are projected to increase by over 30 percent from 2015 to 2030, corresponding to a total cost of over $245 billion, according to a study published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.
https://www.aacr.org/about-the-aacr/newsroom/news-...
https://cebp.aacrjournals.org/content/early/2020/0...
DOI: 10.1158/1055-9965.EPI-19-1534
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Has the Time for At-Home Cancer Care Finally Come?
"...patients have routinely received home treatments using infusion pumps for other conditions, including autoimmune diseases and diabetes. "We asked why this couldn't be a real option for cancer patients, too," ..."The idea of hospital-at-home has been around for years and already has a successful track record."In November 2019, his team got to work creating a model so doctors could prescribe 13 drugs for {cancers for administration} at home.When the program was launched in February 2020, 40 patients signed up. By the beginning of June {2020}, the program had more than 400 patients. "It's skyrocketed," he said. "We scaled that quickly because it became clear that we needed to decrease density in the hospital and infusion suites to have capacity for COVID-19."ReferenceLüthi F, Fucina N, Divorne N, et al. Home care—a safe and attractive alternative to inpatient administration of intensive chemotherapies. Support Care Cancer. 2012;20:575-581.
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High Medical Costs Associated With Metastatic Breast Cancer
- In this study, the authors used 2003–2014 North Carolina cancer registry data linked with administrative claims to develop an algorithm for identifying patients with breast cancer who progressed to metastatic disease. Medical costs due to metastatic breast cancer were estimated by age group and by phase of care. Monthly costs were significantly higher for women with metastatic breast cancer compared with earlier-stage breast cancer and patients without cancer for all age groups and phases of treatment except for initial treatment among women with stage III disease at diagnosis. The highest expected costs were for women aged 18 to 44 during the continuing phase of care, totaling over $200,000.
- These findings highlight the importance of determining whether the excess costs among younger women and during the continuing and terminal phases of treatment provide high value for these women.
(There is a discussion about cost of care by Lillie D Shockney. It seems to focus on the merits of limiting expensive care in order not to bankrupt the patient rather than addressing why we allow medical care in the US to bankrupt patients in the first place.}0 -
FDA Approves Pfizer's Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf)
June 11, 2020 NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim).1 NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
https://investors.pfizer.com/investor-news/press-r...
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New Protocol on Breast Cancer and Breastfeeding
New Rochelle, NY, June 10, 2020—Managing women with breast cancer who are breastfeeding is a complex issue. The Academy of Breastfeeding Medicine presents new recommendations in the peer-reviewed journal Breastfeeding Medicine. Click here to read the article now.
"The aim of this new protocol is to guide clinicians in the delivery of optimal care of breastfeeding women as it relates to breast cancer, from screening to diagnosis, treatment, and survivorship," state coauthors Helen Johnson, MD and Katrina Mitchell, MD.
It addresses the spectrum of care, including oncologic breast surgery, chemotherapy, and adjuvant and endocrine therapy. A section on breastfeeding women who have a previous history of breast cancer is included.
Arthur I. Eidelman, MD, Editor-in-Chief of Breastfeeding Medicine, states: "This protocol is a guide for mothers who are undergoing diagnosis and treatment for breast cancer. It emphasizes that they do not have to categorically give up on their nurturing role as breastfeeding moms."
Breast cancer is the most common malignancy in women worldwide. One in 20 women will develop breast cancer in their lifetime.
https://home.liebertpub.com/news/new-protocol-on-b...
https://www.liebertpub.com/doi/10.1089/bfm.2020.29...
Published Online:9 Jun 2020 https://doi.org/10.1089/bfm.2020.29157.hmj
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City of Hope - Ultrasound to a kill Cancer Cells (apologies if this has been posted already)
https://www.cityofhope.org/breakthroughs/using-ultrasound-to-kill-cancer-cells0 -
Olma the links do not work
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Olma61 - the links did not work for me either. I knew ultrasound was used in detection, but had not heard of using for treatment, so asked Dr. Google. Maybe there is hope
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Live stream: Chasing Cancer
Stephen M. Hahn, U.S. Food and Drug Administration commissioner, will lay out his agenda for the FDA and discuss critical steps the government is taking to approve innovative, life-saving drugs, therapies, and clinical trials for COVID-19 and cancer. As an oncologist, Hahn has spent his career dedicated to advancing cancer treatment. James P. Allison, the 2018 Nobel Prize winner in Medicine for his immunotherapies at MD Anderson Cancer Center, will discuss the next steps in his ground breaking research, one of the most important advances in cancer treatment in 100 years. We'll also focus on DNA and genetic testing, groundbreaking immunotherapies and drugs that topline researchers hope will combat the deadliest cancers.
In a segment presented by Pfizer, Andy Schmeltz, global president & general manager of Pfizer's Oncology division will discuss the challenges, barriers, and inequities within the current healthcare system, and what we can do to fix it.
Join us on Wednesday, June 17 at 10:30 a.m. ET.
Stream here: wapo.st/chasingcancerjune
https://chasingcancerjune.splashthat.com/?utm_medi...
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Hi ladies, sorry about the broken link I edited the post just now to fix it and here is the correct link to the City of Hope article:
https://www.cityofhope.org/breakthroughs/using-ultrasound-to-kill-cancer-cells
Good to see those other links too!
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Lumpie -
Thanks for posting the Post talk -- that sounds like a good one. And they've got two good people -- I've heard interviews with Allison before and they were fascinating.
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Study Finds Wide Variation in the Natural History of Untreated ER-Positive, HER2-Negative Invasive Breast Cancer Tumors
Results of a retrospective study evaluating multiple characteristics of a cohort of individuals with untreated estrogen receptor-positive, HER2-negative invasive breast cancers showed a broad range of tumor growth velocities across patients. This study examined the in-vivo tumor growth kinetics for patients presenting with "missed" ER-positive, HER2-negative invasive breast cancer that had been present, but unidentified, on 1 or more previous serial screening mammographic images performed at least 6 months prior to the diagnosis of breast cancer. Changes in tumor volume over time (ie, tumor growth velocity) and tumor doubling time were estimated for these tumors.The study authors noted that these results "demonstrated a variation of in-vivo growth kinetics in an untreated subset of breast cancers and found that the volume change over time could not be predicted."
They further commented that these results show that more difficult-to-measure factors such as host immune response, tumor microenvironment, and molecular heterogeneity may play a larger role than solely tumor subtype.
https://www.cancertherapyadvisor.com/home/cancer-t...
Reference
Rojas KE, M D-M, Rojas M, et al. The natural history of untreated estrogen receptor-positive, Her2-negative invasive breast cancer. Breast Cancer Res Treat [published online May 12, 2020]. doi: 10.1007/s10549-020-05666-7
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The Chasing Cancer Postponed until June 24th. IF you register, they will send reminder https://chasingcancerjune24.splashthat.com/
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Probably something about "driving" genes: http://news.mit.edu/2020/counting-your-antigens-cancer-immunotherapy-0602. One can see targeted/immunotherapy treatment revolution is not far away...
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BSandra, this is very exciting! That "grad student" must be something! Thanks for posting.
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I'm not sure how I found this subscription or who recommended it (probably someone on this string), but it is excellent. I'm sorry if it's fuzzy. It seems to originate from "Practice Update":
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'Unbelievably Exciting' Results in Rare Type of Breast Cancer
Metaplastic breast cancer (MpBC) is a rare form of triple-negative breast cancer (TNBC), accounting for fewer than 1% of all breast cancers, but it is very aggressive and responds poorly to chemotherapy. So new results with a combination of immunotherapies that resulted in significant tumor shrinkage and survival topping 2 years have led to some excitement, even though the results were seen in only 3 of 17 women who were treated...
There was one complete response and two partial responses with "very little tumor burden left. That gives us the hope that maybe there is a chance for cure in these three patients..."
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It looks like Chasing Cancer with WaPo is an ongoing series? I missed the one June 17, best friend's 60th, but see the one on June 24 is a different topic. So I'm wondering, was the previous one postponed, didn't happen or I just missed it?
Joyner, thanks for that OBR share. Interesting research for another potential benefit of my dr. putting me on a statin.
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Cancer drug: New treatment halts tumour growth [not bc-specific]
More than half of the 40 patients given berzosertib [an ATR kinase inhibitor aka VX-970, M6620] had the growth of their tumours halted [in a phase 1 trial].
Berzosertib was even more effective when given alongside chemotherapy, the trial run by the Institute of Cancer Research (ICR) and the Royal Marsden NHS Trust suggested.
...One of the study's authors, Prof Chris Lord, a professor of cancer genomics at the ICR, said these early signs were "very promising", adding that it was unusual in phase one trials to see a clinical response.
https://www.bbc.com/news/health-53137328
Looks like there's at least one clinical trial testing this drug with bc: https://clinicaltrials.gov/ct2/show/NCT04052555
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debbew, I read about the trial and if I read correctly an exclusion is MBC. ??
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I don't see where it says that breast cancer is excluded. Here's the only reference I see to BC:
I hope that my cutting and pasting works!
Whereas the traditional approach to cancer treatment has been to categorise it by tumour site - breast cancer, lung cancer and so on - the precision-medicine approach targets the genetic abnormality in the tumour, regardless of where it is.
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LoMa, maybe you saw that information on a different site rather than on this one? Perhaps you saw something more in-depth? I hope not!
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joynerL
“the precision-medicine approach targets the genetic abnormality in the tumour, regardless of where it is.“
I wish more doctors would sign into this philosophy but they still go by standard of care in my experience even at MDACC.
I know we can ask for expanded access or compassionate right to try which I may have to do with my Neuroendocrine features. Right now so many centers will not include me in Neuroendocrine drug trials or even Neuroendocrine standard of care because it is breast cancer. Sarah Cannon cancer institute in Nashville said I don’t qualify for their breast trials because of the Neuroendocrine! Arggggggg
i asked about the MATCH trial and my MO said that is in their phase 1 department. I met with a phase 1 doc along time ago and they have not sent me a single trial to even look at.
I talked to the RACHEL trial coordinator ( Bintrafusp Alfa + radiation NCT03524170)BTW- She said early results are not good but a new one should follow this one that looks more promising. I ran a bunch of trials by her that listed MDACC as a trial site. She told me they were all in the phase 1 department not breast! 🙄🤪
So I continue to check here and compile my Trial list. thankfully my current line is working but it's only a matter of time as we all know.
Sorry for the rant.
Dee
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Dee, wow....you're way down the road past me in terms of knowledge of trials and how they work! Thanks for the explanation, though we all wish it were more encouraging!
Here's the latest post from PracticeUpdate. I thought that there would be more excitement about progress in immunotherapies than seems apparent to me:
https://www.practiceupdate.com/C/102335/56?elsca1=emc_enews_topic-alert
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