Breaking Research News from sources other than Breastcancer.org
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Immunotherapy Wins First FDA Approval in Breast Cancer
Atezolizumab OK'd for PD-L1-positive triple-negative disease
March 8, 2019
The FDA granted accelerated approval to atezolizumab (Tecentriq) for advanced triple-negative breast cancer (TNBC), marking the first immunotherapy with a breast cancer indication.
The PD-L1 checkpoint inhibitor was approved in combination with nab-paclitaxel (Abraxane) for metastatic or locally advanced, unresectable TNBC, according to the announcement from Genentech, manufacturer of atezolizumab.
In the PD-L1-positive patients, progression-free survival (PFS) in the atezolizumab arm was 7.4 months compared with 4.8 months in the placebo arm
Response rates in the PD-L1-positive patients were 58.9% with atezolizumab and 42.6% with placebo. Median duration was 8.5 versus 5.5 months, respectively.
Under the conditions of accelerated approval, full approval will rest upon confirmatory trial data.
The most common grade 3/4 AEs (≥2%) include low red and white blood cell counts, decreased neutrophil counts, fatigue, increased aspartate transaminase levels, low blood potassium levels, neuropathy, and pneumonia.
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Vaccine Prolongs Remission in Triple-Negative Breast Cancer
Effect in hard-to-treat subgroup "clinically meaningful"
Treatment with a novel peptide vaccine appeared to delay disease recurrence in triple-negative breast cancer (TNBC) patients with low HER2 expression, a subgroup analysis of a phase II trial found.
At a median follow-up of 26.1 months, disease recurrence occurred in 7.5% of TNBC patients who received nelipepimut-S (NeuVax) compared with 26.7% in the control arm
In the NeuVax and control arms, respectively, rates of disease-free survival (DFS) among the 97 TNBC patients were:
- 92.6% versus 70.2% at 24 months
- 82.3% versus 70.2% at 36 months
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Thanks, Lumpie, for keeping us up to date!
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I can't seem to post links here, so you can find this study with search? If someone else can link the study from nature.com and post it here?
Pharmacological reactivation of MYC-dependent apoptosis induces susceptibility to anti-PD-1 immunotherapy
Combining three drugs (METFORMIN+VENETOLAX+PD-1), they got great and durable results in this study, next clinical trials on patients:
" A two-step treatment regimen, beginning with neoadjuvant metformin+venetoclax to induce apoptosis and followed by adjuvant metformin+venetoclax+anti-PD-1 treatment to overcome immune escape, led to durable antitumor responses even after drug withdrawal. We demonstrate that pharmacological reactivation of MYC-dependent apoptosis is a powerful antitumor strategy involving both tumor cell depletion and immunosurveillance."
"We show that the strong induction of apoptosis by ABv treatment (metformin+venetoclax) increases the density of tumor-infiltrating lymphocytes (TILs). "
"In support of this notion, administration of anti-PD-1 antibody alone did not inhibit tumor growth at all but showed remarkable efficacy when administered together with ABv treatment."
"In summary, we report here the discovery and preclinical validation of a clinically applicable synthetic-lethal MYC-targeted therapeutic strategy for the treatment of breast cancer. The ABv+anti-PD-1 combination showed remarkable efficacy in a number of breast cancer models, which was somewhat surprising in light of the fact that BCL-2 dependency is most often observed in hematologic malignancies. The applicability of the ABv+anti-PD-1 combination for treating other cancer types with high MYC and BCL-2/BCL-XL status is currently being investigated in preclinical models."
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Pharmacological reactivation of MYC-dependent apoptosis induces susceptibility to anti-PD-1 immunotherapy
Published: 06 February 2019 (correction published 20 Feb 2019)
Abstract: Elevated MYC expression sensitizes tumor cells to apoptosis but the therapeutic potential of this mechanism remains unclear. We find, in a model of MYC-driven breast cancer, that pharmacological activation of AMPK strongly synergizes with BCL-2/BCL-XL inhibitors to activate apoptosis. We demonstrate the translational potential of an AMPK and BCL-2/BCL-XL co-targeting strategy in ex vivo and in vivo models of MYC-high breast cancer. Metformin combined with navitoclax or venetoclax efficiently inhibited tumor growth, conferred survival benefits and induced tumor infiltration by immune cells. However, withdrawal of the drugs allowed tumor re-growth with presentation of PD-1+/CD8+ T cell infiltrates, suggesting immune escape. A two-step treatment regimen, beginning with neoadjuvant metformin+venetoclax to induce apoptosis and followed by adjuvant metformin+venetoclax+anti-PD-1 treatment to overcome immune escape, led to durable antitumor responses even after drug withdrawal. We demonstrate that pharmacological reactivation of MYC-dependent apoptosis is a powerful antitumor strategy involving both tumor cell depletion and immunosurveillance.
https://www.nature.com/articles/s41467-019-08541-2
Nature Communicationsvolume 10, Article number: 620 (2019)
(Cannot locate a DOI. Sorry)
Thanks for providing a prompt to this article Minniesi.
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Genetic Testing Recommended for All Patients With Breast Cancer
All with personal history of breast cancer should be offered testing; updated testing recommended
Genetic testing should be made available to all patients with a history of breast cancer, according to an updated consensus guideline from the American Society of Breast Surgeons (ASBS).
Researchers from the ASBS outlined recommendations for genetic testing that medical professionals can use for assessing hereditary risk for breast cancer. Data were included from large datasets, basic science publications, and recent updated national guidelines.
"Our society has a responsibility to act when we see an opportunity to decrease unnecessary morbidity and mortality," Walton Taylor, M.D., president of the American Society of Breast Surgeons, said in a statement. "We do so today with the adoption of our new position on this issue."
The Society's updated statement was developed by the panel members listed {link below}, and on February 10, 2019, was approved by the {American Society of Breast Surgeons} Board of Directors.
https://www.practiceupdate.com/C/80788/56?elsca1=e...
https://www.breastsurgeons.org/about/statements/PD...
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Adjuvant Chemotherapy for ER+ Breast Cancer -
A Sea Change Is Underway
Adjuvant breast cancer treatments—chemotherapy, human epidermal growth factor receptor 2 (HER2)–targeted therapies, and endocrine therapy—prevent recurrence and extend survival. Unfortunately, because risk assessment is imprecise and treatments are not uniformly effective, many women are treated to benefit a small number. Chemotherapy has the most onerous short-term side effects and is the treatment that patients most wish to avoid.
Over the past 15 years, multiple genomic assays have been developed that more precisely characterize the risk of developing recurrent breast cancer.
...use of adjuvant chemotherapy for patients with stage I–II ER+/HER2- disease declined from 26.6% to 14.1% and 81.1% to 64.2% among node-negative and node-positive patients, respectively, between 2013 and 2015.
With the advent of targeted therapy for breast cancer, both oncologists and their patients appear less willing than in the past to take a toxic treatment for a very small benefit.
...a National Comprehensive Care Network database study demonstrated excellent outcomes for patients with small ER+/HER2- tumors not treated with chemotherapy with distant recurrence-free survival rates of 98% (T1a) and 96% (T1b). These data suggest that most patients with small ER+ tumors should not receive chemotherapy and may have also led to a decline in chemotherapy use.
Genomic expression assays may ultimately have an even greater impact on the management of young women with ER+ breast cancer, a population that faces the long-term consequences of treatment toxicities.
Whether we are focusing on traditional chemotherapy or targeted approaches, we must strive to integrate prognostic biomarkers such as pathologic complete response and develop new prognostic and predictive biomarkers. Our goal is to provide the adjuvant treatment that allows each patient to remain cancer free and, at the same time, avoid unnecessary toxicity.
https://www.medscape.com/viewarticle/896998?src=mk...
Philip D. Poorvu; Eric P. Winer
J Natl Cancer Inst. 2018;110(5):443-445. © 2018 Oxford University Press
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Patient recommendations for reducing long‐lasting economic burden after breast cancer
First published: 06 March 2019
Journal: Cancer
In the United States, patients who have breast cancer experience significant economic burden compared with those who have other types of cancers. Cancer‐related economic burden is exacerbated by adverse treatment effects. Strategies to resolve the economic burden caused by breast cancer and its adverse treatment effects have stemmed from the perspectives of health care providers, oncology navigators, and other subject‐matter experts. For the current study, patient‐driven recommendations were elicited to reduce economic burden after 1) breast cancer and 2) breast cancer‐related lymphedema, which is a common, persistent adverse effect of breast cancer.
Of 40 interviewees (mean age, 64 years; mean time since diagnosis, 12 years), 27 offered recommendations to reduce the economic burden caused by cancer and its adverse treatment effects. Nine recommendations emerged across 4 major themes: expanding affordable insurance and insurance‐covered items, especially for lymphedema treatment (among the 60% who reported lymphedema); supportive domestic help; financial assistance from diagnosis through treatment; and employment‐preserving policies.
The current study yielded 9 actionable, patient‐driven recommendations—changes to insurance, supportive services, financial assistance, and protective policies—to reduce breast cancer‐related economic burden. These recommendations should be tested through policy and programmatic interventions.
https://onlinelibrary.wiley.com/doi/full/10.1002/cncr.32012
https://doi.org/10.1002/cncr.32012
Read BCO coverage here: https://www.breastcancer.org/research-news/dx-women-offer-advice-on-financial-burden
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Unusual mechanism of CDK4/6 inhibitor resistance found, may be reversible
Breast cancer cells can acquire resistance to the relatively new drugs known as CDK4/6 inhibitors by producing higher amounts of CDK6, a cell cycle protein, a new study has found, and those cells can transfer their resistant traits to other cancer cells via molecular carriers called exosomes.
This drug resistance mechanism, identified by researchers at Dana-Farber Cancer Institute, is highly unusual, they said, and laboratory studies suggest it may be reversible. Breast cancer cells that developed resistance to a CDK4/6 inhibitor, palbociclib, became sensitive to the drug again after a "treatment holiday" of several weeks when no palbociclib was administered, they said in an article in Cell Reports.....
Experiments showed that cancer cells' resistance to palbociclib could be reversed by stopping treatment with the drug for seven weeks. The treatment "holiday" was tested in mice as well: palbociclib-resistant tumor material was implanted into animals, who were treated with the drug until resistant tumors were established. The drug was then discontinued for 28 days, and after treatment was started again, the tumors shrank.
The discovery that resistance to a CDK4/6 inhibitor is transmitted to tumor cells via exosomes has a potential benefit for patient management, the scientists said. "We may be able to examine patients' exosomes [by means of a blood test] and see if they are becoming resistant earlier than would be apparent because the cancer progressed on radiographic scans," said Shapiro.
Posted on MARCH 05, 2019
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New Trials Recently Added to BCT and MTS (March 2019)
Carefully Selected News and Features About Metastatic Breast Cancer Research
Powered by BreastCancerTrials.org
Below are MBC trials that have been added to BreastCancerTrials.org (BCT) in the last month. These trials can also be found on Metastatic Trial Search (MTS)
All MBC
Triple Negative
HER2 Positive (HER2+)
HER2 Low or Negative
Use Metastatic Trial Search to find all metastatic breast cancer trials that are right for you.
https://metastatictrialtalk.org/2019/03/02/new-trials-9/
{You can sign up for free, periodic updates on MBC clinical trials and updates similar to this at https://metastatictrialtalk.org/}
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Expert Discusses the Role of Liquid Biopsies in Breast Cancer
Published Online:4:16 PM, Mon November 5, 2018
The use of next-generation sequencing (NGS) has the potential to improve the treatment of patients with breast cancer, but there are some challenges that still need to be overcome...
"It's not just a matter of the assay itself," Sparano added. "It's a matter of the assay and the limited number of drugs we have available to treat tumors associated with specific molecular alterations."
In an interview with Targeted Oncology, Joseph A. Sparano, MD, associate director for clinical research, Albert Einstein Cancer Center, Montefiore Medical Center, discussed the potential for liquid biopsy and the ongoing challenge of improving survival for patients with metastatic disease.https://www.targetedonc.com/news/expert-discusses-the-role-of-liquid-biopsies-in-breast-cancer
{Brief interview discusses liquid biopsies in Q and A format.}
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This is a very important research paper that one of the authors has very kindly given me full access to.
"Our findings thus address one of the contemporary challenges in breast oncology, namely identification of the subset of ER-positive patients who have a high risk of recurrence and tumour biomarkers that are more predictive of recurrence than are standard clinical covariates."
In other words, predictions of long-term recurrence can be made for those of us who are ER+/HR+ HER2 -
https://www.nature.com/articles/s41586-019-1007-8....0 -
This study suggests that there is no benefit to Vit D3 supplementation. Yet there are so many others that suggest a strong link between recurrence prevention and Vit D3. I will continue taking my supplements.
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The dose they looked at is less than half the dose my MO recommended (5000 IU/day).
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Traveltext--thanks for posting that link. I ran into the firewall, but found this article about the study:
https://www.sciencedaily.com/releases/2019/03/190313143243.htm
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Ingerp - thanks for posting this. I am so hopeful that this work continues and those who follow after us have clearer information on how to battle this disease.
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Rah2464 I know the science gets better and better. I came home from a Herceptin infusion last Friday to read that the FDA has <finally> approved a subcutaneous version. It won't be long before women will get a simple shot rather than an IV or port access (like they've been doing for quite a while in Europe). It won't happen in time to help me but I am grateful for the treatments we currently have and optimistic about the future as research continues.
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Access to CAR T-Cell Therapies for Medicare Patients
"There is currently no national Medicare policy for covering CAR T-cell therapies. Thus far local Medicare Administrative Contractors (MACs) have discretion over whether to pay for these therapies. In the absence of a national coverage determination (NCD), MACs are empowered to make local coverage determinations (LCD). They are the front line for Medicare patients within their geographic area. Under the new National Coverage Analysis (NCA) memo from CMS, Medicare would cover CAR T-cell therapies under CED across the United States. This would include a patient registry where data are collected on the patient for a two year period. These data would include both clinical characteristics as well as patient reported outcome data."
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...just saw this:
Study in mice examines impact of reused cooking oil on breast cancer progression
https://www.eurekalert.org/pub_releases/2019-03/uo...
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April1964 thanks for this. Very sobering. On the odd occasion I indulge in fries and who knows about the oil used in restaurants.
Thanks to all who post on this this thread. It is appreciated.
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... I think this was a mouse study ... who knows how it translates to humans
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I’m not giving up fries!
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april1964: I hear ya! It's all about quality of life! (But I must say, that article was sobering.)
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the conclusion.... make your fries at home with nice fresh oil!
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Neratinib and Capecitabine for Patients With HER2+ Breast Cancer and Brain Metastases
- The authors of this study evaluated neratinib plus capecitabine for treatment of HER2-positive breast cancer brain metastases. Patients with HER2-positive brain metastases received neratinib 240 mg orally once per day plus capecitabine 750 mg/m2 twice per day for 14 days, then 7 days off. The lapatinib-naïve patients (n = 37) experienced a composite CNS objective response rate of 49%. Lapatinib-treated patients (n = 12) experienced a composite CNS objective response rate of 33%.
- The study authors conclude that neratinib plus capecitabine is active against refractory HER2-positive breast cancer brain metastases.
DOI: 10.1200/JCO.18.01511 Journal of Clinical OncologyPublished online March 12, 20190 -
Reports of Breast Implant Illnesses Prompt Federal Review
The Food and Drug Administration is taking another look at breast implants because of renewed safety concerns.
A New York Times report on the new attention to the risks associated with breast implants, an issue they also note that was assumed to be "settled" a decade ago. The Food and Drug Administration (FDA) is evaluating breast implant risks and benefits, including through a public meeting.
{NYT offers a limited number of free article reads per month.}
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This should help with personalized treatment in the future. https://phys.org/news/2019-03-crispr-chip-enables-digital-dna-amplification.amp
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Many of us will be interested in the article to which wintersocks referred us. I thought I would provide a few highlights. (Thanks wintersocks!)
UK breast cancer death rates falling fastest in 'big six' of Europe
Death rates from breast cancer are falling faster in Britain than in any other of the six most populous countries in Europe, research shows.
The rate of death from the disease has fallen by 17.7% since 2010-2014 thanks to screening, earlier diagnosis and better treatment, a Europe-wide study has found
{Despite the falling} breast cancer mortality rate ..... the UK's ageing population, increase in obesity and other factors mean that the overall number of people dying from breast cancer in Britain is due to keep on increasing, even as the death rate decreases. The disease claims about 11,900 lives a year and is the second commonest form of cancer death among women after lung cancer.
"Despite the good news that death rates are declining in most cancers, the bad news is that, due to growing and ageing populations, the number of people who will die from cancer is increasing.... This represents a significant burden on society, and more needs to be done to prevent cancers occurring in the first place."
Source: Annals of Oncology, Published: 19 March 2019
https://academic.oup.com/annonc/advance-article/doi/10.1093/annonc/mdz051/5382368
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