Thursday, April 23, 2020

FDA expedites approval of two new breast cancer treatments

The approval of two new treatments for breast cancer were expedited by the FDA to help high-risk populations during the coronavirus pandemic
The approval of two new treatments for breast cancer were expedited by the FDA to help high-risk populations during the coronavirus pandemic
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The U.S. Food and Drug Administration (FDA) has approved two new kinds of breast cancer treatments, one targeting HER2-positive cancers and a second for metastatic triple-negative breast cancer. The FDA notes approval for both treatments was expedited due to the novel coronavirus pandemic.
“As part of FDA’s ongoing and aggressive commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease,” says Richard Pazdur, director of the FDA’s Oncology Center for Excellence. “At this critical time, we continue to expedite oncology product development.”
On April 17 the FDA approved a treatment using a new drug called Tukysa (tucatinib). The approval is for Tukysa to be administered in combination with chemotherapy for patients suffering metastatic HER2-positive breast cancer.
The approval is not for Tukysa as a first-line therapy. Instead, patients must have received at least one prior anti-HER2 treatment before commencing Tukysa.
The approval was based on recently published Phase 3 clinical trial data showing positive results from the novel combination treatment. In particular, the treatment offers hope to those patients with brain metastases, an aggressive form of the disease with very low survival rates.
“Tukysa was approved four months prior to the FDA goal date, providing an example of this commitment and showing how our regular work in reviewing treatments for patients with cancer is moving forward without delay,” says Pazdur.
On April 22 the FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy). This therapy is targeted at patients with a particularly aggressive form of breast cancer known as triple-negative breast cancer.
Trodelvy comes with a relatively severe set of potential side effects, so the FDA approval only allows the therapy to be administered to patients following the failure of at least two other available therapies.
The Trodelvy application was also only granted under the provision of what is called "accelerated approval." This means further clinical trials or clinical data will be necessary before a full approval, however, the drug may be administered widely based on the criteria it is, “reasonably likely to predict a clinical benefit to patients” suffering from serious conditions with unmet medical needs.
“Chemotherapy has been the mainstay of treatment for triple-negative breast cancer,” says Pazdur. “The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy.”
As with the Tukysa case, Trodelvy’s approval was expedited due the FDA’s commitment in bringing oncology treatments more rapidly to market during the coronavirus pandemic.

Tuesday, February 18, 2020


HAIR LOSS FROM ALOPECIA, CHEMO, OTHER



Are you kidding me? First it was a cancer diagnosis. Then treatment was determined to be chemotherapy. I worked out a plan with my oncologist and began chemo. Treatment was stressful for sure, but going OK. Then a couple of weeks into chemo – My Hair began falling out. I knew I had to find a solution.

My doctor referred me to Susan. Susan is an Oncology Nurse and has experienced Breast Cancer. After chemotherapy treatment she began losing her hair. Susan said that when she was going through this experience in 1992 there wasn’t anyone to talk with to help as a guide to help her feel that she wasn’t alone on this journey. This is one of those times that you can’t understand until it’s you.

“I never want anyone to share my experience,” said Susan. “I founded Susan’s Special Needs in 1994 where we have helped over 12,000 women experiencing hair loss from chemotherapy, alopecia and other medical treatment.

We are now Susan’s @ Antonino Salon here to help you during the loss of your hair whether from chemotherapy, alopecia or other. Depending upon your chemotherapy drug and cycle will determine how long you will be experiencing hair loss. That will help you decide what is right for you - Synthetic, Human Hair/Synthetic Blend, Human Hair.

CALL 248-544-4287 FREE consultation to explore wig solutions right for you. We look forward to your visit. Susan's @ Antonino Salon, Birmingham, MI is by appointment only on Monday and Tuesday from 10:00 AM - 4:00 PM.

Monday, February 10, 2020


Breakthrough MRI imaging method promises early-stage cancer detection

A new method to detect early-stage cancer is being fast-tracked into human trials within the next two years
A new method to detect early-stage cancer is being fast-tracked into human trials within the next two years
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Researchers are reporting the development of a new imaging method to detect metastatic cancer in the liver. Described as a potential “game-changer” for the field of cancer diagnostics, the researchers believe the method could be applied to a number of other types of cancer, offering an entirely novel way to detect metastatic disease at its early stages.
The research focused on a particular receptor, called chemokine receptor 4 (CXCR4), which was previously found to be overexpressed in certain organs in the presence of a metastatic cancer. In this instance the study was examining the path of a common form of eye cancer that is known to move into the liver in its early stages of metastasizing. This metastatic pathway is challenging to diagnose, and is often only detected in the liver at an advanced stage.
The new study, published in the journal Science Advances, describes the development of a new MRI contrast agent that combines MRI image-enhancing gadolinium with a novel protein designed to home in on and bind to CXCR4 receptors.
“Currently, it is difficult to see early stages of disease in the liver, even in invasive biopsy,” explains Jenny Yang, corresponding author on the new study. “Diagnostic testing using this contrast agent can not only identify the presence of disease but differentiate the stages of disease with high sensitivity and accuracy. That’s the beauty of this work.”
At this stage the research has only been directly validated in lab cell studies and animal tests but human trials should commence within the next couple of years. The promising nature of the innovation has seen it labeled with a fast-track designation from the U.S. Food and Drug Administration (FDA). This designation recognizes the clinical importance of the breakthrough.
“We have already met with the FDA, so we have a blueprint,” says Yang. “We hope within 18 months to two years we can conduct our first clinical trials in patents.”
While initial development and testing has focused on a specific type of metastatic cancer found in the liver, Yang is confident this novel imaging agent will be applicable to several other forms of the disease due to the nature of CXCR4 being overexpressed in a variety of different cancers, including skin, breast and colorectal.
“This is a game changer. It has the possibility to have many more applications, really for any type of cancer,” adds Yang. “We are already applying it to 10 different types of cancer in the lab. We have been using the same contrast agents for 30 years with few breakthroughs. I think this is my biggest scientific contribution. And I hope there are many more to come.”
The new study was published in the journal Science Advances.

Friday, January 10, 2020


New cancer treatment delivers weeks of radiation therapy in a second

A new form of FLASH radiation therapy, which delivers weeks' worth of radiation in a second to cancer patients, can be performed using existing equipment
A new form of FLASH radiation therapy, which delivers weeks' worth of radiation in a second to cancer patients, can be performed using existing equipment
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Radiation therapy is currently our best shot at treating cancer, but it’s far from a perfect solution. It takes a course of weeks or even months, during which time healthy cells often become unfortunate collateral damage. But what if the whole course of treatment could be over in under a second? Researchers at the University of Pennsylvania have now shown just how this might be feasible.
With the right tools, cancer cells on their own aren’t all that difficult to kill. Radiation or drugs can be administered to kill them off relatively easily – the problem is tumors like to hide in crowds, and whatever weapons we fire at them also tend to hit healthy cells around them. Because radiation therapy takes weeks, there are more opportunities for those healthy cells to be affected, leading to all kinds of health problems even if the cancer is destroyed.
For the new study, researchers at Pennsylvania University found that by changing the type of fundamental particle used, they could make FLASH radiotherapy far more effective. Normally, electrons are the particles of choice for this method, but they don’t penetrate very deep into the body. That means they’re only really useful for shallower cancer types such as skin cancer.
In this case the researchers used protons, and showed that linear accelerators already in use in hospitals could be adapted to produce these particles. Since they can pass deeper into the body, they should be more useful against a wider range of tumor types.
The team tested it out on mice with pancreatic flank tumors, and found that the method did inhibit the growth of the cancers with roughly the same effectiveness as regular radiation therapy. Importantly though, the proton FLASH therapy reduced healthy cell loss and didn’t cause intestinal fibrosis, a common side effect of radiation therapy.
“This is the first time anyone has published findings that demonstrate the feasibility of using protons – rather than electrons – to generate FLASH doses, with an accelerator currently used for clinical treatments,” says James M. Metz, co-senior author of the study.
The researchers are currently working on how to translate the treatment to clinical trials. This includes designing a system that can deliver the proton radiation to humans.

Saturday, January 4, 2020





FRIENDS DIDN'T KNOW - CUSTOM TAILORED PERFECT FIT


Note from a client:

“I bought a wig from you over the summer and have been wearing it for all professional and social occasions for about the last 6 weeks.

I’m still learning, but it’s starting to feel more normal. It surely feels like the best of my options for now.

Many of my close friends have complimented my great new haircut and say that they love the look with “more bangs.” We’ve had some good laughs when I quietly tell them that it’s “hair you wear” and they can’t’ believe it at first. Those moments have been great therapy!


Best of all, I’m starting to feel like myself again, in that I’m looking forward to going out and having fun living my life, as I always have.

Thanks for taking such good care of me back in July!”

I am an Oncology Nurse Clinician who experienced Breast Cancer. After chemotherapy I lost my hair. Susan’s Special Needs was founded in 1994 out of my personal frustration finding a salon that understood.  We have helped over 12,000 women experiencing hair loss from Chemotherapy, Alopecia and other medical treatment.

We are now “Susan’s @ Antonino Salon” to help you during the loss of your hair. We will help you decide what’s right for you. Depending upon your chemotherapy drug and cycle will determine how long you will be experiencing hair loss.

CALL 248-544-4287 FREE consultation to explore wig solutions right for you. We look forward to your visit. Susan's @ Antonino Salon, Birmingham, MI is by appointment only on Monday and Tuesday from 10:00 AM - 4:00 PM.

Thursday, January 2, 2020


Google’s AI breast cancer system spots tumors human experts miss

One in five breast cancers are not picked up by trained radiologists looking at mammograms, but AI can help improve this result
One in five breast cancers are not picked up by trained radiologists looking at mammograms, but AI can help improve this result
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A new artificial intelligence system is proving more effective at detecting breast cancer in mammograms than trained radiologists. The software, developed by researchers from Google Health, is not designed to replace human radiologists but instead assist and speed up current diagnostic processes.
Although mammograms are the best diagnostic tool for uncovering breast cancer clinicians currently have at their disposal, they are not a perfect screening tool. One in five breast cancers are not picked up by trained radiologists looking at mammograms. At the other end of the spectrum around 50 percent of women receiving annual mammograms will have a false-positive finding at some point over a 10-year period.
The new AI system was trained on a dataset of nearly 100,000 mammograms. The newly published study, evaluating the performance of the predictive software, was tested on two large mammogram sets, one from the UK and the other from the US. Neither of the two new test datasets were used to train the AI system.
In the US dataset, the software performed significantly better than human experts, producing 5.7 percent fewer false positive diagnoses. Even more impressively, the system recorded 9.4 percent fewer false negatives, suggesting it picked up several breast cancers that human experts missed.
The results in the UK dataset were less impressive but still significant. In the UK mammograms are screened by two separate radiologists, generally reducing the volume of errors, yet the AI system still bested the human experts with 1.2 percent fewer false positives, and 2.7 percent fewer false negatives.
A second arm to this evaluation study was an independent “reader study” conducted by an external research organization. In this test six US radiologists were pitted against the AI system, evaluating 500 randomly sampled mammograms from the US dataset.
Again, the AI system significantly outperformed the human radiologists on average. However, the study does note that although there were cancers picked up by the AI that were missed by all six human experts, there was at least one case picked up by all six humans but completely missed by the AI system. No clear patterns were identified to explain why these particular cases resulted in significant differences between human and AI, but the Google researchers suggest the future of these tools lies in assisting human experts rather than entirely replacing them.
“This is a great demonstration of how these technologies can enable and augment the human expert,” explains Dominic King, one of the UK Google Health researchers working on the project. “The AI system is saying ‘I think there may be an issue here, do you want to check?’”
Daniel Tse, one of the US Google Health researchers working on the project, affirmed this idea to Stat News, suggesting the goal is not to replace human experts but instead find a way to deploy this software in clinical spaces to help reduce human error.
“We believe this is just the beginning,” says Tse. “There are things that these models and technology are really good at, and there are things that radiologists, who spend their whole lives doing this, are really good at.”
The new study was published in the journal Nature.

Monday, December 16, 2019


Study shows how mitochondria can shield cancer cells from chemotherapy

Mitochondria seen in red, cell nuclei (blue) and mtDNA (white dots)
Mitochondria seen in red, cell nuclei (blue) and mtDNA (white dots)
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Chemotherapy is a powerful weapon in the fight against cancer, but the complex nature of the disease means that it doesn’t always produce the desired result. Scientists at the Salk Institute have been researching some of the cellular processes behind these evasive abilities, uncovering a new mechanism that could pave the way for new treatments that see chemotherapy maintain the upper hand.
The work was carried out at the Salk Institute’s Molecular and Cell Biology Laboratory, where medical scientists led by Gerry Shadel set out to investigate the role mitochondria might play in the effectiveness of chemotherapy.
Mitochondria is best known as the power generator of the vast majority of cells, but the scientists have found that it can also act as an early warning sign when something’s not quite right. While most of the DNA we carry is packed inside the nucleus of the cell, mitochondria packs its own small set of DNA, called mtDNA.
When our cells become stressed or are under attack by viruses or chemicals, such as those in chemotherapy drugs, the mitochondria responds by releasing its mtDNA and instigating an immune response to get on top of the threat. When this happens, a set of genes called interferon-stimulated genes (ISGs) spring into action.
These ISGs perform the role of shielding the DNA inside the cell’s nucleus. Unfortunately, it plays the same protective role when it comes to chemotherapy drugs that target the DNA inside cancer cells. The team observed this process at play in melanoma cancer cells grown in culture, and again in mice, where higher levels of ISGs led to higher resistance to chemotherapy drug doxyrubicin.
In this way, the mitochondria acts as a “canary in a coal mine” according to the researchers, serving as an early warning that the cells are under attack. But when this release of mtDNA is triggered by doxyrubicin, it has the undesired effect of protecting the nuclear DNA the drug is designed to attack. With this new understanding, however, comes potential new ways to intervene.
“It says to me that if you can prevent damage to mitochondrial DNA or its release during cancer treatment, you might prevent this form of chemotherapy resistance,” Shadel says.
Shadel and his colleagues are now working towards follow up studies to better understand these processes. The research has been published in the journal Nature Metabolism.
Source: Salk Institute

Monday, December 2, 2019


NO FLYING WIGS – Human Hair. Human/Hair Synthetic. Synthetic.

I am an Oncology Nurse Clinician and experienced Breast Cancer. I was totally unprepared for the patient side. I navigated through a mastectomy and chemotherapy treatment. Wham. I began losing my hair. I had no idea what products and services were available. I found a salon that sold wigs and made my appointment. The salon had chair stations overlooking the parking lot. Now with my hair now dripping off my head I tried on a bunch of wigs and found one that I thought would work. I sadly drove home with my wig in a bag to figure it out for myself.

Taking a break after chemotherapy our family was off to Disney World for some well-deserved family fun. One of our first rides was Splash Mountain. Thanks to our daughter’s fast reaction she caught my wig as it started flying off my head.  There had to be a better way – Susan’s Special Needs custom wig fitting business was born.

We are now Susan’s @ Antonino Salon here to help you during the loss of your hair whether from chemotherapy, alopecia or other. Depending upon your chemotherapy drug and cycle will determine how long you will be experiencing hair loss. That will help you decide what is right for you - Synthetic, Human Hair/Synthetic Blend, Human Hair.

CALL 248-544-4287 FREE consultation to explore wig solutions right for you. We look forward to your visit. Susan's @ Antonino Salon, Birmingham, MI is by appointment only on Monday and Tuesday from 10:00 AM - 4:00 PM.

Thursday, October 17, 2019


Exercise Advice for Surviving Cancer, and Maybe Avoiding It

New guidelines say exercise may help cancer patients live longer, or help you avoid getting cancer in the first place.
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CreditCreditKendrick Brinson for The New York Times
Even a little exercise may help people avoid and survive many types of cancer, according to new exercise guidelines released today that focus on how exercise affects cancer outcomes.
The guidelines, issued jointly by the American College of Sports Medicine, the American Cancer Society and 15 other international organizations, update almost decade-old recommendations with new science and specific advice about how much and what types of exercise may be the most needed, helpful and tolerable for anyone facing a cancer diagnosis.
Cancer is, of course, one of the world’s most common major diseases, with more than 18 million people globally diagnosed with some form of the condition in 2018. It also is often treatable and today, millions of people are cancer survivors.
But there are high fiscal and physical costs related to cancer. Treatments, while frequently effective, can leave people feeling ill, anxious, exhausted and frail, and may cause collateral damage to the heart or other parts of the body.
So, physicians, therapists and scientists, working with cancer patients, continue to look for accessible, inexpensive ways to improve the lives of cancer patients and also, more fundamentally, reduce the risk that someone will develop cancer in the first place.
Exercise was an obvious candidate. Whether aerobic or resistance, exercise is known to build strength, fight fatigue and lift gloom. But many researchers, clinicians, patients and their families have worried that it might be unsafe for people with cancer; that it might, somehow, make people’s condition worse.
In 2008, a large group of researchers convened to comb through the available science about exercise and cancer and decide if there was enough evidence to tell patients that they could and even should work out. In 2010, the group published its recommendations, which amounted to saying that exercise appeared to be safe for most people with cancer and they should try, in general, to be active.
Since then, however, there has been “exponential growth” in research related to exercise and cancer, says Kathryn Schmitz, a professor of public health and cancer control at Penn State University and the immediate past president of the American College of Sports Medicine.
So, last year, she and almost 40 other researchers from 17 international health groups gathered to determine whether there was sufficient evidence now to refine the recommendations about cancer and exercise. The group wound up gathering hundreds of studies involving animals and people that examined the impacts of exercise on dozens of aspects of cancer risk and cancer recovery.
And they concluded that there was more than enough evidence to start suggesting that exercise should be a part of standard treatment for most people with cancer. They also found that exercise should be considered a means to substantially drop the risk of developing cancer in the first place.
Specifically, the scientists, in separate reviews being published today in Medicine & Science in Sports & Exercise and CA: A Cancer Journal for Clinicians, report that physically active people have as much as 69 percent less risk of being diagnosed with certain cancers than sedentary people. Exercise seems to be especially potent at lessening the likelihood of developing seven common malignancies, the new recommendations add: colon, breast, endometrial, kidney, bladder, esophageal and stomach cancers.
The recommendations also point out that, in multiple recent studies, exercise changed the trajectory of cancer once it began. In animal experiments cited in the new reviews, exercise altered the molecular environment around some tumors, stalling or even halting their growth. And in people, exercising during and after cancer treatment was associated with longer subsequent life spans, the reviews found.
Exercise also seems to lessen cancer patients’ feelings of anxiety or depression and their sometimes debilitating fatigue, the new recommendations report.
And while there had been some concern that exercise might increase the risks for or severity of upper-body lymphedema, the swelling and fluid retention that is common among women recovering from breast cancer, exercise was not associated with an increased risk
Based on these findings, the authors of the new recommendations conclude that people with cancer should aim to exercise at least three times per week at a moderate intensity, such as by brisk walking, for at least 30 minutes, and also try to lift weights twice a week, if possible.
These recommendations are a bit lighter than the standard, governmental guidelines for the general public, which call for moderate aerobic exercise five times per week, plus several sessions of weight training.
Dr. Schmitz says the available science indicates that working out three times a week is the most likely to be feasible and safe for almost everyone with cancer. “The evidence is clear that going from nothing” — from being totally sedentary — “to something is helpful” for people completing or recovering from cancer treatment, she says. Check with your doctor before starting an exercise regimen, but for those who are able to, she adds, “more is better.”
She and her colleagues hope that future studies will help to pin down more precise, granular doses of exercise that doctors can prescribe to aid in cancer treatment and prevention in general and against specific types of cancer in particular. They also hope to determine whether or not there is any upper limit on the amount of healthy exercise for people with cancer.
But for now, Dr. Schmitz says, the primary recommendation she and her colleagues would offer to anyone dealing with or hoping to avoid cancer is: “Get up. Move. It’s so simple and so essential. Get up and move.”