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Will Cancer Be Cured By 2020?

After cardiac diseases, cancer is the second most leading cause of death worldwide. According to WHO, 20% of deaths are down to cancer while in 2018, there were 18 million new cases, along with 9.6 million deaths were reported. Although the number of surveillance within five years after the diagnosis of cancer is 43 million. In the US alone, 1,688,780 new cases and 600,920 cancer-related deaths were reported in 2017 by National Cancer Institute (NCI).

Researchers have conducted meticulous studies to discover new ways to cure this deadly disease. Currently, the most effective treatment options are radiotherapy, chemotherapy, surgery, and hormonal therapy. But the concern is; how close are experts are in finding more effective treatment options for cancer? Many innovative therapies are beginning to pick up steam to defeat the battle against cancer and ideally having fewer side effects than available options.

Cancer is not just a game of winners and losers [1], these innovations are aimed to address the issues of aggressive treatment, recurrence, irreversible side effects that healthcare providers and patients both face. Below are some updates on the most advanced cancer research breakthroughs that have given us hope for better therapies and prevention methods with less harm.

1.   Immunotherapy

Immunotherapy aims to reinforce existing arsenals in our body to fight against cancer cells. Some types of cancers have the characteristic of duping our immune system. However, with the help of in vivo and in vitro experiments, researchers are exploring new ways to deactivate the protective system of cancer cells.

According to Nature Immunology, macrophages that usually eat up harmful foreign bodies and cellular debris fail to obliterate highly aggressive cancer cells. The reason behind this is the macrophages read out two different signals from cancer cells that are meant to rep-el them for cleaning mechanism. Hence, by blocking the dual signaling pathway, researchers can make white blood cells unable to perform their action.

2.   Therapeutic virus vaccines

Innovative virus vaccines are proven to be a surprising weapon to fight against cancer. In the UK, a team of scientists has succeeded to use reovirus against brain cancer cells [2] while not harming healthy cells. It can pass the blood-brain barrier hence opens up the possibilities towards betterment.

Another milestone is the discovery of dendritic vaccines, in which they are extracted from a person’s body and armed with tumor-specific antigens that make them hunt and smash the cancer cells. Then the dose is injected back to the patient’s body to boost the therapy. Some concerns raise as it may have some pitfalls of damaging healthy tissues.

To address this, researchers from North Carolina have developed a bio-responsive scaffold system to hold on both chemotherapy and immunotherapy with better control on targeting tumor.

3.   Nanoparticle revolution

Stakeholders believe that nanoparticles can be a game-changer in the treatment of cancer.  They are précised and are less invasive to target specific cells without harming the surrounding environment. They can be used to give hyperthermic treatment to make tumors shrink.

Researchers are working on self-regulating nanoparticles to target undifferentiated carcinoma cells without damaging healthy tissues. They can be used to target stem cells to treat the resilience of cancers. They can even be loaded with drugs to prevent recurrence of degenerative diseases [3] and can be beneficial in the treatment of invasive carcinomas such as endometrial and breast cancers.

4.   Starvation strategy for tumors

Starving cancer cells to death is a novel method to kill them. There are many studies onboard that prove multiple ways of cutting off cancer cells nutritional supplies. One effective way is to stop the glutamine supply. It will maximize the oxidative stress and induce cell death. Moreover, blocking the supply of vitamin B2 can halter cancer stem cells. Therefore the strategy can help to avoid the toxic effects of chemotherapeutic agents.

5.   Epigenetics

This refers to the alteration of gene expression to dominate the representative action to affect cells at a biological level. Recent advancements have shown that cancer cells can harbor epigenetic modifications [4] to promote progression and eradication of carcinoma.

Scientists have to channelize the potential without triggering Huntington’s disease, and this is the biggest challenge and concern for them that makes them more hopeful. The knowledge can be utilized to treat stubborn tumors and progress enzyme inhibitors for better success rates.

In a nutshell

Shawn Brad, Research content writer at King Essay [5] believes that researches have given us innovate safe ways to cure cancers and studies are running at a good pace; however, curing every type of cancer is definitely a matter of time. Promising studies immensely give us hope on some technological terms for upcoming years.

It is difficult to say that a single approach is going to work for a variety of needs, while much advanced emerging ways can be useful in treatments. Hence, there are optimistic efforts, that make us claim that cancer can be eradicated quickly, and further depth in knowledge can give us more targeted and précised tools to turn the tables.


Resource Links:

[1] Cancer is not just a game of winners and losers

[2] reovirus against brain cancer cells

[3] prevent recurrence of degenerative diseases

[4] harbor epigenetic modifications

[5] King Essay

Notable News – June 2019

It’s official! The nation’s cancer mortality rate continues to decline, says cancer.gov. The finding was revealed in this year’s annual report regarding the status of cancer in the country. The report shows that cancer death rates have continued to decline in men, women, and children from 1999 to 2016. Specifically, lung, bladder, and larynx cancers are decreasing, which is attributed to the decline in tobacco use. Conversely, cancers related to obesity are increasing. The highest overall cancer incidence rates occurred in black men and white women. The lowest rates were among Asian/Pacific Islander men and women. In addition, researchers looked specifically at cancer trends among those aged 20 to 49. In this group women had higher cancer and death rates than men, which is the opposite of the data among all age groups. Breast cancer, thyroid cancer, and melanoma were identified as the most common cancers on the rise among 20 to 49 year old women. The report, published last month in the Journal of the National Cancer Institute, is put together by the National Cancer Institute (NCI), the Centers for Disease Control and Prevention (CDC), the American Cancer Society (ACS), and the North American Association of Central Registries (NAACCR). Find more detailed information about the annual report here.

The decline in cancer deaths just may have a lot to do with the amazing strides being made in understanding cancer and its risk factors, ways to diagnose it, and ways to treat it. Researchers at Yale have made a discovery about how metastasis, the spread of cancer, occurs on the molecular level that could lead to new ways of treating cancer, reports medicalexpress.com. While the study focused on renal cancer, understanding metastasis on the molecular level could lead to new testing and treatment for all types of cancer. Find more information about the study and the metastasis process here.

It’s important to know if you are at risk for certain cancers and having children through IVF may be one of them, reports thesun.co.uk. A 21-year study analyzing over 600,000 Danish women suggests that women who have had children using IVF are more likely to develop breast cancer. In addition, women who had their first child through IVF when they were 40 or older, were 65 percent more likely to develop breast cancer than women of the same age who conceived naturally. The drugs given to women during IVF to stimulate the ovaries may be the culprit. They increase levels of estrogen, a known factor in the occurrence of breast cancer. Make sure you are staying on top of your breast cancer screenings if you had children using IVF, and learn more about the study here.

Also reported by thesun.co.uk, is good news about early detection, specifically for prostate cancer. Scientists have developed a simple urine test that could show signs of prostate cancer five years early. The test, which could be available in as few as five years, looks for changes in specific genes. If the changes are noted, further testing is done. The process would mean that some men would not have to have invasive testing procedures and others would know of their prostate cancer risk earlier. Learn more about the promising new test here.

Finally, of interest this month is an article by theatlantic.com regarding the two technologies that are changing the future of cancer treatment, and the way in which oncologists are looking at treating the disease. The article points to immunotherapy and CAR T-cell therapy as kindler, gentler approaches to cancer treatment. Chemotherapy, which is the most successful treatment to date, as the article points out, can make the treatment process brutal. Oncologists are turning to the new therapies to treat cancer without the harsh side effects that come with chemo. The article is a quick read and it provides hope for anyone who is or may be affected by cancer. That means all of us. Check it out here.

Notable News: August 2018

The death of legendary singer Aretha Franklin received a lot of attention this month, but the cancer that killed her is in need of more awareness, say experts in a huffingtonpost.com article. The five year survival rate for pancreatic cancer is a very low eight percent. The disease often has no symptoms in the early stages, spreads early, is resistant to treatment, affects vital functions and, despite being thought of as rare, is increasing in frequency. However, there is some promising new research in the detection of pancreatic cancer (you’ll read about it in the next paragraph). Heightened awareness, funding, and research are needed to help combat this deadly disease. You can start by learning more here and, in case you missed it, you can find this month’s profile in which Alison Greenhill tells the story of her late husband’s experience with pancreatic cancer here.

The promising news is that a blood test could offer early screening for pancreatic and other cancers, according to research reported by dailymail.co.uk. In one study, scientists discovered that they can detect 95 percent of cancers through one blood test thanks to a protein produced by malaria parasites. When ten cancer cells were exposed to the protein, nine of them successfully attached to it. The test can also detect the cancers at any stage and help identify the aggressiveness of the disease. Among the cancers the test can detect are liver and pancreatic. Pancreatic cancer tends to have a low survival rate because it is often not found until the late stages of the disease. This blood test could allow for earlier detection. More can be learned about the potentially life-saving test here.

Another blood test has been found to detect melanoma with an 80 percent accuracy rate, says sciencealert.com. Caught early, the melanoma survival rate is 95 percent, but if it’s not detected early, chances for survival are below fifty percent. The test works by detecting antibodies that the body produces when melanoma forms. Currently, melanoma is detected through biopsies which are invasive and have a slightly lower accuracy rate than the blood test. The researchers hope to take the test to clinical trial and ultimately hope it will be used to detect the disease prior to biopsy in high-risk patients: those with fair skin, a lot of moles, and/or a family history of melanoma. More about this blood test can be found here. There is also a better way to determine which melanoma patients may benefit from immunotherapy. You can learn about that at axios.com here.

Another immunotherapy update comes from a recent study that may offer new insight into immunotherapy treatments, says geekwire.com. While immunotherapy has been a game-changer in treatment for many cancer patients, it doesn’t work at all for others and it can also come with some life-threatening side effects. Researchers set out to better understand the therapies and discovered how the components talk to each other in a process called signaling. It appears that the speed and strength of the signaling affect how the body responds to the treatment. It is the difference in the signaling that may help researchers find a way to reduce or eliminate the dangerous side effects and may also lead to making the treatments more effective. More information about this promising research can be found here.

As important as treatment is, keeping on top of when to be screened can be crucial to successful diagnosis and treatment. There are now more cervical cancer screening options for women aged 30 to 65, and you can learn about those at cnn.com here.

With all the positive research and advances in detection and treatment, it’s important to be aware that not all cancer patients have equal access to the best healthcare. It turns out that the disparities in minority health that we told you about here during National Minority Health month also apply to children. African American and Latino children are more likely to die from cancer, reports npr.org. Race and socio-economic status are factors. A comprehensive look at the research about the inequities in healthcare and survival rates for minority children can be found here.

Hopefully, the healthcare gap and survival rate can be narrowed because a new study shows that life is pretty good for most patients and survivors. The majority of current and former cancer patients who are 50 or older are happy, reports sciencedaily.com. The study showed that two-thirds of cancer patients fit the researchers description of complete mental health which was characterized by high levels of social and psychological well-being and being happy and/or satisfied with their daily lives. The cancer survivors were even happier with three-quarters of them meeting the complete mental health criteria. Learn more about this very happy study here.

ASCO 2018 Lung Cancer Roundtable

A Lung Cancer Roundtable: Takeaways from ASCO 2018

Lung cancer experts Dr. Jeffrey Crawford from Duke and Dr. Edward Kim from Levine Cancer Institute speak about key take-aways from this year’s ASCO meeting including immunotherapy updates, newly identified genes, the role of liquid biopsies and specific questions patients/care partners should be asking as the lung cancer landscape continues to evolve.


Transcript

Andrew Schorr:

Okay.  Here we go.

Hello and welcome to this Patient Empowerment Network program produced by Patient Power.  I’m Andrew Schorr from Patient Power, and we’re discussing an update from the big American Society of Clinical Oncology meeting, ASCO, and what it means for patients and family members dealing with lung cancer today.  I want to thank our financial supporters for making grants to support this program, Celgene and Pfizer.

So we have two noted experts with us.  We have Dr. Jeffrey Crawford from Duke University and the Duke Cancer Institute in Durham, North Carolina, and Dr. Edward Kim from the Levine Cancer Institute down the road also in North Carolina, in Charlotte, North Carolina.  Dr. Crawford, welcome to Patient Power and the Patient Empowerment Network.

Dr. Crawford:

Andrew, thank you.  I’m glad to be here.

Andrew Schorr:

Dr. Kim, welcome to you.

Dr. Kim:

Pleasure, Andrew.

Andrew Schorr:

Okay.  Gentlemen, let’s start.  So I walked into the ASCO exhibit hall, which is many football fields wide and long, and I was impressed with so many companies devoted to helping doctors and their patients understand the specific biology, molecular composition of the tumor that somebody might have for example with lung cancer.  Dr. Kim, is this where it’s going, is that sort of precision medicine?  And why is it so critical for patients and their doctors?

Dr. Kim:

Yeah, thanks, Andrew.  I think it’s really important to know how the new standards are changing.  We’ve been used to a lot of therapies and how we assess folks for decease such as biopsies and histological diagnoses, and now it’s not just about that.  It’s about trying to figure out what genes exist that are unique to each person’s individual tumor.  And we know that these genes are differently made up in different folks, so just to call somebody who has a non‑small cell lung cancer, and that’s the area that myself and Dr. Crawford cover, is really not the whole picture any more.

We’ve seen this in breast cancer.  We’ve just kind of come to accept it over the last couple decades, that you’re either a hormone receptor‑positive breast cancer patient or your tumor is HER2 positive or not or you’re a triple negative, and that’s means none of those markers are present.

Well, we were never that sophisticated in lung cancer, frankly, to have the equivalent of a triple negative even though we did, and we started is seeing this in the early 2000s, especially as we looked at first the mutations like EGFR and translocations like ALK and ROS1, and now that number is just really exploding as far as the number of markers that a clinician has to check just at baseline to make the proper assessment to treat a patient with non small‑cell lung cancer these days.

And that’s exciting, but it’s also daunting in that the data and the drugs and markers are changing so frequently that it’s hard to keep up, and even as an expert it’s hard.

Andrew Schorr:

Now, Dr. Crawford, you’re in research a lot as well, and so this multiplying of genes, you keep identifying new ones, right, and then it’s a matter of finding out, well, which genes are important at which time for which patient, right?

Dr. Crawford:

Correct.  As Ed was saying, it’s a complicated task, and I think we get now a lot of information.  When we do next‑generation sequencing, we get literally hundreds of genes.  Some of them are actionable, some aren’t, and really understanding which are and which aren’t and now to interpret that is becoming a field of its own.  So molecular tumor boards have started to try to dissect this at the institutional level so people can sit down with pathologists, (?) like the pathologist‑clinicians, try to work through how to move forward on an individual patient basis.

Andrew Schorr:

So, Dr. Kim, we hear about immunoncology, immunotherapy, and drugs that are being tested in many cancers to try to help the immune system be boosted, I guess, to fight the cancer.  Maybe you could explain that because there was news about that at ASCO, wasn’t there, for lung cancer?

Dr. Kim:

Yeah.  And certainly it seems like every major meeting, Andrew, has news about immunotherapy.  And the really nice part about it, speaking very selfishly, is that there has been a lot of news about immunotherapy and lung cancer, and I get to tease my melanoma colleagues, that, yeah, you know, we know it’s been around for greater than five, six years in melanoma, but it required a large scale sort of cancer to take this into the main stream.

And lung cancer is one of the largest.  It affects so many people out there, and to have these trials testing immunotherapies and these FDA indications, has really transformed things.  What we explain to people is that it’s not like the vaccine programs in the past in that the immune system is a very sort of gray area for a lot of folks.  Some people think you can take vitamins and boost your immune system.  Other people think you just have healthy living it will do it, and all those things contribute because your immune system is really like your micro environment throughout your entire body, and a lot of things affect it, and it affects a lot of things.

But what’s really cool about these newer generation drugs that are impacting the cancer process is that cancers have become smart.  They are able to build up defenses to be sort of stealth inside the body, and so even though there were bad things happening to you your body couldn’t tell that they were cancer cells versus normal cells.  And so these new checkpoint inhibitors have focused on trying to break down the stealth or the defenses that these cancer cells have been using to invade the immune system.

And so now you’re really empowering your own body’s immune system to fight the cancer.  And that’s really exciting.  The side effects, there are some but have generally been very well tolerable.  There are always a percentage of patients who can get a hyperactive immune system, and that’s usually what causes a lot of symptoms we see, but all in all‑‑you know, we use Jimmy Carter as a poster child, he’s like 150 years old, and he’s on an immunotherapy being treated for a stage 4 melanoma and doing very well.  So that’s what my patients see out there, that’s why they’re asking about it.  We have to select the right people who is appropriate.

Andrew Schorr:

Well, Dr. Crawford, let’s talk about selection.  So we’ve alluded to testing to understand what’s at work or what sort of immune levels, we hear these terms PD‑1 and PD‑L1, and they’re even mentioned on telephones commercials for lung cancer drugs.  So how do we know whether this changing world of immunotherapy applies to an individual patient?

Dr. Crawford:

Well, that’s a good question.  So I think we’re learning as we go about biomarkers for immunotherapy, but certainly the one that’s out there most notably is PD‑L1, and so that’s a marker of this protein that Dr. Kim was talking about.  It’s an immune checkpoint, so PD‑L1 when it finds the PD‑1 receptor down regulates or lowers the immune system, and that’s a natural, naturally occurring process.  It’s important so our immune system does get overly revved up, but what happens in cancers it often gets overly depressed and suppressed, so we have inhibitors, drugs that work by inhibiting that reaction that allow the immune system to emerge and attack the cancer.

So what’s really cool about this is that the immune system itself is what destroys the cancer when you take these agents.  This is not like chemotherapy or even targeted therapy where there’s a direct cytotoxic effect on the cells.  This is really enabling your immune system to take over and attack the cancer and destroy it.  So it’s remarkable when we see an x‑ray with cancer disappearing based on restoring the immune system.

So PD‑L1 is clearly an important marker because it’s the way these first‑generation immune checkpoint inhibitors work through that process.  So one would assume that the PD‑L1 measurement would be predictive of who is going to benefit and who is not.  And in some sense it is, but it’s not at all like EGFR testing, where we are pretty confident when we have an EGFR mutation we’ll have a very high response rate, while with PD‑L1 even in patients with expression above 50 percent only about half of them get a good response.

And on the other end patients with very low response, very low levels of PD‑L1, they still have a response of 8 or 10 percent.  So it’s not a perfect marker by any means, but it has been helpful in identifying patients likely to benefit.  And what’s come out of ASCO is more and more about how to select patients for immunotherapy or a combination of chemo and immunotherapy or other options.

Andrew Schorr:

Dr. Kim, let’s talk about biopsy for a minute or how you get the information from the patient as to what’s going on and then what to do about it, if you will.  So getting a lung biopsy is not easy, and I know sometimes there’s a problem getting enough tissue to do all the analysis you want, and now we’ve been hearing about more and more companies that are doing liquid biopsy.  Okay.

So here’s Mr. Jones, you want him to have a lung biopsy.  Would there also be a liquid biopsy or‑‑and not just at diagnosis but would you be doing some of this along the way to see if treatment is working?

Dr. Kim:

Yeah, we’ve always been attracted to some of the other cancers that utilize liquid tests, ovarian cancer, CA125, PSA, prostate cancer, although we’re still not really clear on where we’re supposed to be using that to screen patients, but that has given people is principle that they like to follow things.  And that’s why cholesterol, for instance, was such a powerful sort of marker even though the relevance of it has been questioned by cardiologists.  People can see there is an effect.

So, first of all, we have to say that nothing has completely replaced tissue.  That is really the gold standard.  It still is.  I tell our interventionalists, whether it’s a pulmonologist, interventional radiologist or anyone, I don’t want a diagnosis.  I want tissue.  Because they can make a diagnosis by doing some brushings or some cytology, and they can tell me it’s an adenocarcinoma favoring lung.  That is not helpful.  We need to absolutely have data that allows us to send for these molecular tests which includes, as Jeff mentioned, PD‑L1.

We need EGFR mutation, ALK, ROS1, BRAF.  These are all very important markers now that need to be sent.  And in some cases, at some centers they send for the larger panels.  What you get are 3‑ to 500 genes.  I don’t need 3‑ to 500 genes, but there are certainly clinical trials out there that can help match patients into trials based on these genes, so it is some utility.

But the blood‑based markers and the biopsies are improving.  There are definitely very‑‑there are good data that show concordance when they’re positive.  So if you do a blood test and it shows a positive mutation for EGFR, for instance, you can be pretty confident that the tissue has that as well.  The problem is that when you get a negative result.  And the negative result, those percentages aren’t disconcordant because (?) really show the amount of accuracy, and so you can’t take a negative test at face value.  We don’t standardly do liquid biopsies in patients unless the patient really has a contraindication to doing a traditional tissue biopsy.

As far as the surveillance aspect, as you mentioned, we do that on research.  So on our research studies we do follow patients at every cycle with another blood draw, in addition to what they give in labs, so it’s not an extra stick.  It’s just extra biopsy.  And we do try to follow to see if we can see some of these different mutations either go up or down based on how the treatment is working or not working.  And we’re hopeful that this type of research down the road can lead to more predictive assays that are easier to gather so we can either surveil patients to see if they have cancer, if it’s gone away, if it’s come back.

You can imagine somebody who has been treated for cancer, who has no evidence of disease on a CAT scan but maybe with blood surveillance we can get an early sign if something is coming back.  These are all possibilities and are being investigated, but right now it’s really a backup plan if tissue can’t be adequately gathered.

Andrew Schorr:

Dr. Crawford, of course you’re doing research as well.  Do you agree with this, where we are now and where we’re headed?

Dr. Crawford:

Absolutely.  I think what’s happened in lung cancer is because of this need for tumor tissue, as Dr. Kim has pointed out, it’s really transformed all the interventional things we’ve been doing.  We were moving in the 90s to smaller and smaller biopsies, smaller and smaller needle aspirations just to make a diagnosis, but now we’ve gone back the other way where we’re retraining our pulmonologists to get larger cores of tissues.  They’re developing new techniques to get more tissue, endobronchial biopsies.  CT interventional people have been enormously helpful for getting core biopsies so we get adequate tumor tissue to do the molecular tests we’ve been talking about.

So that’s really fundamentally important and important to have at every institution hospital across the country.  It’s one thing for Levine or Duke to be able to do this, but it really needs to be done in smaller community hospitals and done well by interventional people who can get the tissue we need because the samples can always be tested at a central site if the pathology labs can’t do it locally.  We have to be able to get the tumor tissue.

Andrew Schorr:

Let’s pull this together for a little bit.  I want to see if I’ve got this right.  So you’re having a revolution now in more genes being identified and trying to decide what’s actionable, whether you have approved medicines or combinations or drugs in trials, that both of you have alluded to, could for research purposes you identify something and where that could offer hope to a patient where otherwise the existing therapies might not match up.

So what actions should patients and family members be talking about?  And you said, Dr. Crawford, like at the community level or if they have a university hospital as a choice to go.  What should they be doing now because obviously anybody diagnosed with lung cancer or their family member, we want the longest life and the best chance right now, and yet you have an evolving field.  So what would‑‑Dr. Crawford, how would you counsel patients and family members so that with what you have available, either as approved therapies or in trials, could be available to them?

Dr. Crawford:

Well with, first, let me back up a second to say we’ve been talking mainly about advanced lung cancer.

Andrew Schorr:

Right.

Dr. Crawford:

So it’s important that patients get diagnosed early.  It’s important that patients who are eligible for CT screening and to go that so we can detect lung cancer at an earlier stage and hopefully offer them curable surgery, and then for them to get evaluated by a multidisciplinary team if they’re in early stages to see is surgery alone the right thing, surgery and chemotherapy, a combination with radiation, so all those standards are still present in early‑stage disease.

Now, as we may talk about, immunotherapy and targeted therapy may have a role there as well, but I think our curative strategies remain intact there.  So it’s very important to have availability of a multidisciplinary team that can really assess cancer at all stages.

For the advanced cancer patients then, what’s particularly important is for every patient to get molecularly defined tumor testing being done.  So we not only need to know the pathology, as Dr. Kim has said.  We really need to know the molecular phenotype of cancer to really make the best treatment approach for patients with advanced disease.  And in most patients that should happen before they ever talk about chemotherapy.  We need to know are there better approaches for that patient, and we’re not going to know that without these tests being done.

Andrew Schorr:

How about you, Dr. Kim?  I mean, still chemotherapy is still around, still in combination.  People understand there are side effects, not that there are not side effects with the new immunotherapies, but people would like to skip to the most effective treatment first.  So what recommendations would you have for our listeners?

Dr. Kim:

Yeah.  You know, we’re talking strictly about the advanced lung cancer patients.  The new standards in non‑small cell, both nonsquamous and squamous, now contain an immunotherapy combined with chemotherapy in markers that are lower selected or unselected.  I agree with Jeff.  You know, the biggest struggle we always want to tell our patients is be patient.  Do not let the chemotherapy start without having the results of your markers.

And that’s where sort of this new diagnosis of cancer comes in, the fear of it growing while you’re waiting a couple of weeks for the results of these markers, but we have to reassure patients it’s okay because if you just wait the extra one to two weeks.

And I understand it could take longer getting the biopsy to get enough tissue, sending it away, taking three weeks, and then your doctor, who is maybe not as sophisticated at reading these very, very, 18‑page reports, take some time to evaluate it.  It could be five weeks right there very easily, and we don’t like to wait that long.

But if you do have a marker present, and if it is‑‑and now almost 50 percent of the patients with non‑small cell have this, have a marker, maybe we’ll be able to give you something in lieu of chemotherapy that’s not a pill, single‑agent immunotherapy.  And certainly as a default now we’re seeing again new standards of care.  New standards of care are combination therapy, chemotherapy with immunotherapy based on data that’s been presented in the last couple months.

And so as a biomarker person I love seeing marker‑enriched populations receiving less therapy, but as we begin to incorporate these drugs in our standard regimens we’re seeing improvements that are undeniable and are forcing us now to readjust or new standards.

Andrew Schorr:

Dr. Crawford, so I’ve heard along the way, and I know knowledge is expanding, whether or not some of these newer approaches apply to people whether‑‑you know, whether they smoked or not, whether they had a history.  Where are we now with having the widest array of approaches for the widest array of people whether they’re smokers or not?

Oh, we lost your audio.  Go ahead.

Dr. Kim:

Am I back?

Andrew Schorr:

Yeah.

Dr. Kim:

So smoking is clearly an important factor in outcome for patients, and it’s also somewhat predictive of likelihood of different things.  We know smokers have a lower rate of EGFR and ALK translocations, mutations.  We also know that they have a higher rate of PD‑L1 expression and may be more likely to respond to some of these immunotherapies, but those are just generalized statistics.  And we have smokers who have EGFR mutations, and we have never smokers who respond beautifully to immune checkpoint therapy, so the answer is we have to do the molecular testing and sort out who has what.  Smoking may influence that frequency, but on any individual patient basis we have to have the tests to know how to best to treat them.

Andrew Schorr:

That’s good news.  So, Dr. Kim, you had referred earlier about cancer being kind of wily, if you will.  So is it possible that the molecular testing results at time of diagnosis further down the road may be different?  In other words, some other gene is driving the cancer should it come back or it’s still going, and you need a different approach.  In other words you have to change horses, if you will.

Dr. Kim:

Yeah, that’s a great point, Andrew.  You know, back in 10 years ago, almost 11 years ago when we initiated this trial while I was at MD Anderson called BATTLE, the whole principle was to rebiopsy patients once they completed or once the first line of therapy stopped working.  And for that very point you brought up is that these tumors change.  If you use a baseline tissue that’s a very different environment that that tissue was exposed to.  It has not been treated with chemotherapy, it’s not been under different stressors, and nor has it now begun growing after getting chemotherapy.

So a patient, just as you say, who has been treated maybe there was some success but then it‑‑with chemotherapy it’s always a little transient, and then now the tumor is growing despite being treated, that could be a different tumor.  It’s been shown also by the Boston group that you get transformation to small cell, of all things, in about 15 percent of patients.  And so different histologists altogether.  So who knows what will evolve out of the cancer that’s been treated that is now beginning to grow.

And so I think it’s really important to have a repeat biopsy when this occurs to help again drive the appropriate treatment.  And, as we talked about earlier, if it’s difficult sometimes a liquid biopsy can even be done at this setting if it’s difficult or the patient is has a difficult area to get tissue.

Andrew Schorr:

So, Dr. Crawford, you have lung cancer meetings throughout the year, but the ASCO meeting with like 40,000 people across all cancers from around the world, it’s a big meeting.  You’re involved in research and, of course, with existing therapies as well, how positive do you feel about change and even the rate of change to offer hope for people dealing with lung cancer today?

Dr. Crawford:

I’m as excited about lung cancer as I’ve ever been, and I’ve been doing this for quite a while.  The rate of change is, as Ed has pointed out, is dramatic.  The number of new agents that we have seen over the last year, both targeted therapies and immunotherapies, and the rate of change, it’s not just ASCO every year.  AACR, a meeting that’s normally more basic research, had major breakthrough discoveries (?) inaudible, as well I’m sure this year, and Europe will have additional new discoveries as they did last year.

So it’s really changing every few months, our guidelines through NCCN have to be changed almost monthly, and I think that’s a good thing.  It’s telling us that new knowledge is really being moved very quickly into the patient care arena.

Andrew Schorr:

Dr. Kim, so we’ve talked largely about non small‑cell lung cancer, and you’ve rattled off some of the different types.  There’s a percentage of people, smaller percentage, but people with small cell‑lung cancer.  Were there things you were hearing there at ASCO that could offer hope or in research to help this population as well?

Dr. Kim:

And certainly Jeff is the expert here.  He’s had a long career with it.  Small cell has always been that tough cancer where you get teased a little bit.  Again, if you’re fortunate enough to find someone in limited stage you can try to deliver curative intent therapy.  If they happen to be in an extensive stage it really becomes about trying to give chemotherapy that has a high response rate, and so you feel good about that, but then the difficult aspect of it is that in fact it doesn’t last forever.  And so when it does again not respond, it’s not responding, we’ve got to figure out some things.

The immunotherapies have been very widely tested, and so there are some therapies that are coming.  There are some that are approved, nivolumab, ipilimumab have been used.  They’re trying to incorporate in combination with chemotherapy with these immunotherapies.  There are some other drug classes, (? Phonetic) roba‑T and others that are being looked at very closely in small cell.  So I love the fact that there’s spillover in the small cell because it wasn’t really a high area of importance for a lot of development of drugs, which was unfortunate because we still see those patients, but it’s nice to see that there’s a lot of studies been looking at these types of drugs.

Andrew Schorr:

Okay.  Dr. Crawford, any other comment you wanted to make about small cell?

Dr. Crawford:

I would say it’s an area that’s been difficult to see advances.  Small cell presents generally at more advanced stage, so very few patients can have surgery.  Chemo and radiation can still be curative for early‑stage patients with lymph node involvement who don’t have distant disease, but in the advanced stage setting we’ve been using the same chemotherapy for 20 years.  Our supportive care has gotten better, we’ve made some advances, but we’re hoping immune therapy and others will make a difference.

It’s kind of interesting.  Small cell, you would think, since it’s prevalent largely in smokers, people with smoking exposure, could be very‑‑a lot of mutations being present.  We know that total mutation burden is a nice predictor of benefit in non small‑cell lung cancer, so we think that would‑‑might play out here.  There is PD‑L1 expression in small cell but it’s not as intense.  And there is some separation by PD‑L1 score of benefit for immune checkpoint therapy in small cell, but the responses in general are less than they have been in non‑small cell.  So we’re going to need more, more homework to figure this one out, but I think we’re taking some steps in the right direction.

And as Dr. Kim pointed out, roba‑T is a targeted therapy, maybe one of the first targeted therapies we’ve had in small cell that attacks antigen present on a lot of small cell called (?) B L L 3, and there are other therapies being developed against that B L L 3 because we know that’s an important marker.  So I hope we will see agents that are truly targeted therapies in small cell in the next few years.

Andrew Schorr:

Okay.  So I think as we pull this together, and I think you were rattling off some acronyms, and that’s sort of what we’ve been seeing a lot in lung cancer now.  We’ve talked about EGFR and ALK and ROS1, and we talked about also PD‑L1.  So I know for patients it can be confusing, but look back, review this program with Dr. Crawford and Dr. Kim were saying about if you have someone diagnosed with advanced lung cancer to get that molecular test (? Inaudible) and make sure that the experts like this in your major center like this, that they have the information.  And then if you need to (? Inaudible) you may get (? Inaudible).  So (? Inaudible) but there’s help in second opinions from people like this.  Dr. Crawford, did I get it right?

Dr. Crawford:

I think you did.  You’re a good student.

Andrew Schorr:

Okay.  All right.  Well, we have two professors with us, Dr. Edward Kim from the Levine Cancer Institute in Charlotte, North Carolina, my old home down, and Dr. Jeffrey Crawford from Durham and Duke University.  I’ll say that even though I went to the University of North Carolina eight miles down the road.

Dr. Kim:

You had to say that.

Andrew Schorr:

Yeah.  Thank you.  Thank you both for your work in treating patients and in researching, helping give us a window into this ASCO conference, but I get the sense you‑‑you said it, Dr. Crawford‑‑you’re having meetings every couple of months and talking to your peers all the time, and this is a faster changing field.  Thank god, right?  So thank you so much.  Dr. Crawford from Duke, thank you so much for being with us.

Dr. Crawford:

Andrew, thank you so much and thanks to all the patients who are joining in today.  It’s for you we do all that.

Andrew Schorr:

Yeah, thank you.  And Dr. Kim, thanks.  I interviewed you years ago, and you were at MD Anderson.  Now you’re in Charlotte and you have a wonderful program there.  Thank you for being with us.

Dr. Kim:

Thank you, Andrew.  It’s our pleasure, and again, we’re just as excited as the patients because we get to offer them these really cool therapies and research studies.

Andrew Schorr:

Right.  Okay.  All right.  All the best to our patients and family members watching.  For the Patient Empowerment Network, I’m Andrew Schorr from Patient Power.  Remember, knowledge can be the best medicine of all.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Notable News

Immunotherapy is back in the headlines this month with nytimes.com reporting another treatment being approved by the FDA. This second therapy is called Yescarta and is made by Kite Pharma and uses the patients own cells to create a “living drug” that is administered to the patient through a one-time injection. The patients altered cells then battle the cancer and the results from the trial are remarkable. Of the 101 patients who received the treatment in the trial 54 percent had complete remissions and 28 percent had partial remissions. Six months later 80 percent of the patients were still alive. But, as with Kymriah, the other FDA-approved immunotherapy treatment, made by Novartis, the side-effects can be severe and sometimes life-threatening. In the trials leading to the approval of Yescarta two patients died as a result of the side effects.

Yescarta has been approved for adults who have an aggressive form of the blood cancer, non-Hodgkin’s lymphoma and have undergone two rounds of failed chemotherapy. The treatment is expensive at a cost of $373,000 partly because it must be manufactured individually for each patient. An estimated 3,500 people per year in the United States will be eligible for treatment with Yescarta. You can learn more here and you can review our past updates about immunotherapy treatments here and here.

The number of changes it takes to turn a healthy cell into cancer has been one of the most argued topics in cancer research, but as reported by bbc.com British scientists have put an end to the decades-long debate. It turns out that very few mutations, a handful or less, are responsible for whether a cell becomes cancerous or not. In fact, the researchers, who studied the DNA form 7,664 tumors to pinpoint the “driver mutations” discovered that it takes ten mutations to form colorectal cancer, four mutations for breast or liver cancer, and only one mutation to form thyroid or testicular cancer.

The researchers were able to identify which mutations were dictating the formation of cancer by using Charles Darwin’s theory of evolution and the forces of natural selection saying that the driver mutations would appear more often than those that do not make the cells cancerous. Their findings could lead to the development of more drugs that specifically target the driver mutations which would improve treatment for patients. You can find out more here.

Another sweet research breakthrough reported this month at usatoday.com comes out of Belgium where researchers have been working since 2008 to better understand the relationship between cancer and sugar which in turn helps to understand something called the Warburg Effect — where tumor cells rapidly breakdown glucose to form energy that fuels tumor growth. Researchers found that sugar, or glucose, overstimulated the proteins found mutated in human tumors that cause the cells to grow faster and that may explain how the Warburg Effect relates to tumor aggressiveness.

At this point, the research is not considered a medical breakthrough and does not indicate that eating a low-sugar diet could prevent a cancer diagnosis, but it does lay the groundwork for more research and provides a little food for thought. More details can be found here and remember to check back next month to see what has evolved in Notable News.

Notable News

Knowledge is power, but staying on top of and researching all the latest headlines can be a time-consuming and daunting process. That’s why we’re doing it for you. That’s right. We’ll keep an eye on the most interesting and newsworthy developments of the past month or so and then we’ll summarize them for you here. We’ll even provide you with links to the more detailed articles at the end of each summary. The best part? We’re starting right now.

There’s a lot of buzz about immunotherapy and rightly so. This month an article on time.com featured a successful immunotherapy test trial in which a young leukemia patient’s own immune cells were used to fight her cancer. The genetically modified immune cells are called chimeric antigen receptor (CAR) T cells and with one application they can be used to train the body to fight the cancer cells, hopefully, indefinitely. The modified cells are basically drugs living inside the body. That means patients won’t need to take regular doses of medications or be subject to other, sometimes unpleasant, treatments. There is a huge push for the Food and Drug Administration to move the therapy beyond the testing phase so more people can benefit. So far, the results are promising. Two men underwent the CAR T therapy in 2010 and both remain in remission today. Researchers are proceeding with caution though. The CAR T cells are individualized, therefore very expensive, and so far the process only works on some types of blood cancers There are also some pretty intense side effects. When the modified cells enter the body and start killing off the cancer cells the immune system response is acute and can include things like high fever, difficulty breathing, and kidney failure. All told, the latest developments in immunotherapy are worth keeping an eye on. Read more here. You can also learn more about it here. And even more, including a bit about the history of the research and the men behind the research here.

An unexpected hurdle has emerged in cancer research: not enough patients. Hard to believe, but as reported by nytimes.com earlier this month, there are more drugs and clinical trials than there are patients to test them on. Here’s why. Inspired by the latest developments in the aforementioned immunotherapy, companies are in overdrive and have created a surge in trials for new drugs that use the body’s own immune system to combat cancer. These drugs have the potential to yield a huge profit should the FDA give the stamp of approval. None of the companies want to be left out of the earnings so they are all trying to develop their own version of drugs that treat similar cancers. That alone is enough to spread thin the eligible patients. Factor in the specificity of some of the trials and the patient pool decreases even more. In addition, the rapid increase in trials have made some of the major medical facilities wary and they have dialed back their participation. You can find more details here.

A routine blood test may soon be the best method of early detection. Researchers in Japan have developed a method that uses a single drop of blood to test for 13 cancers. The test is relatively inexpensive, would be done as part of a comprehensive medical exam, and use a molecular substance called MicroRNA to detect the cancers in early stages. Clinical trials are underway as of earlier this month. This promising development was reported at pressherald.com and more details can be found here.

Stay tuned. In the months to come, we’ll help keep you informed which will help keep you empowered.

Immunotherapy Patient Summits 2017

The Cancer Research Institute (CRI), the world’s leading nonprofit organization dedicated exclusively to advancing scientific efforts to develop new and effective immunotherapies for all forms of cancer, announced that its 2017 Immunotherapy Patient Summit Series will travel to five U.S. cities to provide free educational programming designed for cancer patients and caregivers who are seeking to learn more about cancer immunotherapy and clinical trials.

Immunotherapy is a type of biological therapy that uses substances to stimulate or suppress the immune system to help the body fight cancer, infection, and other diseases. Some types of immunotherapy only target certain cells of the immune system. Others affect the immune system in a general way. Types of immunotherapy include cytokines, vaccines, bacillus Calmette-Guerin (BCG), and some monoclonal antibodies.

Building on the success of its inaugural Immunotherapy Patient Summit hosted in New York City last September, CRI has expanded the 2017 program to include the following cities:

Who Should Attend?

People of all ages, cancer types, and stages are encouraged to attend this FREE half-day Saturday event. Caregivers, friends, family, and advocates are also welcome to join us at this important educational summit.

The half-day events will bring together patients, caregivers, and expert scientists and clinicians to discuss the latest cancer research and treatment focused exclusively on immunotherapy. Each event will offer foundational education and information on immunotherapy treatment and research, patient perspectives on immunotherapy clinical trials, and cancer-specific breakout sessions. Patients can also meet with clinical trial navigators who can help connect them to immunotherapy trials for which they might be eligible. Across all the events, patients will have an opportunity to interact with scientists and clinicians who are leading the way in this important field, hear from patients who have benefited from immunotherapy, and interact with others from their community.

What Will Be Discussed?

Summit topics will include

  • Immunotherapy basics you need to know
  • Latest research update from the experts
  • Patient experience with immunotherapy
  • Clinical trials: what they are, how to access them, and patient experiences
  • Cancer specific breakout sessions

How Can You Participate?

Register today (at no cost) for the event nearest to you below. For those unable to attend in person, register for the live streaming option. Space is limited, so don’t delay.

To reach as broad an audience as possible, a live streaming option during the New York City event will also be available to individuals throughout the U.S. and abroad.

The summit series kicks-off immediately following Cancer Immunotherapy Month™, a global awareness campaign in June CRI created five years ago to call public attention to exciting breakthroughs in cancer immunotherapy and the need for more research to make this promising treatment approach an effective option for all cancer patients. By extending educational efforts beyond June, CRI will be able to reach more patients in need of critical information to help inform healthcare decisions.

“CRI has dedicated more than six decades to advancing the science of immunotherapy with the ultimate goal of harnessing our immune system’s potential to cure all cancers, and we have reached a critical point where patients are playing an even greater role in the success of these efforts,” said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute. “We are proud to expand our patient focus and, alongside our scientist and donor communities, facilitate patient knowledge of immunotherapy and clinical trials that will help lead to breakthroughs in cancer care.”


About the Cancer Research Institute

The Cancer Research Institute (CRI), established in 1953, is the world’s leading nonprofit organization dedicated exclusively to transforming cancer patient care by advancing scientific efforts to develop new and effective immune system-based strategies to prevent, diagnose, treat, and eventually cure all cancers. Guided by a world-renowned Scientific Advisory Council that includes three Nobel laureates and 26 members of the National Academy of Sciences, CRI has invested $344 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org.

Stage III Lung Cancer Survivor

His Choice – His Terms

Meet Randall Broad –

Randy is a Patient Empowerment Network board member and 7-year lung cancer survivor. Randy attended the 2015 American Society of Clinical Oncologist (ASCO) annual conference held in Chicago, Illinois the weekend of May 29 – June 2, 2015. This was Randy’s first year at ASCO. This year, ASCO focused on the voice of the patient. Randy says this shifting perspective is finally “putting the patient first or making the patient a huge part of the treatment equation.”

Screen shot 2015-06-07 at 3.56.46 PMRandy was diagnosed with stage III non-small lung carcinoma on March of 2008: “It was March 28th, 2008,” says Randy. Randall Broad – a professional small business owner and a father to two kids – says, “I had been healthy pretty much my entire life.” Following his diagnosis, Randy says, ” I fired my ‘first’ crew.” Randy identifies this as the turning point for his role in his care.

“It is so incredibly important that you find the right team- it is a team, it is not one person.” Randy’s local hospital, where he had been treated his whole life, recommended an internal oncologist. Broad says, “when I interviewed the surgeon he basically pushed me out of his room – I don’t think that was his intent, but that is what he did.”

From March 28th, 2008 – January of 2009, Randy made an early distinction between acceptance and fighting against cancer. “I chose the cancer over letting it choose me, meaning that I am going to embrace this, accept it as part of my life because if I try to fight it, beat it, I figured it would probably win.“ Early in Randy’s journey with lung cancer, surgery became the next option but the visualization of his cancer revealed it was inoperable.

When one is newly diagnosed, one typically has no idea of where to look or seek a network of survivors for advice.  With Lung Cancer’s high mortality rate it makes it all the more challenging. Randy demonstrates a relentless conviction to choose his perspective and not give into his cancer. He says it was not until he had lived a couple of years with the disease that he learned about advocacy organizations and focused on being a proactive patient-advocate. “You don’t go to the yellow pages and look it up,” says Randy.

With a great amount of content available online, Randy says there is more information about the disease but not information about where to actually be treated. After moving past the first experience, Broad found his feet tepidly at the steps of the Seattle Cancer Care Alliance. He says meetings with Dr. Renato Martin at SCCA validated the credibility of this surgeon. Broad describes relationship building as a key element to solidify quality care.

From August to November of 2008, Randy received radiation, and chemotherapy combined with radiation. He could sometimes spend up to 13 hours a day at the University of Washington Medical Center and Seattle Cancer Care Alliance. To counteract the physical exhaustion from treatment and cancer, Broad attempted yoga, massages, facials, pedicures, acupuncture and prescribed medication – these remedies only provided a small sigh of relief.

Screenshot from http://itsanextraordinarylife.com/

Screenshot from http://itsanextraordinarylife.com/

At the time of Randy’s diagnosis in March of 2008, his two kids were 13 and 14-years old – a highly formative time in their lives. Prior to being diagnosed with cancer, Randy focused on his small business to provide a sustainable life for him and his children. “I didn’t spend as much time with my kids.” Cancer opened the doorway for Randy to rectify his relationships with his children. Randy says, “My kids are the most important aspect of my life.”

Patient Empowerment

Randy and his children committed themselves to affirmative thinking. When treatment concluded in January of 2009, Randy was deemed cancer free – yet he continued to have scans every couple of months. He says, “Every year that passes, the chances of it reoccurring is minimized.” Broad was diagnosed with cancer over six years ago and still remains cancer free today.

Randy now shares his journey nationally and is committed to empowering patients to be proactive. He presents at about ten speeches a year. One of Broad’s first speaking engagements was with 60 lung cancer patients. After his speech, 20 people approached him to say, “It never dawned on me to fire my crew – my oncology team.”

Randy says he left ASCO with an important message: value-based healthcare. Value-based healthcare places patients and physicians in a greater role to examine all treatments costs and outcomes. Randy has dedicated his life to the empowerment of individuals with all types of cancer. As Randy’s book says, It’s an Extraordinary Life.

Stay up-to-date with Randall Broad’s latest speaking engagements and written work: It’s an Extraordinary Life.

We also invite you to click this link to peer into a vivid and poignant moment printed words cannot convey.

Targeted Therapies: What does it all mean?

Screen Shot 2015-06-03 at 4.06.15 PM

Screenshot from http://www.asco.org/

Screen Shot 2015-06-03 at 4.04.50 PM

Carol Preston interviews Leukemia expert at ASCO 2015.

When my kids were little, I loved reading to them Arnold Lobel’s Frog and Toad books including “The Corner” in Frog and Toad All Year. In it, Frog assures Toad on a cold, rainy day that spring is just around the corner. Frog says that when he was younger, on a similar cold, rainy day, he searched for spring around many corners until he eventually found it-sunshine and flowers-around the corner of his house.

And so it is with us cancer patients, constantly peering around every corner for the still elusive cure. Researchers at ASCO 2015 offered the most encouraging, hopeful news yet that we won’t have to look around the corner much longer.

Or will we?

Cancer is a tricky disease, in fact many tricky diseases, constantly morphing and exploiting loopholes to outwit us. The buzzwords at this year’s annual meeting in Chicago included “immunotherapy,” combination therapy and “biomarkers.” Immunotherapy has become the fourth arm to battle cancer, after surgery, chemotherapy and radiation. On the upside, scientists are making great strides to develop ways for the body’s immune system to fight the cancer. These are called checkpoint inhibitors. Inhibitors basically release the brakes in cells to allow our immune systems to charge and attack the bad guys, e.g. cancer cells. And since the cancer is being attacked at a molecular level, this should work for everyone. But it doesn’t. And that has proved vexing to researchers. Every specialist with whom PEN spoke at ASCO – from melanoma to lung and prostate cancer to colorectal disease – acknowledges that they don’t yet know why the inhibitors aren’t working for all of us.

That’s where the biomarkers come in. Researchers are working to identify specific markers on an individual’s cell to determine if a specific anti-PD1 or

PD-L1 inhibitor will work on a patient. Or why it won’t work.

For my cancer Chronic Lymphocytic Leukemia, CLL, combination therapy made headline news at ASCO. Through clinical trials, scientists have found that combining a checkpoint inhibitor, Ibrutinib, with a standard chemotherapy called bendamustine along with the monoclonal antibody Rituxan yielded an 80% response rate. That’s a “wow,” but it still isn’t 100%. What is it about the 20% that their bodies resisted the combo therapy?

Maybe the key to unlock the mystery lies with genetics. On the last day of the conference, ASCO announced a joint effort with the NCI, National Cancer Institute, to conduct basket trials. These trials group patients together with specific genetic mutations in a patient’s tumor rather than the location of the tumor. So a prostate cancer patient may achieve complete remission or, dare we say, cure by being treated with a drug developed for breast cancer because of the same genetic mutation found in both.

Will that be the magic bullet that cures cancer? I am optimistic that the answer is just around the corner.

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