Barry Stein

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Posts by Barry Stein

FDA fast-tracks Taiho Oncology’s TAS-102 for Colorectal Cancer

Otsuka

The US Food and Drug Administration has granted Fast Track designation for TAS-102 (trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation by Taiho Oncology, a unit of Japanese drugmaker Otsuka (TYO: 4768).

The New Drug Application is for the treatment of refractory metastatic colorectal cancer (mCRC), and the company has initiated a rolling NDA submission to the FDA. According to the American Cancer Society, an estimated 136,830 people will be diagnosed with, and 50,310 people will die from, cancer of the colon or rectum during 2014 in the USA.

“We are pleased that TAS-102 has been granted Fast Track designation,” said Fabio Benedetti, senior vice president and chief medical officer at Taiho Oncology, adding: “Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have limited treatment options to manage their disease. We have initiated our rolling NDA submission to the FDA, and are committed to submitting the rest of the filing as efficiently as possible.”

The results from the Phase III RECOURSE trial of TAS-102 in 800 patients affected with mCRC, whose disease had progressed after or who were intolerant to standard therapies, are the foundation for Taiho Oncology’s NDA submission to the FDA.

Taiho Oncology, Otsuka, TAS-102, Fast-track designation, USA, FDA, Colorectal cancer, NDA

 

Calcium, Vitamin D, Dairy Products, and Mortality Among Colorectal Cancer Survivors

Calcium, Vitamin D, Dairy Products, and Mortality Among Colorectal Cancer Survivors: The Cancer Prevention Study-II Nutrition Cohort

Yang B, McCullough ML, Gapstur SM, et al

J Clin Oncol. 2014;32:2335-2343

Study Summary

Diet and lifestyle changes may play an important role in cancer pathogenesis. Yang and fellow American Cancer Society investigators analyzed the role of calcium, vitamin D, and dairy product intake before and after diagnosis of nonmetastatic colorectal cancer. The study population comprised 2284 participants in a prospective cohort study.

In multivariate analysis, post-diagnosis total calcium intake was inversely associated with all-cause mortality (relative risk [RR] for those in the highest relative to the lowest quartiles, 0.72; 95% confidence interval [CI], 0.53-0.98; Ptrend = .02). An inverse association with all-cause mortality was also observed for postdiagnosis milk intake (RR, 0.72; 95% CI, 0.55-0.94; Ptrend = .02), but not for vitamin D intake. Prediagnosis intakes were not associated with mortality.

Viewpoint

Diet and modifiable lifestyle factors are important issues for survivors of localized colorectal cancer. Unfortunately, randomized trials in this setting are difficult to conduct, require prolonged follow-up, and may not be able to control for all lifestyle factors. Therefore, data from well-conducted prospective cohort studies may be good enough to make recommendations to patients.

This study suggests that increased milk and calcium intake is associated with improved outcomes. Limitations include the primarily white study population with known higher rates of lactase persistence; in addition, the lack of association with vitamin D intake is inconsistent with prior reports.[1] Increased milk and calcium intake, along with reduced red meat intake and regular exercise, can be discussion points for survivors of colorectal cancer interested in modifiable lifestyle risk factors.

Abstract

Avec de la viande rouge, mangez des pommes de terre froides

 

Avec de la viande rouge, mangez des pommes de terre froides 

La consommation (excessive) de viande rouge est associée à un risque accru de cancer du côlon. Il s’avère qu’une série d’aliments peuvent atténuer cet effet.

Le premier message, c’est qu’il est important de limiter ses apports en viande rouge : 300 g par semaine, et en tout cas pas plus de 500 g, si possible en choisissant des coupes maigres et en retirant le gras avant la cuisson. Et donc, expliquent ces chercheurs de l’université Flinders (Australie), il est utile d’accompagner sa viande d’aliments riches en fibres (cela on le savait) et en amidon résistant.

Cet amidon présente la particularité de ne pas être (pré)digéré par l’estomac et par l’intestin grêle et dès lors d’arriver intact dans le gros intestin, où il va produire des substances bénéfiques appelées acides gras à chaîne courte. L’équipe australienne a conduit une expérience sur des volontaires adultes et a pu démontrer que l’amidon résistant contrait l’apparition de molécules néfastes liées à la viande rouge.

Comme sources alimentaires, on mentionnera les légumineuses (en particulier les haricots, les pois chiches et les lentilles), les grains entiers (blé, maïs, riz…), les bananes assez vertes, ainsi encore que les pommes de terre cuites et refroidies. Cela ne signifie évidemment pas que la viande rouge peut alors être consommée à volonté, mais que des apports réguliers d’aliments riches en amidon résistant – et en fibres, encore trop négligées ! – peuvent avoir un effet protecteur très intéressant contre le cancer colorectal.

publié le : 21-10-2014

Source: Cancer Prevention Research (http://cancerpreventionresearch.aacrjournals.org)

Boehringer Ingelheim Global Phase III study in patients with Metastatic Colorectal Cancer (mCRC).

Tue, 10/21/2014 – 8:30am

Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. Prognosis is very poor for patients with mCRC with fewer than 10% surviving for more than five years after diagnosis.

LUME-COLON 1 [ClinicalTrials.gov identifier: NCT02149108] is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of nintedanib plus best supportive care (BSC), versus placebo plus BSC, after previous treatment with standard chemotherapy and biological agents. This new study will build on previous Phase I/II studies evaluating nintedanib in mCRC.
Nintedanib is an investigational compound in mCRC; its safety and efficacy have not been established.

“Based on previous clinical studies with nintedanib, BI will initiate the LUME-COLON 1 study to evaluate this compound as a potential treatment option for patients with refractory colorectal cancer,” said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc.

“Patient needs are the driving force behind BI’s innovation in cancer research, and the initiation of this global Phase III study represents our commitment to addressing a critical need in the colorectal cancer community.”

L’analyse de sang, piste d’avenir pour le soin

SOPHIE GUIRAUD

Cancer : l’analyse de sang, piste d’avenir pour le soin 
Marc Ychou et Alain Thierry, partenaires de la start-up DiaDx.

CHRISTOPHE FORTIN

Alain Thierry a mis au point une “biopsie liquide” présentée jeudi au congrès international d’oncologie digestive à Montpellier.

Il y a six mois, il a eu les honneurs de la revue scientifique Nature Medicine : pour la première fois, un chercheur montrait l’intérêt d’une “biopsie liquide”, qui consiste, depuis un échantillon sanguin, à rechercher des mutations génétiques dans l’ADN pour traiter les cancers colorectaux. Depuis, l’idée a fait du chemin. Ce jeudi, Alain Thierry, chercheur Inserm à l’institut de recherche en cancérologie de Montpellier (IRCM), a présenté ses travaux à la conférence internationale d’oncologie digestive organisée jusqu’à samedi au Corum. Le concept est aujourd’hui expérimenté dans une quinzaine de centres en France. Une start-up a été créée. Un développement est envisageable à l’horizon 2016.

Une prise de sang plutôt qu’une biopsie

Explications : “Toutes les cellules relarguent de l’ADN dans le sang, l’ADN circulant”, indique le chercheur. Que se passe-t-il chez un malade ? “Quand une personne a un cancer, l’ADN circulant est relargué en plus grande quantité. C’est un biomarqueur intéressant pour analyser la tumeur. Le test sanguin que nous avons mis au point évite de faire une biopsie pour accéder à des informations capitales dans les choix thérapeutiques à venir. On recherche des mutations génétiques qui, si elles sont présentes, rendent inefficaces un traitement par anticorps”, décrypte Alain Thierry.

Pionnier allemand

L’Allemand Klaus Pantel (CHU de Hambourg), pionnier et expert de l’étude des cellules tumorales circulantes, sera à Montpellier du 14 au 16 octobre 2014 pour une formation de la communauté scientifique et médicale. Il donnera un cours du master international “Cancer Biology” coordonné par le docteur Catherine Panabières, du CHU de Montpellier. Les deux établissements (CHU de Montpellier et de Hambourg) sont associés sur un projet européen de détection des cellules tumorales circulantes dans le cancer de la prostate.

18 000 décès du cancer colorectal par an en France

La méthode a plusieurs avantages : “On gagne du temps, avec un résultat obtenu en 48 h plutôt qu’en un mois. Le test est moins invasif, plus précis, moins coûteux.” L’histoire est loin d’être terminée : “On est dans un programme de recherche clinique”, précise le professeur Marc Ychou, de l’ICM (Institut régional du cancer de Montpellier), associé à Alain Thierry au sein de la start-up DiaDx. Le potentiel est conséquent. Le cancer colorectal touche 40 000 nouveaux patients par an en France, pour 18 000 décès. Enfin, précisent le chercheur et le médecin, “le test est adaptable aux cancers solides comme le sein et le poumon”.

Training Dogs to Sniff Out Cancer

 

Training Dogs to Sniff Out Cancer

By 

 September 11, 2014 2:50 pmoto

McBaine, a cancer detection dog.Credit Penn Vet Working Dog Center

PHILADELPHIA — McBaine, a bouncy black and white springer spaniel, perks up and begins his hunt at the Penn Vet Working Dog Center. His nose skims 12 tiny arms that protrude from the edges of a table-size wheel, each holding samples of blood plasma, only one of which is spiked with a drop of cancerous tissue.

The dog makes one focused revolution around the wheel before halting, steely-eyed and confident, in front of sample No. 11. A trainer tosses him his reward, a tennis ball, which he giddily chases around the room, sliding across the floor and bumping into walls like a clumsy puppy.

McBaine is one of four highly trained cancer detection dogs at the center, which trains purebreds to put their superior sense of smell to work in search of the early signs of ovarian cancer. Now, Penn Vet, part of the University of Pennsylvania’s School of Veterinary Medicine, is teaming with chemists and physicists to isolate cancer chemicals that only dogs can smell. They hope this will lead to the manufacture of nanotechnology sensors that are capable of detecting bits of cancerous tissue 1/100,000th the thickness of a sheet of paper.

“We don’t ever anticipate our dogs walking through a clinic,” said the veterinarian Dr. Cindy Otto, the founder and executive director of the Working Dog Center. “But we do hope that they will help refine chemical and nanosensing techniques for cancer detection.”

Since 2004, research has begun to accumulate suggesting that dogs may be able to smell the subtle chemical differences between healthy and cancerous tissue, including bladder cancer, melanomaand cancers of the lung, breast and prostate. But scientists debate whether the research will result in useful medical applications.

Photo

Trainers tend to notice early on that certain dogs have natural talents that make them better suited for specific kinds of work.Credit Penn Vet Working Dog Center.

Dogs have already been trained to respond to diabetic emergencies, or alert passers-by if an owner is about to have a seizure. And on the cancer front, nonprofit organizations like the In Situ Foundation, based in California, and the Medical Detection Dogs charity in Britain are among a growing number of independent groups sponsoring research into the area.

A study presented at the American Urological Association’s annual meeting in May reported that two German shepherds trained at the Italian Ministry of Defense’s Military Veterinary Center in Grosseto were able to detect prostate cancer in urine with about 98 percent accuracy, far better than the prostate-specific antigen (PSA) test. But in another recent study of prostate-cancer-sniffing dogs, British researchers reported that promising initial results did not hold up in rigorous double-blind follow-up trials.

Dr. Otto first conceived of a center to train and study working dogs when, as a member of the Federal Emergency Management Agency’s Urban Search and Rescue Team, she was deployed to ground zero in the hours after the Sept. 11 attacks.

“I remember walking past three firemen sitting on an I-beam, stone-faced, dejected,” she says. “But when a handler walked by with one of the rescue dogs, they lit up. There was hope.”

Today, the Working Dog Center trains dogs for police work, search and rescue and bomb detection. Their newest canine curriculum, started last summer after the center received a grant from the Kaleidoscope of Hope Foundation, focuses on sniffing out a different kind of threat: ovarian cancer.

“Ovarian cancer is a silent killer,” Dr. Otto said. “But if we can help detect it early, that would save lives like nothing else.”

Dr. Otto’s dogs are descended from illustrious lines of hunting hounds and police dogs, with noses and instincts that have been refined by generations of selective breeding. Labradors and German shepherds dominate the center, but the occasional golden retriever or springer spaniel — like McBaine — manages to make the cut.

The dogs, raised in the homes of volunteer foster families, start with basic obedience classes when they are eight weeks old. They then begin their training in earnest, with the goal of teaching them that sniffing everything — from ticking bombs to malignant tumors — is rewarding.

“Everything we do is about positive reinforcement,” Dr. Otto said. “Sniff the right odor, earn a toy or treat. It’s all one big game.”

Trainers from the center typically notice early on that certain dogs have natural talents that make them better suited for specific kinds of work. Search and rescue dogs must be tireless hunters, unperturbed by distracting environments and unwilling to give up on a scent – the equivalent of high-energy athletes. The best cancer-detection dogs, on the other hand, tend to be precise, methodical, quiet and even a bit aloof — more the introverted scientists.

“Some dogs declare early, but our late bloomers frequently switch majors,” Dr. Otto said.

Handlers begin training dogs selected for cancer detection by holding two vials of fluid in front of each dog, one cancerous and one benign. The dogs initially sniff both but are rewarded only when they sniff the one containing cancer tissue. In time, the dogs learn to recognize a unique “cancer smell” before moving on to more complex tests.

What exactly are the dogs sensing? George Preti, a chemist at the Monell Chemical Senses Center in Philadelphia, has spent much of his career trying to isolate the volatile chemicals behind cancer’s unique odor. “We have known for a long time that dogs are very sensitive detectors,” Dr. Preti says. “When the opportunity arose to collaborate with Dr. Otto at the Working Dog Center, I jumped on it.”

Dr. Preti is working to isolate unique chemical biomarkers responsible for ovarian cancer’s subtle smell using high-tech spectrometers and chromatographs. Once he identifies a promising compound, he tests whether the dogs respond to that chemical in the same way that they respond to actual ovarian cancer tissue.

“I’m not embarrassed to say that a dog is better than my instruments,” Dr. Preti says.

Photo

The dogs, raised in the homes of volunteer foster families, begin their training at 8 weeks of age, starting with basic obedience classes.Credit Penn Vet Working Dog Center.

The next step will be to build a mechanical, hand-held sensor that can detect that cancer chemical in the clinic. That’s where Charlie Johnson a professor at Penn who specializes in experimental nanophysics, the study of molecular interactions between microscopic materials, comes in.

He is developing what he calls Cyborg sensors, which include biological and mechanical components – a combination of carbon nanotubes and single-stranded DNA that preferentially bond with one specific chemical compound. These precise sensors, in theory, could be programmed to bind to, and detect, the isolated compounds that Dr. Otto’s dogs are singling out.

“We are effectively building an electronic nose,” said Dr. Johnson, who added that a prototype for his ovarian cancer sensor will probably be ready in the next five years.

Some experts remain skeptical.

“While I applaud any effort to detect ovarian cancer, I’m uncertain that this research will have any value,” said Dr. David Fishman, a gynecologic oncologist at Mount Sinai Hospital in New York City. One challenge, he notes, is that any cancer sensor would need to be able to detect volatile chemicals that are specific to one particular type of cancer.

“Nonspecificity is where a lot of these sort of tests fail,” Dr. Fishman said. “If there is an overlap in volatile chemicals — between colon, breast, pancreatic, ovarian cancer — we’ll have to ask, ‘What does this mean?’ ”

And even if sensors could be developed that detect ovarian cancer in the clinic, Dr. Fishman says, he doubts that they would be able to catch ovarian cancer in its earliest, potentially more treatable, stages.

“The lesions that we are discussing are only millimeters in size, and almost imperceptible on imaging studies,” Dr. Fishman says. “I don’t believe that the resolution of the canine ability will translate into value for these lesions.”

McBaine remains unaware of the debate. After correctly identifying yet another cancerous plasma sample, he pranced around the Working Dog Center with regal flair, showing off his tennis ball to anyone who would pay attention. In an industry saturated with hundreds of corporations and thousands of scientists all hunting for the earliest clues to cancer, working dogs are just another set of (slightly furrier) researchers.

Des selles fluo pour déceler un cancer

Des selles fluo pour déceler un cancer

Agence QMI 05/09/2014 15h08
Photo Fotolia

L’utilisation d’enzymes fluorescentes lors d’examens des selles d’individus pourrait permettre d’y déceler des traces de cancer colorectal, estiment deux chercheurs de l’Université McMaster, à Hamilton, en Ontario.

Les docteurs Yingfu Li, un biochimiste et Bruno Salena, un gastroentérologue, travaillent à ce projet en collaboration avec la Société canadienne du cancer qui leur a accordé une subvention de 200 000 $.

L’idée leur est venue lors d’une conversation au cours d’une partie de golf: le Dr Li a raconté qu’il étudiait les enzymes fluorescents tandis que le Dr Salena, lui, traitait des patients atteints du cancer colorectal.

«Nous nous sommes mis à échanger sur les possibilités de détection précoce du cancer à l’aide de ces enzymes, et j’ai trouvé ça très intéressant, a indiqué le Dr Salena. J’ai regardé les données du Dr Li et je me suis dit qu’on pourrait expérimenter quelque chose de nouveau.»

Les chercheurs tenteront d’identifier des enzymes qui émettront un rayonnement lorsqu’ils sont dans des échantillons de selle de patients ayant un diagnostic de cancer colorectal, mais qui demeureront neutres dans le cas d’échantillons sains.

Si leur recherche, étalée sur deux ans, est un succès, les médecins pourraient à l’avenir faire passer ce test dans leur bureau. Utilisé sur des échantillons d’urine, ce test pourrait aussi servir à détecter les cancers du rein ou de la vessie.

Même s’il est traitable dans 90 % des cas, le cancer colorectal est le deuxième cancer le plus meurtrier au Canada.

 

Poop that glows: McMaster researchers developing colorectal cancer test

Researchers at McMaster University in Hamilton search for DNA enzymes to create early warning test

 Adam Carter CBC News

McMaster University researchers Dr. Yingfu Li, right, and Dr. Bruno Salena are conducting a research study to find enzymes that would cause glowing feces in colorectal cancer patients as an early warning system.

McMaster University researchers Dr. Yingfu Li, right, and Dr. Bruno Salena are conducting a research study to find enzymes that would cause glowing feces in colorectal cancer patients as an early warning system. Mike Lalich/Canadian Cancer Society. Researchers from McMaster University in Hamilton are working on what they call simple, non-invasive test for colorectal cancer: glowing poop.

Biochemist Dr. Yingfu Li and gastroenterologist Dr. Bruno Salena say the test they’re developing under a grant from the Canadian Cancer Society is an innovative way to get more people checked for cancer. “I find it very exciting as a clinician,” Salena said. “If we can produce a simple, cost-effective test here, the costs for a population are much less all around.”

‘If we could offer a simpler test, you’d get more people receptive to this type of screening.’- Dr. Yingfu Li, cancer researcher

To start the study, researchers are amassing a pool of as many as a quadrillion DNA sequences. With this massive pool, they plan to search for specific DNA enzymes that will glow in the feces of people with colorectal cancer. If they’re successful, the detection tool could one day be used in the doctor’s office as a simple, inexpensive test for cancer.

Colorectal cancer is the second leading cause of cancer deaths for men in Canada, behind lung cancer, and the third-leading cause of death among women, behind lung and breast cancer, according to Canadian Cancer Statistics 2014. But doctors say when colon cancer is caught early, it’s 90 per cent treatable. There are currently two at-home tests that can detect tiny amounts of blood in stool samples when cancer is present, but they can produce many false positives.

Getting more people screened

A colonoscopy is a more accurate test, but it’s invasive, expensive and not recommended for the general population until age 50, doctors say. The cancer society says anyone with risk factors for colon cancer, such as a “first-degree” relative with the disease, should work with their doctors to develop the plan that is right for them. Li says he has first-hand understanding of the need for less invasive screening procedures. He recently turned 50, and had a colonoscopy – something that “wasn’t easy.” “If we could offer a simpler test, you’d get more people receptive to this type of screening,” he said. Both men are confident they’ll be able to find the DNA enzymes necessary to make this work. Li is in the middle of proving a similar process is possible in another study on Clostridium difficile (C. difficile). “That’s given us the confidence to think this will work,” he said.

Supporting research

Dr Siân Bevan, director of research for the Canadian Cancer Society, says the “serendipitous” collaboration of Li and Salena — they met playing golf — has allowed them to tackle an old problem in a new way.“It’s a great example of the importance of supporting innovation in cancer research,” Bevan said. “In fact, in part because of the strength of the applications, this is the largest number of Innovation Grants we’ve funded since we launched the program.”The two doctors applied for the cancer society Innovation Grant in July. So far, 51 grants totalling almost $10 million have been issued under the program. “We’re very fortunate to receive this grant,” Li said.

Salena says researchers have already studied 30 colorectal cancer patients’ stool samples, and by next summer, they should have a panel of molecules that can be tested alongside them. If the test works, there’s no reason the same system couldn’t be implemented to test other types of cancer, Salena says, like using a glowing urine sample to find prostate cancer. “We’re really going to do our best to make this happen.”

Aider l’ACCCC vous aider et lever des fonds importants. Il ne vous coûtera pas un sou. www.plaisirslaitiers.ca/consommezassez/app

Les Producteurs laitiers du Canada (PLC) ont mis au point une grande campagne de collecte de fonds pour aider l’Association canadienne du cancer colorectal, la Fondation des maladies du cœur et de l’AVC et Ostéoporose Canada. Ils ont développé une application pour promouvoir des modes de vie sains et des portions alimentaires recommandées par le Guide alimentaire canadien, tout en ayant une façon amusante de suivre ses propres habitudes alimentaires.Chaque jour que vous rentrez et sauvegardez vos portions alimentaires quotidiennes des quatre groupes alimentaires, les PLC feront un don de 1$ à l’organisme de choix. Alors s’il vous plaît, choisissez l’ACCC! Votre participation se fait en sélectionnant l’ACCC en tant que partenaire, ce qui pourrait nous permettre de gagner jusqu’à 50 000$ pour nous aider à la sensibilisation du cancer du côlon, l’éducation de la maladie et des programmes de soutien. Cette initiative est un excellent moyen de non seulement veiller à une alimentation équilibrée et saine, mais aussi pour nous aider à soutenir les milliers de Canadiens touchés par la deuxième cause de mortalité parmi les cancers dans le pays.

Alors s’il vous plaît, téléchargez l’application Consommez Assez pour les appareils Apple et Android dans la boutique d’applications et choisissez l’ACCC pour votre organisme de charité. Aidez-nous à vous aider, et ensemble, nous pouvons sauver des vies!

http://www.plaisirslaitiers.ca/consommezassez/app

HELP THE CCAC HELP YOU AND IT WONT COST YOU A PENNY! www.dairygoodness.ca/getenough/app

The Dairy Farmers of Canada (DFC) have come up with a great fundraising campaign to help the Colorectal Cancer Association of Canada, Heart & Stroke and Osteoporosis. They have developed an App to promote healthy lifestyles and healthy food portions in accordance with the Canada Food Guide, with a fun way to track your own eating habits. elEach day you input and save your daily food servings from the 4 food groups the DFC will donate $1 to the charity of choice. So please choose the CCAC! With your participation by selecting the CCAC as a partner we can earn up to $50,000 to assist us in Colon Cancer Awareness, Education and Support programs. It’s a great way not only to ensure you are eating healthy, but to help us help the thousands of Canadians touched by the second biggest cancer killer in the country.

 

So please down load the Get Enough Helper for Apple and Android apps in the App Store and choose the CCAC as your charity. Help us help you and together we can save lives!

 

http://www.dairygoodness.ca/getenough/app