THE COST OF NEW DRUGS FOR BREAST CANCER PATIENTS

The newest recommendation of the American Society of Clinical Oncology (ASCO) 2014 for HER2+ metastatic breast cancer patients recommends the use of new drugs like pertuzumab and T-DM1 for first and second line, respectively.  The Perjecta costs is 6.000 USD a month and for trastuzumab is 4500 USD a month. Thus, the costs for first line (without including the costs for taxotere) will be over 10000 USD a month!. For the T-DM1 (recommended second line), the drug will cost 9800 USD a month! … it is clear that but the costs of such new medicines for uninsured patients or 99% of patients from countries in development will be impossible to afford! I strongly disagree with this!

© Luis Mendoza

RAMUCIRUMAB STEAM AHEAD: NOW LUNG CANCER TRIAL SUCCEEDS

The investigational drug ramucirumab (Lilly) is steaming ahead through clinical development. The company has just announced positive top-line results from a phase 3 trial in non-small cell lung cancer (NSCLC).

This is the third successful pivotal trial for the drug; the other 2 were in gastric cancer. In all of the 3 trials reported so far, it has shown a significant improvement in both overall and progression-free survival.

Two more pivotal trials, in hepatocellular and in colorectal cancer, are in progress, with results expected in 2014. But a large trial in breast cancer has failed.

Ramucirumab is an angiogenesis inhibitor, a targeted antibody that specifically blocks VEGF-2. It is seen as a successor to bevacizumab (Genentech/Avastin), and is predicted by analysts to have similar blockbuster sales potential.

Success in NSCLC Trial

The latest trial, known as REVEL, was a global phase 3 trial in more than 1200 patients with NSCLC (both squamous and nonsquamous) who had progressed after failure of platinum-based chemotherapy. Patients were randomized to received docetaxel alone or docetaxel with ramucirumab.

"REVEL is the first positive phase 3 study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line NSCLC," the company said.

Full results of this study are due to be presented at an upcoming meeting, and the company plans to submit these data to regulatory authorities in 2014.

Success Also in Gastric Cancer

Ramucirumab is already awaiting approval for use in gastric cancer in both the United States and Europe. That application was based on the just-published REGARD trial, conducted in patients with advanced gastric cancer who had progressed after chemotherapy ( Lancet. 2014;383:31-39). Monotherapy with ramucirumab showed an improvement in overall survival (5.2 vs 3.8 months with placebo), and was hailed by experts as a " new standard of care" when the results were presented at a meeting.

A second trial in gastric cancer, known as RAINBOW, involved a similar patient population and showed that the combination of ramucirumab with paclitaxel was superior to paclitaxel used alone as second-line therapy.

The company says that it plans to also submit these data for approval.

Failed in Breast Cancer

However, a phase 3 trial in breast cancer was not successful. Known as ROSE, this trial compared ramucirumab and docetaxel with placebo and docetaxel as a first-line treatment in 1144 patients with unresectable, locally recurrent, or metastatic HER2-negative breast cancer. It found no improvement in progression-free survival.

Source: medspace

SCIENTISTS QUERY HEALTH RISK OF FOOD PACKAGE CHEMICALS

The health risks of chemicals in plastic bottles are the subject of some debate 

Scientists say "far too little" is known about the health risks of chemicals used in food packaging, and some could cause cancer. 

Research is needed to understand the effect on the human body and embryonic development of at least 4,000 chemicals used in packaging, they said. 

Links between packaging and obesity, diabetes and neurological diseases need to be explored, scientists warned.

But critics have said that the call is alarmist. 

Scientists Jane Muncke, John Peterson Myers, Martin Scheringer and Miquel Porta called for an investigation into the health risks of food packaging in a commentary piece published in the Journal of Epidemiology and Community Health.

'Lifelong exposure' 

They noted that chemicals such as formaldehyde, which they said can cause cancer, were used in many materials, such as plastics used for fizzy-drink bottles and tableware. 

Substances could leach into food, and they added that the risks of "lifelong exposure" to such chemicals were not documented, said the researchers. 

"Whereas the science for some of these substances is being debated and policymakers struggle to satisfy the needs of stakeholders, consumers remain exposed to these chemicals daily, mostly unknowingly," they said. 

But carrying out analysis would not be easy, they said, as there are no unexposed populations for comparison. 

The call for research has attracted criticism. 

Dr Ian Musgrave, senior lecturer in pharmacology at the University of Adelaide, said it was "very hard to take seriously" the claims that formaldehyde in plastic bottles could cause cancer. 

He said it was present in many foods naturally, and to consume as much formaldehyde as that in an apple someone would have to drink "at least" 20 litres of plastic-bottled water. 

Dr Musgrave added: "Obviously the concern about formaldehyde from food packaging is significantly overrated, unless we are willing to place 'potential cancer hazard' stickers on fresh fruit and vegetables."

'High levels of fat' 

Jon Ayres, Professor of Environmental and Respiratory Medicine at the University of Birmingham, said the scientists painted an "alarmist" picture. 

He said there was "no denying" that ingesting lower doses of some substances could "in principle" be harmful, but the issue was how to recognise and quantify any effect. 

Prof Ayres added: "But can these effects really be anything other than modest at worst when few have been recognised to date?"

He said that simply calling for a different approach to the chemicals "does not really help". 

Dr Oliver Jones, lecturer at the RMIT University in Melbourne, Australia, said: "More research is always welcome from a scientist's point of view.

"But I would hazard a guess that the high levels of fat, sugar and salt in a lot of today's processed food are more of a health concern than any migration of chemicals from the packaging."

Source: bbc

iKNIFE DETECTS CANCER CELLS IN TUMOR OPERATIONS

When surgeons remove tumor tissue they try to leave a "margin" of healthy tissue to ensure all the cancer is removed. Sometimes this means the patient has to remain under general anaesthetic for another 30 minutes or so while tissue samples are sent for analysis to check if the margin is clear. Even then, it is still possible that some cancerous tissue remains, and the patient has to undergo further surgery to remove it.

Now, a new technique based on an "intelligent knife," called the "iKnife," promises to remove the need for lab analysis and the accompanying delay, and it also helps avoid repeat surgeries.

The iKnife sniffs the "smoke" created by the electrosurgical removal of cancerous tissue and tells the surgeon almost immediately if the tissue it has come from is healthy or cancerous.

This first study appears online this week in Science Translational Medicine, in which the iKnife is tested in the operating room.

In tissue samples from 91 patients, researchers at Imperial College London using the iKnife achieved 100% accuracy in diagnosing whether the samples were cancerous or not.

Study author Dr. Zoltan Takats is the inventor of the iKnife. Asked if his new surgical tool would be confined to use in only certain types of cancer, he told Medical News Today:

"It is a generally applicable tool, we believe it will be useful for many different types of cancer surgeries."

On the question of cost-effectiveness, Dr. Takats told us:

"We believe that it will be a cost-saver - due to elimination of intraoperative histology, shorter intervention times and lower rate of re-operations."

iKnife combines electrosurgery with new mass spectrometry techniques

The iKnife is a combination of an established technology called electrosurgery that was invented in the 1920s and a new technology that is still emerging, called rapid evaporative ionization mass spectrometry (REIMS).

In electrosurgery, the surgeon's knife delivers an electric current that heats the target tissue and cuts through it while causing minimum loss of blood.

The heat from the current vaporizes the tissue, which gives off a smoke that is normally sucked away with an extractor.

The mass spectrometer technology behind REIMS almost instantly identifies the chemicals present in human tissue by analyzing the smoke that is released during electrosurgery.

Cells produce thousands of metabolites in various concentrations, depeding on their cell type. So once the REIMS technology is primed with the profiles of healthy and cancerous cells, it can rapidly use these to screen the sample of smoke and inform the surgeon whether it is from a tumor or healthy tissue.

Results delivered in under 3 seconds

By comparing the chemical profile of the tissue it is sampling to the reference library, the iKnife can deliver a result in under 3 seconds, say the researchers.

But for this study, the surgeons carrying out the procedures were not allowed to see the nearly instant readings from the iKnife.

The researchers now hope to run a clinical trial that tests whether giving surgeons access to iKnife readings during operations improves outcomes for patients.

Dr. Takats says in a statement:

"These results provide compelling evidence that the iKnife can be applied in a wide range of cancer surgery procedures."

As the technology delivers almost instant results, it allows "surgeons to carry out procedures with a level of accuracy that hasn't been possible before", he adds, noting that they "believe it has the potential to reduce tumor recurrence rates and enable more patients to survive."

Source: Medical News Today

NEW TASK FORCE RECOMMENDATIONS FOR BRCA MUTATION SCREENING

Updated recommendations issued by the United States Preventive Services Task Force (USPSTF) state that primary care physicians should screen women who have a family history of either breast, ovarian, tubal, or peritoneal cancers as they may be carriers of a mutation in one of the breast cancer susceptibility genes—BRCA1 or BRCA2. Screening should be done with one of several screening tools available and included in the current update. 

The task force recommends against testing for women who have an average risk of being diagnosed with breast cancer. 

“The goal of the recommendation is to encourage clinicians to assess a woman’s family history of BRCA-related cancers, so as to identify those women who may benefit from further evaluation,” Douglas K. Owens, MD, professor and director of the Center for Health Policy at the Stanford University School of Medicine and one of the USPSTF members, told Cancer Network in an email. 

The current update from the task force, which is chaired by Virginia A. Moyer, MD, MPH, reaffirms the last update of these recommendations made in 2005. 

“The main change is that there is now evidence to support the use of screening tools that clinicians can use to screen women and identify those who are candidates for genetic counseling and further evaluation,” said Owens. “The grades of the recommendation have not changed.” 

The updated recommendations are published in the Annals of Internal Medicine. 

Those women who have one or more family member with a potentially harmful BRCA mutation should be offered genetic counseling and testing. 

The tools listed in the recommendation include the Ontario Family History Assessment Tool, Manchester Scoring System, Referral Screening Tool, Pedigree Assessment Tool, and the FHS-7 tool. All are questionnaires that add up risk factors for these cancers such as the number of family members with a history of breast or ovarian cancer and the age of onset. The tools are a way to help clinicians discuss whether there are factors present that make it more likely their patient is a BRCA mutation carrier. The task force estimates that the tools are more than 85% sensitive. No one test was recommended for use over another. 

The two most simple and quickest to use, according to the task force, are the Referral Screening Tool and FHS-7. 

Use of these structured screening tools to assess the need for more in-depth genetic counseling may be relatively new for some clinicians, Owens noted. 

BRCA mutation testing should only be done for those patients who have either a personal or family history that suggests a role of inherited cancer susceptibility. Testing for these mutations are now more widely available following a June 2013 decision by the Supreme Court. 

In the United States, approximately 12.3% of women will develop breast cancer during their lifetime and 2.7% will die of their disease according to the National Cancer Institute. About 1.4% will develop ovarian cancer and 1% will die of their disease. 

Analyses of the penetrance of BRCA1 and BRCA2 genes suggest that a woman’s risk of a breast cancer diagnosis jumps from 45% to 65% by the age of 70 if she is a carrier of a deleterious BRCA mutation. A mutation in the BRCA1 gene increases ovarian cancer risk to about 39% by age 70 and to 10% to 17% for those who are BRCA2 mutation carriers. 

Between 1 in 300 and 1 in 500 women carry a BRCA mutation (between 0.2% and 0.3% of the population) with a higher prevalence (about 2.1%) for the general Ashkenazi Jewish women population. 

Understanding the chance of being diagnosed with breast cancer is important. A recent survey and analysis of more than 2,500 adults published in Genetics in Medicine shows that despite the recent coverage of breast cancer risk and Angelina Jolie’s decision to undergo a double mastectomy, women still do not have a better understanding of breast cancer risk including how rare Angelina Jolie’s decision was and what to do if one is positive for a deleterious mutation that confers an increased cancer risk. 

The study also showed that many did not understand the relationship of overall cancer risk and risk in the context of a family history of cancer. “Perhaps even more striking and worrisome is that about half of all individuals aware of the story and without a family history of cancer rated their cancer risk as lower than the population average relative to those without a family history and unaware of the story,” said the authors. 

This type of analysis points to a greater need for primary care physicians to discuss cancer risk with patients to guide their education and awareness about the issue, particularly as the genetics of cancer is increasingly an important factor in diagnosis and treatment. 

The endorsement of family history screening tools to identify candidates for testing could be problematic because the correct threshold for testing is still not resolved, noted Mark Robson, MD, an oncologist who specializes in identifying and managing women with inherited breast cancer risk and the director of the clinical genetics service at the Memorial Sloan-Kettering Cancer Center in New York. 

“The limitation here is that USPSTF has not provided guidance about testing for affected women, who should be the first ones tested in a family,” said Robson in an email. “The USPSTF has not really provided much in the way of endorsement for the screening and prevention interventions that would follow from testing.” 

Source: cancernetwork.com

MAJOR DECLINE IN LUNG CANCER REPORTED

“Eliminating tobacco use is the most important thing we can do to prevent lung and other cancers, as well as the many other diseases its use causes. Today’s news confirms that we are making progress. However, the global health challenges from tobacco are still growing.

“This new CDC report shows how far we’ve come in the U.S. as we approach the 50th anniversaries of both the Surgeon General’s first report on tobacco and ASCO’s founding. Having shown that we can make substantial progress, we must continue to do everything possible to expand tobacco control programs in the United States and especially overseas, where tobacco use is taking an even greater toll.

“ASCO believes it is our responsibility as cancer doctors to help our patients quit and oppose tobacco use in all its forms. We are deeply committed to proactive tobacco control globally and have set an aggressive agenda for slashing tobacco use, deploying every public health, policy, and legal approach available.”

—Clifford A. Hudis, MD, FACP

Source: ASCO post 

POTENTIAL NEW TARGET IDENTIFIED IN PANCREATIC CANCER

Researchers have identified a potential new method for treating pancreatic cancer, using calcium to overload pancreatic cancer cells and, thus, induce cell death in cancerous cells while sparing healthy cells. 

The key to this discovery, made by Jason Bruce, PhD, from the Physiological Systems and Disease Research Group at the University of Manchester, and colleagues, was identifying the “power source” for calcium pumps in the cancer cells that keep calcium levels low, assisting in cell survival. 

According to background information in the study, maintaining a low concentration of calcium is key to cell survival. Plasma membrane Ca²⁺ ATPase (PMCA) is a protein in the plasma membrane of cells that removes calcium from the cell. PMCA is fueled using adenosine triphosphate (ATP). 

Prior research has shown that many cancer cells, including pancreatic cancer, shift from ATP produced from mitochondria metabolism to a glycolysis ATP. Mitochondria generate approximately 90% of a cells’ energy in normal healthy cells. However, in pancreatic cancer cells it is thought that PMCA may have its own supply of glycolytic ATP, and it is this fuel supply that gives cancer cells a survival advantage over normal cells. 

“Designing drugs to cut off this supply to the calcium pumps might be an effective strategy for selectively killing cancer cells while sparing normal cells within the pancreas,” said Bruce in a prepared statement. 

In order to determine whether pancreatic cells were fuelled by mitochondrial or glycolytic ATP, the researchers used pancreatic tumor cells to test the effect of mitochondrial and glycolytic inhibition on cell death. The results of the study were published in the Journal of Biological Chemistry. 

Mitochondrial inhibition had no effect on cell death compared with control experiments. However, the researchers found that glycolysis inhibition induced ATP depletion, an irreversible increase in calcium, and ultimately cell death. 

“Collectively, the present study suggests that glycolytic ATP synthesis is critically important for maintaining PMCA activity and low resting Ca2+, in human pancreatic ductal adenocarcinoma cell lines,” the researchers wrote. “Furthermore, these findings are translational and provide insights into a potentially new therapeutic avenue for the treatment of pancreatic ductal adenocarcinoma.” 

Source:  cancernetwork.com

DISCLOSING MEDICAL COSTS CAN HELP AVOID "FINANCIAL TOXICITY"

High costs of cancer treatments can be an “undisclosed toxicity” that can harm a patient’s overall health and well-being, according to an article in The New England Journal of Medicine.¹ High medical bills can not only cause stress and anxiety but may also compel patients to cut back on spending for other basic needs—such as food, leading to less healthy diets—or to take medications less frequently than prescribed. 

“This is a very frequent cause of nonadherence,” the article’s lead author, Peter A. Ubel, MD, Professor of Business, Public Policy, and Medicine at Duke University, Durham, North Carolina, said in an interview with The ASCO Post. “It is a medical problem. Patients may not be showing up for tests or taking their pills because they can’t afford it. Dr. Ubel also tackled the issue of physicians rarely discussing medical intervention costs in an op-ed article he wrote for The New York Times.²

Not Always Easy to Know

“Because treatments can be ‘financially toxic,’ imposing out-of-pocket costs that may impair patients’ well-being, we contend that physicians need to disclose the financial consequences of treatment alternatives just as they inform patients about treatments’ side effects,” Dr. Ubel and colleagues wrote. They acknowledged that “it is very difficult, and often impossible for the clinician to know the actual out-of-pocket costs for each patient, since costs vary by intervention, insurer, location of care, choice of pharmacy or radiology service, and so on,” but added, “some general information is known.”

To those who say that they can’t disclose costs to patients because they themselves don’t know the prices, Dr. Ubel responds, “But you have an idea. For treatments you prescribe or use frequently, you have a pretty good idea. You know that some things are likely to cost your patients next to nothing and some things can cost a lot. That is a good starting point.”

While discussing costs of medical treatment would add time in an already tight schedule, Dr. Ubel challenged physicians to “think about how much time we spend trying to adjust medicines and revisit problems that we later found out occurred because patients were taking the pills every other day because they couldn’t afford them.” A recent study found that found 24% of cancer patients avoided filling prescriptions to save money, 19% partially filled prescriptions, and 20% took less than the prescribed amount of medication. In addition, 46% reduced the amount spent on food and clothing.³

Cheaper Alternatives

“Patients experience unnecessary financial distress when physicians do not inform them of alternative treatments that are less expensive but equally or nearly as effective,” Dr. Ubel and colleagues wrote in The New England Journal of Medicine. “We discovered this phenomenon when interviewing a convenience sample of breast-cancer survivors who had participated in a national study of financial burden. Many women reported discussing treatment-related costs with their physicians only after they had begun to experience financial distress.”

Physicians should be aware of these cheaper alternatives “because they used to be the main treatment before newer, more expensive ones came along,” Dr. Ubel told The ASCO Post. “They might be out of the habit of using these alternative treatments and some doctors won’t think that they are reasonable alternatives because they are no longer the ‘best’ treatment, but I just want to redefine ‘best,’ because best is what fits a patient’s goal the closest. And sometimes the patient’s goal might be to trade off a little bit of medical benefit to protect his or her financial interest.”

Determining what is best for particular patients should also factor in type and frequency of testing. “Frequent MRI and CT scan imaging to follow-up on tumor progress can all be very expensive, and awareness of those costs might make you change which tests you use or how frequently you look,” Dr. Ubel said.

‘Not Financial Counselors’

During a talk at a medical school, a medical student asked Dr. Ubel, “Am I supposed to be a financial counselor, too?” After the talk, the student went up to him and said, “If I had known this was part of medicine, I would never have become a doctor. This is not about becoming a doctor.” 

As Dr. Ubel noted, “He expressed absolute visceral distress at the thought that this would be part of what he would do.” 

Given the potential medical consequences of undisclosed financial toxicity, “I think the more we think about this as a medical topic instead of a financial topic, the better,” Dr. Ubel said. “Doctors don’t want to feel like they are financial counselors. That is why we use phrases like financial toxicity and think of it as a treatment side effect. We want people to really think about this in medical terms.”

Making It Easier to Estimate Costs

Efforts by insurance companies to develop technologies to better estimate costs, as well as price-transparency legislation passed in several states, may make it easier to avoid financial toxicity. 

“I do think that those things are on the horizon and are going to happen in the next handful of years,” Dr. Ubel said. “If patients don’t already know the prices, they will quickly be able to figure them out. I would not be surprised if some electronic medical records start routinely including cost and price information so doctors are aware of it, especially in health systems such as accountable care organizations that are trying to control costs.”

In the op-ed piece in The New York Times, Dr. Ubel stated, “The Affordable Care Act will have only a modest impact on patient exposure to health-care costs because the limits it sets on out-of-pocket costs are still high compared with most people’s resources.” Whether or not disclosure of medical costs will have an impact on medical costs, “only time will tell,” Dr. Ubel said, but at least patients would have the information needed to make informed choices. “And I would predict that more frequent discussions of cost would reduce spending,” Dr. Ubel added. ■

Source: ASCO post 

SYMPTOMS OF PROSTATE CANCER

Not everyone experiences symptoms of prostate cancer. In many cases, signs of prostate cancer are first detected by a doctor during a routine check-up. Some men, however, will experience changes in urinary or sexual function that might indicate the presence of prostate cancer. These symptoms include: 

A need to urinate frequently, especially at night 

Difficulty starting urination or holding back urine 

Weak or interrupted flow of urine 

Painful or burning urination 

Difficulty in having an erection 

Painful ejaculation 

Blood in urine or semen 

Frequent pain or stiffness in the lower back, hips, or upper thighs 

Please note that these symptoms can also indicate the presence of other diseases or disorders of the prostate, such as benign prostate hypertrophy (BPH) (enlargement of the prostate) or prostatitis (inflammation of the prostate). More information about prostate cancer my book “Manual of prostate cancer” 

http://bookstore.authorhouse.com/Products/SKU-000607546/Manual-of-Prostate-Cancer.aspx

“This manual is not intended as a substitute for professional healthcare. It is a preliminary guide to educate patients about treatment options and about the disease itself, so they will be better prepared to discuss it with their health care practitioners”

RADIOTERAPIA DEL CANCER DE PROSTATA

Durante las últimas décadas, la radiación externa ha evolucionado hasta ciertos niveles que actualmente permiten administrar una mayor dosis de radiación de forma segura. Por ejemplo, las técnicas de bidimensionales, que se usaban para planificación de la radioterapia  utilizados hasta principios de 1990, permitían una limitación de la dosis de irradiación hasta los 60 - 70 Gy (gray, unidad de radiación) debido a las toxicidades agudas y crónicas. Actualmente los médicos utilizan una terapia tridimensional (3D), que es una técnica mediante la cual se dirige las radiaciones hacia el tumor desde varios ángulos logrando que los órganos alrededor de la próstata reciban menos irradiación. La terapia de radiación 3D utiliza un programa informático para integrar imágenes obtenidas de un scanner de tomografía computarizada  (el cual enseña la anatomía interna del paciente) al sistema de planificación e irradiación del paciente. Las nuevas técnicas permiten a los médicos dar dosis más altas de radiación a la próstata y reducir la exposición a la radiación a los tejidos sanos cercanos. Esta nueva técnica de irradiación provoca pocos efectos secundarios. Más información del cáncer de próstata en mi libro “Cáncer de Próstata” (disponible como e-book en español)

 http://bookstore.authorhouse.com/Products/SKU-000619846/CNCER-DE-PRSTATA.aspx

 “Este manual no pretende ser un sustituto de la atención médica profesional. Es una fuente de información con datos actualizados y científicamente confirmados para educar a los pacientes sobre las opciones de tratamiento y de la enfermedad en sí. Este manual esta también dirigido a ayudar a los pacientes y sus familiares a estar mejor preparados para discutir dichos temas con sus médicos.”