NCI Cancer Center News
Tiny mutation triggers drug resistance for patients with one type of leukemia
A multi-institutional team of researchers has pinpointed exactly what goes wrong when chronic lymphocytic leukemia (CLL) patients develop resistance to ibrutinib, a highly effective, precisely targeted anti-cancer drug. In a correspondence published online May 28 in the New England Journal of Medicine, they show how the mutation triggers resistance.
Click here to read the full press release.
Study mentioned: N Engl J Med. 2014 May 28. [Epub ahead of print]
Resistance Mechanisms for the Bruton's Tyrosine Kinase Inhibitor Ibrutinib.
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Friday, 30 May 2014
Alberta to propose law that would ban people under 18 from tanning beds
Alberta’s health minister says a new law will be introduced later this year that will keep people under 18 out of tanning beds.
Fred Horne had earlier said legislation would protect youth from skin cancer, but he didn’t indicate if that meant including such a ban.
Read more from Global Mail.
Fred Horne had earlier said legislation would protect youth from skin cancer, but he didn’t indicate if that meant including such a ban.
Read more from Global Mail.
Sure, we’ll (eventually) beat cancer. But can we afford to?
Matt Herper’s tour de force article in the latest Forbes magazine suggests that companies and researchers are – perhaps – turning the tables on cancer using novel immunotherapies that are producing nearly unheard of outcomes even in late stage disease. The trillion dollar question: Can we afford to win the war on cancer, given current trends in drug development and pricing?
What is really remarkable about Herper’s article is how quickly the oncology field is changing. The search for drugs over the last decade or so has focused on disrupting tumor biology through targeted therapies modeled after Novartis ’ small-molecule blockbuster Gleevec for CML, or monoclonal antibodies like Herceptin for breast cancer. This approach is reflected in the nearly 50% market share captured by targeted drugs in the world’s largest oncology markets.
Read more here.
What is really remarkable about Herper’s article is how quickly the oncology field is changing. The search for drugs over the last decade or so has focused on disrupting tumor biology through targeted therapies modeled after Novartis ’ small-molecule blockbuster Gleevec for CML, or monoclonal antibodies like Herceptin for breast cancer. This approach is reflected in the nearly 50% market share captured by targeted drugs in the world’s largest oncology markets.
Read more here.
Wednesday, 28 May 2014
Summary Basis of Decision (SBD) for Bosulif
Health Canada has issued a Notice of Compliance under the Notice of Compliance with Conditions (NOC/c) Guidance to Pfizer Canada Inc. for the drug product, Bosulif. Based on Health Canada's review, the benefit/risk profile of Bosulif is favourable for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy, and for whom subsequent treatment with imatinib, nilotinib and dasatinib is not clinically appropriate. Read more here.
Vectibix (panitumumab) - Rare cases of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis
Amgen Canada Inc., in consultation with Health Canada, would like to inform you of important updates to safety information regarding the risk of Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) associated with the use of Vectibix®. Vectibix is indicated as monotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Read more here.
CI5: Cancer incidence in five continents
Cancer Incidence in Five Continents (CI5) is the result of a long collaboration between the International Agency for Research on Cancer and the International Association of Cancer Registries. The series of monographs, published every five years, has become the reference source of data on the international incidence of cancer. The CI5 databases provide access to detailed information on the incidence of cancer recorded by cancer registries (regional or national) worldwide. Read more here.
European Medicines Agency recommends to extend indications for ofatumumab
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product ofatumumab (Arzerra). Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Read more here.
Monday, 26 May 2014
New trial: A Phase IV Multicentre Trial to Evaluate Real-world Health Outcomes and Economic Impact of Panitumumab Versus Standard-of-care in the Treatment of Patients With Chemotherapy-refractory Metastatic Colorectal Cancer
Summary:
This is a phase IV multicentre trial to evaluate real-world health outcomes and economic impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The study will enable real-life health economics and outcome research (HEOR) to assess the impact of panitumumab in the Quebec population. The primary objective is to evaluate real-world health outcomes and economic impact of panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with SOC. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab. During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation.
Trial Description
Primary Outcome:
The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting
More details here.
This is a phase IV multicentre trial to evaluate real-world health outcomes and economic impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The study will enable real-life health economics and outcome research (HEOR) to assess the impact of panitumumab in the Quebec population. The primary objective is to evaluate real-world health outcomes and economic impact of panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with SOC. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab. During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation.
Trial Description
Primary Outcome:
The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting
More details here.
European Medicines Agency recommends to refuse a change to the marketing authorisation for bevacizumab
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product bevacizumab (Avastin). The change concerned an extension of indication to add treatment of glioblastoma. Read more here.
ESMO, UICC, NCD Alliance and other endorsing partners issue palliative care statement at WHA
ESMO, UICC, the NCD Alliance and other endorsing partners have delivered a joint statement at the 67th World Health Assembly in Geneva supporting the adoption of the ‘Strengthening of palliative care as a component of integrated treatment throughout the life course’ resolution. “We are united in our belief that palliative care is an essential health service for people with chronic and life-limiting illnesses - including HIV/AIDS and advanced NCDs such as diabetes, dementias, cancer, heart and lung disease,” states the joint declaration. Read more here.
European Medicines Agency recommends granting a marketing authorisation for obinutuzumab
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product obinutuzumab (Gazyvaro) 1,000 mg concentrate for solution for infusion intended for the treatment in combination with chlorambucil of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy. Read more here.
IARC/WHO and IACR launch new guidelines for planning and developing cancer registries in low- and middle-income settings
The International Agency for Research on Cancer (IARC), the World Health Organization (WHO), and the International Association of Cancer Registries (IACR) have launched new guidelines for establishing cancer registries. The publication provides essential guidance on the key steps in planning a registry, including accessing sources of information, monitoring the quality of the data, and reporting results. The guidelines serve as a vital tool to help low- and middle-income countries attain the highest possible standard of cancer registration, and address the limitations and challenges these registries may face. Read more here.
Read the full guidelines here.
Read the full guidelines here.
Dying with cancer from patient and provider perspectives
In the Health Section of this week’s Washington Post and in greater detail in the Narrative Matters portion of this month’s Health Affairs, Dr. Diane Meier, a noted expert in the field of palliative medicine and a professor of Geriatrics and Palliative Medicine at Mount Sinai in New York, writes about the role of palliative care in oncology. Dr. Meier uses one case example to illustrate the wishes of one of her patients, Jenny, to be able to anticipate and adjust to what comes next as she deals with a metastatic cancer diagnosis. Read more here.
Friday, 23 May 2014
Canadian Cancer Society honours leading tobacco control scientist with prestigious cancer research award
Dr David Hammond, a University of Waterloo scientist, is the recipient of the William E. Rawls Prize for the remarkable impact he has made in cancer prevention at an early stage in his career. He is recognized around the world as a leading expert in tobacco control research, particularly tobacco packaging and warning labels. Read more here.
Mayo Clinic first to show virotherapy is promising against multiple myeloma
In a proof of principle clinical trial, Mayo Clinic researchers have demonstrated that virotherapy — destroying cancer with a virus that infects and kills cancer cells but spares normal tissues — can be effective against the deadly cancer multiple myeloma. Two patients in the study received a single intravenous dose of an engineered measles virus (MV-NIS) that is selectively toxic to myeloma plasma cells. Both patients responded, showing reduction of both bone marrow cancer and myeloma protein. One patient, a 49-year-old woman, experienced complete remission of myeloma and has been clear of the disease for over six months. Read more here.
Team validates potentially powerful new way to treat HER2-positive breast cancer
In a paper appearing online in Nature Chemical Biology, a multi-institution team led by CSHL Professor Nicholas Tonks reports that it has found a means of inhibiting a protein, called PTP1B, whose expression is also upregulated in HER2-positive breast cancer. They show that PTP1B plays a critical role in the development of tumors in which HER2 signaling is aberrant. Therefore, PTP1B may be a therapeutic target via which to treat the disease. Read more here.
Summary Basis of Decision (SBD) for Giotrif
Health Canada has issued a Notice of Compliance to Boehringer Ingelheim (Canada) Ltd. for the drug product, Giotrif. Giotrif, a protein kinase inhibitor, was authorized as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor-naïve patients with metastatic (including cytologically proven pleural effusion) adenocarcinoma of the lung with activating EGFR mutation(s). Read more here.
Review says inexpensive food a key factor in rising obesity
A new review summarizes what is known about economic factors tied to the obesity epidemic in the United States and concludes many common beliefs are wrong. The review, authored by Roland Sturm, PhD of RAND Corporation and Ruopeng An, PhD, of the University of Illinois at Urbana-Champaign, notes that paradoxically, rising obesity rates coincided with increases in leisure time, increased fruit and vegetable availability, and increased exercise uptake. The review appears early online in CA: A Cancer Journal for Clinicians and finds at least one factor fueling the obesity epidemic: Americans now have the cheapest food available in history. Read more here.
Thursday, 22 May 2014
Molecule linked to aggressive pancreatic cancer offers potential clinical advances
Mayo Clinic researchers have discovered an enzyme they say is tightly linked to how aggressive pancreatic cancer will be in a patient. They say the study provides key insights into the most aggressive form of the disease, which is one of the deadliest human cancers. It also offers a number of possible future clinical advances, such as a way to gauge outcome in individual patients, and insight into potential therapy to shut down activity of the enzyme, known as Rac1b. Read more here.
Study calls for revisiting cardiac screening guidelines for survivors of childhood cancer
One of the first studies to analyse the effectiveness of screening survivors of childhood cancer for early signs of impending congestive heart failure (CHF) finds improved health outcomes but suggests that less frequent screening than currently recommended may yield similar clinical benefit. The researchers utilised a simulation-based model to estimate the long-term benefits associated with routine screening. The study's findings suggest that the current CHF screening guidelines for survivors of paediatric cancer should be re-examined. Read more here.
Many breast cancer patients having unnecessary double mastectomies: study
The majority of women who had double mastectomy following a breast cancer diagnosis had no major genetic or family risk factors, according to a new U.S. study, which concluded that doctors must help patients make more informed decisions in order to cut down on overtreatment of the disease. The study, published in the online edition of JAMA Surgery, looked at data from 1,447 women who were recently diagnosed with breast cancer. Read more here.
Wednesday, 21 May 2014
Blood test may spot pancreatic cancer earlier
Researchers at the MD Anderson Cancer Centre at the University of Texas, Houston, have unveiled a new blood test that may help doctors diagnose pancreatic cancer at an earlier stage, thus improving a patient's chance of survival. According to study author Dr. Ayumu Taguchi, the blood test aids in ruling out suspected cases of pancreatic cancer, thereby not requiring patients to undergo evasive screening procedures. While a larger trial is currently underway, initial results indicate that this test enabled the identification of four markers of "identified cases of pancreatic cancer nine out of 10 times, sorting malignancies from other diseases like chronic pancreatitis or pancreatic cysts."
To read more about this study, presenetd on May 19, 2014 at the American Association for Cancer Research (AACR) Special Conference in New Orleans, click here.
Tuesday, 20 May 2014
E-cigarettes boost success of quitting smoking: study
Smokers trying to quit are 60 per cent more likely to report success if they switch to e-cigarettes than if they use nicotine products like patches or gum, or just willpower, scientists have reported. Presenting findings from a study of almost 6,000 smokers over five years, the researchers said the results suggest e-cigarettes could play an important role in reducing smoking rates and hence cutting tobacco-related deaths and illnesses. Read more here.
A mathematical biologist against cancer
Patients have long received cancer treatments at the maximum tolerated dose on a regular schedule. Franziska Michor, a mathematical biologist from the Dana-Farber Cancer Institute in Boston, USA, has turned to math and evolutionary theory to determine whether clinicians can make existing therapies work better simply by altering the time course by which they are administered. Her models are now being put to the test in prospective human clinical trials. Read more here.
Systematic, agnostic study of genetic predictors of toxicity from anti-cancer therapy
The burden of chemotherapy-associated toxicity is well known, but there are relatively few tools that increase the precision of anti-cancer drug prescription. A group of researchers from the University of Oxford, UK proposed a shift in emphasis from the focused study of polymorphisms in drug metabolic pathways in small sets of patients to broader agnostic analyses to systematically correlate germline genetic variants with adverse events in large, well-defined cancer populations. The authors advocate that, whenever possible, randomised trials of novel antineoplastic agents should function as vehicles for a genome-wide exploration of germline determinants of toxicity. The use of a blood sample should also enable all patients to be analysed, rather than a subset. Read more here.
Detailed studies reveal how key cancer-fighting protein is held in check
St. Jude Children’s Research Hospital scientists have mapped the structural details of how p53 attaches to its regulatory protein, called BCL-xL, in the cell. The protein p53 is a key activator of the cell's protective machinery against genetic damage, such as the mutations that drive cancer cells' explosive growth. The detailed understanding of how these two molecular puzzle pieces fit together will help scientists design drugs that release p53 in cancer cells, triggering their suicide, called apoptosis. Read more here.
Some electronic cigarettes may increase health risks
High-voltage electronic cigarettes (e-cigarettes) may expose users to increased levels of toxic chemicals, including formaldehyde and acetaldehyde, according to research led by Maciej Goniewicz, PhD, PharmD, a researcher in the Department of Health Behavior at Roswell Park Cancer Institute (RPCI). Dr. Goniewicz and colleagues examined various chemicals in vapors generated from the same e-cigarette at variable voltages. Read more here.
Analysis finds wide variation in lung cancer rates globally
The only recent comprehensive analysis of lung cancer rates for women around the world finds lung cancer rates are dropping in young women in many regions of the globe, pointing to the success of tobacco control efforts. However, rates continue to increase among older women in many countries, indicating a need for more concentrated efforts to initiate or expand comprehensive tobacco control programs across the globe to curtail future tobacco-related lung cancer deaths. Read more here.
‘Super nurses’ take pressure off cancer specialists, patients
Involving nurses more deeply in patient care can help patients who have questions about the details and side effects of therapy or about prognosis, as well as provide reassurance and take some of the pressure off specialists. To practise in cancer and palliative care, however, most cancer centres require nurses to undergo advanced and specialized training. Read more here.
Dogs can detect prostate cancer in urine: study
Highly-trained dogs are able to detect prostate cancer in urine with 98 per cent accuracy, according to a study presented May 18 at the annual meeting of the American Urological Association in Orlando. “This study gives us a standardized method of diagnosis that is reproducible, low cost and non-invasive,” said lead author Dr. Gianluigi Taverna, chief of the prostatic diseases unit at the Humanitas Research Hospital in Milan, Italy. Read more here.
Friday, 16 May 2014
Measles virus cancer therapy shows promise, prompts caution
Mayo Clinic researchers stirred excitement by saying they had treated a patient’s blood cancer with a specially engineered measles virus, but even scientists involved in the work caution the response does not prove they have a cure. Dr. Stephen Russell, the report's lead author and a hematologist at the Mayo Clinic, and his colleagues write in the journal Mayo Clinic Proceedings that multiple myeloma in a 49-year-old woman seemed to disappear after she received an extremely high-dose injection of a measles virus engineered to kill the cancer cells. Read more here.
Thursday, 15 May 2014
Religious groups' views on end-of-life issues
In the summaries, religious leaders, scholars and ethicists from 16 major American religious groups explain how their faith traditions' teachings address physician-assisted suicide, euthanasia and other end-of-life questions.
Views on end-of-life medical treatments : growing minority of Americans say doctors should do everything possible to keep patients alive
At a time of national debate over health care costs and insurance, a Pew Research Center survey on end-of-life decisions finds most Americans say there are some circumstances in which doctors and nurses should allow a patient to die. At the same time, however, a growing minority says that medical professionals should do everything possible to save a patient's life in all circumstances.
View the report by PewResearchCenter.
View the report by PewResearchCenter.
USC and NYU scientists develop a molecule to block cancer growth in mice
A team of researchers from USC and NYU has developed and patented a small molecule that interferes with cancer progression with minimal side effects. The molecule prevents two critical proteins from interacting by mimicking the surface topography of one protein—like wearing a mask— which tricks the other protein into binding with it. This stops a “transcription factor,” which would have created an aberrant gene expression that contributes to cancer growth. Read more here.
Wednesday, 14 May 2014
Dartmouth scientists identify genetic blueprint for cancers of the appendix
Using next generation DNA sequencing, Dartmouth scientists have identified potentially actionable mutations in cancers of the appendix. Dartmouth pathologists studied 38 specimens of LAMN and adenocarcinoma tumors (some of which had progressed to PMP) from their archives to look for shared genetic errors that might be responsible for the abnormal cell growth. Tissue samples were sequenced using the AmpiSeq Hotspot Cancer Panel v2, which pathologists had verified for the clinical screening of mutations in 50 common cancer-related genes for which treatments exist. This was the first study making use of a multigene panel in appendiceal cancers to support the use of potential targeted therapies. Read more here.
US cervial cancer rates higher than previously reported
Cervical cancer rates in the United States are higher than previously believed, particularly among 65- to 69-year-old women and African-American women, according to a study led by a researcher at the University of Maryland School of Medicine. Previous research finds an age-standardized rate of about 12 cases of cervical cancer per 100,000 women in the United States, with the incidence reaching a peak at age 40-44 and then leveling off. However, these estimates included women who had hysterectomies in which the lower part of the uterus, the cervix, was removed. By excluding these women, who are no longer at risk of developing this cancer, from their analysis, the researchers calculated a rate of 18.6 cases of cervical cancer per 100,000 women. Read more here.
Children of nicotine-addicted parents more likely to become heavy smokers
The more time a child is exposed to a parent addicted to smoking, the more likely the youth will not only take up cigarettes but also become a heavy smoker. So warns a team of researchers led by Georgetown Lombardi Comprehensive Cancer Center scientists. The study is among the first to take a prospective, intergenerational view of the impact a parent’s behavior has on smoking risk for their adolescent offspring. The findings suggest that parental smoking cessation early in their children’s lives is critical to prevent habitual smoking in the next generation. Read more here.
E-cigarettes and mental health
Researchers at University of California, San Diego School of Medicine report that people living with depression, anxiety or other mental health conditions are twice as likely to have tried e-cigarettes and three times as likely to be current users of the controversial battery-powered nicotine-delivery devices, as people without mental health disorders. They are also more susceptible to trying e-cigarettes in the future in the belief that doing so will help them quit, the scientists said. The FDA has not approved e-cigarettes as a smoking cessation aid. Read more here.
Heavy mobile phone use may increase risk of some brain cancers: study
People who use mobile phones intensively appear to have a higher risk of developing certain types of brain cancer, French scientists said this week, reviving questions about phone safety. Individuals who used their cellphone for more than 15 hours each month over five years on average had between two and three times greater risk of developing glioma and meningioma tumours compared with people whose used their phone rarely, they found. The study -- appearing in the latest issue of British journal Occupational and Environmental Medicine -- is the latest foray in a long-running exploration of mobile-phone safety. Read more here.
Tuesday, 13 May 2014
Triple negative breast cancer more likely to be diagnosed in black women, regardless of socioeconomic status
Press release from American Cancer Society, May 12, 2014
An analysis of a large nationwide dataset finds that regardless of their socioeconomic status, black women were nearly twice as likely as white women to be diagnosed with triple-negative (TN) breast cancer, a subtype that has a poorer prognosis. The analysis also found that Asian/Pacific Islander women were more likely to be diagnosed with another subtype of breast cancer: so-called human epidermal growth factor receptor 2 (HER2)–overexpressing breast cancer. The study appears early online in Breast Cancer Research and Treatment.
Study mentioned:
Breast Cancer Res Treat. 2014 May 3. [Epub ahead of print]
Association of race/ethnicity, socioeconomic status, and breast cancer subtypes in the National Cancer Data Base (2010-2011).
An analysis of a large nationwide dataset finds that regardless of their socioeconomic status, black women were nearly twice as likely as white women to be diagnosed with triple-negative (TN) breast cancer, a subtype that has a poorer prognosis. The analysis also found that Asian/Pacific Islander women were more likely to be diagnosed with another subtype of breast cancer: so-called human epidermal growth factor receptor 2 (HER2)–overexpressing breast cancer. The study appears early online in Breast Cancer Research and Treatment.
Study mentioned:
Breast Cancer Res Treat. 2014 May 3. [Epub ahead of print]
Association of race/ethnicity, socioeconomic status, and breast cancer subtypes in the National Cancer Data Base (2010-2011).
Health Canada in a battle over cancer-drug maker’s shutdown
The Globe and Mail
Ottawa has temporarily shut down a Southern Ontario pharmaceutical maker to “prevent injury to the health of consumers,” but the federal drug regulator has not recalled any of the inexpensive chemotherapy drug produced at the plant, leading the company to claim it has been unfairly shuttered for minor infractions.
Health Canada suspended the licence of Biolyse Pharma Corp. on April 11, saying in a letter to the St. Catharines-based generic drug maker that an inspection beginning in January “raised significant concerns relating to aseptic manufacturing, chemical testing, microbiological testing controls and documentation.”
Read more about the news here.
Ottawa has temporarily shut down a Southern Ontario pharmaceutical maker to “prevent injury to the health of consumers,” but the federal drug regulator has not recalled any of the inexpensive chemotherapy drug produced at the plant, leading the company to claim it has been unfairly shuttered for minor infractions.
Health Canada suspended the licence of Biolyse Pharma Corp. on April 11, saying in a letter to the St. Catharines-based generic drug maker that an inspection beginning in January “raised significant concerns relating to aseptic manufacturing, chemical testing, microbiological testing controls and documentation.”
Read more about the news here.
Clinical trials: clearer rules, better protection for patients
Transparency: studies to be made publicly available
Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with EU ministers and passed by Parliament in April.
In negotiations, MEPs amended the draft to improve transparency, by requiring that detailed summaries be published in a publicly-accessible EU database, including full clinical study reports to be published once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn. Fines would be imposed on sponsors who do not comply with these requirements.
Read more on the European Parliament website.
Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with EU ministers and passed by Parliament in April.
In negotiations, MEPs amended the draft to improve transparency, by requiring that detailed summaries be published in a publicly-accessible EU database, including full clinical study reports to be published once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn. Fines would be imposed on sponsors who do not comply with these requirements.
Read more on the European Parliament website.
Friday, 9 May 2014
Cancer prevention website aims to inform Albertans of preventable risks
Alberta Health Services has launched a new campaign, complete with online information, with the intention of educating Albertans of cancer risks and offering cancer prevention tips. Alberta Prevents Cancer provides information on the impact diet choices, physical activity, cancer screenings, and alcohol and tobacco have on cancer risk. According to AHS, lifestyle modifications could reduce an Albertan’s risk of a cancer diagnosis by as much as 50 per cent. Read more here.
Visit the website, Alberta Prevents Cancer, here.
Visit the website, Alberta Prevents Cancer, here.
IMPAKT 2014 news
News from the IMPAKT 2014 Breast Cancer Conference (8-10 May 2014, Brussels, Belgium).
Adoption of Multi-gene Assays in Hormone Receptor-Positive, HER2-Negative Breast Cancer
In a survey among physicians with at least 5 years of experience in treatment of breast cancer, a majority of respondents indicated that they would use multi-gene assays in clinical practice in a subset of patients with hormone receptor (HR)-positive, HER2-negative disease but they also cited several barriers.
Therapeutic Effect and Markers of Response of Palbociclib in HER2-Positive Breast Cancer Models
Tissue based markers are available to direct rational utilisation of selective CDK4/6 inhibitor palbociclib, according to the study performed in a combination of cell culture, mouse models, and human primary tumour explants.
Enzalutamide With or Without an Aromatase Inhibitor for Advanced Breast Cancer
In a first trial of enzalutamide alone or combined with an aromatase inhibitor in women with advanced breast cancer, pharmacokinetics and tolerability of enzalutamide have shown to be similar to that reported in men with metastatic castration-resistant prostate cancer.
Molecular Subtype of a Breast Cancer Relapse Influences Patient Post-Relapse Survival
Translational results from randomised phase III TEX trial show that breast cancer relapse characteristics display aggressive features with an over-representation of ER-negative, HER2-positive and highly proliferative tumours.
Combination of mTOR and AKT Inhibitors in Patients with Advanced Breast Cancer
A combination of mTOR inhibitor, ridaforolimus and novel AKT inhibitor, MK-2206 showed activity in heavily pretreated hormone positive and negative breast cancer patients who exhibit PI3K pathway dependence based on low RAS signature score.
Adoption of Multi-gene Assays in Hormone Receptor-Positive, HER2-Negative Breast Cancer
In a survey among physicians with at least 5 years of experience in treatment of breast cancer, a majority of respondents indicated that they would use multi-gene assays in clinical practice in a subset of patients with hormone receptor (HR)-positive, HER2-negative disease but they also cited several barriers.
Therapeutic Effect and Markers of Response of Palbociclib in HER2-Positive Breast Cancer Models
Tissue based markers are available to direct rational utilisation of selective CDK4/6 inhibitor palbociclib, according to the study performed in a combination of cell culture, mouse models, and human primary tumour explants.
Enzalutamide With or Without an Aromatase Inhibitor for Advanced Breast Cancer
In a first trial of enzalutamide alone or combined with an aromatase inhibitor in women with advanced breast cancer, pharmacokinetics and tolerability of enzalutamide have shown to be similar to that reported in men with metastatic castration-resistant prostate cancer.
Molecular Subtype of a Breast Cancer Relapse Influences Patient Post-Relapse Survival
Translational results from randomised phase III TEX trial show that breast cancer relapse characteristics display aggressive features with an over-representation of ER-negative, HER2-positive and highly proliferative tumours.
Combination of mTOR and AKT Inhibitors in Patients with Advanced Breast Cancer
A combination of mTOR inhibitor, ridaforolimus and novel AKT inhibitor, MK-2206 showed activity in heavily pretreated hormone positive and negative breast cancer patients who exhibit PI3K pathway dependence based on low RAS signature score.
NIH study demonstrates that a new cancer immunotherapy method could be effective against a wide range of cancers
A new method for using immunotherapy to specifically attack tumor cells that have mutations unique to a patient’s cancer has been developed by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health. The researchers demonstrated that the human immune system can mount a response against mutant proteins expressed by cancers that arise in epithelial cells which can line the internal and external surfaces (such as the skin) of the body. These cells give rise to many types of common cancers, such as those that develop in the digestive tract, lung, pancreas, bladder and other areas of the body. The research provides evidence that this immune response can be harnessed for therapeutic benefit in patients, according to the scientists. Read more here.
Thursday, 8 May 2014
Read the SIOP-Europe agenda on the challenges for children and adolescents with cancer
The European Society for Paediatric Oncology, a fellow founding member of ECCO, recently released their policy paper on the challenges for children and adolescents with cancer in Europe. 6,000 young people die of cancer yearly in Europe and many more are survivors of childhood cancer.
Read the paper online here.
Read the paper online here.
Molecular tumour board helps in advanced cancer cases
With accelerating development of personalised cancer treatments matched to a patient's DNA sequencing, proponents say frontline physicians increasingly need help to maneuver through the complex genomic landscape to find the most effective, individualised therapy. In a recent paper, researchers at the University of California, San Diego School of Medicine and Moores Cancer Center detail their experience evaluating 34 patients between December 2012 and June 2013 using a molecular tumour board – a new type of advisory group comprised of multidisciplinary experts, including those in the fields of tumour genetics, basic science and bioinformatics. Read more here.
Journey Forward: how can we make survivorship care planning a reality?
The Journey Forward poster presented by NCCS at the meeting highlighted publicly and immediately available resources and tools that support the accurate and efficient creation and delivery of Survivorship Care Plans to cancer survivors and their health care providers. The presentation focused on facilitating the delivery of high quality coordinated care and highlighted new software functionalities, including the first-of-its-kind innovation between Journey Forward and C/NET Solutions allowing for the successful export of patient data from the CNExt Registry software into the Journey Forward Survivorship Care Plan Builder. Read more here.
Laparoscopic electric morcellators - risk of spread of unsuspected uterine sarcoma - notice to hospitals
Electric (powered, motorized) morcellators have helped contribute to the increase in minimally invasive gynecologic procedures (laparoscopic and robotic-assisted) such as hysterectomy and myomectomy for the treatment of women with uterine fibroids. By facilitating the removal of large surgical specimens through small incisions, these devices allow for a minimally invasive surgical approach along with its intended benefits. However, Health Canada is concerned about Canadian and international reports of inadvertent spread of unsuspected uterine malignancies associated with the use of these devices. Read more here.
Temodal (temozolomide) - risk of liver problems - for health professionals
Merck Canada Inc., in consultation with Health Canada, would like to inform you of new warnings for TEMODAL® (temozolomide) regarding cases of hepatic injury, including fatal hepatic failure reported post-marketing. TEMODAL® is an antineoplastic agent indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. It is also indicated for treatment of adult patients with glioblastoma multiforme or anaplastic astrocytoma and documented evidence of recurrence or progression after standard therapy. Read more here.
Wednesday, 7 May 2014
Training guide for cancer registry personnel
The Manual for cancer registry personnel, a classic resource written to help people working in population-based cancer registries, is now available online. The chapters follow the order of the tasks which have to be performed starting with learning to recognize appropriate medical vocabulary. Other chapters discuss identifying information sources, coding medical diagnoses, managing and analyzing registry data, and maintaining confidentiality. Read the full IARC manual here.
European Medicines Agency recommends a variation to the terms of the marketing authorisation for denosumab
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product denosumab (Prolia). "Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures." Read more here.
New model can predict therapy outcomes in prostate cancer with bone metastasis
To create the computational model, which they call “hybrid cellular automata,” researchers created simulations of different cell types involved in bone metastasis of prostate cancer, including two types of bone cells called osteoclasts and osteoblasts, and prostate cancer cells. They then created algorithms to simulate the interactions of these cells among themselves and with other bone metastasis-related factors in the microenvironment, including the proteins TGF-beta, RANKL, and other bone-derived factors. Read more here.
Tuesday, 6 May 2014
Basic cancer research: why is it essential for the success of personalised cancer therapy?
Professors Carlos Caldas and Yosef Yarden recently wrote a position paper on the behalf of the EACR, which was published in the European Journal of Cancer (EJC). It describes the "irreplaceable leading role" of basic research in the future of cancer therapy, and how allocating resources to basic studies could be the key to unlocking new achievements in personalised treatment.
Click here to read the 2-page position paper (reprinted in the 2014 EACR Yearbook)
Click here to view the Pubmed listing for the article
Click here to read the 2-page position paper (reprinted in the 2014 EACR Yearbook)
Click here to view the Pubmed listing for the article
Treatment guidelines for aggressive form of breast cancer
The American Society of Clinical Oncology (ASCO) has released two sets of guidelines for treating patients with an aggressive form of breast cancer. 15-20% of breast cancers are HER2-positive, carrying "high levels of the HER2 protein, which causes tumor cells to grow and divide faster than happens with most other breast cancers." According to Dr. Eric Winer, co-chair of the expert panel that developed the guidelines, doctors now have several treatment options for HER2-positive breast cancer, "all of which are associated with improved survival."
To read more about these guidelines, click here.
Monday, 5 May 2014
Withdrawal of application for EMA change to the marketing authorisation of pazopanib
GlaxoSmithKline Research & Development has officially notified the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of pazopanib (Votrient) to include maintenance treatment in women with ovarian, fallopian tube or primary peritoneal cancer whose disease improved or remained stable after first-line chemotherapy. Votrient is a cancer medicine that contains the active substance pazopanib. It has been authorised since June 2010 for treating advanced renal-cell carcinoma and certain forms of soft-tissue sarcoma. Read more here.
European Medicines Agency recommends a variation to the terms of the marketing authorisation for two HPV vaccines
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal products Gardasil and Silgard. The CHMP adopted extension of indication to prevention of premalignant anal lesions and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. Read more here.
The role of postoperative radiation therapy for endometrial cancer
The American Society for Radiation Oncology (ASTRO) has issued a new guideline, “The Role of Postoperative Radiation Therapy for Endometrial Cancer: An ASTRO Evidence-Based Guideline,” that details the use of adjuvant radiation therapy in the treatment of endometrial cancer. ASTRO’s Guidelines Panel of 17 leading gynecologic specialists compiled and reviewed extensive data from 330 studies from MEDLINE, EMBASE and the Specialized Register of the Cochrane Gynaecological Cancer Review Group published from 1980 to 2011. Read more here.
Read the full guideline here.
Read the full guideline here.
Human fat: a Trojan horse to fight brain cancer?
Johns Hopkins researchers say they have successfully used stem cells derived from human body fat to deliver biological treatments directly to the brains of mice with the most common and aggressive form of brain tumor, significantly extending their lives. The experiments advance the possibility, the researchers say, that the technique could work in people after surgical removal of brain cancers called glioblastomas to find and destroy any remaining cancer cells in difficult-to-reach areas of the brain. Read more here.
Experimental blood test spots recurrent breast cancers and monitors response to treatment
Investigators at the Johns Hopkins Kimmel Cancer Center have designed a blood test, the cMethDNA assay that "accurately detected the presence of cancer DNA in the blood of patients with metastatic cancers up to 95% of the time in laboratory studies." According to Dr. Saraswati Sukumar, no useful laboratory test presently exists to monitor patients with early stage breast cancer who appear to be well, but may have an asymptomatic recurrence. By accurately detecting the presence of advanced breast cancer, cMethDNA may aid in monitoring response to cancer treatment more precisely.
To read more about this study, appearing in the May 2014 issue of Artemis, the Johns Hopkins monthly breast cancer newsletter, click here.
Friday, 2 May 2014
Call for proposals: Transnational access to large prospective cohorts in Europe
The BBMRI-LPC project (Biobanking and Biomolecular Research Infrastructure – Large Prospective Cohorts) brings together large prospective cohort studies across Europe to facilitate collaborative transnational research project. This initial call for research proposals will provide free access to samples and exposure data for selected research projects. Read more here.
Immunogenic mutations in tumor genomes correlate with increased patient survival
In this new study, the authors used a collection of over 500 tumor samples to computationally predict, using both the mutation profile and the individual's immune type, which tumor mutations are likely to be "immunogenic," causing an immune response in the patient. They found that patients with one or more immunogenic mutations had higher expression of a known T cell marker, indicative of an anti-tumor T cell response. Furthermore, these patients had higher overall survival rates than patients without immunogenic mutations, suggesting the mutations are eliciting a protective immune response. Read more here.
Brain tumor cells penetrated by tiny, degradable particles carrying genetic instructions
Working together, Johns Hopkins biomedical engineers and neurosurgeons report that they have created tiny, biodegradable "nanoparticles" able to carry DNA to brain cancer cells in mice. The team says the results of their proof of principle experiment suggest that such particles loaded with "death genes" might one day be given to brain cancer patients during neurosurgery to selectively kill off any remaining tumor cells without damaging normal brain tissue. Read more here.
One in three Americans mixing supplements with drugs
In a recent study, researchers analyzed data on 9,950 adults from the National Health and Nutrition Examination Survey. In this nationally representative sample of adults, 34.3 percent reported using dietary supplements and prescription medications together. Furthermore, adults diagnosed with a medical condition were 2.5 times more likely to mix supplements with drugs than those without a medical condition. The authors concluded that dietary supplement use was highest among patients with medical conditions like osteoporosis, arthritis, cancer, liver conditions, heart conditions and diabetes while prescription medication use was highest among patients within many of the same categories. Read more here.
Low vitamin D linked to aggressive, advanced prostate cancers
Researchers at Northwestern University's Feinberg School of Medicine in Chicago have conducted a new study suggesting that low blood levels of vitamin D may be linked to more advanced, aggressive cases of prostate cancer in men. According to study author Dr. Adam Murphy, vitamin D "regulates the growth rate of normal cells and cancer cells"; a normal vitamin D level is considered to be in the range of 30-80 nanograms/millilitre (ng/ml). Northwestern University's study, conducted on 667 Chicago men between the ages of 40-79 who were undergoing prostate biopsies, indicates that those who tested positive after the biopsy had very low levels of vitamin D (under 12 ng/ml, thus becoming susceptible to a more aggressive and advanced form of the cancer.
To read more about this study, click here
Thursday, 1 May 2014
A visit with Dr. Garfield
The Science Citation Index (SCI) began in 1964 as a five-volume print edition of indexed scientific work. Dr. Eugene Garfield’s unique way of making connections between scientific research proved to be just the beginning of the vast world of research discovery and analytics with Thomson Reuters Web of Science™. Fifty years later, Garfield’s foundational work for the Web of Science is an integral part of the evolution of search. On May 8th — the 50th anniversary of SCI — watch Dr. Eugene Garfield talk about the origin of SCI and its evolution since 1964. Read more here.
The G-I-N 2014 Conference
The Guidelines International Network, G-I-N, is a global network, founded in 2002. It has grown to comprise 98 organisations and 107 individual members representing 40 countries from all continents (July 2013). The network supports evidence-based health care and improved health outcomes by reducing inappropriate variation throughout the world.
This year's conference will be held in Melbourne, Australia, on 20-23 August 2014. The Conference theme “Creation and Innovation: Guidelines in the Digital Age” will be addressed through plenary presentations, workshops, oral and poster presentations and much more.
Some interesting pre-conference workshops include the following topics:
- GRADE and Guideline Development
- Translating research findings and evidence-based guidelines into clinical practice
- Contextualising international guidelines: A practical approach in guideline construction
- Information technology in the development, dissemination and implementation of guidelines
- Adding to evidence – the role of clinical and lay members and health economics in developing clinical guidelines
More about the Conference is here.
This year's conference will be held in Melbourne, Australia, on 20-23 August 2014. The Conference theme “Creation and Innovation: Guidelines in the Digital Age” will be addressed through plenary presentations, workshops, oral and poster presentations and much more.
Some interesting pre-conference workshops include the following topics:
- GRADE and Guideline Development
- Translating research findings and evidence-based guidelines into clinical practice
- Contextualising international guidelines: A practical approach in guideline construction
- Information technology in the development, dissemination and implementation of guidelines
- Adding to evidence – the role of clinical and lay members and health economics in developing clinical guidelines
More about the Conference is here.
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