Breast cancer

Clinical trials allow breast cancer patients to experience treatment of the future

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The way Dr. Mahsa Mohebtash sees it, clinical trials allow breast cancer patients to sample the treatments of the future.

“I’m very upfront with patients. I think it is a privilege to be in a clinical trial,” said Mohebtash, chief of medical cardiology and hematology at Medstar Union Memorial Hospital’s Cancer Center. “It may have an added benefit—or it may not. But you will have the opportunity to get the drug of the future now.”

Patients who are taking part in a clinical trial receive extremely intensive are, are very closely monitored and have their own nurse with whom they meet one on one, Mohebtash explained.

“And on the other side, it’s a benefit to society,” she said. “You will help patients in five or 10 years.”

Yet only 3 to 5 percent of breast cancer patients take part in clinical trials, she said.

According to a recent article in Forbes magazine , the highest rate of enrollment is in cancer trials, but participation in the U.S. still hovers at around 5 percent.

Dr. Elias Zerhouni, president of Global R&D for Sanofi and former director of the U.S. National Institutes of Health, wrote that patients don’t seem to be afraid of taking part in such trials.

Rather, there’s a lack of information about them.

Nearly half of adults surveyed do not understand what clinical trials are. When educated about them, a third of adults would take part in them. So encouraging physicians to talk to their patients about clinical studies, and encouraging patients to become self-advocates for their own care, is part of the solution,” Zerhouni wrote in the article.

Mohebtash said there are a dozen open clinical trials currently at MedStar Union Memorial, and 32 open at all MedStar locations.

Eight of them are for breast cancer patients, though Mohebtash couldn’t say how many patients are in those trials.

Still, she’s had patients travel from out of state to participate in clinical trials, and has seen successes firsthand that could be attributed to studies and trials done at MedStar.

Mohebtash named one long-term breast cancer survivor, diagnosed in her late 20s, who’s now 40. That patient was a part of two vaccine studies.

Maybe it was just the biology of the cancer, Mohebtash said. Or maybe it was the vaccines.

“We don’t know,” she said.

Mohebtash, who has been with MedStar since 2009, said it’s an exciting time for breast cancer research. Many advances have been made in targeted therapies—drugs that are designed to target a certain protein or gene—and immunotherapy, which uses your immune system to attack the cancer.

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Artificial Intelligence is faster and 99% more accurate. Is it the next big step in the medical field?

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Researchers have developed machine learning software that can accurately diagnose a patient’s breast cancer risk 30 times faster than doctors, based on mammogram results and personal medical history.

The system could help doctors give better diagnoses the first time around – which means fewer mammogram callbacks and false positives.

“This software intelligently reviews millions of records in a short amount of time, enabling us to determine breast cancer risk more efficiently using a patient’s mammogram,” said one of the researchers, Stephen Wong, from Houston Methodist Research Institute. “This has the potential to decrease unnecessary biopsies.”

A mammogram is a breast X-ray that aims to spot any potentially cancerous cells before symptoms arise.

In many countries, women over the age of 50 are advised to get a precautionary screening every two years, but as good as that system is, 50 percent of the tests in the US yield false positive results. In other words, one in two healthy women are wrongly being told they might have cancer.

On top of that, there’s a big grey area of ‘suspicious’ mammograms, which fall anywhere between a 3 and 95 percent cancer risk, and these patients are recommended to have follow-up biopsies.

Right now, about 20 percent of biopsies in the US are unnecessarily performed, according to the researchers, and the new AI has been designed to greatly reduce that number by making a more accurate diagnosis the first time.

Computer software is already used to help doctors analyse mammogram images themselves, but this system takes things one step further, by looking at the doctors’ reports on these scans, as well as a patient’s full medical history, to more accurately determine breast cancer risk

In the most recent demonstration, the researchers tested the AI on 500 breast cancer patients’ mammogram results and pathology reports.

Within a few hours, the software had come back with diagnostic information – specifically, it identified the breast cancer subtype each patient had.

The researchers then double checked the AI diagnoses with clinical results, and showed that the software was 99 percent accurate. The same analysis would have taken doctors more than 500 hours.

“Accurate review of this many charts would be practically impossible without AI,” said Wong.

To be clear, the AI so far hasn’t been tested in a real-world setting – the results analysed in this study were from existing breast cancer patients – but the researchers have now provided enough evidence to warrant follow-up trials.

It also won’t be able to prevent all false positives or suspicious mammogram results – sometimes there’s just not enough information available to make a diagnosis. But it should help doctors make a more accurate conclusion.

We’re looking forward to seeing how this software could make breast cancer diagnosis – as well as other cancers – faster and more accurate, and save people the time and stress of unnecessary further testing. 

The results have been published in the journal Cancer.

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Breast cancer growth is halted by osteoporosis drug, study finds

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An existing osteoporosis drug has been found to halt the growth of breast cancer cells, and researchers are now investigating its potential as a new treatment for high-risk women. 

The drug, called denosumab, could one day be prescribed as a preventative breast cancer treatment for women with mutations in the BRCA1 gene – which famously gave Angelina Jolie an estimated 87 percent risk of breast cancer and a 50 percent risk of ovarian cancer.

In a healthy state, the genes BRCA1 and BRCA2 produce tumour suppressor proteins that help repair damaged DNA, and ensure the stability of the cell’s genetic material. 

But if these genes are mutated and not functioning properly – something that can be passed down by a person’s mother or father – they can produce faulty proteins, and will be unable to repair DNA damage. 

This can lead to new cells developing further mutations that make them a whole lot more susceptible to breast and ovarian cancer growth. “About half of women who inherit a harmful mutation in BRCA1 or BRCA2 will develop breast cancer by the age of 70,” Ian Sample reports for The Guardian.

If a woman tests positive for these types of mutations, there are a number of precautionary measures she can take to mitigate the risk of either developing cancer, or not detecting it fast enough for effective treatment. 

The US National Cancer Institute lists enhanced screening, prophylactic (risk-reducing) surgery, and chemoprevention as the main ones. But a new study suggests that there might be another option – taking the osteoporosis drug denosumab in pill-form to keep the harmful effects of these genetic mutations at bay.

“We were interested in finding an alternation option, a non-surgical approach for these women,” Emma Nolan from the Walter and Eliza Hall Institute of Medical Research in Melbourne told The Guardian.

Nolan and her colleagues analysed breast tissue from a woman with BRCA1 mutations to discover a group of cells that grew so rapidly, they appeared to be precursors of breast cancer. 

Inside these cells, the team found a protein called the RANK receptor, which signals to breast cells when they need to grow, particularly during pregnancy and menstruation. If this protein is deregulated – say, in women with a malfunctioning BRCA1 gene – breast cells can start dividing and multiplying uncontrollably, resulting in breast cancer.

This discovery, reported by the team earlier this year, was exciting in itself, because it gave scientists a clear, single target on which to test new treatments. Even more exciting was the fact that the RANK receptor protein was already targeted by denosumab to combat bone weakness in osteoporosis patients, or in patients where breast cancer has spread to the bone.

When the team tested ree on mice engineered to developed breast cancer and in isolated human breast cancer cells, it was found to prevent or delay the development of tumours.

“We are very excited by these findings because it means we’ve found a strategy that might be useful to prevent breast cancer in very high risk women, particularly BRCA1 mutation carriers,” said one of the team, Geoff Lindeman, a medical oncologist at the Royal Melbourne Hospital.

The team is remaining cautious about the results, published in Nature Medicine, because until they’re replicated in actual, living humans – instead of mice or isolated breast tissue – they’re nothing more than a jumping off point. A major clinical study is now underway with at-risk volunteers, and it’s expected to span two years.

With a London-based group reporting earlier this year that they managed to shrink breast cancer tumours in just 11 days using combination drug therapy, and a silicon ‘nano-balls’ treatment rendering up to 50 percent of mouse breast cancer subjects “functionally cured”, real developments are being made in this space. Let’s just hope the clinical trials give us more positive news.

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ICMR issues consensus document for management of breast cancers

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The Indian Council of Medical Research (ICMR) has issued a consensus document for management of breast cancers. This consensus document summarises the modalities of treatment including the site-specific anti-cancer therapies, supportive and palliative care and molecular markers and research questions. It also interweaves clinical, biochemical and epidemiological studies.

The consensus document is based on review of available evidence about effective management and treatment of cancers in Indian setting by an expert multidisciplinary team of oncologists whose endless efforts, comments, reviews and discussions helped in shaping this document to its current form. This document also represents as first leading step towards development of guidelines for various other cancer specific sites in future. Development of these guidelines will ensure significant contribution in successful management and treatment of cancer and best care made available to patients. This document would help practicing doctors, clinicians, researchers and patients in complex decision making process in management of the disease.

This document has been designed to optimize the outcome of the patients based on the available evidence as well as the resources at majority of the regional cancer centres. This will bring uniformity in the practice of this disease at various cancer treatment centres and thus promote seamless collaborative studies to address India specific research questions.

Breast cancer is the most common female cancer in the world with an estimated 1.67 million new cancer cases diagnosed in 2012. While the age adjusted incidence rates of breast cancer in India is lower than the western countries, because of the large population, the burden of breast cancer is high. With an annual incidence of approximately 1,44,000 new cases of breast cancers in India, it has now become the most common female cancer in urban India.

There is general consensus in Indian oncologists regarding the use of surgery, with breast conservation when feasible and the indication for radiotherapy, chemotherapy and hormone therapy in various stages of breast cancer. Breast conservation rates are low even for stage I & II breast cancers in most Indian centres and reflects the lack of access to modern radiotherapy. The quality of mastectomy, axillary lymph node dissection and pathology reporting varies significantly across the country. The choice of chemotherapy regimen and hormonal agents for different stages of breast cancer is determined not only by the prognostic and predictive factors but also by the logistics and access. Similarly the treatment for recurrent or metastatic disease is not uniform and is governed by several factors including the previous treatment, patient’s ability to tolerate additional treatment and access to such treatment.

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AbbVie begins phase III study of Veliparib in patients with advanced breast cancer

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AbbVie announced the initiation of a Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), when added to carboplatin and paclitaxel, two chemotherapeutic medicines, in patients with advanced breast cancer. Specifically, the combination of veliparib, carboplatin and paclitaxel will be compared to treatment with carboplatin, paclitaxel and placebo in patients with human epidermal growth factor receptor 2-(HER2) negative metastatic or locally-advanced breast cancer, containing BRCA1 and/or BRCA2 gene mutations.

“Our Phase III programme for veliparib represents an innovative approach to developing this type of anti-cancer compound. By adding veliparib to DNA-damaging therapies, such as carboplatin and paclitaxel, we can evaluate its potential to provide incremental benefit to existing treatments,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This is the third Phase III trial evaluating the efficacy and safety of veliparib, and the second evaluating the addition of veliparib to chemotherapy for the treatment of patients with difficult-to-treat forms of breast cancer.”

The randomised, double-blind, Phase III clinical trial will recruit approximately 270 patients. The primary efficacy outcome of the trial is progression-free survival (PFS). The secondary pre-specified outcome measures include overall survival (OS), clinical benefit rate (CBR), objective response rate (ORR) and duration of response (DOR).

Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerases (PARP) inhibitor being evaluated in multiple tumour types. PARP is a naturally-occurring enzyme in the body that repairs damage to DNA, and in certain types of cancers, repairs cancer cells. Discovered and developed by AbbVie researchers, veliparib is being developed to help prevent DNA repair in cancer cells and increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in more than a dozen cancers and tumour types, including Phase III studies in non-small cell lung cancer and breast cancer.

Breast cancer is the second most common cancer in the world and the most commonly diagnosed cancer in women worldwide.1 The HER2 gene, which normally helps cells in the breast remain healthy and function normally, can play a role in the development of breast cancer. Specifically, in approximately 25 per cent of breast cancers, the HER2 gene does not work properly, causing cells in the breast to grow and divide in an uncontrolled way. This process, known as HER2 gene amplification or over expression, results in HER2-positive breast cancer. HER2-positive breast cancers tend to grow faster, metastasize more quickly and are more likely to recur, compared to patients diagnosed with HER2-negative breast cancer.

It is estimated that at least five percent of breast cancer cases result from inherited mutations or alterations in the BRCA1 and BRCA2 breast cancer susceptibility genes. Women with these mutations have a 40- to 85-per cent lifetime risk of developing breast cancer. Additionally, men with BRCA2 mutations carry an increased risk of breast cancer.

  Source: PharmaBiz