Patients with advanced, incurable cancer denied palliative care

Many patients with advanced, incurable cancer do not receive any palliative care, reveals new research to be presented later this month at the ESMO 2014 Congress in Madrid, Spain, 26-30 September. The findings are astonishing as they come at the same time as 15 new oncology centres in Europe, Canada, South America and Africa are being awarded the prestigious title of ‘ESMO Designated Centre of Integrated Oncology and Palliative Care.’

Dr Alexandru Grigorescu, medical oncology consultant at the Institute of Oncology Bucharest, Romania, member of the ESMO Palliative Care Working Group, said: “The integration of palliative care in oncology is a challenge. This is especially the case for countries with few resources, where the healthcare budget is low, with insufficient palliative care specialists and some drugs are unavailable as hospitals do not have the funds to buy them.”

ESMO brings a new approach to palliative care, namely by integrating it with specific anticancer treatment conducted in medical oncology departments,” continued Grigorescu. “In this context, we conducted a study to assess palliative care needs and delivery in patients with advanced, incurable cancer.”

The research was conducted in five Romanian and one Swiss institutes. It found that 17% of patients received no palliative care interventions and 26% did not have their symptoms addressed. One-fifth of patients wanted to discuss end-of-life issues with a healthcare professional, but it occurred in just 15% of cases. Only 10% of patients had a care plan.

Grigorescu said: “Our study shows that there are significant gaps in the delivery of palliative care for patients with advanced, incurable cancer. Our findings argue for healthcare decision-makers to increase the budget for palliative care. We hope the study will make a point about the importance of treating patients during this period. In Romania we do not have an independent speciality of palliative care, so it should be the responsibility of medical oncologists.”

ESMO promotes good practice in palliative care for cancer patients through –among others– the ESMO Designated Centres of Integrated Oncology and Palliative Care accreditation programme. The designation recognises that centres have achieved a high standard of integration of medical oncology and palliative care and is valid for three years.

Prof Nathan Cherny, former chair of the ESMO Palliative Care Working Group and initiator of the Designated Centres programme, said: “The ESMO Designated Centres programme is the premier initiative worldwide for providing incentives and a structured model to enable centres to develop integrated programmes in oncology and palliative care. The ESMO designation is widely recognised and indicates that the centre has made philosophical and infrastructural commitments to meet the physical and psychological challenges of patients and families with advanced cancers.

Cherny, an oncologist and palliative medicine specialist who is chair of humanistic medicine at Shaare Zedek Medical Centre, Jerusalem, Israel, added: “The designation also indicates that the centre is not only providing a clinical service but that it has programmes developed both to push the boundaries of knowledge through research and to teach the essential skills required for the provision of palliative care to cancer patients.”

Since the programme began in 2003, the Designated Centre accolade has been awarded to 175 centres, of which 25 are in resource and/or regulation restrictive countries. In addition to the 15 new centres joining the prestigious group this year, 44 centres have achieved reaccreditation.

Commenting on ESMO’s activities in the field of palliative care, Cherny said: “ESMO has a 15 year history of a commitment to the improvement of the quality of palliative care for cancer patients in Europe and around the world. ESMO was the first major oncology organisation to develop a dedicated working group to this task, and to develop policies for individual clinicians, for cancer centres and for the training of oncologists. ESMO has researched its own membership to identify deficits in knowledge and practice and has developed educational tools to address the shortcomings that were identified.”

ESMO has been a leading player in identifying barriers to the availability and accessibility of essential pain relieving medication in Europe and in the developing world. Cherny said: “The findings from the Global Opioid Policy Initiative (GOPI) study have major policy implications that are relevant to over five billion of the world’s population. We are working with our partners to promote legislative reforms to guarantee that all patients have access to affordable, effective pain medication to relieve the tragedy of needless suffering caused by undertreated cancer pain.”

To promote better care for patients with advanced cancer ESMO published a guide for patients and their families and a companion volume for oncologists. The ESMO Guidelines Working Group is developing evidence-based clinical practice guidelines to assist oncologists in the provision of palliative care. This month three new guidelines have been published. Cherny said: “Together these publications help patients with advanced and incurable cancer ask appropriate questions and have meaningful discussions with their oncologist that lead to coordinated and holistic care. The patient book has been translated into 11 languages and is an invaluable resource.”

With its strong commitment to research, best practice and palliative care, ESMO has become a key partner in palliative care initiatives,” added Rolf A. Stahel, ESMO President.

Cherny concluded: “Palliative care has been a central part of ESMO’s work in research, education and public health policy initiatives both in Europe and around the world. This year’s new and reaccredited ESMO Designated Centres will ensure that more patients with cancer receive appropriate, high quality palliative care along with the best of their cancer care – and this makes a difference.

ESMO 2014 Congress in Madrid, Spain, 26-30 September.

Further Information 

A guide for patients with advanced cancer: Getting the most out of your oncologist: http://www.esmo.org/Patients/Getting-the-Most-out-of-Your-Oncologist

User’s manual for oncology clinicians: http://oncologypro.esmo.org/Publications/User-s-Manual-for-Oncology-Clinicians

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EMAS publishes position statement on breast cancer screening in Elsevier journal Maturitas

Elsevier, a world-leading provider of scientific, technical and medical information products and services, today announced the publication of a position statement by the European Menopause and Andropause Society (EMAS) in the journal Maturitas on the topic of breast cancer screening.

Breast cancer is the most prevalent cancer in women, with slightly more than ten percent developing the disease in Western countries. Mammography screening is a well-established method to detect breast cancer. However there are concerns about over diagnosis with population-based screening programmes. Some tumors grow so slowly that they will not threaten the health of women during their lifetime. The women will die from another cause and thus it is argued that these tumors should not have been treated. Treatments can be invasive and painful, have major side-effects, especially in those with significant co-morbidities. While this is easy from an epidemiological standpoint, it is a dilemma for the treating physician dealing with individual women. It is virtually impossible to make the diagnosis of breast cancer and to predict the future behavior of that tumor. Thus individualization is proposed so that women may be categorized into ‘low to moderate’ and ‘high’ risk based on familial risk and the first screening mammogram so that further screening can be tailored.

Depypere et al., (2014). EMAS Position statement: Individualized breast cancer screening versus population-based mammography screening programmes. Maturitas, EPub Ahead of Print, DOI: 10.1016/j.maturitas.2014.09.002 [Article]

Wild berry extract may strengthen effectiveness of pancreatic cancer drug

Worth considering micronutrient and drug combo for hard to treat cancers, say researchers

The findings prompt the researchers to suggest that adding ‘nutraceuticals’ to chemotherapy cycles may improve the effectiveness of conventional drugs, particularly in hard to treat cancers, such as pancreatic cancer. They base their findings on the effectiveness of extract of chokeberry (Aronia melanocarpa) in killing off cancer cells—a process known as apoptosis.

Chokeberry is a wild berry that grows on the eastern side of North America in wetlands and swamp areas. The berry is high in vitamins and antioxidants, including various polyphenols—compounds that are believed to mop up the harmful by-products of normal cell activity.

The researchers chose to study the impact of the extract on pancreatic cancer, because of its persistently dismal prognosis: less than 5% of patients are alive five years after their diagnosis. They cultured a well known line of pancreatic cancer cells (AsPC-1) in the laboratory and assessed how well this grew when treated with either the chemotherapy drug gemcitabine, or different levels of commercially available chokeberry extract alone, and when treated with both.

The toxicity of chokeberry extract on other normal lining cells was tested and found to have no effects up to the highest levels used (50 ug/ml), suggesting that it may not be able to prevent the formation of new blood vessels (anti-angiogenic properties), a process that is important in cancer cell growth. But the analysis indicated that 48 hours of chokeberry extract treatment of pancreatic cancer cells did induce some cell death (1 ug/ml).

And low doses of the extract greatly boosted the effectiveness of gemcitabine, when the two were combined, added to which lower doses of the conventional drug were needed. This suggests either that the compounds work together synergistically, or that the extract exerts a “supra-additive” effect, say the researchers.

They go on to say that the potential of naturally occurring micronutrients in plants, such as those found in chokeberry, has not been adequately explored, at least in clinical trials. And they point to similar experimental studies, indicating that chokeberry extract seems to induce cell death and curb invasiveness in brain cancer, as well as other research, highlighting the potential therapeutic effects of particular polyphenols found in green tea, soya beans, grapes, mulberries, peanuts and turmeric.

This work, first adds reinforcement to the concept that therapy for intractable cancers might usefully be augmented by the inclusion of micronutrient supplementation into regimens,” the researchers write.

More specifically, it suggests that elements in chokeberry extract, while not intrinsically toxic, can have supra-additive effects in combination with at least one other conventional cytotoxic drug,” they conclude.

Abdullah Thani et al., (2014). Cytotoxicity of gemcitabine enhanced by polyphenolics from Aronia melanocarpa in pancreatic cancer cell line AsPC-1. J Clin Pathol.,  doi: 10.1136/jclinpath-2013-202075. EPub Ahead of Print [Abstract]

Many patients in cancer centers may not experience a dignified death

A new study that surveyed physicians and nurses in hospitals within cancer centers in Germany suggests that many patients there do not experience a dignified death. Published early online in Cancer, a peer-reviewed journal of the American Cancer Society, the study indicates the need for cancer centers to invest more in palliative care services, adequate rooms for dying patients, staff training in end-of-life care, and advance-care-planning standards.

Previous research has shown that hospitals are often ill-prepared to provide care for dying patients. To investigate whether the circumstances for dying on cancer center wards allow for a dignified death, Karin Jors, MA, of the University Medical Center Freiburg, and her colleagues surveyed physicians and nurses in 16 hospitals belonging to 10 cancer centers in Baden-Württemberg, Germany. The survey addressed topics regarding end-of-life care including structural conditions such as rooms and staff, education/training, working environment, family/caregivers, medical treatment, communication with patients, and dignified death.

Among 1131 survey respondents, 57 percent believed that patients could die with dignity on their ward. Half of the survey staff members indicated that they rarely have enough time to care for dying patients, and 55 percent found the rooms available for dying patients unsatisfactory. Only 19 percent of respondents felt that they had been well-prepared to care for dying patients (and only 6 percent of physicians felt so). Palliative care staff reported much better conditions for dying patients than staff from other wards, with 95 percent of palliative care staff indicating that patients die with dignity on their wards. Generally, physicians perceived the circumstances for dying patients much more positively than nurses, especially regarding communication and life-prolonging measures. While 72 percent of physicians reported that patients can usually die a dignified death on their ward, only 52 percent of nurses shared this opinion.

In our ageing society, it is predicted that the number of hospital deaths will continue to rise in the coming years, and many of these deaths will be attributable to cancer. For this reason, it is particularly important that cancer centers strive to create a comfortable, dignified experience for dying patients and their families,” said Jors. “Above all, this requires that staff members are provided with the adequate resources to care for these patients.”

The investigators encourage the integration of palliative care into standard oncology care, beginning as early as diagnosis. They also note that physicians and nurses would benefit from increased education and training in end-of-life care. To promote the development of standards for end-of-life care, establish a comprehensive palliative care curriculum for health care staff, and to encourage further research in this field, the Palliative Care Center of Excellence in Baden-Württemberg (KOMPACT) was established in 2014. “This center combines the expertise of five academic, specialist palliative care departments. We believe that this cooperation is a valuable tool for improving patient care in the end-of-life setting,” said Jors.

Jors et al., (2014). Dying in cancer centers: Do the circumstances allow for a dignified death? Cancer, EPub Ahead of Print, DOI: 10.1002/cncr.28702 [Abstract]

New antifungal as effective as existing drugs with fewer adverse events

A newly developed antifungal, isavuconazole, is as effective as an existing drug, voriconazole, against invasive mold disease in cancer patients with less adverse effects, according to phase 3 clinical data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious disease meeting of the American Society for Microbiology.

There is a growing need for new antifungal therapies like isavuconazole because serious fungal infections caused by Aspergillus and other molds are on the rise due to the increasing numbers of immunosuppressed patients, including those with active cancer. These infections are associated with high morbidity and mortality. If approved, isavuconazole has the potential to be an important new option for the treatment of these life-threatening fungal infections,” says Andrew Ullman of Julius Maximilians University in Wuerzburg, Germany, one of the researchers presenting data.

Invasive fungal infections are important causes of morbidity and death for patients with hematological malignancies. Many leukemia and lymphoma patients receive high-dose chemotherapy, sometimes followed by stem cell transplantation, compromising their immune systems. The genus Aspergillus comprises several hundred species of mold that are ubiquitous in the environment but pose little threat to people with healthy immune systems. Immunocompromised patients, however, are more vulnerable to infection

Ullman presented results from a large randomized Phase 3 study comparing the efficacy and safety of isavuconazole, a newly developed antifungal, with voriconazole in a subset of patients with uncontrolled cancer. The results showed that isavuconazole was as effective as voriconazole for treatment of invasive mold disease. In addition, isavuconazole had significantly fewer drug-related adverse events than voriconazole.

In this study, isavuconazole had significantly fewer adverse events than voriconazole, particularly in the eye, skin, and hepatobiliary (liver, gall blabber, and bile duct) organ classes. These results show the potential of isavuconazole as a potent antifungal in the fight against invasive mold disease,” says Kieren Marr of Johns Hopkins University who also presented data from the clinical trial.

Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal being developed by Astellas and Basilea Pharmaceutica International Ltd. for the treatment of life-threatening invasive fungal infections. Recently Astellas submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).

54th Interscience Conference on Antimicrobial Agents and Chemotherapy, 2014, Washington, DC.

Novel immunotherapy vaccine decreases recurrence in HER2 positive breast cancer patients

Women who received trastuzumab, Herceptin, as part of standard treatment show greatest benefit

A new breast cancer vaccine candidate, (GP2), provides further evidence of the potential of immunotherapy in preventing disease recurrence. This is especially the case for high-risk patients when it is combined with a powerful immunotherapy drug. These findings are being presented by The University of Texas MD Anderson Cancer Center at the 2014 American Society of Clinical Oncology’s Breast Cancer Symposium in San Francisco.

One of only a few vaccines of its kind in development, GP2 has been shown to be safe and effective for breast cancer patients, reducing recurrence rates by 57%. Further, women with the highest overexpression of HER2 (known as HER2 +3) had no cancer recurrences when they were administered the vaccine after completing trastuzumab (Herceptin), a type of immunotherapy drug known as a monoclonal antibody. HER2 is an oncoprotein that promotes tumor growth and is expressed to some extent in 75-80% of breast cancers.

This is an important and different avenue in immunotherapy research, in that we are investigating ways to prevent cancer recurrence by stimulating the immune system to treat cancer,” says principal investigator Elizabeth Mittendorf, M.D., Ph.D., associate professor of Surgical Oncology. “The ultimate goal is to develop a preventative tool that will minimize the risk of recurrence in women who have already had breast cancer and for whom standard therapies have failed.”

The findings are the result of a phase II randomized trial that paired the GP2 vaccine, designed to stimulate the CD8+ cells, commonly known as “killer” or “toxic” T cells, with an immune stimulant known as granulocyte/macrophage colony stimulating factor (GM-CSF). The trial included 190 patients with varying levels of HER2; 89 women received the GP2 vaccine with a GM-CSF adjuvant and a control group of 91 patients received GM-CSF alone. Eight patients experienced early recurrence or developed a second malignancy and did not complete the vaccine trial. The vaccine is injected subcutaneously and the initial series consisted of monthly inoculations for six months, followed by four cycles of booster shots administered every six months thereafter. The patients were monitored for nearly three years.

For all 190 patients, including those who did not complete the trial, the disease-free survival (DFS) rate was 88% among those who received the vaccine and 81% in the control group – representing a 37% reduction in recurrence. Excluding the patients who did not complete the vaccine series, the results are higher – 94% DFS rate versus 85% who did not get GP2 – a 57% risk reduction.

Women with HER2 +3 who were administered trastuzumab as part of the standard of care prior to receiving the vaccine experienced no cases of cancer recurrence. According to Mittendorf, trastuzumab may act like a primer for the vaccine. Trastuzumab stimulates CD4+ T cells to release substances that fight cancer cells and initiates an antibody response. Thus, it may prepare the immune system, making the vaccine even more effective. MD Anderson is now testing this combination of immunotherapies in other clinical trials.

The GP2 study supports previous MD Anderson research on similar breast cancer vaccines, such as AE37, which showed a significant immune response and improved recurrence rates in triple-negative breast cancer patients. Another candidate, E75, known as NeuVax or nelipepimut-S, showed a 50% recurrence decrease in high-risk patients. Currently, NeuVax is being tested internationally in a phase III clinical trial.

We believe many more patients will benefit in some way from immunotherapy,” says Mittendorf. “The challenge will be identifying the right immunotherapeutic approach for each individual patient. When doctors are able to do that, cancer therapy, and immunotherapy specifically, will follow a more personalized approach.”

American Society of Clinical Oncology’s Breast Cancer Symposium, 2014, San Francisco.