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Discrepancies in access to new cancer drugs revealed Версия для печати Отправить на e-mail
02.10.2014
  • Canada and Europe sometimes years slower than USA in approving cancer drugs
  • Breast cancer patients in Eastern Europe have inadequate access to trastuzumab

Lugano/Madrid, 26 September 2014 -- Access to potentially life-extending cancer drugs varies significantly in different regions of the world, two new studies show at the ESMO 2014 Congress in Madrid, Spain.

Researchers say the results demonstrate the need for better collaboration between doctors and health authorities on an international scale, to ensure patients have access to the best treatments.

Coordinated action is needed at an international level to ensure new cancer-fighting drugs are approved in a timely manner, oncologists said at the Congress. Their call came after a survey revealed that patients in some regions sometimes wait years longer than their counterparts elsewhere for new drugs to be approved.

The drug approval process is important to ensure that safe and effective therapies are made available for patients, explains study senior author Dr Sunil Verma from Sunnybrook Odette Cancer Center, Toronto, Canada.

To try and understand disparities in the drug approval time among various countries, Verma and coauthor Nardin Samuel compared approval times for 41 cancer drugs in Canada, the USA and the European Union.

They found that the average time to approval for these drugs by the US Food and Drug Administration (FDA) was 6 months shorter than for the European Union’s European Medicines Agency (EMA) and 7.6 months faster than Health Canada. Azactidine, for example, approved for haematological malignancies, had the greatest delay between FDA and Health Canada approval, stretching to 66.1 months. The EMA approved azactidine 10.3 months earlier than Health Canada but 55.8 months after the FDA.

The fastest approval time among the drugs studied was for cabazitaxel, which was approved for metastatic prostate cancer by the FDA just 17 days after the drug’s manufacturer filed for approval. In Canada and Europe, the times to approval for cabazitaxel were 11.63 months and 11.03 months, respectively.

This is the first study to systematically compare cancer drug approvals between three major regulatory bodies, the authors say. While approval from regulatory agencies plays an important part in helping ensure the safety and efficacy of new drugs, delays in the approval process can have an impact on patient care, they note.

“Our main aim as clinicians is to ensure that patients are given an opportunity to receive proven, effective and safe treatment in a timely manner. We need to balance due diligence to review appropriate treatment by regulatory agencies and providing treatment to our patients that is effective,” Verma says.

“There needs to be a dialogue amongst industry, regulatory agencies, patient bodies, research community and oncology professionals on how best we can reduce the time to approval while ensuring safety for approved drugs. We also need a coordinated international approach to reduce the disparity in time to access new drugs around the world.”

Commenting on the study, Professor David Cameron, director of the Edinburgh Cancer Research Centre, UK, noted: “This interesting study compares the times to regulatory approval in USA, Canada and Europe. There was little difference overall between the approval times for the EMA (Europe) and Health Canada, but both of these agencies approved new anti-cancer agents significantly later than the FDA in USA. Interestingly one drug, carbazitaxel, was approved in under 1 month in the USA.”

“It is not clear why there were these differences, but they are of some concern in the sense that they suggest that in the absence of data to the contrary, there may be bureaucratic rather than medical/scientific reasons for differential geographical approval timelines --which of course will lead to differential geographical benefits from new agents,” Cameron said.

Clearly more work is needed to understand the reasons for these differences, and any potential patient impact, but this work should stimulate such deeper investigations, Cameron said.

Access to breast cancer drug lacking in Eastern Europe

In a second study, Dr Felipe Ades Moraes from Institut Jules Bordet in Brussels, Belgium and colleagues found that patients in Eastern Europe had less access to the HER2 positive breast cancer targeted drug trastuzumab than their counterparts in Western Europe and the USA; differences they say can be linked to discrepancies in cancer survival. 

Trastuzumab is used to treat breast cancer in patients with HER-2 positive tumours, which account for around 20% of breast cancers. The drug was first approved for use by the US Food and Drug Administration in 1998.

“The development of trastuzumab is considered to be one of the greatest improvements in breast cancer treatment in recent years,” Ades Moraes said. “But we found that there were significant differences in trastuzumab procurement between countries in Western Europe, the USA and Eastern Europe and that these differences could be partially related to discrepancies in cancer survival between these regions.”

The researchers had previously shown that there were differences in health expenditure among the European Union countries and that these differences were related to discrepancies in cancer survival. “The more spent, the fewer patients died after a cancer diagnosis,” Ades Moraes says.

Now the researchers say they have shown that differences in the uptake of innovative and life-saving drugs may be one of the explanations for why these discrepancies exist.

Using national registry data, the researchers estimated the number of new cases of HER2-positive breast cancer patients per year in 24 countries, including 14 in Western Europe and 9 in Eastern Europe. They then estimated the number of likely trastuzumab treatments per year using trastuzumab procurement data for each country.

Tracking how many possible patients could have been treated with the supply of trastuzumab within individual countries between 2001 and 2013, the researchers found that Eastern European countries acquired insufficient trastuzumab to treat all the patients who would benefit from it.

“Trastuzumab procurement levels only increased in Eastern Europe after 2005 when the drug received extended approval for use after surgery, to increase the cure rate of breast cancer, while Western Europe and the USA had a faster uptake, seen since the drug’s first approval in the metastatic setting (2000 and 1998, respectively) and acquired sufficient amounts of the drug to treat virtually all patients,” Ades Moraes said.

"Advances in all areas of healthcare, ranging from screening to surgery and radiotherapy, endocrine treatment, and chemotherapy, have all contributed to the decreasing breast cancer mortality trend in the USA and Europe,” the researchers say.

“Our demonstration of the higher trastuzumab uptake in countries with higher breast cancer survival strengthens the notion that the uptake of life-saving drugs is one of the many important factors in improving cancer survival."  

“As cancer treatment and cancer drugs become more complex and more expensive, a close relationship between health authorities and doctors can dramatically improve patient care and cancer survival by determining priorities in health budget allocation,” Ades Moraes says.

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More than 70% of young oncologists in Europe suffer symptoms of burnout Версия для печати Отправить на e-mail
02.10.2014

Lugano/Madrid, 26 September 2014 -- Across Europe, more than 70% of young cancer specialists are showing signs of burnout, the largest survey of its kind has revealed. The results, reported at the Congress of the European Society for Medical Oncology (ESMO 2014) in Madrid, have prompted calls for serious action to address the issue at all levels.

“Oncology is an exceptionally rewarding career, but it can be demanding and stressful at times,” said Dr Susana Banerjee, lead author of the study and a consultant medical oncologist at The Royal Marsden NHS Trust in London, UK.

“Oncologists make complex decisions about cancer management, supervise the use of toxic therapies, work long hours, and continually face patients suffering and dying,” she said. “Furthermore, young oncologists are now facing increased administration, complaints/medico-legal issues, increasing expectations and workload with reduced resources. Taken together, these factors make oncologists at risk of developing burnout, a syndrome characterised by emotional exhaustion, depersonalisation (treating people as if they are objects), and loss of meaning or purpose in work.”

Banerjee and other members of the ESMO Young Oncologists Committee surveyed 595 oncologists under the age of 40 from across Europe and they report that 71% of participants showed burnout.

“The ESMO Young Oncologists Committee burnout survey has shown that burnout is a common, universal problem for young oncologists today,” Banerjee said.

Burnout could lead to serious personal consequences for the doctor such as anxiety, depression, alcohol or substance abuse and suicide, she noted. Doctors suffering burnout might also face professional consequences including challenges when it comes to delivering compassionate, high-quality patient care.

In addition, there is a risk that oncologists who experience burnout may leave clinical practice sooner than planned, with potential impact on the oncology workforce and ultimately patient care.

Differences across Europe

The survey showed that rates of burnout varied significantly across Europe. They were highest in central Europe, affecting 84% of respondents, and lowest in Northern Europe including the UK, where 52% of respondents were affected.

Factors significantly linked to higher risk of developing burnout were poor work/life balance, inadequate vacation time. Personal factors include not being in a relationship, living alone and not having children. Hospital factors included having a small workforce, higher numbers of patients and no access to support services.

Although there was no significant difference in burnout between men and women, men were found to have higher depersonalisation scores than women (60 vs 45%).

Action needed

Banerjee said that the first step in addressing burnout is to recognise the extent and implications of the problem for the current and future generations of oncologists.

“I believe as a profession, doctors have a duty to try and address this growing issue at all levels --from universities, individual hospitals and professional societies such as ESMO,” she said. “Burnout should not be stigmatised as a weakness. We need to support colleagues by focusing on recovery and prevention.”

Strategies including promoting a philosophy of good work/life balance, having the opportunity to discuss stressful aspects of work as well as access to support services should be encouraged, she added.

Achieving a good work/life balance is vital, she said. “This can include interests outside daily clinical practice such as research, teaching and mentoring students as well as interests outside of work such as hobbies, exercise and spending time with family and friends.

Achieving job satisfaction and enjoying being an oncologist is likely to have a positive impact in improving patient care, communication and relationships with colleagues.

“Although it is important to recognise this issue, the ESMO Young Oncologists Committee believes that by no means should these results discourage young colleagues who want to become medical oncologists,” said Dr Raffaele Califano, Chair of the Ccommittee. “This specialty remains one of the most fascinating and rewarding where physicians can make a huge difference in patients outcomes and quality of life.”

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Anamorelin shown to improve appetite and body mass in patients with cancer anorexia-cachexia Версия для печати Отправить на e-mail
02.10.2014

Phase III trial indicates the drug is safe and well tolerated in advanced
non-small cell lung cancer

Lugano/Madrid, 27 September -- A new drug, anamorelin, improves appetite and body mass in patients with advanced lung cancer who are suffering cancer anorexia and cachexia, according to phase III data presented at the ESMO 2014 Congress in Madrid, Spain. 

“Anorexia and cachexia are among the most troubling and distressing symptoms of advanced cancer, for both patients and their families,” says the study’s principal investigator, Dr Jennifer Temel from the Department of Medicine, Massachusetts General Hospital, Boston, USA.

Symptoms of the wasting syndrome can include a loss of weight and muscles, together with fatigue, weakness, and loss of appetite. The condition is very common in patients with advanced lung cancer. Anamorelin aims to address the symptoms by mimicking the effects of the so-called “hunger hormone” ghrelin, which is secreted by the stomach.

The large, randomized controlled ROMANA 1 and 2 trials are the first phase III studies examining the impact of anamorelin on anorexia-cachexia in patients with advanced lung cancer.

In the ROMANA studies, patients with unresectable stage III or IV non-small cell lung cancer with cachexia were randomized to receive either 100 mg anamorelin or placebo, given orally each day for 12 weeks.

Among 484 participants in ROMANA 1, those taking anamorelin experienced a median increase in lean body mass of 1.10 kg in 12 weeks, compared to a loss of 0.44 kg for those taking placebo. Body weight increased in the anamorelin arm by an average of 2.2 kg, compared to 0.14 kg in the placebo arm of the study. Patient symptoms or concerns regarding anorexia-cachexia, including appetite, also significantly improved over 12 weeks in patients taking anamorelin. The most frequent drug-related adverse events included hyperglycemia and nausea.

In ROMANA 2, 495 participants with advanced non-small cell lung cancer experiened similar benefits. Body weight increased by 0.95 kg on average, compared to a loss of 0.57 kg for those receiving placebo, and patient symptoms/concerns regarding anorexia-cachexia significantly improved over 12 weeks.

Patients receiving anamorelin did not experience improvements in their muscle strength, as measured by hand grip strength, although Temel notes that particular test can be difficult to administer in this patient population.

In summary, she says: “Having a safe and well tolerated drug in our armamentarium to improve the incredibly troubling symptoms of anorexia and cachexia will have a dramatic impact on both patients and their families.”

Commenting on the results, Associate Professor Florian Strasser from Cantonal Hospital St.Gallen, Switzerland, Chair of the ESMO Palliative Care Working Group, said the results of the Romana trials are promising. “These studies are paving the way towards a multi-component and most likely also a multi-modal treatment for patients suffering from Cancer Anorexia-Cachexia Syndrome.”

Cancer anorexia-cachexia syndrome is characterized by four interacting components: loss of muscle mass, decreased nutritional intake, metabolic and inflammatory alterations driven by active cancer disease, and decreased physical and psychosocial function, Strasser explained. Patients and their family members experience symptoms and concerns associated with each domain such as weakness, loss of appetite, early satiety, taste problems, fatigue or eating-related distress.

“Current management includes nutritional counseling, resistance training and increase of physical activity, psychosocial support and multimodal symptom control. However, these interventions are limited in their effect, and no pharmacological treatment is available to address the relevant components of the syndrome. In addition to quality of life of patients and family members, it has an impact on anticancer treatment efficacy and toxicity as well as survival.”

“Both the Romana I and II trials report an improvement of both muscle mass and patients’ symptoms and concerns while minimal and manageable side effects occur,” Strasser said.

“This is the first anti-cachexia drug for which reports from two placebo-controlled, double blind phase III trials show a consistent effect on different components of the cancer anorexia-cachexia syndrome,” Strasser said. “Further data are needed to show whether the increase of muscle mass is accompanied by a gain of fat mass, which would confirm that patients can build reserves while having more appetite. This would be a novel finding: a drug stimulating appetite resulting in more muscle mass and increasing reserves.”

Strasser noted that the lack of effect of the drug on hand-grip strength (HGS) as reported in the trial requires further explanation. “HGS measures only upper but not lower extremity strength, and it does not inform enough about physical function and daily living. The populations studied are relatively young and in a good performance status, without information on multimodal management, namely reversible secondary nutrition impact symptoms. Further data need therefore to show whether the improved symptoms and concerns are related to the known mechanism of the oral ghrelin agonist.”

Since both effective anticancer treatment as well as state-of-the-art early integrated palliative medicine with multimodal interventions can improve the cancer anorexia-cachexia syndrome and modify the effects of anti-cachexia drugs, such information is needed to better understand the results, he said.

“Do these trials already show a true clinical benefit, the clinical effectiveness, in a real world population? Probably not yet. The data are promising since the outcomes reported cover more than one relevant component of the CACS and are related to each other. Anamorelin responds to a yet unmet frequent clinical need having an impact on both the patient and the tumour control outcomes with minimal risk,” Strasser said.

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Rolapitant reduces nausea and vomiting in phase III trial Версия для печати Отправить на e-mail
02.10.2014

Lugano/Madrid, 27 September 2014 – Rolapitant reduces nausea and vomiting in patients receiving cisplatin-based chemotherapy, according to the results of a phase III trial presented for the first time today at the ESMO 2014 Congress in Madrid, Spain.

Dr Martin Chasen, lead author and medical director, Palliative Care, Ottawa Hospital Cancer Centre, Canada, said: “This agent makes a significant difference in the way people tolerate their chemotherapy. Patients experienced no loss in quality of life and, in fact, many saw meaningful improvements. One of the patients in the rolapitant cohort reported that he had just finished 18 holes of golf one week after receiving chemotherapy. This is in sharp contrast to many patients on current standard anti-emetics that are too ill to get out of bed within a week after each cycle of cisplatin.”

“We must treat nausea and vomiting, not just the cancer,” added Chasen, emphasising that some patients are extremely sensitive to cisplatin effects and recalling that he had one or two patients with curable cancers who refused treatment after one round of cisplatin. “They preferred to die,” he said.

The phase III trial investigated rolapitant, a novel antagonist of the NK-1 receptor, for the prevention of severe nausea and vomiting often experienced by patients receiving cisplatin-based chemotherapy, which may cause dose reductions and treatment discontinuation. The multicentre trial randomised 532 patients 1:1 to receive rolapitant plus granisetron/dexamethasone or placebo plus granisetron/dexamethasone prior to cisplatin-based chemotherapy.

The primary endpoint was complete response (defined as the patient having no emesis and not requiring any rescue medication) in the delayed phase (>24-120 hours) post-chemotherapy. Key secondary endpoints included complete response during the acute (0-24 hours) and overall (0-120 hours) phases.

The trial met its primary endpoint, with 72.7% of patients receiving rolapitant achieving complete response in the delayed phase compared to 58.4% of those receiving placebo (p<0.001). Rolapitant also improved the complete response rate compared to placebo in the acute (83.7% vs 73.7%, p=0.005) and overall (70.1% vs 56.5%, p=0.001) phases. Patients receiving rolapitant tended to report that chemotherapy had less of an impact on their daily quality of life (72.8% vs 67.8%, p=0.231).

Chasen said: “Rolapitant demonstrated a significant effect in both the acute and delayed phases. Our primary endpoint was achieved in the delayed phase, an incredible result. We know that the NK-1 receptor in the brain must be blocked to control nausea and vomiting --there are other agents that block this for a short time; rolapitant is an exceptionally long term receptor blocker that binds to the receptor and remains in place for up to 120 hours, therefore not allowing the chemotherapy to induce nausea and vomiting.”

The investigators tested the agent in patients receiving cisplatin, possibly the strongest inducer of emesis.  “Without a doubt this drug can be evaluated in other less emetogenic cancer treatments,” said Chasen.

He pointed out that rolapitant may also save costs. For example, in Ottawa patients can have a visit from a nurse following their chemotherapy who administers intravascular hydration and nutrients. Chasen said: “Patients receiving rolapitant may not require this service. They are able to eat and drink as they should.”

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Phase III trials presented at ESMO 2014 report major advances in supportive care for cancer patients Версия для печати Отправить на e-mail
02.10.2014

Lugano/Madrid, 27 September 2014 -- Phase III trials presented at the ESMO 2014 Congress report major advances in supportive care for cancer patients. Therapies have been shown to reduce chemotherapy-induced nausea and vomiting, bleeding in patients with venous thromboembolism (VTE) and cancer anorexia-cachexia syndrome (CACS).

Rolapitant was found to reduce nausea and vomiting in patients receiving cisplatin-based chemotherapy in a phase III trial. Such symptoms are often experience by patients on cisplatin and can cause dose reductions and treatment discontinuation.

The trial met its primary endpoint, with 72.7% of patients receiving rolapitant achieving complete response (defined as the patient having no emesis and not requiring any rescue medication) in the delayed phase (>24-120 hours post-chemotherapy) compared to 58.4% of those receiving placebo (p<0.001).

ESMO spokesperson Dr Roberto Labianca, director of the Cancer Center, Ospedale Giovanni XXIII, Bergamo, Italy, said: “In this well conducted large-scale clinical trial there was a clear advantage in patients receiving rolapitant when treated with highly emetogenic chemotherapy. It is remarkable that this effect was observed worldwide across different geographic regions. As the new drug is very selective and long-acting, and also well tolerated, it could be easily introduced in clinical practice in order to prevent  both acute and delayed chemotherapy-induced nausea and vomiting.”

Oral rivaroxaban reduced the risk of bleeding in patients with cancer and acute VTE who participated in the EINSTEIN DVT and EINSTEIN PE phase III trials. Both studies compared rivaroxaban to standard treatment with enoxaparin/vitamin K antagonist (VKA) for the treatment of symptomatic VTE in patients with cancer. Anticoagulant therapy is indicated to prevent recurrent VTE but is associated with a high risk of major bleeding.

The study found that the incidence of recurrent  VTE  and of mortality was similar between the rivaroxaban and enoxaparin/VKA groups for patients with active cancer and a history of cancer. The risk of major bleeding significantly reduced with rivaroxaban in patients with active cancer, with a hazard ratio of 0.42 but was similar between treatments for patients with a history of cancer.

Labianca said: “Rivaroxaban is an oral drug, with the same antithrombotic effect as compared to the traditional drugs, but with a reduced risk of bleeding. This characteristic can be very important in clinical practice, allowing an easier and more convenient treatment of such a serious complication of cancer.”

The phase III ROMANA 1 trial investigated the efficacy and safety of anamorelin HCI, a novel, selective ghrelin receptor agonist, for the treatment of CACS in patients with unresectabe advanced non-small cell lung cancer.

Dr Labianca said: “This is really an important advance, as the study emphasises the absolute need of establishing an approach of simultaneous palliative care in patients with advanced disease (such as NSCLC) treated with antitumour drugs and affected with serious symptoms like CACS.”

He concluded: “These studies demonstrate the research efforts directed toward improving the quality of life for patients with cancer and the significant advances that have been made to control some of the most severe repercussions of treatment.”

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