Tag Archives: treatment

Risks and benefits – what do we patients have a right to know?

Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet

Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet

The principle of informed consent is supposed to safeguard our rights as patients to accept or reject a proposed medical treatment on the basis of an understanding about the risks and benefits it offers.

There are big variations, however, in how it is put into practice, which may impact on the decisions patients take regarding, for instance, when to stop chemotherapy.

Last year, a Supreme Court judgement in a medical negligence case (Montgomery v Lanarkshire Health Board) updated what informed consent means in the UK, effectively bringing it more into line with the principle of shared decision making, by giving legal weight to the patient’s concerns and priorities.

Doctors must now ensure that patients are aware of any “material risks” involved in a proposed treatment, and of reasonable alternatives, with the legal test of what constitutes a material risk being decided by “whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk… or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”

The Court spelt out that the duty to assess whether a patient would regard certain information as significant requires doctors to engage in a dialogue with their patients, and that it is not up to the doctor to make assumptions about how a patient would rate the significance of any given risk, no matter how small.

Information on quality of life

What does this mean in practice for cancer patients? Taking the example of decisions on taking chemotherapy, whether the intent is curative or palliative, doctors offering this treatment must be able to provide information about the impact on quality of life and prognosis.

A risk to quality of life can be as significant to a patient as any medical risk.  But while doctors have always been required to make information on medical risk explicit in the consultation, information about how patients experience impact on quality of life, presented in lay language, is often missing.

In the light of the Temel study of palliative care in patients with incurable non-small-cell lung cancer – which found that patients offered palliative care soon after their diagnosis tended to have less chemotherapy and yet lived longer – a failure by the profession to address this information gap could be regarded as some kind of professional conspiracy.

Information on prognosis

A recent Dutch study into making decisions about chemotherapy treatment indicates that doctors need also to be much clearer in informing patients about the extent of benefit they can expect. The study asked patients (including patients with terminal prognoses) about the levels of benefit (chance of cure, additional months, symptom relief) they would require to accept mild or intensive chemotherapy regimens. The responses, on average, indicated they would expect high levels of benefits  “beyond what is realistically achievable”.

Following completion of the questionnaire, all the cancer patients in the study went on to receive chemotherapy, despite the likelihood of benefit being in most cases below their stated minimum threshold, suggesting the majority entered treatment with unrealistic expectations, which raises questions about what information they were given and how.

The study went on to explore the reasons for the lack of realism among patients. It raised concerns about the quality of communication between patients and doctors, and it pointed to an earlier Dutch study which looked at collusion in doctor-patient communication about imminent death, and indicated that social attitudes such as “not giving up” reinforce unrealistic expectations and thus acceptance of toxic therapy.

A study of English data published in August offers an interesting addition to our insight on the overuse of toxic therapies in patients who do not stand to benefit. It looked at the use of Systemic Anti-Cancer Therapy (chemotherapy) in breast and non-small-cell lung cancer patients in England in 2014. The patients were divided into two groups, those treated with curative intent and those for whom the treatment was “palliative”, ie it could delay not cure the cancer. They analysed the outcomes for a total of 23,228 patients with breast cancer and 9,634 patients with non-small cell lung cancer in the two groups, and how many of these patients died within 30 days of their last chemotherapy treatment.

In the palliative care group 1289 (8.4%) died within 30 days, while in the curative group 0.3% of the breast cancer patients and 2.7% of the NSCLC patients died within 30 days. There is no evidence that the deaths are clustered, so it is reasonable to assume that practice standards are similar among all the providers although the authors highlighted a small group of outliers.

Patient reported outcomes measures

Where does this leave our rights to accurate information by which to decide on whether or not to accept chemotherapy, particularly in a palliative setting?

I think we need a rapid and comprehensive adoption of patient reported outcome measurements in oncology care, aimed at providing reliable evidence-based descriptions of the impact of systemic treatment on life quality and on the prognostic pathway.

Where is the research on what cancer patients see as significant risk? None of the existing quality-of-life tools are adequate – apart from anything else they measure a researcher’s view of the criteria that matter, not a patient view.

Only through patient-reported outcomes data, effectively communicated, can we reduce the number of patients having their last days affected by toxicity. Using patient reported data could also help doctors break the “collusion” reported in the study from the Netherlands. And in countries like the UK, where patients’ rights to information they consider significant is now enshrined in law, we might also avoid a situation where doctors could be taken to court.

 

 

Extreme oncology in Romania

Geta Roman is a Bucharest-based freelance journalist writing about history and medicine. For more than 10 years she was a health editor for Romanian newspapers Cotidianul and Evenimentul Zilei

Geta Roman is a Bucharest-based freelance journalist writing about history and medicine. For more than 10 years she was a health editor for Romanian newspapers Cotidianul and Evenimentul Zilei

Being an oncologist in Romania is an extreme job. Being a patient with cancer in Romania is an extreme experience.

We have 250 oncologists to care for at least 500,000 people with cancer (the figures are uncertain because the National Cancer Registry is not up and running). Our hospitals are crowded, we lack medication, many patients waiting for chemotherapy or radiotherapy, and doctors and nurses are overwhelmed. At the same time, oncology is a field rife with corruption, with the patient caught in the middle.

The National Health Insurance and Ministry of Health are trying to find solutions: more money has been offered to doctors who work in emergency departments, and the private sector is now involved in providing radiotherapy and chemotherapy treatments, paid for by National Health Insurance. But it’s nowhere near enough to resolve the crisis in our cancer services.

The young doctors who are preparing to take the place of the older generation when they retire, and the older doctors who are forced to care for more patients than they can handle, propose the same solution for resolving this crisis: more money for doctors’ salaries, to keep them from leaving the country.

An experienced oncologist earns around €1,000 per month working in the public health system, while the younger ones earn only around €300-400 depending on their experience.

Flori Vladutescu is a Resident doctor in her second year in one of the biggest hospital in the country. She chose to become one because of the impact of cancer on her own life: her mother died from breast cancer when Flori was only four years old, and in the past years she has given close support to her sister, who was diagnosed with stage III breast cancer. She would like to know whether they have the breast cancer gene mutation, but the tests are too expensive, and are not covered by the public system.

Right now, Flori has decided to stay in Romania to care for people with cancer. She’s been promised a job in Giurgiu, 60 km from her hometown, Bucharest. “Cancer patient are special, more sensitive, you have to work with them to solve the physical problems, but you need a special attitude. I learnt that from my oncology teachers, who are also different – nicer, more human…” says Flori.

Initially she had intended to leave the country after finishing her residency. But she changed her mind, and is set on taking the job in Gurgui. “I’ve already gone there. I met the doctor who I will work with, and I saw all those patients who need help. I felt for them.” Her biggest challenge, she says, will be how to manage financially. “Half my salary will go on petrol, if I choose to commute from Bucharest every day” She think she may look for somewhere more local to stay.

“Half my salary will go on petrol”

The doctor in charge of the oncology outpatient clinic in Giurgiu, Florin Onisim, says that poor organisation ends up wasting doctors’ time, making an impossible job even more impossible. A new system of electronic registration was implemented over the past year, but no additional staff were recruited to input all the data. “It is extremely bureaucratic,” says Onisim. Before this system, I was able to see 70 people daily, now only around 30–35,” he says.

People living in and around Giurgiu are relatively lucky in one respect – they live not far from Bucharest, which has the biggest concentration of public and private cancer services in the country, so most of them have the option to travel to find an expert.

The situation is worse in other parts of the country. In Vaslui, one of the poorest cities, along the eastern border of Romania, the county hospital – which caters for a population of 375,000 – has no oncologist at all. In Resita, a city with 65,000 people, in the west part of Romania, the only oncologist in the area is responsible for the more than 8,000 patients recorded in the cancer registry.

Every time the local authorities try to hire oncologists, they face the same obstacle: no doctors are interested in going there, because of the low salaries offered by public hospitals. They prefer to join the exodus of more than 10,000 doctors who have gone to work in other European countries since 2007, when Romania became an EU member. Or they stay and work in the private sector in Romania.

The solution to both is better payments for doctors.

Cancer patients receiving chemotherapy at a major Bucharest hospital

Cancer patients receiving chemotherapy at a major Bucharest hospital

ProtecT and survival: what do we make of major prostate cancer trial?

Simon Crompton

Simon Crompton

It’s a study worthy of headlines, and it got them. The early results of the ProtecT trial have been published – and they’re important if only because this is the first randomised study comparing three common approaches to localised prostate cancer: surgery, radiotherapy and active surveillance.

The news stories have been clear on the main finding of the trial: “Monitoring of prostate cancer as effective as treatment”; “Prostate cancer patients live just as long with no treatment, experts have revealed”. The stories followed the upbeat lead of press releases from the researchers’ own institutions, the universities of Bristol and Oxford: “Active monitoring is as effective as surgery and radiotherapy, in terms of survival at 10 years, reports the largest study of its kind,” they said.

The researchers found that around 1% of the 1,643 men with localised prostate cancer had died after ten years, regardless of whether they had undergone a prostatectomy, radiotherapy or a programme of regular testing to check for progression (active surveillance). And those on active surveillance had the added benefit of avoiding the severe side effects that can result from treatment. Positive about the benefits of monitoring over intervention, then.

Increased risk of metastasis

But if you’d read the editorial in the New England Journal of Medicine accompanying the study’s publication, you might believe you were reading about entirely different research. This focused on the finding that, although similar numbers in each group survived at ten years, those in the active surveillance group were more than twice as likely to have metastases and disease progression.

To the editorial author, radiation oncologist Anthony V D’Amico, an increased risk of metastasis in active surveillance was the most significant conclusion to be drawn from the research.

“Therefore, if a man wishes  to avoid metastatic prostate cancer and the side effects of its treatment,” he wrote, “monitoring should be considered only if he has life-shortening coexisting disease such that his life expectancy is less than the 10-year median follow-up of the current study.”

No definitive conclusions

The fact is that, though important, these results are still too limited for anyone to be able to draw definitive conclusions about the merits of active surveillance. If anything, they seem to have further polarised the stances of those set on opposite sides in the prostate cancer overtreatment debate.

So next, to move on, we need to see what happens beyond 10 years in terms of mortality. And we need a more stratified breakdown of what happened to men with different Gleason scores (indicators of cancer aggression). The men included in the active surveillance group in this study had higher Gleason scores than would normally be eligible for active surveillance – so the overall results may not reflect this approach accurately.

The headlines, of course, never reveal the full story.

Setting the record straight on cancer research

Buist-colour

Cancer research is about testing evidence strenuously and objectively and can’t be judged by innuendo, conspiracy theories and pseudoscience, writes Steve Buist.

First things first. I’m not a doctor, and I’m certainly not an oncologist, so do with that information what you wish.
I do have a degree in biological science, and I’ve written about cancer for the past 18 years, which has given me the chance to learn from some of the best researchers around.
Science is the process of gathering information through the ongoing application of critical thinking. Science is about evidence and testing that evidence strenuously and objectively.
I believe in evidence-based medicine. I also believe in evidence-based journalism.
Recently, the Hamilton Spectator published an opinion piece with the provocative headline, “War on cancer, like the one on drugs, has failed us.
The piece relied heavily on innuendo, conspiracy theories and pseudoscience rather than evidence. I think it was irresponsible, bordering on dangerous.
Among the piece’s most absurd statements: that there is no known cure for cancer, that we should stop looking for a cure for cancer, that Big Pharma is sitting on a cure for cancer (which seems contradictory to the first two points), that people don’t die of cancer, and that 75 per cent of doctors would refuse chemotherapy themselves.
Where to even begin?
Let’s tackle the last point first, which the author stated came from “one survey” he had seen.
It turns out that, upon closer inspection, the 75 per cent figure has been taken out of context  from a survey that asked doctors a very specific question about a very specific type of harsh chemotherapy for a very specific type of incurable cancer in its terminal stage. That’s irresponsible.
No cure for cancer? That will come as a surprise to the many men who have been treated successfully for testicular cancer, which has a 97 per cent survival rate, or prostate cancer, which has a 96 per cent cure rate (based on five year survival). For women with breast cancer, nearly 90 per cent of them can expect to survive five years or more.
Overall, two out of three cancer patients will now survive at least five years, the amount of time once considered the standard to be deemed a cure. That’s up significantly from about 50 per cent two decades ago.
Could medicine be doing better? Sure. The war on cancer has been disappointing, if a 100% survival is seen as the goal. Treating metastatic cancer remains a particular challenge.
But part of the problem is that we’ve given one label – cancer – to a disease with a couple of hundred different types. It’s not surprising that finding solutions to hundreds of different problems has proven to be a challenge.
There is no one cancer and what’s become clear is there’s no one magic bullet that eradicates it.
Big Pharma sitting on a cure until they figure out how to monetize it, “as has been rumoured for years,” according to the author?
That’s out there with the faked moon landing type of conspiracy theory.
I’ve been critical of the pharmaceutical industry but that’s a level of cynicism even I can’t comprehend. It’s also highly insulting to the people who have to treat cancer every day.
Do you think someone is sitting on a cure for heart disease because they’re trying to figure out how to monetize it? Osteoporosis? Dementia? Diabetes?
Why would anyone think cancer is different?
Besides, there’s already a simple and effective way to monetize these things – prove that they work and the world will beat a path to your door. Can you imagine what would happen to the stock price of a company that announces it can cure cancer?
Oddly enough, there is one point we do strongly agree on – not enough is done to promote the prevention of cancer.
More than half of all cancer cases are preventable. Changing our behaviours – no smoking, more exercise, better diets, less drinking, protection from the sun – could seriously reduce the cancer burden.
But it still means a significant chunk of cancer can’t be prevented.
People do die from cancer. Too many people. Treatments are still needed.
All the more reason why the war on cancer must continue.

Steve Buist is the Spectator’s investigations editor. He has written several multipart series on cancer and in 2014, he was named best cancer reporter in a competition sponsored by the European School of Oncology. You can read his winning entry here

Targeting and Trust: QoL in clinical research

Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet

Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet

I took a random selection of 20 abstracts from ASCO 2016. None of them mentioned that quality of life had been researched in the study but looking up the detail held in clinicaltrials.gov it turns out that 16 of them did have a quality of life component in them. Whether that will be reported when the study is published is a different question. Experience suggests that it will be mentioned, but that for the most part the detailed QoL data will go unreported.

These are the days of ‘big data’ in healthcare. Increasingly we are seeing databases linked, common standards being adopted to allow similar fields to be aggregated, and increasingly comparisons can be made between key outcomes. The International Cancer Benchmarking Partnership is providing fascinating comparisons on survival outcomes from several different administrations – and it is getting into the detail of differences in the ways that national data is gathered.

The first QoL in cancer study appears to have been in the 1970s. The first paper I could find which looked at developing a methodology dates from the 1980s. We now have a proliferation of methodologies dominated by the EuroQoL EQ-5D which gives the kind of generic background view needed for health technology agencies (HTA) to assess the value of the treatment. Other methodologies relate solely to the study to which they are being applied. Unfortunately for cancer patients, the EQ-5D is too crude report the kind of detail that cancer patients need to know to make informed choices about treatment. For that reason too it can only ever be part of the picture for HTA appraisals.

What do cancer patients need from quality of life information? The full picture of the impact of a proposed treatment in the context of the treatment pathway being followed. We want side effects information, how side effects are treated, and want to know how patients feel when taking the treatment in their own words, not those of some detached academic. We want to know about long-term side effects and what comes after if this treatment fails.

The pathway is the key issue in terms of quality of life – it is not a moment in time, it is life. However there are no data covering the succession of treatments, assessing the interactions that can arise as side effects aggregate, and the challenge of describing treatment and quality of life as end-of-life approaches is avoided.

I looked around to see whether anyone is aggregating quality of life data in a way which could provide this picture. No-one. Why not, after all there is at least 30 years’ worth of data around? The quick answer is the usual big data problem, different methodologies, data fields do not match, each study looks at the treatment being tested not at the patient. The pathway is ignored.

“No-one is aggregating quality of life data in a way which could provide this picture”

We are entering the world of targeted therapies. Targeting is a challenge for randomised studies: they can be unethical, either randomising patients when there is good evidence to indicate one arm is more effective than another, or using cross-overs, which invalidate the randomisation. Phase 2 studies usually do not include quality of life because there is no control group baseline with which to compare the treated patient. A strong response rate (60%+) is enough to ensure entry into clinical practice. One result is that patients are offered new treatments without being able to see a full picture of the step they are taking. Possibly just as important, health technology agencies are denied the whole picture of value which they need to make decisions.

Let us leave aside any questions about whether patients will accept such treatments – these issues disappear when survival itself is your primary challenge. Yet, as trials for targeted treatments reach statistical significance faster and with fewer patients than trials for traditional drugs, patients face increasing uncertainty about the impact of therapies they are taking. We need something to mitigate that uncertainty.

A first step would be aggregating existing QoL data to derive a picture of each cancer pathway, modified as clinical standards evolve. It would provide a baseline for comparing new treatments.

A second step would be using one tool/methodology for all QoL in cancer research. Agreeing that step when there are so many competing methodologies is likely to be difficult.

The third step would be requiring a relevant patient group to be the determinant of the measures to be adopted in each QoL study, small or large. Not easy to arrange but do-able.

A fourth step would be mandating full analysis and reporting of QoL data when it is undertaken in a clinical study. That should not be impossible.

If the cancer research community does not take on this challenge we could affect one of the binding factors of cancer care, trust between patient and doctor. Targeted therapy is an amazing development but we are journeying together into an unknown future built on that trust alone, something we haven’t done for more than thirty years.

We welcome contributions to this blog. If you have a topic you would like to write about, please send your post to Corinne Hall – chall@eso.net You can find our guidelines here – How to write a blog

 

 

The real definition of active surveillance: what it means for a patient

Simon Crompton

Simon Crompton

It was only on the second day of ESO’s conference on active surveillance of low risk prostate cancer this weekend that the question was raised: what actually is active surveillance?

“Watchful waiting” and “active surveillance” were for many years regarded as the same thing. In fact, that Bible of medical veracity Wikipedia still equates the two – as observational approaches that allow men with low risk prostate cancer the opportunity to avoid or delay aggressive tests and treatments.

But the field has changed and specialised rapidly in the past 20 years, with the European School of Oncology taking a lead on extending knowledge in the field – organising three expert conferences, of which this was the latest. Those urologists, radiologists and public health experts attending such events are very clear that active surveillance is different from watchful waiting.

What’s the difference?

As Axel Semjonow from the University Hospital Muenster, Germany, explained: watchful waiting delays the need for palliative treatment, while active surveillance delays the need for curative treatment. Active surveillance is more likely to involve a schedule of assessment and tests, such as biopsy. Watchful waiting is more likely to apply to men with a life expectancy of less than ten years and will often follow active surveillance.

But these definitions only became widely used in 2008.

The rapid acceptance that active surveillance is an important strategy for treating low risk prostate cancer has had a lot to do with growing concerns about overdiagnosis and overtreatment in prostate cancer. For many men, biopsies, prostatectomy and radiotherapy produce effects far worse than their cancer ever would. A recent study showed that just 1% of men whose low risk prostate cancer is managed through active surveillance go on to die of the disease.

Conferences such as this are incredibly important for determining the best ways of selecting patients for active surveillance and of monitoring them while on the programme.

But active surveillance is still an emerging art, under-researched and ill-defined. The role of MRI scanning, for example, was a continual source of debate during the conference. We know a lot about its ability to diagnose prostate cancer. But in terms of its accuracy at monitoring disease progression, there are few yardsticks.

When cure seems the only goal

And, beyond the realms of such meetings, the very meaning of active surveillance is poorly understood. There are still varied definitions in scientific papers and guidelines. For prostate cancer patients, mere scientific statements of meaning do little good. Active surveillance offers many men the chance of a long and good quality of life without treatment side effects, but that might be hard to understand amid the stress of diagnosis when “cure” seems the only goal.

As several participants at the conference pointed out, amid the excitement of scientifically advancing this important field, the difficulty of patients understanding the approach and their personal risk should not be forgotten. Good communication has to be at the heart of programmes – and making sure that everyone understands what active surveillance really means today would be a good start.

Highlights from the conference:

 

Uganda says “we can” on World Cancer Day

Guest blogger – Esther Nakkazi, freelance science journalist

Guest blogger – Esther Nakkazi, freelance science journalist

“We can – I can – get involved in cancer prevention and control”

This is the theme for World Cancer Day being promoted by Ugandan health ministry.

And this year it seems that the government is not just talking the talk, it is walking the walk with plans to provide the legal basis and funding to support a comprehensive approach to cancer control in the country.

When the 10th Parliament convenes after the May elections, the Cancer Bill will be high up on the agenda.

Its primary objective will be to establish the Uganda Cancer Institute as an autonomous agency of Government mandated to undertake and coordinate the prevention and treatment of cancer and cancer-related diseases and conduct research.

With only 25 oncologists in the whole country, Uganda currently struggles to care for the almost 30,000 people who are diagnosed with cancer every year. Speaking at a press conference at the Ministry of Health ahead of World Cancer Day, Jackson Orem, Director of the Uganda Cancer Institute, spoke of his hope of increasing survival from the current rate of 20% to 50%, through improved prevention, earlier detection and care. And he sounded confident the proposed measures would be debated as planned. “The Cancer Bill is already before the committee of health. It will be their priority in the next parliament,”he said.

With 60% of new cancer cases caused by infections, immunisation programmes will be key to cutting new cases. Cervical cancer, associated with infection with the HPV virus, is the single biggest cause of cancer death among women, with Kaposi sarcoma, associated with HIV infection, and liver cancer, associated with hepatitis also major killers.

Anthony Mbonye, the commissioner for community health services at Uganda’s Health Ministry, spoke of the government’s commitment to vaccination programmes. “Human Papilloma Virus (HPV) vaccination against cancer of the cervix is now available across the country and girls aged 10 years can access it in all our health facilities,” he said, adding that the Hepatitis B vaccine is now part of the routine childhood immunisations, and vaccination is also available for adults in high-burden districts, and will soon be available across the country.

As an autonomous agency, the Uganda Cancer Institute will be a corporate body governed by a Board of Directors. The Bill spells out that the Institute will undertake and coordinate the prevention and treatment of cancers in Uganda, including providing comprehensive medical care services to patients affected with cancer and other cancer-related diseases, and coordinating cancer-related activities both within and outside Uganda.

The Bill also provides for the Institute to conduct on-the-job training in oncology and related fields for its staff as well as to provide public education and training on cancer.

Importantly it includes provisions for funding the Institute and its work.

Orem hopes this will be an important step to establishing a truly national cancer service. “We want every cancer patient to be diagnosed and followed up. We need to get their contacts so that they are always within our systems,” he said.

But his aspirations go beyond Uganda’s own borders. “The UCI,” he said, “will be the centre for training oncologists in East Africa in an effort to increase human resource in the region.

Grand opening of the new Ugandan Cancer Institute buildings May 2015

Grand opening of the new Ugandan Cancer Institute buildings May 2015

We welcome contributions to this blog. If you have a topic you would like to write about, please send your post to Corinne Hall – chall@eso.net You can find our guidelines here – How to write a blog

Smoke gets in your eyes

Simon Crompton

Simon Crompton

The title of Europa Donna’s annual London symposium last week was “New directions in breast cancer”. By the end of the evening, possible new directions were clear, but the route to take was not.

One of the two speakers was Daniel Leff, a cancer surgeon from Imperial College London, who addressed the difficulties of defining the correct margins when surgically removing breast cancer. The object had to be, he said, reducing the chances of reoperation.

He tantalised the audience with the question: “Can surgical smoke be informative?”

Potential of spectrometer analysis

Researchers at Imperial have used mass spectrometers to analyse the smoke arising from tissue incision with electrosurgical knives – a technique known as Rapid Evaporative Ionisation Mass Spectrometry (REIMS). Different types of cell produce different chemical concentrations when burned, so the chemical profile can indicate whether the tissue being cut is cancerous or not.

Identification of cancerous tissue using the technique during surgery, said Leff, was 93% accurate.

It’s a truly impressive technological development, that has potential to radically reduce reoperation rates for breast cancer.

The cost question

But how much did the machinery cost, asked a member of the audience? Half a million pounds, answered Leff. And how much did a pathologist cost? The answer was not given, but the point was made…

Pathologists already have advanced (and cheaper) techniques which can accurately indicate to surgeons which areas are cancerous and which are not. The question, said audience members, was why they were not being used. Leff himself acknowledged that pathology analysis using frozen section and touch imprint cytology were highly effective ways of determining the extent of breast disease and reducing the need for re-excision. But they are not widely used in the UK.

Novelty intoxication

On the systemic therapy side, Stephen Johnston, Professor of Breast Cancer Medicine at the Royal Marsden Hospital, spoke of the real promise of the drug Palbociclib as a first-line treatment for ER-positive breast cancer, and (in combination with Fulvestrant) as a second-line treatment as well. The cost of Palbociclib? Around £90,000 for one year’s treatment. The pressing question of how such expensive drugs are to be made widely available was raised, but not addressed.

New directions in breast cancer are exciting, involving, often inspiring. But we know how easy it is to become intoxicated with novelty and infatuated with technology. Sometimes, it isn’t new directions we need to hear about, but what is already here but under-utilised – and how we can best use what is proven, affordable and practicable to benefit the greatest number of women possible, as soon as possible.

Europa Donna, the European Breast Cancer Coalition, has a Facebook page.

 

 

 

 

 

The price isn’t right, but neither is the effect

Marc Beishon

Marc Beishon

 

Concern about the high prices of cancer drugs is nothing new but there are signs now that the issue may be coming to a head. There is a flood of new agents coming onto the market and, if anything, the prices charged are still going up, with more agents reaching eye-watering levels above $100,000 a year. Global annual spending on cancer drugs has now hit $100 billion for the first time.

At the upcoming European Cancer Congress, a study by a UK pharmacologist on how much it costs to make cancer drugs such as imatinib (Glivec) will reveal that Americans in particular are paying hugely more than the manufacturing cost, but Western European prices are also high.

Just a few weeks ago, a group of more than 100 senior oncologists, mostly in the US, launched a ‘grassroots’ petition calling on the powers that be in America to address the harm that high drug prices cause patients. Writing in Mayo Clinical Proceedings, the oncologists says the average price of new cancer drugs in the US increased 5- to 10-fold over 15 years, to more than $100,000 a year in 2012 and the cost of drugs for each additional year lived (after adjusting for inflation) has increased from $54,000 in 1995 to $207,000 in 2013.

Of course, the US has particular conditions that determine drug prices – its Medicare system for older people is not allowed to negotiate prices, and the lack of a universal healthcare system means many patients are faced with huge ‘co-pays’ on drugs through their private insurers. As the Mayo article says: “For a patient with cancer who needs one cancer drug that costs $120,000 per year, the out-of-pocket expenses could be as high as $25,000 to $30,000.” In calling for people to sign the petition, the oncologists say: “The individuals most harmed and least engaged in these discussions are cancer patients because they are exhausting their energy, resources, and time fighting for their lives,” and note that advocacy proved successful in stimulating treatments for those affected by the AIDS epidemic.

Cancer drug prices are of great concern elsewhere, of course. In European hospitals and healthcare systems the pressure on budgets for new drugs is great. In the UK, for instance, there are endless arguments over reimbursement for new treatments. In 2011 the government resorted to setting up a special cancer drugs fund for England to pay for treatments that the National Health Service would not otherwise fund.

At European Union level, there are a string of initiatives, such as the new European Commission expert group on Safe and Timely Access to Medicines for Patients (STAMP), which in turn is hearing updates on various projects such as the European network for Health Technology Assessment, and the network of Competent Authorities on Pricing and Reimbursement. But joint negotiation of pricing among countries, which could lower cost, is not in the Commission’s remit, although there is a joint procurement agreement for vaccines and other “medical countermeasures”. There is though a move by Belgium and the Netherlands to engage in joint drug price negotiation, initially for orphan drugs, where small patient numbers can mean high prices, and which will also involve cooperation on registries and evaluation.

The US oncologists propose a number of actions that could help, including price negotiation, allowing drug imports, faster access to generics, a reform of the patent system, and perhaps most importantly, taking steps to include both the cost and efficacy of drugs in assessments of treatment value and in guidelines. In fact, England already has what many countries, notably the US, lack – a body that recommends reimbursement only for treatments that meets value for money criteria, namely the National Institute for Health and Care Excellence (NICE), which uses QALYs (quality adjusted life years). But the hasty establishment of the cancer drugs fund shows that the pressure to access treatments beyond NICE’s recommendations (and the NHS budget) is great, as stories about patients denied drugs flood the media.

The high price of cancer drugs would of course be less of a problem if they were more effective, but breakthroughs have been the exception not the rule. As Fatima Cardoso, co-chair of the Advanced Breast Cancer conference, has recently commented in Cancer World: “In early breast cancer the standards of care haven’t changed in more than two decades; in advanced disease median overall survival is still a dismal two to three years.”

Certainly, more can be done to add to measures of drug effectiveness. This year, the European Society of Medical Oncology introduced the first version of the Magnitude of Clinical Benefit Scale (MCBS), which grades therapies with both curative intent and palliative intent, and which its developers say is a validated tool that can be used to prioritise drugs for assessment and develop clinical guidelines founded on magnitude of benefit rather than just level of evidence. A quick check on several grade 4 (out of 5) palliative drugs in the MCBS shows they are also recommended by NICE, so there may be some duplication here, initially, although at least one with a grade 5 score, the breast cancer drug Kadcyla, was turned down by NICE owing to its very high price and is now one of several drugs cut from the NHS cancer drugs fund.

Meanwhile in the US, the American Society of Clinical Oncology (ASCO) has just launched a framework for assessing the value of new cancer therapies “based on treatment benefits, toxicities and costs”. Developed by ASCO’s Value in Cancer Care Task Force, this aims to be a “user friendly” tool that oncologists can use with patients to discuss the value of new treatments compared with standard ones, and has been out for consultation. A paper in JAMA Oncology has also looked at how applying a value-based cost can work in a drug used in metastatic lung cancer, but political forces in the US are hard to influence along these lines.

Along with efforts to pin down cost-effectiveness and to carry out more meaningful clinical trials, Cardoso says a priority is to ensure that each patient is treated according to current knowledge and guidelines, which is often not the case. And in England, Karl Claxton, an economics professor specialising in health technology, has published research that calls into question the cost-effectiveness threshold that NICE uses – saying that it is in fact too high. His study made the news, as the implication is that some money spent on cancer drugs, and particularly the drugs funded by the special fund, would be more effectively deployed across the health system, both on standard cancer care and other health conditions.

The UK’s NHS has had long battles with drug companies over price but drugs are also rejected because of lack of effect. Were the US to take similar steps to agree on what constitutes an effective new therapy then there could be a move towards more meaningful drug development as well as lower prices for patients. As the authors of the ESMO MCBS paper also say: “A key challenge for the future will be to establish whether there can be harmonisation between the different approaches to value in Europe and the US.”

 

 

 

I will survive… Are you positive about that?

Peter McIntyre

Peter McIntyre

Is a positive attitude about survival useful or appropriate when someone is diagnosed with cancer? Is optimism always an asset as an approach to life, or indeed death?

We all love positive energy and celebrate someone who triumphs against the odds, but for many that is not possible. Cancer can be relentless and pitiless; half of those diagnosed with this disease die from it, irrespective of their determination to fight.

A daunting number of friends and relatives have recently died from cancer; more or less within a year of diagnosis. Their own and family reactions will be familiar to you who work in the field. They staggered under the news. Then hopes rose as they learnt about possible treatments. During a period of maximum engagement, they did their best as patient or supporter to reach the distant shore of survival.

In my unscientific sample however, the undertow proved too strong.

As treatments failed, the patient became exhausted; options narrowed, hope became fragmented. The narrative switched to unlikely new treatments, and eventually a need for some breathing space and a bit more time. The final stages were rapid.

Where do you find resilience?

I am wondering what those of you who apply your skills and knowledge to saving life tell yourselves about those you cannot save. Where do you find resilience you need for the next patient?

It is evident that a positive approach to cancer is not always about winning a battle. Sometimes a cure is simply out of reach. In such cases, treatment and care to achieve the best possible quality of life, delivered with compassion, cannot be ‘failure’.

Certainly, the people I know found real positives in loving human interaction after curative treatment ended.

A cousin who put a premium on his independence experienced a remarkable strengthening of his marriage and family life in his final year.

A relative who died leaving a son under the age of two spent her final days surrounded by love. She and her husband made plans for their son after her death; her father read to her; her brother crossed the world to be with her.

A man in the final days of life asked for a latte and Danish pastry to be brought to his bedside. He and his sister responded with almost ridiculous pleasure to this familiar treat he could neither eat nor drink.

As a journalist, I am aware of my own ignorance. But even the most skilled and knowledgeable lack the power of life and death or the gift of prophecy. Neither cutting edge treatment nor a positive approach guarantees survival.

At a certain stage, a determination by the patient to make the most of remaining life and by professionals and family to deliver treatment and care with compassion offers a route to the happiest possible ending. Better to help the patient to be ready for anything, than to stake all on what may prove to be a false positive.