Project summary

BHTC: A Feasibility Study

Introduction

What are the advantages of Hadron Therapy (HT)?

The term hadron points to the use of atomic nuclei. In HT-practice protons and carbon nuclei are the most commonly used hadrons. They can be accelerated at energy levels suitable for use as a radiotherapy beam.

Compared to the standard radiotherapy, in which the X-ray beams are composed of photons, HT has two clear advantages. First hadron beams allow very accurate dose deposition on the tumour, with a minimum of radioactive dose on healthy tissue. Moreover hadron beams composed of carbon nuclei, have the additional second advantage of a substantially higher Relative Biological Effectiveness (RBE) on tumour cells. Both advantages have been clearly demonstrated in the past, and predict very promising developments in HT.

What is the purpose of this study?

The radiotherapy specialists of all 7 University Hospitals in Belgium – each of them member of the Belgian Hadron Therapy Centre Foundation - are convinced, that there is sufficient scientific evidence to demonstrate the need of at least one Belgian Hadron Therapy Centre for our population of 10 million people.

They want to be given the opportunity and the resources to provide evidence for this need by executing a study on the eligible patients as a first part of a comprehensive feasibility study for such a HT centre.

What would be the purpose of a HT centre in Belgium?

The Belgian University Hospitals propose that the objective of a HT centre would be restricted to perform clinical and translational research at the start of its exploitations and, as evidence is gathered and exploitation allows the treatment of larger patient numbers, it would increasingly progress to a treatment centre that assures cost break-even with the treatment reimbursement income.

This centre should be designed for both proton and carbon ion beam delivery, a position to re-assess with the outcome of this first study.

On the necessity and suitability of Randomised Clinical Trials (RCT)

Because of practical and ethical constraints there are very few RCT reports available from the existing hadron therapy centres worldwide, to demonstrate the medical evidence of their superior treatment.

The international society of radiotherapists is convinced that RCT cannot and should not remain the only methodology to clinically assess the need of HT. There are other more appropriate, and at the same time scientifically and statistically robust methods, of estimating the potential of the eligible indications for HT.

What are the eligible indications to be studied for a HT centre?

There exists a group of generally accepted historical indications. In Belgium this group was estimated by KCE at some 50 to 100 patients per year. RIZIV / INAMI decided 2 years ago to pay their treatment in HT centres abroad. Practice however is that these possibilities are more theoretical than feasible. Less than a handful of patients could be treated during the past 2 years, sometimes at extremely high costs. One paediatric patient was treated in the USA at a cost of well over 350.000 €, the costs at the accompanying Belgian university hospital not taken into account.

Since this shortage of treatment possibilities is not going to get better in the next decades, we have the moral duty to raise the question whether we want to continue to deprive patients from the appropriate therapy. Today we are in the best case financing research abroad, or in the worst case spending public money for commercial goals.

A far larger group of patients, estimated at 1500 to 5000 per year for a population of 10 million people, would greatly benefit from HT. This group is growing steadily as new results emerge from the operational HT centres worldwide. Today it consists of:

  • Patients for whom the decreased dose of radiation of healthy tissue using HT should drastically improve their life quality by avoiding side effects in these tissues.
  • Another subgroup corresponds to the tumours for which the present best treatments do not allow to administer the required radiation dose, because of sensitive tissues in the vicinity of the tumour.
  • Very radio-resistant tumours make up another subgroup. In their case the required radiation dose on the tumour is much too large and would inadmissibly endanger all tissue in the radiation path.
  • Also the case of paediatric patients is an almost obvious case, because of the very high sensitivity to side effects, to impaired growth and development and to secondary induced tumours in the healthy tissue of younger people.

On methods for assessing HT treatment

More profound knowledge in assessing the advantages of HT therapy could have been extracted from literature than the 2007 KCE study concluded with. It should not surprise either that since then very interesting new publications have appeared or others are expected to appear in short, bringing new exciting information on the benefits and the needs of HT.

Most important however is the facts that when one does not restrict oneself to the most obvious and direct clinical data, the potentials of HT do dramatically expand. This means that all data (in clinical jargon also the data of “phase I and phase II clinical studies”, “case-based studies” as well as “in-silico studies”) should be used to their full extent whenever they permit to study the comparative effects of HT and standard best practice radiotherapy.

These effects can be expressed in terms of dose distribution in both cancerous and healthy tissues, of biological effects in these tissues, in patient response to them and in epidemiological feedback. A large toolbox for modelling physical, biological and clinical trials is available for the purpose of consolidating this data and should now be fully deployed for the purpose this study!

HT costs unacceptably high?

It is often argued that HT is simply too expensive because of the impressive investment costs as well as the extensive and highly schooled personnel requirements to run such a HT centre. Let it be clear that it is exactly one of the goals of this proposed study to compare the cost of HT over the life of a HT eligible cancer patient with other state of the art radiotherapies. Reputed universities and research centres have reported on their experience and almost invariably come to the conclusion that the costs for a QALY (quality adjusted life year) for HT treatments is well below today’s accepted standards for new anti-cancer targeted treatments. This study should cast a clearer light on this matter.

Final remarks

The negative perception of cancer as a fatal, non-treatable disease has greatly been eradicated in the last 4 decades. Radiotherapy has been cornerstone in this evolution by successfully implementing novel diagnostic and treatment technology as well as by optimizing comprehensive treatment modalities. Classical radiotherapy however approaches the end of this long and successful road. Further potential for marginal improvements rapidly becomes alarmingly expensive.  Society in its due right however, requires further improvement and expects cancer survivors to restore their quality of life to the pre-treatment level and to maintain it for long.

All arguments for and against HT are no less valid in France, the Netherlands, Germany, Italy and the UK or in Sweden than is the case for Belgium. These countries have decided - very often only after large scale feasibility studies - to invest in HT centres in one or another form.

Belgium cannot keep on postponing a thorough investigation in the potentials of a HT centre, simply on the grounds of lacking RCT evidence, which we know for good practical and ethical reasons will not be available in the next decades. This attitude would not only result in postponing the decision to build, but also in Belgium losing rapidly its position as a high-ranking radiotherapy country very fast. Before long patients or third parties will start claiming HT treatment, instead of health care and clinical experts keeping control, such as is already the case in some countries.

May 2013: the final report and the executive summary are available via the links: