RINECKER PROTON THERAPY CENTER STATUS REPORT: NINTH MONTH OF CLINICAL OPERATION, DEZEMBER ‘09
END OF YEAR REPORT ON THE OPERATION OF THE RINECKER PROTON THERAPY CENTER IN MUNICH
2009 - our first year
From a medical perspective, the facility delivered what we promised you and what the manufacturers promised us. Even if accusations could be made about self-interest, I do not shy away from stating that the RPTC is currently the best, most precise and benign cancer radiotherapy facility in the world.
We are at present still in a part-time operational phase (alternating with the manufacturer) using only the first 2 out of a total of 5 treatment units, which are already put into clinical operation. Despite these continued operational limitations, the facility to date has already delivered proton radiation to 30 different types of cancer and localisations. 269 patients from 19 nations have by now completed therapy or are currently undergoing therapy.
The RPTC remains the only facility in the whole of Europe able to implement the application of the best form of ion therapy for cancer – i.e. proton scanning of all localisations where irradiable cancer is found - and without having to recourse to studies and experiments.
We want to keep on being the best and will continue working towards that in 2010.
Our plans for 2010
We had expected a slow inflow of patients from the time of the operational start-up of our first treatment unit in March. But the intake was overwhelming, the number of inquiries far exceeded our therapy capacity – and in the beginning even our ability to medically process the inquiries promptly was outpaced. As a consequence the RPTC decided to limit its press relations activities to a minimum and keep a low profile. Alongside the technical work, which for its part led to a doubling of capacity this year with the operational start-up of the second treatment unit, we have made great efforts (at great expense to be quite honest) to accelerate the processing of inquiries. We have only recently reached a stage where we are able to guarantee that this task can be completed with only minor delays. We will continue to work on this issue in 2010. We are seeking to have every inquiry medically appraised within one week, so that those patients we are unable to treat, be it due to the unsuitability of the clinical picture or because of our still limited therapy capacity, can at least be informed of this fact as soon as possible. We know that we have to apologize for deficiencies arising in this respect in the past. We will do everything to ensure that our organization will in future be better able to respond to the high demand.
Improved admission of all patients with compulsory health insurance
With regard to proton-scanning cancer therapy, the statutory health insurance funds in Germany fall into 3 dissimilarly sized categories. At the forefront is AOK-Landesverband Bayern, which was the first statutory health insurance fund to conclude treatment contracts with RPTC on behalf of its patients. This AOK also acts as the clearing center for patients from other German AOKs, as well as for EU patients with compulsory health insurance able to benefit from the EU-wide agreement on statutory health insurance funds. The form of contract introduced by AOK Bayern has been adopted by many other statutory health insurance funds which have consequently entered into similarly worded agreements with us.
The second category are those health insurance funds, which even though they have not yet concluded contracts with us, are very unbureaucratic and (so important for cancer patients) are willing to quickly enter with us into cost transfer agreements for individual patients.
However, there is another third category containing various statutory health insurance funds that operate a complicated approval policy incorporating the "Medical Review Board of the Statutory Health Insurance Funds" (or abbreviated in German as MDKs). The resulting delays are sometimes so long as to be unacceptable for patients with rapidly growing carcinomas. It should also be noted that indications for proton therapy can only be issued by radiology specialists, who (in the opinion of the legislators at least) should be trained and certified as having special technical expertise in proton therapy.
Perhaps that is also one reason why the Federal Government has again modified the complicated German Social Insurance Code V, Section 116b in April 2007. While the old two-page contracts between us and the funds remain valid as before, the contractual solutions still required in respect of the other medical funds will, as of now, be replaced by administrative regulations issued by the Bundesländer (federal lands). In this regard Bavaria has also included our affiliated CHIRURGISCHE KLINIK DR. RINECKER into the state's hospital plan for radiooncology. Consequently we provide in-patient treatment to compulsory insured patients by applying proton scanning therapy. The new regulation constitutes a radical simplification of the system for out-patient radiotherapy cases (i.e. the majority of patients) in that the RPTC is actually not required to conclude an agreement with each of the approximately 180 statutory health insurance funds in Germany, even where these often remote and sometimes small hospitals only very seldom come into contact with us. The extension of the current in-patient approval by the Government of Bavaria to include out-patient cases is purely an administrative formality, but one which is quite laborious given the extremely complicated legislation that has accumulated to downright historic proportions. So this simplification of patient admissions has been tangled up for months (to the detriment of some patients) in bureaucratic machinations. We now regard it as one of our tasks in 2010 to remove these complications as soon as possible in the interests of all compulsory insured patients.
Increase of staff numbers
We provide a modern workplace with good salaries. By what appears most important to me: we are creating the future for the technical and medical development of cancer radiotherapy.
The legislators in Germany have stipulated that radiotherapists and medical physicists may only deploy proton therapy if they have acquired a "specialist proton certificate". This specialist certificate (without that many nevertheless believe, to be able to judge over proton therapy) can currently only be obtained in Germany from ourselves and in the Heidelberg Ion Therapy Center which is just now commencing operations (in Berlin proton therapy is being applied to eyes only). This means that by the same token we can only increase our staff numbers gradually as the operational start-up of our other treatment units progresses. We are doing our best to ensure that these processes run hand-in-hand with one another.
Completion of the operational start-up
The facility is currently operating with two of the four identical full-body treatment units (gantries). Numbers three and four are mechanically ready, they are taking the accelerated protons from the common radiation source and can already target irradiation and they have successfully passed the initial government-prescribed safety tests. They are currently in the calibration and quality assurance phase, termed "validation" by the manufacturer. This takes time. Consider for a moment that these gantries can irradiate from a 360° angle, for a large volume tumor they can affix up to 10,000 individual irradiation points – and so it is possible to verify this high number of points from every direction for the purposes of quality assurance.
The mechanical elements and the software of the facility (see below for more details) are set up to deliver irradiation with a precision better than +/- one millimeter. A wildly incredible level of performance for the lay man when you consider that the proton beam coming from the radiation source runs up to 92 metres to the farthest gantry. And all that purely by using magnetic control within a vacuum, without any contact or template. This is the only way that the radiation intensity can be maintained and the patient prevented from being exposed to the irradiation of harmful neutrons scattered as a result of the collision of matter – one of the benefits of the scanning system. But every patient who will undergo radiotherapy on one of the newly operational gantries will want to be sure that the optimum and repeatedly high quality of the tumor irradiation is guaranteed.
These quality assurance calibrations for the other two gantries (identical to the two already in operation) are currently on schedule. With completion scheduled for the end of February and June respectively, we are predicting that the capacity increases so urgently required will become available during March and July 2010.
Treatment unit for eyes and small tumors
In Germany, cancer of the eyes (usually melanomas) is already being irradiated with protons in Berlin. This was the reason that we decided to make our last step the clinical operational start-up for the eye and very small head area tumors. This unit is technically less sophisticated than the large gantries, which can irradiate with proton energies of up to 250 MeV and so reach particle speeds of up to 180,000 km/s enabling penetration depths of up to 38 cm anywhere in the body. What is simple with this last therapy unit is balanced however by its even more complex targeting system for eyes. This should render redundant the current improvisations employed during targeting (what is in effect manual positioning of small metal plates behind the eyeball in the area around the tumor) to the benefit of what is ultimately a more accurate and (as stipulated) documentable target system. This new targeting system will be a combination of magnetic resonance imaging and computed tomography in the eye region in order to ensure demonstrably optimum precision in this area. We are developing this in partnership with the manufacturer, Varian.
Post-operative irradiation for breast cancer
Medical progress has fortunately allowed to largely depart from the previous practice of undertaking mastectomies where breast cancer was diagnosed, in favour now of the surgical removal of tumors combined with post-irradiation. Radiotherapy using x-rays is effective as currently practiced. But the symmetry of both localisations, left and right breast, means one can precisely analyse late effects of x-ray by comparing left and right. This shows a higher probability for the occurrence of lung cancer (bronchial carcinomas) on the side of the treated breast as a long term consequence. There is also an increased frequency of coronary artery calcification and heart attacks which again is a long term consequence of irradiation for treatment applied to the left breast, which is due to the asymmetrical position of the heart.
It is hoped internationally that the improved accuracy and localised preservation offered by proton radiotherapy can reduce these side effects. Theoretically this is possible – protons enable better targeting, but must be aimed better! And in practice this is usually quite difficult not just because of the high mobility of the breast but also that of the skin over the whole chest area. All the more so if the lymph nodes are at the same time being irradiated in the direction of the armpit area along with the former tumor bed.
Our future plan is to irradiate patients lying face-down with the breast hanging free - our 360° gantries enable this. This current problem that we will be continuing to work on in 2010 is the immobilisation. Our plan is to use surface profile comparisons to correct the positions three-dimensionally with the assistance of lasers that they remain sufficiently identical from diagnosis to irradiation to the next irradiation. We are working on this.
My staff, physicians, medical physicists and physicists are thrilled with this superb therapeutic instrument - our proton scanning facility. They would not swap places with anyone else. They are all extremely motivated about using this instrument to enable us to stay ahead of the competition.
This is where the idea of "hyper-precision irradiation" came up. The mechanical aspects, quality control and the software of the facility are set up to control the beam three-dimensionally with levels of precision equal to or better than +/- one millimetre. This means, for example, that the 150-tonne gantries, which are able to rotate 360°, can always hit what is called an isocenter, the center of the irradiation point, with millimeter precision. That means extremely precise welding (by an Ochsenfurt-based company) of these 150-tonne steel machines; that means keeping the four devices in three-storey, fully acclimatized rooms to prevent any distortion whatsoever through warming up. But that also means the complete equalization of tiny measured deviations in the range of 0,7 mm during turning. This is performed with the assistance of control software in which the exact locations of these deviations are programmed.
This also means the deployment of a special high-precision x-ray positioning system for the patient table and therefore for the patient too, a system based on our own proprietary patent which the equipment manufacturer Varian now uses as a production standard.
As a physician I was nevertheless surprised when my physicists presented diagrams to me that established the basis for an increase of precision upwards of 0.25 mm for the beam centre-point. Why? We are not even able to determine the organ and tumor positions this precisely, even though the target computer tomographs we use were especially improved for this purpose. But it may be the case, say our medical physicists and physicists, that an error in the organ position is additive to the sub-millimetre deviations. If it is technically possible, why not try for the best?
As you see we have plenty to work on within 2010.
Here's wishing you all the best and a very successful 2010 to ourselves.
Hans Rinecker MD, PhD
Chairman of the Supervisory Board