QUARTERLY REPORT DECEMBER 2010
PD Dr. med. habil.
Chairman of the Board
2010 – Our second year
The RPTC is currently treating patients at all four of our large therapy rooms, the gantries. At the fifth therapy room, the fixed beam for ocular tumors and very small tumors in the cranial area, we are still optimizing a precise targeting system which will improve therapy for eye tumors as compared to the current state of medical technology.
All signs point to the fact that we have become the world leader in proton therapy with our high-precision, modern scanning system. This applies not only to the number of therapy rooms, but also to the number of patients currently undergoing treatment as well as to the performance of the equipment with its superior targeting system, its unsurpassed beam precision, and quality control.
Looking back over the past year
We carried out many plans. We were able to realize most, but not all, of them.
By this time, with regard to patient management, we are able to ensure immediate and detailed viewing of incoming treatment inquiries and the accompanying documents after we were able to add a sufficient number of radio-oncologists to our team. By this point, assessment for treatment eligibility at our center takes place within 3 business days. In the event of exceptions, the Call Center immediately informs the patient of the delay. During this time, we have also caught up on delays in issuing discharge summaries; initially these delays were unfortunately unavoidable. Not only does the larger number of our radio - oncologists contribute to this, but also the experience that referring oncologists are increasingly better informed with regard to the performance and the limits of the proton scanning system leading to the fact that the referrals for treatment inquiries are becoming more and more “targeted“ and we thus have to deal with fewer time-consuming and regrettable treatment rejections.
The optimized approach for all patients with statutory insurance was unfortunately not able to be fully assured yet. Those statutory health insurance companies with whom we do not have direct agreements that automate payments are, as a rule, cooperative in processing individual cost reimbursement inquiries and are very accommodating towards the patients. Unfortunately, Barmer Ersatzkasse and DAK are exceptions to this. These problems may be resolved through a ruling by the Bavarian Ministry of Health according to section 116 b of the Social Security Code V. We already discussed this a year ago. However, the Ministry, under Dr. Söder, has not yet issued any positive ruling for the state of Bavaria, in contrast to the government of Baden Württemburg; we are thus inexplicably authorized to irradiate patients in the RPTC on an inpatient basis, which is hardly necessary, but not on an outpatient basis. This in fact creates a three-tiered medical system in Bavaria: Patients with private insurance who are reimbursed, patients insured through AOK and other statutory insurance companies that have signed contracts with us who are also reimbursed, and some unfortunate remaining patients who must wait for Dr. Söder’s Section 116 b decision which is pending in the administrative workings of the Ministry. There was nothing else we could do except take this failed ruling to the Social Court which recommended mediation - and this is unfortunately still being delayed by the government. Thankfully, this only affects a few patients, but it is a tragedy nonetheless.
Forming the team has been largely completed. It is widely recognized that the RPTC, with its technology, represents the future of radiation therapy. We are in the fortunate position of being able to select the most qualified and dedicated medical-technical-radiology-assistants, medical physicists, and radiation oncologists. An inevitable problem is still the fact that there are few radio-oncologists with technical qualification in proton therapy, due to the lack of proton therapy in university teaching hospitals in Germany up to now. There are enough radiation oncologists with this type of qualification in the USA, but they are not allowed to practice here, because they cannot read the German radiation protection regulations and guidelines - according to the agency. We therefore have to train our employees ourselves in proton therapy, which is time consuming. But we are making progress.
The start-up of operations has been completed to a large extent: All four large gantries are in clinical operations. We have been able to gain much experience from the 9000 (nine thousand) individual radiation sessions performed to date on 450 patients who have completed treatment and to some extent also have undergone follow-up examinations. All experiences were entered into the improvement of the software which was very cooperatively worked out by the manufacturer Varian of Palo Alto in collaboration with us. The RPTC is still the “showcase” for the new product line from Varian, the largest manufacturer of radiation equipment worldwide. This ensures that the manufacturer continues to optimize the development of the equipment. The optimizations primarily help to make operations easier and thus increase equipment productivity after operational and patient safety already has been ensured and tested. In any case, we are enthusiastic about the reliability, performance and also the development potential of our radiation system.
The proton technology part of the treatment room for ocular and small tumors has likewise been completed. One aim is to treat the smallest tumors, e.g. near the nerves in the cranium. This area of application should cover those small tumors which can be treated even better with this thin beam, despite the higher-than-expected precision of our gantries. With the beam precision of our four gantries on the one hand, and the fixed beam on the other hand, the entire area of indications of the so-called CyberKnife using x-rays can be replaced through proton technology with its better local dose distribution. As indicated earlier, a combined tumor localization technique in the eye using CT and MRI examinations together is presently being developed, in order to advantageously replace the previously customary local approximations of the tumor position at the retina of the eye. We are continuing to work on this.
Postoperative radiation for breast cancer has unfortunately not yet been realized. Last year, we stated that the positioning technique for the highly mobile breast and skin of the chest wall has to be improved. The laser surface contour acquisition needed for this purpose was not yet able to be achieved. There is not a large market for these lasers; one of the vendors has discontinued production. We will not recommend proton therapy for this application until reproducibly reliable positioning can be provided.
We are moving much closer to the dream of ultra high-precision radiation. It is based on the very precise control of patient positioning, the so-called image-guided radiotherapy. The patented precision targeting system of our gantries according to our experience, accurately comprises these accuracy requirements. The second pillar of the ultra high-precision radiation is an extremely consistent proton beam as it is best delivered among all various radiation source designs by the cryogenic cyclotron used here. The third pillar is the correction of all position errors during beam transport and the very slight mechanical error of the gantries due to measurement of the beam online. Namely continuous - and automatic, computer-guided fine corrections with the scanning control system. This sounds very complicated. But by now, we can already guide the beam position significantly better than 1 mm. Our goal of better than 0.25 mm will be achieved.
What remains to be done in 2011
Our ongoing projects are clear:
The Bavarian tragedy of the three-tiered medical system for a small percentage of patients with statutory health insurance must be eradicated.
Our ambition is to offer superior proton radiation therapy for tumors of all conceivable sizes that can be irradiated. The targeting system of the fixed-beam therapy site will be put into service.
We hope to finally be able to achieve patient position control for irradiation of the breast.
Software optimization which is currently in progress will benefit the numbers of patients to be treated in our facility.
We have to learn to exploit the full potential of "ultra high precision radiation." The biggest problem in local cancer treatment methods - surgery and radiation - is localizing all cancer cells. The teleradiological treatment methods (that is external irradiation) always have the same problem: a percentage of tumors in the body is not fixed in position - to some degree at the stomach and the upper, mobile parts of the colon (as a rule, the small intestine does not develop carcinomas). The further limitation is that sufficient dosages cannot be administered to the tumor due to collateral damage to the surrounding tissue that also is irradiated applies much less for proton therapy than in the case of x-ray radiation. The “ultra high-precision proton scanning therapy” can now sterilize a spherical volume of tissue anywhere in the body with a minimum diameter (at the gantries) of only 10 mm. Because of this precision, the limits of treatability are generally defined in practice not by the radiation technically possible, but rather by the uncertainty of current diagnostic methods. To a certain degree, the development of the therapy has, for the first time, overshot the possibilities of cancer localization methods.
This is also the reason why we here at the RPTC are replacing our still-new equipment for positron emission tomography, the combined PET-CT, with a farther developed equipment which increases the accuracy of this isotope method (for professionals: with the additional time-off-flight analysis). This will be the best imaging method for cancer diagnostic procedures at present.
There is naturally one additional task confronting us with increasing frequency: More and more RPTC patients have to undergo follow-up examinations. These follow-up examinations are also legally stipulated: after two months initially. We are attempting to conduct these examinations or have them conducted by oncologists working together with us for those patients who live very far away (we are currently treating cancer patients from 29 countries). This is going to involve a lot of groundwork for us.
With best wishes for you and for us for a successful 2011.