RINECKER PROTON THERAPY CENTER STATUS REPORT: SECOND MONTH OF CLINICAL OPERATION, MAY ´09
Case Report: A life-saving treatment attempt with a high-tech proton radiotherapy method at RPTC in the case of recurrent bile duct carcinoma after partial surgical hepatectomy. Despite chemotherapy, the tumour once again increased to a size of 8 x 6 x 4 cm. Chemotherapy was discontinued due to ineffectiveness and overly significant adverse effects. The patient came to us in April 2009 with tumour recurrence in the liver (see CT scan).
Elsewhere, he had been excluded from treatment due to the location and size of the tumour: the dimensions did not allow for any surgical procedures. The size of the tumour also ruled out other methods, such as catheter embolisations etc. Conventional radiation therapy was rejected, since the scatter of x-ray radiation (see first monthly report: Liver Radiation Planning) would have destroyed the remaining healthy liver tissue. The patient, a physician, referred himself in early April 2009 based on information from the Internet.
Only the high degree of accuracy and effectiveness of the equipment installed in the RPTC enabled treatment which the patient tolerated very well (see comparative target planning):
As compared to x-ray radiation, protons reduce the scatter radiation in the vital, healthy remaining liver tissue to be preserved. All in all, the dose in healthy tissue decreased by a factor of 2.4.
The proton scanning method at RPTC avoids the excessive anterior dose typical in the case of older scattering proton beam equipment as much as possible (since with that method, only the posterior margin of the tumour was actually conformally radiated). This patient could no longer tolerate such an excessive dose spread.
The displacement of the liver of up to +/- 1.5 cm that occurs during spontaneous respiration would have required the target area to be expanded, which the liver tissue, in this extreme case, could no longer have been expected to tolerate. Therefore, we administered the radiation treatment under general intubation anaesthesia under oxygen insufflations in apnea in order to avoid unnecessarily enlarging the area to be radiated.
A world’s first! The anaesthetist Dr. M. Eckermann (team photo) discusses this: “In the past, we tried to compensate for respiratory movements by radiating the patient only in the intervals between individual breaths. However, this increases the radiation time, prevents the legally required target area documentation or makes it more difficult, and requires the patient to breathe absolutely calmly and evenly, which hardly ever happens in practice, given the stress of treatment. The RPTC technique with the patented, rapid targeting method in patient positioning (see first monthly report) is very advantageous for our method, because together with the intensive and thus brief radiation, the apnea is limited to a measured 60 to 120 seconds. In addition, reduction in the number of radiation sessions made possible by proton scanning naturally reduces the amount of anaesthesia required. This is harmless to the patient since, due to the painlessness of the radiation, it is similar to a deep sleep that is used in the case of many patients in a critical state for healing. Since the intubated and relaxed patient is insufflated with oxygen, there is, as expected, no oxygen deficiency. The lack of expiration leads to only a slight increase in carbon dioxide during these brief periods of time; this is completely harmless. The continually maintained airway pressure during diagnostics and radiation leads to accuracy of the target position which itself is positively striking to us: with our method, we were able to precisely align the liver and the tumour on an average of +/- 1 mm. The result of this individual case still requires statistical backup; however, we see an excellent opportunity here for also treating bronchial carcinoma (lung cancer) without unnecessary damage to surrounding tissues.”
The radio-oncologist Prof. Dr. Herbst, the medical director of the RPTC (team photo) summarises the therapeutic outcome: “The high-tech procedure available to us allowed a treatment attempt for the benefit of a patient who had no other options which, to my knowledge, had never been performed in that way before, nor would be possible elsewhere. Despite the extremely large tumour, we achieved a tolerable radiation plan for the healthy liver and the patient (see radiation diagram). “I’m convinced that this method will prove its value very well and namely in all cases of tumours affected by respiratory movements, which is precisely the case with liver and especially lung tumours. I think that, in the future, the method will be chosen for all radiation facilities which have the equipment for it, thus protons, scanning systems and our online precision targeting system”.
Patient enquiries, waiting list and developing the treatment capacity at the RPTC. The number of patient enquiries at the Call Centre (tel.: +49 (0) 89/ 660 680) reached 2068 within the first eight weeks of operation.
Unfortunately, our initially limited capacity allowed for only 224 treatment requests to be handled individually so far. The lead times were quite long for those legally compulsory patients referred by their insurers (see below) to the medical service of the respective insurance company. ProHealth administrator Dipl.-Wirt.-Ing. N. Adler (photo) explains: “The occasional referral to the medical service of the statutory health insurance unfortunately still leads to delays which might be tolerable in the case of slow growing tumours, such as prostate carcinomas, but are not acceptable in the case of rapidly growing types of cancer, such as lung cancer”. We have to get through a learning curve here: any patient who urgently needs treatment should not be excluded due to administrative delays“.
One bottleneck in RPTC’s treatment capacity in the first eight weeks turned out to be the amount of work needed for individual treatment planning. The individual dose plans are drawn up according to the radio-oncologists’ specifications by specialised medical physicists with technical qualifications in proton therapy, based on CT scans on which the dimensions of the tumours have been marked by the physician. “We can develop radiation plans relatively quickly for prostate carcinomas, for example – thus standard cases in which the geometric proportions are always similar”, says the lead medical physicist at RPTC, Dipl.-Phys. M. Mayr (photo), “in the past, a lot of time was needed for more complex plans for radiating liver or pelvic tumours, for example, since many manual optimisations had to be performed. Improved, faster, and simply more practical XiO software from the Elekta company was not online until the third week of May. We hope to be able to use the first radiation site much more often with this“.
“We will then be able to increase capacity at the first radiation site from 5 patients per day currently to 8 initially, including complex cases“, says Dipl.-Phys. Dr. Jörg Hauffe (photo), the CEO of PROHEALTH AG. “While the actual radiation times have already become very short and correspond to our planning, we now perform multiple tests prior to our day’s work which aid first and foremost in data acquisition. However, this will be finished in the near future”. The second gantry, which is currently in the set-up and calibration phase, is to be fully operational at the end of July, according to the manufacturer Varian. Then the work time at the facility will still be divided between clinical operations and remaining facility finalisation.
New Insurance Agreement. In regard to compulsory health insurance, there had previously been contracts with AOK, Landesverband Bayern. As with all treatments at AOK’s expense, it is mandatory that patients from other AOK state associations go through a regional transfer procedure with regard to the Bavarian AOK. In addition, we have agreements with company health insurance agencies and also with the Bavarian state association in this case. The patient must enquire if his/her company health insurance is a member. In addition, the state association of the Landwirtschaftlichen Krankenkassen und Pflegekassen Bayerns (LdL/LdLP) and the insurance association responsible for so-called “mini jobs” have a contractual relationship with us. The Techniker Krankenkasse (TKK) and the Innungskrankenkasse (IKK) which has merged with it have been newly added, likewise the Landesverband Bayern.
The prevailing social insurance code was changed, as it already happened often. In the future, the responsible committee of the respective federal state decides which contracts shall be newly drafted between compulsory health insurance schemes and clinics such as ours. This procedure applies to the RPTC but has not yet taken effect in the regulatory statutes.
Postoperative Radiation of Breast Carcinomas. The federal organisation for limiting financial expenses of treatment for legally insured patients, the so-called Gemeinsame Bundesausschuss der Krankenkassen und Ärzte (GBA) (Federal Joint Committee of Insurance Companies and Physicians), has recently barred reimbursements for postoperative radiation of breast cancer patients, for economic reasons. The enormous advantage for women with regard to replacing mastectomy with removal only of the tumour and subsequent radiation of the breast has been clouded by older as well as more recent statistics (see references on this point) that subsequent radiation with x-rays has adverse effects. For example, women whose left breast (near the heart) have undergone subsequent radiation more often suffer heart attacks due to coronary sclerosis caused by the scatter of x-ray radiation within the heart. This can theoretically be avoided with protons. The Federal Ministry of Health brought legal action against the GBA on the side of the developer of proton radiation but lost at third instance. The trial was lost only because of formal legal reasons: the Federal Social Court wished to uphold the GBA’s self-determination; breast cancer treatment became subject to a political power-play.
The GBA’s rationale was the lack of statistics for postoperative proton radiation for breast cancer. Therefore, once again, out of economic interests, and without any scientific rationale, it is also insinuated that x-ray and proton doses could mysteriously deviate from proven, well-known dose effect curves for these radiations.
The opinion will change with time: Proton radiation of the female breast previously showed the problem that protons not only can be used for precise targeting but also must be precisely targeted. They must be targeted in the soft tissue areas of the post-surgical breast as well as in the area of the bony skeleton. The significant movement of the skin in the area of the ribcage and the movement of the breast itself had previously impeded this necessary precision. PROHEALTH AG is working to solve this problem: “We are currently considering radiating women post-surgery in the prone position from below. The moveable radiation equipment in the RPTC permits this. The problem involves placing the patient in a position that can be precisely reproduced each time”, says the project director, Dr. Ilona Funke, from Dr. Rinecker’s surgical clinic (photo); “we are working on combining the recently launched laser surface scanner for position control with the positioning devices of the radiation equipment. I’m optimistic that we’ll be successful in this in the near future”. This method thus represents an advancement of the precision targeting method already regularly implemented at RPTC, the so-called IGRT (Image Guided Radio Therapy).
University Collaboration. In order to facilitate university collaboration, discussions have been taking place for several months with the Ludwig Maximilian University. PROHEALTH AG has offered the university to treat fortunately rare paediatric tumours requiring radiation treatment on a case-by-case basis in the RPTC. Throughout the world, the predominant scientific opinion has formed to prefer protons for children over x-ray therapy, due to the adverse effects. In the case of radiating tumours in children, it is imperative to reduce the even more serious risk of secondary tumour development in the area of the scattered radiation.
Report Bayerisches Fernsehen [Bavarian TV Station]. Click on the Rundschau Magazin report on the RPTC dated 07 May 2009.