INTRABEAM Experience the new flexibility in radiotherapy

Transcription

1 INTRABEAM Experience the new flexibility in radiotherapy

2 Radiotherapy with INTRABEAM Over the years, diagnostic and therapeutic interventions have developed into more patient-focused, individualized, less invasive techniques. A perfect example of this paradigm shift is the INTRABEAM system produced by Carl Zeiss. This revolution in radiotherapy comprises many advantages and affords a new dimension of flexibility. Efficient local tumour control Safety shown by clinical experience Improved patient convenience Over 10 years of clinical experience Optimized system mobility Effective internal radiation Go where the tumor is is the philosophy that impels INTRABEAM. The sterile INTRABEAM applicator can be positioned directly into the tumor bed, allocating the precise radiation dose exactly where it is needed most. Radiotherapy delivery with the INTRABEAM system stands for highly effective radiation with low doses. This approach is possible because the INTRABEAM X-ray source generates low energy X-rays characterized by high relative biological effectiveness (RBE) allowing superior tumor-cell killing. Maximum versatility in radiation oncology Using a variety of applicators, the system can be tailored to your specific needs in radiooncology: INTRABEAM has both FDA and CE approval for the radiotherapy of all solid tumors. Based on evidence from clinical studies, INTRABEAM has an impressive record of proven efficiency in a wide range of solid tumors, including breast cancer, brain tumors as well as gastrointestinal and gynecological tumors. Flexibility and cost effectiveness INTRABEAM s flexibility outperforms traditional radiotherapy systems. Low shielding requirements allow the system to operate in any location, resulting in high utilization rates. Compared to traditional external beam radiation, and most brachytherapy devices, the intraoperative treatment with INTRABEAM shortens the duration of treatment and requires less working time on the part of physicists, physicians, and technicians, resulting in superior cost effectiveness. 2

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4 Our data show that 50 kv photon radiation from INTRABEAM induce more efficient cell killing of the breast cancer cell lines tested than the same dose given with 380 kev photon radiation from a 192Ir source. Source: Wenz F, Herskind C et al. Intraoperative Radiotherapie (IORT) beim Mammakarzinom mit dem INTRABEAM Gerät. Aktueller Stand der TARGIT-Studie. Gynäkologie :

5 INTRABEAM means radiobiological accuracy Don t miss the target Precision targeting and maximum tumor control shape the design and the treatment philosophy incorporated in the INTRABEAM platform. Following tumor resection, the sterile applicator of INTRABEAM is anchored directly in the cavity after excision of the tumor to achieve the highest radiation dose exactly where it is needed most: in the tumor bed. In conventional radiation, the tumor bed is often missed because of difficulty in locating it due to postoperative changes, even with state-of-the-art imaging techniques. Surviving faction Less can be more Accelerated electrons of the INTRABEAM X-ray source strike a gold target at the tip of a 10 cm long drift tube, resulting in the emission of low-energy X-rays (50 kv) in an isotropic dose distribution. These low-energy X-rays are characterized by high relative biological effectiveness (RBE) and efficient tumor cell killing. 1, 2 Mathematical models of radiotherapy and clinical trial data show that a smaller numbers of well-targeted doses of radiotherapy can be more effective than fractionated radiotherapy of higher doses α-rays 15 MeV radiation 50 kv radiation 15 MeV neutrons increasing LET Dose [Gy] 100 colonies 10 colonies 1 colony Sparing sensitive structures The radiation emitted by INTRABEAM is characterized by a steep dose fall-off in the periphery. This effect is of twofold importance: Firstly, INTRABEAM s radiation distribution mimics the declining tumor cell density with increasing distance from the tumor margins. 4 Secondly, the rapidly attenuating dose helps to avoid irradiation of sensitive organs and healthy tissue. Consequently, INTRABEAM minimizes the damage to vital structures that can occur, even with state-of-the art external beam radiotherapy. 5 Radiotherapy on time A delay in the delivery of radiotherapy due to long waiting lists or priority of chemotherapy can degrade the treatment process. Postponements in the initiation of radiotherapy are associated with higher rates of local recurrences in many cancers. 6 Consequently, delays in starting radiotherapy should be as short as possible. With INTRABEAM, radiotherapy can be performed intraoperatively, obviating any time delay. Counteract tumor-stimulating effects of the wound fluid Wound fluid from surgical interventions can trigger cancer-cell proliferation by activating various biological processes, including the expression of growth factors and cytokines, which have a stimulating effect on tumor cells. By contrast, the fluid obtained from wounds irradiated with INTRABEAM does not stimulate cancer cells, counteracting any potentially detrimental effects. 7 5

6 Current treatment method BCS up to 6.5 weeks Whole Breast Irradiation 50 Gy / 25 fractions Tumor Bed Boost 16 Gy / 8 fractions IORT Boost Replacement (TARGIT Boost) BCS IORT 20 Gy / 1 fx up to 5 weeks One time treatment (TARGIT Definitive Dose) BCS IORT 20 Gy / 1 fx 6

7 INTRABEAM in oncologic indications INTRABEAM technology has been used successfully around the world in the treatment of solid tumors in all body areas for over a decade. The risk-adapted approach Over the last three decades, localized breast cancer therapy has led to substantial improvement for patients. Ultra-radical surgical methods have largely been replaced by a breast-conserving surgery approach. INTRABEAM allows the use of this risk-adapted strategy in radiotherapy. Advances in diagnostic imaging and the introduction of mammography screening programs in many countries have made the early diagnosis of subclinical breast cancers possible. In these scenarios, partial breast irradiation is a risk-adapted strategy if poor prognostic factors can be excluded. 9 Therapy options with INTRABEAM in breast cancer Effective single treatment in patients with good prognostic factors In patients with good prognostic factors (T1-3, N0-1, M0), INTRABEAM can completely replace external beam radiotherapy. Recent data from a multinational, randomized clinical study (TARGIT-A) prove that for selected patients with a favorable prognosis, targeted intra-operative radiotherapy (TARGIT) with INTRABEAM is equivalent to conventional external radiotherapy (Figure xy). 10 TARGIT is well tolerated, and no statistically significant difference in the total rate of side effects between TARGIT and external beam radiation was detected. Intraoperative boost with INTRABEAM saves time Boost irradiation with 16 Gy improves the therapeutic outcomes in breast cancer and is considered the standard of care in breast cancer treatment. 11 Patients who are not suitable for single intraoperative treatment INTRABEAM can nevertheless benefit when intraoperative therapy with INTRABEAM is delivered as a boost, replacing the external boost at the end of external beam radiation. Giving an intraoperative boost at the time of surgery can reduce the subsequent dose of external beam radiation required and can further help avoid deleterious effects due to the delayed initiation of radiotherapy. Study data show lower rates of recurrences when the boost is administered intraoperatively with INTRABEAM as compared to external boost application. 12 INTRABEAM helps to avoid mastectomy On pre-irradiated breast cancer patients with local recurrence, repeated external irradiation is not possible in many cases as the tissue tolerance has been exceeded. The standard therapy in this case is radical mastectomy. INTRABEAM offers the chance to preserve the breast, even in the event of local recurrence. 13, 14 Mastectomies are also performed when women from remote areas cannot stay in or travel daily to an urban medical facility for the six weeks of postoperative radiotherapy. In such cases, INTRABEAM ensures that radiation therapy can be administered, even in difficult circumstances. 7

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9 INTRABEAM with other applications More than 10 years ago INTRABEAM received both FDA and CE approval for the irradiation of solid tumors in all areas of the body. The INTRABEAM treatment flexibility results in a wide range of oncological applications in addition to breast cancer therapy. Irradiation during neurosurgical interventions, treatment of colorectal carcinomas, skin cancer or spine metastasis are performed in routine therapy and within the framework of clinical studies in a number of centers around the globe. Other applications: Cerebral metastases Spinal metastases Oral cancer Gastrointestinal cancer Endometrial cancer Skin cancer Internal Radiation Monitor Cathode Gun Accelerator Section Beam Deflector Electron Beam Gold Target Dose regimen accuracy The critical treatment parameters are constantly monitored during the entire treatment. Treatment deviations are clearly signaled on the control panel visually and or through audible indicator. The INTRABEAM system contains a complete set of instrumentation for validating dose rate and distribution. 9

10 Cerebral metastases Post-operative irradiation of brain tumors and cerebral metastases is often delayed due to wound healing problems and long patient recovery times following the operation. INTRABEAM offers a cost-efficient and immediate treatment subsequent to a stereotactic biopsy. A substantial number of studies have proven the value of INTRABEAM in the treatment of brain and cerebral tumors in both 16, 17, 18, 19, 20, 21 children and adults. Spinal metastases For the many cancer patients who develop spinal metastases in the course of their disease, percutaneous kyphoplasty and vertebroplasty are a valuable treatment option. By using intraoperative radiotherapy with INTRABEAM during kyphoplasty or vertrebroplasty, the metastasis can be sterilized and simultaneously stabilized, a process resulting in reduction of the patient s pain. It also brings back mobility, significantly enhancing the patient s quality of life. The first clinical trial experience of this approach has yielded very promising results. 15 Oral cancer Delivering a boost radiation intraoperatively with INTRABEAM has potential advantages in the treatment of oral cancers. After resection, the margins of the tumor can be sterilized immediately, which may have a positive impact on local recurrence rate. Additionally, the numerous sensitive structures in this anatomical region can be spared due to the steep fall-off of the low-energy radiation emitted by INTRABEAM. A geographical miss is unlikely since the applicator can be positioned directly in the tumor bed. First study data have convincingly demonstrated the value of this concept. 22 Gastrointestinal cancer In cancer surgery, the ultimate goal is to remove the tumor completely. However, a complete resection of the tumor is not possible in many patients, meaning that cancer cells remain present in the tumor bed or in neighboring structures. Intraoperative radiotherapy with INTRABEAM can improve local control of colorectal tumors in cases of local recurrence and local advanced tumors. 22 The value of INTRABEAM has also been demonstrated in the setting of laparoscopic hemicolectomy in patients with colon cancer and gastrectomy in patients with 24, 25 gastric cancer. 10

11 Endometrial cancer In endometrial cancer the most common malignancy of the female genital tract the use of INTRABEAM is also feasible and has some potential advantages compared to most commonly used 192Ir high-dose rate (HDR) afterloading, which is highly expensive, given the necessary source changes and the complex radiation protection requirements. By comparison, INTRABEAM can be used in non-shielded spaces with no radioisotopes involved. First clinical trial evidence has proved that it is possible to create a homogeneous cylindrical dose distribution similar to 192Ir HDR afterloading, suggesting that INTRABEAM can be used effectively in this common female cancer. 26 Skin cancer The versatility of INTRABEAM is also displayed in the treatment of skin cancer. Particularly in the treatment of non-melanoma skin cancer, irradiation is an important therapy option, primarily for patients with a high surgical risk. In a prospective study, it was shown that intraoperative radiotherapy with INTRABEAM was as effective in the management of non-melanoma skin cancer as conventional radiotherapy techniques. 27 The well-known advantages of INTRABEAM precise radiation delivery, low shielding requirements, and cost effectiveness also held true for the treatment of skin cancer. 11

12 The INTRABEAM system at a glance

13 1 INTRABEAM carrier system The carrier system combines performance with maximum reliability and flexibility. Electromagnetic couplings lock the radiation source with millimeter accuracy in the treatment position. Suitable for mobile use in any operating room. Weight: 275 kg Transportposition: 740 x 1940 x 1500 mm Nominal voltage: 100V / 115V / 230V 2 Miniature X-ray source The radiation source emits soft X-ray radiation (max. 50 kv) in isotropic distribution. The target tissue is irradiated homogeneously. Weight: 1,6 kg Dimensions: 70 x 175 x 110 mm (width x height x length) 3 Spherical applicators a complete set of spherical applicators with diameters of 1.5 to 5.0 cm allows exact adaptation to the size of the tumor bed. The applicators are sterilizable and can be reused. 4 INTRABEAM cart All INTRABEAM components are completely flexible and movable. Most components, such as the 1.6 kg light x-ray source, are stored in a storage container inside the INTRABEAM Cart. The cart and floor stand can be easily stowed away with all com ponents when not in use. With its open space on top of the cart, the system quality check can be done easily on the cart. The touch pad terminal, control console, dosimeter and everything else needed for system quality assurance and the treatment are mounted ergonomically on the cart. With 12 casters in the base, the carrier can be moved smoothly to any position in the OR. Max. load capacity: 95 kg Dimensions: 900 x 1690 x 600 mm Nominal voltage: 230 V 13

14 References Herskind C, Steil V, Tiefenbacher U et al. Radiobiologic aspects of intraoperative radiotherapy (IORT) with isotropic low-energy X-rays for early-stage breast cancer. Radiat Res 2005; 163: Marthinsen AB, Gisetstad R, Danielsen S et al. Relative biological effectiveness of photon energies used in brachytherapy and intraoperative radiotherapy techniques for two breast cancer cell lines. Acta Oncol 2010; 49(8): The START Trialists Group. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol 2008; 9: Herskind C, Griebel J, Kraus-Tiefenbacher U, Wenz F. Sphere of equivalence a novel target volume concept for intraoperative radiotherapy using low-energy x rays. Int J Radiat Oncol Biol Phys 2008; 72: Herskind C, Steil V, Kraus-Tiefenbacher U, Wenz F. Radiobiological aspects of intraoperative radiotherapy (IORT) with isotropic low-energy x rays for early-stage breast cancer. Radiat Res 2005; 163: Huang J, Barbera L, Brouwers M et al. Does delay in starting treatment affect the outcomes of radiotherapy? A systematic review. J Clin Oncol 2003; 21(3): Belletti B, Vaidya JS, D Andrea S et al. Targeted intraoperative radiotherapy impairs the stimulation of breast cancer cell proliferation and invasion caused by surgical wounding. Clin Cancer Res 2008; 14(5): Vaidya JS. Partial breast irradiation using targeted intraoperative radiotherapy (Targit). Nat Clin Pract Oncol 2007; 4(7): Vaidya JS, Tobias JS, Baum M et al. Intraoperative radiotherapy for breast cancer. Lancet Oncol 2004; 5: Vaidya JS, Joseph DJ, Tobias JS et al. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet 2010; 376: Poortmans PM, Collette L, Bartelink H et al. The addition of a boost dose on the primary tumour bed after lumpectomy in breast conserving treatment for breast cancer. A summary of the results of EORTC boost versus no boost trial. Cancer Radiother 2008; 12(6 7): Vaidya JS, Baum M, Tobias JS et al. Efficacy of Targeted Intraoperative Radiotherapy (TARGIT) boost after breast conserving surgery: Updated results. J Clin Oncol 2008; 26: 565 Kuerer HM, Arthur DW, Haffty BG. Repeat breast-conserving surgery for in-breast local breast carcinoma recurrence: The potential role of partial breast irradiation. Cancer 2004, 100: M. Keshtgar, JS Tobias JS Vaidya N. et al. Breast cancer patients treated with intra-operative radiotherapy [IORT] alone when conventional external beam radiation therapy [EBRT] was not possible. J Clin Oncol 2008; 26: Abstract Wenz F, Schneider F, Neumaier C et al. Kypho-IORT a novel approach of intraoperative radiotherapy during kyphoplasty for vertebral metastases. Radiat Oncol 2010; 5:11 Kalapurakal JA, Goldman S, Stellpflug W et al. Phase I study of intraoperative radiotherapy with photon radiosurgery system in children with recurrent brain tumors: preliminary report of first dose level (10 Gy). Int J Radiat Oncol Biol Phys 2006; 65 : Curry WT, Cosgrove GR, Hochberg FH et al. Stereotactic interstitial radiosurgery for cerebral metastases. J Neurosurg 2005; 103: Takakura K, Kubo O. Treatment of malignant brain tumors. Gan To Kagaku Ryoho 2000; 27 Suppl 2: Eljamel MS, Mosely H, Perry J et al. Intraoperative radiosurgery and tumour fluorescence guided resection is associated with long survival in glioblastomas. Poster abstract presented at the AANS annual meeting 2007, Washington DC, USA; Abstract Eljamel MS, Liaguart I, Perry J et al. Intraoperative radiotherapy using mobile miniature X-ray source in malignant brain tumors. Poster abstract presented at the AANS annual meeting 2008, Chicago, USA; Abstract Pantazis G, Trippel M, Birg W et al. Stereotactic interstitial radiosurgery with the Photon Radiosurgery System (PRS) for metastatic brain tumors: a prospective single-center clinical trial Int J Radiat Oncol Biol Phys 2009; 75(5):

15 Rutkowski T, Wygoda A, Hutnik M et al. Intraoperative radiotherapy (IORT) with low-energy photons as a boost in patients with early-stage oral cancer with the indications for postoperative radiotherapy : treatment feasibility and preliminary results. Strahlenther Onkol 2010; 86(9): Algur E, Mahadevan A, Deibel C et al. Interstitial photon radiosurgery system for re-current and locally advanced rectal cancer: a retrospective review of 24 patients. ASCO Gastrointestinal Cancers Symposium, Jan 27 29, 2005, Hollywood, Florida, USA. Abstract No 208 Lyadov KV, Yu A, Sinyakin S, Improvement of curativity of video-assisted surgery for colorectal cancer due to intra-operative contact radiotherapy using the INTRABEAM system. Poster abstract presented at the ISIORT annual meeting 2008, Madrid, Spain Lyadov KV, Krymskiy VA, Yu A et al. Evaluation of safety on intraoperative radiotherapy using the INTRABEAM system in combined treatment of gastric cancer. Poster abstract presented at the ISIORT annual meeting 2008, Madrid, Spain Schneider F, Fuchs H, Lorenz F et al. A novel device for intravaginal electronic brachytherapy. Int J Radiat Oncol Biol Phys; 74(4): Bodner WR, Hilaris BS, Alagheband M et al. Use of low-energy X-rays in the treatment of superficial non-melanomatous skin cancers. Cancer Invest 2003; 21(3): Wenz F, Welzel G, Blank E et al. Intraoperative radiotherapy as a Boost during breast-conserving surgery using low-kilovoltage x-rays: The first 5 years of experience with a novel approach. Int J Radiat Oncol Biol Phys 2010; 77: Kraus-Tiefenbacher U, Bauer L, Scheda A et al. Long-term toxicity of an intraoperative radiotherapy boost using low energy X-rays during breastconserving surgery. Int J Radiat Oncol Biol Phys 2006; 66(2):

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