Horizon Scanning Technology Briefing National Horizon Scanning Centre Helical Tomotherapy Hi-ART System for external cancer radiotherapy August 2006 This technology briefing is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes.
Helical Tomotherapy Hi-ART System for external cancer radiotherapy Target groups Patients with solid tumours which are irregular in shape, changeable in shape/size, or in locations difficult to treat by conventional methods (e.g. close to vital structures) such as in the prostate, breast, head and neck, lung, spine, and liver. Patients with recurrent tumours who have reached their maximum dose tolerance of radiation from conventional sources. Patients with multiple myeloma. Technology description Helical tomotherapy is a novel 360 radiation treatment modality that combines a helical computed tomography (CT) scanner for online imaging with a linear accelerator that delivers intensity modulated radiotherapy (IMRT). Helical tomotherapy is available using the TomoTherapy Hi-ART System. The on-board CT scanner provides image guidance and dose verification, allowing adjustments for slight, but critical, changes in the shape and position of the tumour. It is intended to be a substitute for the curative or palliative treatment of specific cancers using conventional methods. Innovation and/or advantages The novel features of the Hi-ART system are the integration of IMRT radiation delivery with CT image guidance and verification, and inverse treatment planning. It is intended to offer the following advantages over conventional radiotherapy: Faster operating times. More accurate pre-treatment localisation of the target on a daily basis (the megavoltage CT images provide greater anatomical detail). 1, 2, 3, 4, 5 More precise conformal dose coverage of the tumour, and hence the possibility of higher doses per session and shorter courses of treatment. Lower doses to adjacent critical structures, and therefore fewer adverse effects. Developer TomoTherapy Inc. Purpose Diagnosis or identification of disease Prevention e.g. immunisation, public health programme Continuous therapy e.g. dialysis, life support Service delivery changes Investigation, assessment or staging of known disease Screening programme or tests to identify latent or early disease Patient management and pathways of care Susceptibility testing for identifying risk of disease Individual treatment e.g. drug, device, procedure, radiotherapy Rehabilitation Place of use Home care e.g. home dialysis Secondary care e.g. general, nonspecialist hospital General public e.g. over the counter Community or residential care e.g. district nurses, physio Tertiary care e.g. highly specialist services or hospital Primary care e.g. used by GPs or practice nurses Emergency care e.g. paramedic services, trauma care Aug 2006 2
Stage of development and availability in EU/UK Phase III clinical trials or Pre-registration in EU (drugs) equivalent Licence or CE mark application in Licence or CE mark application in UK/EU likely within 12 months UK/EU likely within 24 months Launch or use in UK/EU likely Established product, but this is a within 24 months new indication in development CE marked Launch or use in UK/EU likely within 12 months Likely launch or marketing date, or licensing plans: Seventy machines are currently in use worldwide, mostly in North America. The first UK system has been in clinical use since May 2006 (at the Cromwell Hospital, London). NHS or Government priority area: Cancer Cardiovascular disease Children Diabetes Chronic conditions Mental health Older people Public health Renal disease Women s health None identified Relevant guidance Clinical guidance published on generic IMRT UK: National Coordinating Centre for Health Technology Assessment (NCCHTA) report on prostate cancer (2003). 6 United States: National Comprehensive Cancer Network (2005) 7 Blue Cross-Blue Shield Association (2005) 8 National Cancer Institute (2004) 9 American Association of Physicists in Medicine (2003). 10 American College of Radiology (2002) 11 Despite the fact that IMRT is already in routine clinical use in North America (treating around 30% of radiotherapy patients in the US), the consensus of these reports is that clinical evidence from randomised controlled trials is still needed to evaluate whether it is superior to conventional radiotherapy. Clinical need and burden of disease In England in 2002, the overall incidence of cancer was 227,065 cases (prostate cancer: 27,174; liver cancer: 2,312; breast cancer: 35,047; and lung cancer: 30,345). Overall cancer mortality in England was 125,629 in 2004 (prostate cancer: 8,533; liver cancer: 2,168; breast cancer: 10,348; and lung cancer: 26,453). Patients with solid tumours which are irregularly-shaped and/or close to vital structures or sensitive tissues account for around 30% of those receiving radiotherapy 12 and up to 40% including re-treatments. However, less than 1% of all UK radiotherapy patients are currently treated using advanced techniques such as IMRT. 13 Existing comparators and treatments Standard external radiotherapy: 3D conformal radiotherapy (3D-CRT). Intensity Modulated Radiotherapy (IMRT) is in phase III clinical trials in the UK (for breast, prostate, and head and neck cancers), with preliminary results expected within Aug 2006 3
12-24 months. In the United States, IMRT is already the primary therapy used for prostate, head, neck, and breast cancers. Helical tomotherapy is one form of IMRT (which uses CT imaging). However, the function of image guidance radiotherapy (IGRT), i.e. the capability for 3D crosssectional imaging available on a linear accelerator, may also be combined with other IMRT systems; currently available products are the Elekta Synergy system and the Varian On-Board imager system. The Hi-ART system offers a fully integrated IMRT/IGRT package with CT imaging. Efficacy and safety Research on the physical and dosimetric aspects suggests that helical tomotherapy may be superior to conventional radiotherapy in terms of radiation-dose distribution (including avoidance of sensitive structures) and dose-rate. 14,15,16,17 However, no full randomised clinical trials have yet been published. Trial name or code Sponsor 3D-conformal radiation vs. helical tomotherapy in prostate cancer. NCT00326638 18 Ottawa Health Research Institute Status Ongoing Ongoing Location Canada Canada Design - randomised, controlled, un-controlled, casecontrol, case series etc. Phase III, interventional treatment, randomised, open label, active control, parallel Participants in trial assignment, safety/efficacy n = 72. Prostate Cancer. Comparison of helical tomotherapy IMRT vs. standard 3D-CRT Tomotherapy in high-risk prostate cancer. NCT 00126802 19 Alberta Cancer Board Phase I/II, interventional treatment, randomised, open label, uncontrolled, single group assignment, safety/efficacy n = 40. Hypofractionated/dose escalated CRT treatment, high risk prostate cancer Follow-up Completing May 2014 Primary outcome Late rectal toxicity Rectal toxicity Secondary outcomes Acute rectal toxicity; acute and late bladder toxicity disease specific survival at 5 years; biochemical relapse-free survival at 5 years, local control rates at 5 years, quality of life. Expected reporting date November 2015 Late 2007 Prostate-specific antigen and magnetic resonance spectroscopy imaging (MRSI) disease control. Estimated cost and cost impact The Hi-ART System costs approximately 2 million + VAT, with annual warranty costing up to 8% of capital costs. The purchase cost for standard IMRT is in the range 1.1-3.3 million, plus 40,000-71,000 for annual servicing. The upgrading of existing linear accelerator systems to deliver IMRT costs between 219,000 and 437,000. Experts consulted commented that investment in IMRT systems with online image guidance (IGRT) was likely to be more cost-effective in the longer term than the modification of conventional radiotherapy machines. It is estimated that 20-30% of current linear accelerators might usefully be replaced with image-guided IMRT for use in specialist centres on selected patients (e.g. those with prostate or lung cancer). Aug 2006 4
Potential or intended impact speculative Although the Hi-ART system is novel it may not represent a significant breakthrough and the case for the Hi-ART system versus other IMRT systems (e.g. Elekta and Varian) has not yet been made. Whilst IMRT is likely to be proved superior to conventional radiotherapy, the resource implications of evaluating which IMRT system best meets the needs of the NHS will be significant. Patients Reduced morbidity Quicker or more accurate diagnosis Reduced mortality or increased survival Earlier identification of disease Improved quality of life for patients and/or carers Changed pathway of care or outcome Services Increased use e.g. length of stay, out-patient visits Service reorganisation required Staff or training required - significant Decreased use e.g. shorter length of stay, reduced fewer therapy sessions may be required. referrals Costs Increased unit cost compared to alternative Savings: shorter courses of treatment (due to higher doses per session) References Increased costs: more patients coming for treatment Increased costs: major capital investment needed 1 Jeraj R et al. Radiation characteristics of helical tomotherapy 2004; Med Phys 31(2): 396-404. 2 Beavis AW. Is tomotherapy the future of IMRT? Br J Radiol 2004; 77(916): 285-295. 3 Welsh JS et al. Helical tomotherapy: an innovative technology and approach to radiotherapy. 2002; Technol Cancer Res Treat 1(4): 311-6. 4 Grigorov et al. Optimization of helical tomotherapy treatment plans for prostate cancer. Phys Med Biol 2003; 48: 1933-1943. 5 Van Vulpen M et al. Comparing step-and-shoot IMRT with dynamic helical tomotherapy plans for head-andneck cancer. Int J Radiat Oncol, Biol Phys 2005; 62(5): 1535-1539. 6 The National Coordinating Centre for Health Technology Assessment (NCC-HTA). Clinical and costeffectiveness of new and emerging technologies for early localised prostate cancer: a systematic review. 2003; Health Technol Assess 7(33): 1-157. 7 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, Prostate Cancer Panel 2005; 44. www.nccn.org. 8 Blue Cross Blue Shield Association, Technology Evaluation Center, Special Report: intensity-modulated radiotherapy for cancer of the breast or lung. 2005; TEC Assessment Program Vol 20: No. 15. 9 National Cancer Institute (NCI) guidelines for the use of IMRT in clinical trials. 2004 www.cancer.gov/rrp/imrt2004. 10 American Association of Physicists in Medicine (AAPM), Radiotherapy Committee guidance document on delivery, treatment planning, and clinical implementation of IMRT. 2003; Med Phys 30 (8): 2089-2115. www.aapm.org/pubs/reports. 11 American College of Radiology (ACR) Practice Guideline for intensity-modulated radiotherapy (IMRT) 2003; 705-710. www.aapm.org/pubs/reports. 12 ECRI (formerly Emergency Care research Institute) Target Report 816, Jan 2002, updated Apr 2006. 13 Williams P. Paper presented at the annual scientific meeting of the Institute of Physics & Engineering in Medicine (IPEM), Manchester, June 2005. 14 Fiorino C et al. Significant improvement in normal tissue sparing and target coverage for head and neck cancer by means of helical tomotherapy 2006; Radiotherapy Oncol 78: 276-282. 15 Han C & Liu A. Dosimetric comparisons of helical tomotherapy treatment plans and step-and-shoot intensitymodulated radio surgery treatment plans in intracranial stereotactic radiosurgery 2006; Int J radiat Oncol, Biol, Phys 65(2) 608-616. Aug 2006 5
16 Scrimger RA et al. Reduction in radiation dose to lung and other normal tissues using helical tomotherapy to treat lung cancer, in comparison to conventional field arrangements. Am J Clin Oncol 2003; 26(1): 70-71. 17 Balog J et al. Clinical tomotherapy commissioning dosimetry. Clinical helical tomotherapy 2003; Med Phys 30: 3097-3106. 18 3D-conformal radiation vs helical tomotherapy in prostate cancer, Ottowa Health Research Institute, Canada. ClinicalTrials.gov identifier NCT00326638. 19 The role of tomotherapy (dynamic IMRT and megavoltage CT scanning) in hypofractionated/dose escalated conformal radiation treatment using magnetic resonance spectroscopy (MRS) scans to predict and document the pattern of local failure for high risk prostate cancer. Alberta Cancer Board. ClinicalTrials.gov identifier NCT 00126802. The is funded by the Research and Development Division of the Department of Health, England The, Department of Public Health and Epidemiology University of Birmingham, Edgbaston, Birmingham, B15 2TT, England Tel: +44 (0)121 414 7831 Fax +44 (0)121 414 2269 www.pcpoh.bham.ac.uk/publichealth/horizon Aug 2006 6