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UK SABR service
development experiences
Maria Hawkins
GenesisCare Consultant Clinical Oncologist
Honorary consultant Clinical Oncologist Oxford University Hospitals NHS FT
Page 2
My participation in this Event does not interfere with any other obligations I have undertaken, in particular in connection with my current employment (if any) and that my
institution has no objections to my participation in the Event.
I acknowledge that I have no imposing duty or obligation to refer to the institution or any other health care organization, patient, or physician to any health care institution
or provider supplied by GenesisCare or its affiliates or to endorse or recommend the ordering or purchasing of any product or service of GenesisCare or its affiliates.
I hereby certify that I will comply with all applicable provisions of law and other rules and regulations of any and all governmental authorities in performing my obligations
under my Speaker Letter Agreement, as well as GenesisCare’s own ethics codes and policies, and that I have been furnished with copies of the relevant GenesisCare codes
and policies. I hereby agree that my will at all times fully cooperate with GenesisCare in meeting its obligations thereunder and that my will be bound by the ethical
principles underlying such regulations.
I further agree to keep strictly secret all confidential information of GenesisCare or its affiliates which I learn during the Event. I will perform all services in compliance with
applicable laws and regulations and apply my best efforts to the performance of the services.
I also grant GenesisCare permission to use my speech of presentation in other capacities within the Scope of Work. I also authorize and license GenesisCare to reproduce or
distribute the materials used in the Scope of Work via the GenesisCare websites. GenesisCare shall maintain the appropriate attribution to Speaker. GenesisCare may modify
the materials however, any modification of statements of Speaker that would fundamentally distort the meaning of Speaker’s statements are not authorized by this
authorization and license. This authorisation and license shall be for the purpose of advertising, promotion of marketing of GenesisCare and its products and services, and
for any other purpose that is in the spirit of the original Scope of Work. For example, the presentation or speech may be recorded, taped, captured via “LiveMeeting” and
may be added to the GenesisCare website.
To the extent that it has not been previously collected, GenesisCare may require collecting certain personal data from my like my name and email address. GenesisCare will
do so only for the purposes required under this Letter Agreement, and always in compliance with applicable law. We will only transfer my data to GenesisCare affiliates, to
the extent necessary for the fulfilment of this Letter Agreement, and specifically, to Genesis Care UK Limited, Wilson House, Waterberry Drive, Waterlooville, Hampshire ,
PO7 7XX and my hereby consent to such transfer to the extent that it is done solely for the purposes of this Letter Agreement and in compliance with applicable law.
I also acknowledge that my are an independent contractor, subject to GenesisCare’s direction only as to specific interests where GenesisCare wants the benefit of my
services and advice. Nothing in this Speaker Letter Agreement makes my an employee or agent of GenesisCare, or authorises Speaker to speak for, represent or obligate
GenesisCare in any way.
Disclosure
3
Stereotactic body radiation principles
• Method to deliver a high dose radiation to target
• Single/few fraction treatment
• Rapid dose fall-off
• High precision
• Measures to account for motion
• Goal: tumour ablation
• Concept initially developed in 1951by Lars Leksell
(neurosurgeon!) allowing delivery of a single session of RT for cranial lesions
Int J Radiat Oncol Biol Phys 2004
Standard Radiation Therapy
• Delivered 5-6 wks, Mon-Fri
• Low dose RT/day (1.8 – 2Gy)
• Combined with chemo
• Normal tissue can repair
• Acute > Chronic toxicity
• Less Convenient (worse quality of
life)
• Good long term data (level1)
Stereotactic Radiation Therapy
• Delivered over one week
• High RT/day (5-30 Gy)
• No concurrent therapy
• More difficult for normal tissues to
repair the damage
• Chronic > Acute Toxicity
• Better quality of life
• Less data (level3)
Stereotactic body radiotherapy SBRT requirements
Highly specialized SBRT specific treatment
delivery systems and complex patient
immobilization
Linear Accelerators equipped with on treatment
imaging systems and conventional patient
immobilization
Stereotactic Radiation Requirements• Accurate imaging to define the target in 3D
• CT/4DCT
• MRI/PET
• Motion management/characterization
• Abdominal compression
• Breath hold techniques
• Tracking or gating
• 3D Localization during treatment
• Fiducial markers
• Cone beam CT (CBCT) imaging
Adoption of SBRT
Page 7
Pan Cancer 2011
Cumulative adoption United states
International survey >1000 Radiation Oncologists
Page 8
Lewis Am J CO 2015
42%US, 11%=Canada 10% Japan, 7% Western Europe 6% Australia, 3% S Korea
Indications for body SBRT-Primary tumours
Stage 1 inoperable lung cancer
Local Control rates >85% at 3 and 5 years dose >100Gy equiv in
2Gy fractions
Hepatocellular carcinoma not suitable for other ablative techniques
Less evidence: cholangiocarcinoma, renal cell carcinoma, pancreatic
cancer
Page 9
Lung 50Gy/5 fractions
The aim of SABR in patients with oligometastases is to:
• achieve local control at the metastatic site and prevent the clinical
sequelae of disease progression at that site
• improve disease free survival with the aim of enabling the patient to
defer systemic therapy, or at least delay time until the next systemic
therapy is required, thus maximising quality of life
• improve overall survival.
Page 11
Indications for body SBRT- metastatic disease
• Metastatic carcinoma with either a histologically or cytologically proven
primary site or a male patient with a PSA>50 and clinical evidence of
prostate cancer
• 1-3 sites of metastatic disease (defined after appropriate imaging) which can
be treated with stereotactic radiotherapy to a radical radiation dose.
• A maximum of two sites of spinal metastatic disease
• Maximum size of any single metastasis 6cm (5 cm for lung or liver
metastases)
• Disease free interval > 6 months; unless synchronous liver metastases from
colorectal primary (see liver metastases section)
• Not more than three oligometastatic sites treated in total per patient
• Expected life expectancy > 6 months
• Performance status ≤ 2
Page 12
Paraaortic node Spine pelvic side wall
30Gy/3# 27Gy/3# 30Gy/3#
Minimum technology requirements
• Imaging for planning: CT, contrast enhanced CT, MRI, PET, 4DCT
• Planning processed: advanced calculation algorithms, 6MV, beam
profile modelling for small field sizes to be undertaken
• Radiation beam delivery system: small MLC, high dose rate, size of
the mechanical isocenter sphere should be within 1 mm in radius.
• Immobilization of patient (comfortable and rigid), motion management
• Target definition- unambiguous, set-up margins well defined
• Geometric verification: on line imaging and repositioning
Page 14
Patient selection –MDT team
• Team: clinical oncologist, radiologist, medical physics, radiographer
• Patient selection – meet clinical criteria ?
• Immobilization, planning issues/solutions (tumour close to an organ
at risk, on treatment verification tolerances?
• Peer review of contours and plans
• Toxicity discussions
Page 15
16
Immobilization- abdominal compression
Workforce
• A multidisciplinary working party should develop,
implement and maintain the SBRT service
– Additional resources are needed (staffing, training, etc)
– Start with prospective risk assessment and timeline
– Clear documentation and short-term/long-term audit are essential
– Ongoing education is high priority (QA, planning, delivery and
verification technologies and techniques)
– Training in all likely treatment circumstances should be provided
Training requirements
Page 18
clinician Medical physicist Radiation therapy
technologist
General methods for SBRT Yes Yes Yes
Patient selection yes
Patient immobilization and
accounting for motion
Yes Yes
Imaging acquisition Yes Yes
Target definition yes
Dose planning yes
Dose prescription yes
Treatment delivery yes yes
Toxicity patterns
Follow-up
yes
NHS England’s Commissioning through Evaluation
• NHS England’s Commissioning through Evaluation (CtE) programme
enables a limited number of patients to access treatments that are
not funded by the NHS
There are two main phases to the programme
• Phase 1 – an agreed number of patients are recruited to a CtE
scheme within just a few selected centres across England. The
National Institute for Health and Care Excellence (NICE) helps to
identify the total number of patients who need to be recruited to the
scheme to support data analysis
• Phase 2 – the analysis phase will vary in length, depending on the
evaluation measures agreed
Page 19
SABR available via Commissioning through evaluation
programme
Oligometastic Disease 17 centres
• Barts Health NHS Trust
• Guy’s and St Thomas’ NHS Foundation Trust
• Leeds Teaching Hospitals NHS Trust
• Mount Vernon Cancer Centre (North and East Hertfordshire Foundation Trust)
• Newcastle upon Tyne Hospitals NHS Foundation Trust
• Nottingham University Hospitals NHS Trust
• Oxford University Hospital NHS Trust
• Royal Surrey County Hospital NHS Foundation Trust
• Sheffield Teaching Hospitals NHS Trust
• South Tees Hospitals NHS Foundation Trust
• The Christie NHS Foundation Trust
• The Clatterbridge Cancer Centre NHS Foundation Trust
• The Royal Marsden Foundation Trust
• University College London Hospitals NHS Foundation Trust
• University Hospitals Birmingham NHS Foundation Trust
• University Hospitals Bristol Foundation Trust
• University Hospitals of Leicester NHS Trust
Page 20
Re-irradiation of pelvis and spine
8 centres
• Barts Health NHS Trust
• Guy’s and St Thomas’ NHS Foundation Trust
• Leeds Teaching Hospitals NHS Trust
• Nottingham University Hospitals NHS Trust
• Mount Vernon Cancer Centre (North and
East Hertfordshire Foundation Trust)
• Oxford University Hospital NHS Trust
• The Royal Marsden NHS Foundation Trust
• University Hospitals Birmingham NHS
Foundation Trust
Hepatocellular carcinoma
7centres
• Barts Health NHS Trust
• Guy’s and St Thomas’ NHS Foundation Trust
• Leeds Teaching Hospitals NHS Trust
• Mount Vernon Cancer Centre (North and
East Hertfordshire Foundation Trust)
• Oxford University Hospital NHS Trust
• The Royal Marsden NHS Foundation Trust
• University Hospitals Birmingham NHS
Foundation Trust
Page 21
22
Potential benefits for SBRT
• Prospective studies proof feasibility and efficacy
• Local control 60-100%
• Favourable toxicity profile
• Non-invasive
• Convenient
• Possibly cost effective
SABR implementation
• Audit of toxicity and outcomes key to safe delivery
Page 23
Page 24
Study & Service Evaluation
Prospective SBRT Clinical Outcomes study for metastatic disease GC16-01 (SBRT Mets)
Aim(s):
To prospectively collate clinical indications for SBRT delivered for metastatic disease within GC consortium and to
evaluate clinical patient outcomes for comparison to published literature.
This will require data provision of clinical indications and rationale for SBRT and clinical follow-up of the patient
using standard measurement tools for treatment related-toxicity, local control, patterns of failure, and disease free
survival.
A clinical SBRT proforma form will need to be completed and baseline status recorded.
Following completion of treatment, clinical review of disease control and toxicity will be completed at each follow-
up visit where appropriate at intervals of approximately 1 month, 3 months, 6 months, 9 months, 12 months then 6
monthly thereafter.
GCUK Service Evaluation for SBRT for Metastasis and
Development of a Prospective Database
Page 25
Primary Objective for Study 1
• Acute toxicity of SBRT as defined by CTCAE v. 4 treated in this service evaluation.
• Primary endpoint: Grade 2 toxicity at 3 months
Primary Objective for Study 2
• Late toxicity of SBRT as defined by CTCAE v. 4 treated in this service evaluation.
• Primary endpoint: Grade 2 toxicity at 12 months
Secondary Objectives
• To assess deliverability of SBRT and dose constraints achieved compared to published data.
• To evaluate local control of the clinical cohort
• To evaluate time to secondary therapy (DFS)
GCUK Service Evaluation for SBRT for Metastasis and
Development of a Prospective Database
Page 26
• Multidisciplinary team effort
• Communication
• Audit of practice, outcomes and technology
Key to success
Thank-you
References

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Professor Maria Hawkins - UK SABR Service Development Experiences

  • 1. UK SABR service development experiences Maria Hawkins GenesisCare Consultant Clinical Oncologist Honorary consultant Clinical Oncologist Oxford University Hospitals NHS FT
  • 2. Page 2 My participation in this Event does not interfere with any other obligations I have undertaken, in particular in connection with my current employment (if any) and that my institution has no objections to my participation in the Event. I acknowledge that I have no imposing duty or obligation to refer to the institution or any other health care organization, patient, or physician to any health care institution or provider supplied by GenesisCare or its affiliates or to endorse or recommend the ordering or purchasing of any product or service of GenesisCare or its affiliates. I hereby certify that I will comply with all applicable provisions of law and other rules and regulations of any and all governmental authorities in performing my obligations under my Speaker Letter Agreement, as well as GenesisCare’s own ethics codes and policies, and that I have been furnished with copies of the relevant GenesisCare codes and policies. I hereby agree that my will at all times fully cooperate with GenesisCare in meeting its obligations thereunder and that my will be bound by the ethical principles underlying such regulations. I further agree to keep strictly secret all confidential information of GenesisCare or its affiliates which I learn during the Event. I will perform all services in compliance with applicable laws and regulations and apply my best efforts to the performance of the services. I also grant GenesisCare permission to use my speech of presentation in other capacities within the Scope of Work. I also authorize and license GenesisCare to reproduce or distribute the materials used in the Scope of Work via the GenesisCare websites. GenesisCare shall maintain the appropriate attribution to Speaker. GenesisCare may modify the materials however, any modification of statements of Speaker that would fundamentally distort the meaning of Speaker’s statements are not authorized by this authorization and license. This authorisation and license shall be for the purpose of advertising, promotion of marketing of GenesisCare and its products and services, and for any other purpose that is in the spirit of the original Scope of Work. For example, the presentation or speech may be recorded, taped, captured via “LiveMeeting” and may be added to the GenesisCare website. To the extent that it has not been previously collected, GenesisCare may require collecting certain personal data from my like my name and email address. GenesisCare will do so only for the purposes required under this Letter Agreement, and always in compliance with applicable law. We will only transfer my data to GenesisCare affiliates, to the extent necessary for the fulfilment of this Letter Agreement, and specifically, to Genesis Care UK Limited, Wilson House, Waterberry Drive, Waterlooville, Hampshire , PO7 7XX and my hereby consent to such transfer to the extent that it is done solely for the purposes of this Letter Agreement and in compliance with applicable law. I also acknowledge that my are an independent contractor, subject to GenesisCare’s direction only as to specific interests where GenesisCare wants the benefit of my services and advice. Nothing in this Speaker Letter Agreement makes my an employee or agent of GenesisCare, or authorises Speaker to speak for, represent or obligate GenesisCare in any way. Disclosure
  • 3. 3 Stereotactic body radiation principles • Method to deliver a high dose radiation to target • Single/few fraction treatment • Rapid dose fall-off • High precision • Measures to account for motion • Goal: tumour ablation • Concept initially developed in 1951by Lars Leksell (neurosurgeon!) allowing delivery of a single session of RT for cranial lesions Int J Radiat Oncol Biol Phys 2004
  • 4. Standard Radiation Therapy • Delivered 5-6 wks, Mon-Fri • Low dose RT/day (1.8 – 2Gy) • Combined with chemo • Normal tissue can repair • Acute > Chronic toxicity • Less Convenient (worse quality of life) • Good long term data (level1) Stereotactic Radiation Therapy • Delivered over one week • High RT/day (5-30 Gy) • No concurrent therapy • More difficult for normal tissues to repair the damage • Chronic > Acute Toxicity • Better quality of life • Less data (level3)
  • 5. Stereotactic body radiotherapy SBRT requirements Highly specialized SBRT specific treatment delivery systems and complex patient immobilization Linear Accelerators equipped with on treatment imaging systems and conventional patient immobilization
  • 6. Stereotactic Radiation Requirements• Accurate imaging to define the target in 3D • CT/4DCT • MRI/PET • Motion management/characterization • Abdominal compression • Breath hold techniques • Tracking or gating • 3D Localization during treatment • Fiducial markers • Cone beam CT (CBCT) imaging
  • 7. Adoption of SBRT Page 7 Pan Cancer 2011 Cumulative adoption United states
  • 8. International survey >1000 Radiation Oncologists Page 8 Lewis Am J CO 2015 42%US, 11%=Canada 10% Japan, 7% Western Europe 6% Australia, 3% S Korea
  • 9. Indications for body SBRT-Primary tumours Stage 1 inoperable lung cancer Local Control rates >85% at 3 and 5 years dose >100Gy equiv in 2Gy fractions Hepatocellular carcinoma not suitable for other ablative techniques Less evidence: cholangiocarcinoma, renal cell carcinoma, pancreatic cancer Page 9
  • 11. The aim of SABR in patients with oligometastases is to: • achieve local control at the metastatic site and prevent the clinical sequelae of disease progression at that site • improve disease free survival with the aim of enabling the patient to defer systemic therapy, or at least delay time until the next systemic therapy is required, thus maximising quality of life • improve overall survival. Page 11
  • 12. Indications for body SBRT- metastatic disease • Metastatic carcinoma with either a histologically or cytologically proven primary site or a male patient with a PSA>50 and clinical evidence of prostate cancer • 1-3 sites of metastatic disease (defined after appropriate imaging) which can be treated with stereotactic radiotherapy to a radical radiation dose. • A maximum of two sites of spinal metastatic disease • Maximum size of any single metastasis 6cm (5 cm for lung or liver metastases) • Disease free interval > 6 months; unless synchronous liver metastases from colorectal primary (see liver metastases section) • Not more than three oligometastatic sites treated in total per patient • Expected life expectancy > 6 months • Performance status ≤ 2 Page 12
  • 13. Paraaortic node Spine pelvic side wall 30Gy/3# 27Gy/3# 30Gy/3#
  • 14. Minimum technology requirements • Imaging for planning: CT, contrast enhanced CT, MRI, PET, 4DCT • Planning processed: advanced calculation algorithms, 6MV, beam profile modelling for small field sizes to be undertaken • Radiation beam delivery system: small MLC, high dose rate, size of the mechanical isocenter sphere should be within 1 mm in radius. • Immobilization of patient (comfortable and rigid), motion management • Target definition- unambiguous, set-up margins well defined • Geometric verification: on line imaging and repositioning Page 14
  • 15. Patient selection –MDT team • Team: clinical oncologist, radiologist, medical physics, radiographer • Patient selection – meet clinical criteria ? • Immobilization, planning issues/solutions (tumour close to an organ at risk, on treatment verification tolerances? • Peer review of contours and plans • Toxicity discussions Page 15
  • 17. Workforce • A multidisciplinary working party should develop, implement and maintain the SBRT service – Additional resources are needed (staffing, training, etc) – Start with prospective risk assessment and timeline – Clear documentation and short-term/long-term audit are essential – Ongoing education is high priority (QA, planning, delivery and verification technologies and techniques) – Training in all likely treatment circumstances should be provided
  • 18. Training requirements Page 18 clinician Medical physicist Radiation therapy technologist General methods for SBRT Yes Yes Yes Patient selection yes Patient immobilization and accounting for motion Yes Yes Imaging acquisition Yes Yes Target definition yes Dose planning yes Dose prescription yes Treatment delivery yes yes Toxicity patterns Follow-up yes
  • 19. NHS England’s Commissioning through Evaluation • NHS England’s Commissioning through Evaluation (CtE) programme enables a limited number of patients to access treatments that are not funded by the NHS There are two main phases to the programme • Phase 1 – an agreed number of patients are recruited to a CtE scheme within just a few selected centres across England. The National Institute for Health and Care Excellence (NICE) helps to identify the total number of patients who need to be recruited to the scheme to support data analysis • Phase 2 – the analysis phase will vary in length, depending on the evaluation measures agreed Page 19
  • 20. SABR available via Commissioning through evaluation programme Oligometastic Disease 17 centres • Barts Health NHS Trust • Guy’s and St Thomas’ NHS Foundation Trust • Leeds Teaching Hospitals NHS Trust • Mount Vernon Cancer Centre (North and East Hertfordshire Foundation Trust) • Newcastle upon Tyne Hospitals NHS Foundation Trust • Nottingham University Hospitals NHS Trust • Oxford University Hospital NHS Trust • Royal Surrey County Hospital NHS Foundation Trust • Sheffield Teaching Hospitals NHS Trust • South Tees Hospitals NHS Foundation Trust • The Christie NHS Foundation Trust • The Clatterbridge Cancer Centre NHS Foundation Trust • The Royal Marsden Foundation Trust • University College London Hospitals NHS Foundation Trust • University Hospitals Birmingham NHS Foundation Trust • University Hospitals Bristol Foundation Trust • University Hospitals of Leicester NHS Trust Page 20
  • 21. Re-irradiation of pelvis and spine 8 centres • Barts Health NHS Trust • Guy’s and St Thomas’ NHS Foundation Trust • Leeds Teaching Hospitals NHS Trust • Nottingham University Hospitals NHS Trust • Mount Vernon Cancer Centre (North and East Hertfordshire Foundation Trust) • Oxford University Hospital NHS Trust • The Royal Marsden NHS Foundation Trust • University Hospitals Birmingham NHS Foundation Trust Hepatocellular carcinoma 7centres • Barts Health NHS Trust • Guy’s and St Thomas’ NHS Foundation Trust • Leeds Teaching Hospitals NHS Trust • Mount Vernon Cancer Centre (North and East Hertfordshire Foundation Trust) • Oxford University Hospital NHS Trust • The Royal Marsden NHS Foundation Trust • University Hospitals Birmingham NHS Foundation Trust Page 21
  • 22. 22 Potential benefits for SBRT • Prospective studies proof feasibility and efficacy • Local control 60-100% • Favourable toxicity profile • Non-invasive • Convenient • Possibly cost effective
  • 23. SABR implementation • Audit of toxicity and outcomes key to safe delivery Page 23
  • 24. Page 24 Study & Service Evaluation Prospective SBRT Clinical Outcomes study for metastatic disease GC16-01 (SBRT Mets) Aim(s): To prospectively collate clinical indications for SBRT delivered for metastatic disease within GC consortium and to evaluate clinical patient outcomes for comparison to published literature. This will require data provision of clinical indications and rationale for SBRT and clinical follow-up of the patient using standard measurement tools for treatment related-toxicity, local control, patterns of failure, and disease free survival. A clinical SBRT proforma form will need to be completed and baseline status recorded. Following completion of treatment, clinical review of disease control and toxicity will be completed at each follow- up visit where appropriate at intervals of approximately 1 month, 3 months, 6 months, 9 months, 12 months then 6 monthly thereafter. GCUK Service Evaluation for SBRT for Metastasis and Development of a Prospective Database
  • 25. Page 25 Primary Objective for Study 1 • Acute toxicity of SBRT as defined by CTCAE v. 4 treated in this service evaluation. • Primary endpoint: Grade 2 toxicity at 3 months Primary Objective for Study 2 • Late toxicity of SBRT as defined by CTCAE v. 4 treated in this service evaluation. • Primary endpoint: Grade 2 toxicity at 12 months Secondary Objectives • To assess deliverability of SBRT and dose constraints achieved compared to published data. • To evaluate local control of the clinical cohort • To evaluate time to secondary therapy (DFS) GCUK Service Evaluation for SBRT for Metastasis and Development of a Prospective Database
  • 26. Page 26 • Multidisciplinary team effort • Communication • Audit of practice, outcomes and technology Key to success