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ARTFORCE - Radiation Protection Zr-cetuximab
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ARTFORCE - Radiation Protection Zr-cetuximab Presentation Transcript

  • 1. Radiation Protection regarding 89Zr-cetuximab Frank Hoebers, MD PhD Maastro Clinic, Maastricht MAASTRO Clinic January 2014
  • 2. Klik om deOutline bewerken stijl te • Learning Objectives • Target audience • Background of ARTFORCE study • Aspects of radiation safety • Practical guidelines for nursing and treating staff
  • 3. Klik Learning Objectives om de stijl te bewerken The objective of this session is to train medical personnel on radiation safety measures for the ARTFORCE head and neck study
  • 4. Klik om de stijl te bewerken Target Audience Personnel involved in the study: • Nursing staff on day care unit and wards (cisplatin / cetuximab) • Radiotherapy Technologists on linacs • Treating physicians • Consider to train chief-nurses of groups who will only see patients in extra-ordinary circumstances: – e.g. during admission of the patient to emergency room or short stay ward Make sure to have radiation exposure experts available in case of possible emergencies
  • 5. Background: Cetuximab-based therapies Klik om de stijl te bewerken In recurrent and metastatic HNSCC: Extreme Study: Vermorken et al., NEJM, 2008 The addition of cetuximab prolonged the median overall survival from: 7.4 months in the chemotherapy-alone group TO 10.1 months in the group that received chemotherapy plus cetuximab
  • 6. Treatment ofde stijl te bewerken Klik om locally advanced HNSSC cisplatin / RT cetuximab / RT cisplatin / cetuximab / RT RTOG 0522 n = 940: cisplatin-cetuximab /RT vs cisplatin /RT • PFS: 2-Y: 63% vs. 64% • OS: 2-Y: 83% vs. 80% • more toxicity Pignon, 2009 Bonner, 2010 Ang, ASCO 2012
  • 7. Klik om de stijl te bewerken Cetuximab • Small improvements in outcome in combination with chemotherapy and radiotherapy • Adds to the toxicity profile in Chemo-RT • Efficacy difficult to predict Need for a selection tool to predict cetuximab efficacy in individual patient
  • 8. Efficacy of Cetuximab determined by Klik om de stijl te bewerken • Presence of target (EGFR, epidermal growth factor receptor) • Access of drug to target (pharmacokinetics/-dynamics): • Vascular perfusion • Interstitial pressure • Non-target uptake in normal tissue Role for non-invasive, in vivo imaging of uptake?
  • 9. Radioactive labeledbewerken Klik om de stijl te cetuximab • In vivo imaging using tracer labelled to drug • Cetuximab has long half life => select suitable tracer • 89Zirconium: half life 78 hours
  • 10. 89Zr-Cetuximab uptake in tumor models Aerts et al. JNM 2009 • • Uptake present in several tumours expressing EGFR No uptake in EGFR negative tumour
  • 11. 89Zr-Cetuximab: Phase I – Results Klik om de stijl te bewerken 18FDG PET-CT 89Zr-Cetuximab PET J. van Loon et al. Radiotherapy and Oncology, Vol. 106, suppl 1, Febr 2013, p 57.
  • 12. ARTFORCE study design N = 268 patients to be recruited in several european centres Randomization after informed consent 89Zr-Cetuximab Cisplatinum: 40mg/m2 weekly i.v. + Standard RT Tumour + involved nodes: 35 x 2.0Gy = 70Gy Elective nodes 35 x 1.55 = 54.25Gy Cisplatinum: 40mg/m2 weekly i.v. + Redistributed RT Tumour 50% PET: 35 x 2.0 -2.4Gy = dose gradient 70-84Gy Tumour other + involved nodes 35 x 2Gy = 70Gy Elective nodes 35 x 1.55 = 54.25Gy scan Cetuximab: 250mg/m2 weekly i.v. + Standard RT Tumour + involved nodes: 35 x 2.0Gy = 70Gy Elective nodes 35 x 1.55 = 54.25Gy Cetuximab: 250mg/m2 weekly i.v. + Redistributed RT Tumour 50% PET: 35 x 2.0 -2.4Gy = dose gradient 70-84Gy Tumour other + involved nodes 35 x 2.0Gy = 70Gy Elective nodes 35 x 1.55 = 54.25Gy
  • 13. Imaging de stijl Zr Cetuximab with 89 te bewerken Klik om 89Zr-cetuximab scan procedures: • Administration of 60 MBq on day -7 • Scan 1 on day -3 • Scan 2 on day 1 (is also start of chemoradiotherapy) Day -7 -6 Administration of 60 MBq -5 -4 -3 Scan 1 -2 -1 1 2 Scan 2 + Chemoradiotherapy Starts 3 …
  • 14. Radiation safety Klik om de stijl te bewerken Radioactivity: general principles to reduce exposure: • Increase the distance to the radioactive source: • Quadratic law: double distance  reduce exposure by a factor of 4 • Reduce residence time at source
  • 15. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing Respect a 2-week period of radiation protection measures: Week 1 Week 2 Week 3 Injection Start treatment: 2nd administration: 3rd administration: 89Zr-cetuximab RT + Cisplatin/Cetuximab Cisplatin/Cetuximab Cisplatin/Cetuximab • Cisplatin: nurses and staff at chemotherapy ward • Cetuximab: nurses and staff at day care unit • Radiotherapy: linac team, outpatient clinic, nurses, dieticians, etc. • 2x PET-CT: technicians on scanner
  • 16. Radiation safety Klik om de stijl te bewerken • 89Zirconium: half life of 78.41 hrs. • Radiation exposure has been estimated for personnel (nurses and RTT’s): • Administration of cisplatin during 24 hrs. hospital stay: 7.91 uSv + 7.15 uSv • Administration of cetuximab in day care unit: 6.97 uSv • 5 fractions of radiotherapy on linac: 1.74 uSv • These doses are low and within accepted limits: • Natural background radiation per year: +/- 2000 uSv • Dose limit for radiological worker per year: 6000 uSv • Dose limit for non-occupational exposure (nurses/family) per year: 1000 uSV • Transatlantic air flight: 15-30 uSv
  • 17. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing • Consider to mark study patient in Electronic Patient File: • Date of administration of 89Zr-cetuximab • And following 2 weeks • Appoint contact persons for questions: • Local study P.I. • Local Radiation Safety Authority • Arrange for a 24x7 coverage
  • 18. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing Protection of nursing staff during 2-week period of guidelines • Respect general and standard hygienic measures when in contact with patient and wear gloves • There is no need for mouth mask or protective glasses Rotate nursing staff if: • Several patients are hospitalized during the 2-week period of radiation protection measures • A patient needs to be hospitalized for more than 1 day For RTT’s: no rotation necessary per se Avoid contact between pregnant personnel and study patients during the 2-week period!
  • 19. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing Protection of Fellow Patients during 2-week period of guidelines • Planned admission < 2 days: • No need for 1-bed room (depending on distance between beds) • Admission > 2 days: • Preferably 1-bed room to reduce exposure to fellow patients • During the stay at the Emergency Room: • Separate room: allow 1.5m distance between 2 patients • Waiting room of radiotherapy faciltiy: no specific measures
  • 20. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing Body Excreta of study patients during 2-week period of guidelines • Urine, faeces, sputum, pus, and perspiration: • Do not contain 89Zr-cetuximab • Therefore: • Joint bathroom is allowed • Standard procedures for cleaning are suitable (toilet, sheets, plates, cutlery, beds, floors, etc.) • Waste (foods, diapers, etc.) can be discarded using standard waste containers
  • 21. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing Body Excreta of study patients during 2-week period of guidelines • Blood: • Potential source of 89Zr-cetuximab • Therefore, in case of contamination of staff by blood: • Contact local P.I. and local Radiation Safety Authority a.s.a.p. • Rinse (skin of staff) with water
  • 22. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing Body Excreta of study patients during 2-week period of guidelines • Blood: • Potential source of 89Zr-cetuximab • Therefore, in case of contamination of material by blood: • Contact local P.I. and local Radiation Safety Authority ASAP • Contamination of materials: disposables / nondisposables • E.g. gloves, sheets, gauzes, surgical equipment, endoscopes • Collect in separate labeled containers and keep away from people in separate room
  • 23. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing Body Excreta of study patients during 2-week period of guidelines • Planned blood samples: • Contact your local Clinical Chemistry and Laboratory Medicine Department for local regulatory agreements • Use venipuncture, not finger prick • Label tubes and forms with appropriate adhesive stickers • Consider transport in lead shielded container and avoid pneumatic tube transport systems • In most centres, analysis of radioactive bloodsamples is performed under controlled conditions by certified staff
  • 24. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing Body Excreta of study patients during 2-week period of guidelines • Unplanned blood samples (outside office hours): • Contact your local Clinical Chemistry and Laboratory Medicine Department for local regulatory agreements • Use venipuncture, not finger prick, label tubes and forms with stickers • Consider transport in lead shielded container and avoid pneumatic tube transport systems • Discuss who will perform the analysis of bloodsamples at the Clinical Chemistry Laboratory
  • 25. Practicalom de stijl te bewerkenstaff Klik guidelines for nursing After venipuncture • Discard used needles in standard needle container • Consider not completely filled and unused tubes as contaminated and collect and store these separately as discussed before
  • 26. Klik om de stijl te bewerken ARTFORCE HN trial • Risk of radiation exposure is small in standard controlled situations • Adhere to the protocol • Discuss any remaining issues with your local P.I. or local Radiation Safety Authority