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ARTFORCE - Radiation Protection Zr-cetuximab

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Information about ARTFORCE - Radiation Protection Zr-cetuximab
Education

Published on February 17, 2014

Author: maastroclinic

Source: slideshare.net

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Radiation Protection regarding 89Zr-cetuximab Frank Hoebers, MD PhD Maastro Clinic, Maastricht MAASTRO Clinic January 2014

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

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

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

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

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

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

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?

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

89Zr-Cetuximab uptake in tumor models Aerts et al. JNM 2009 • • Uptake present in several tumours expressing EGFR No uptake in EGFR negative tumour

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.

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

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 …

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

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

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

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

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!

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

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

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

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

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

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

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

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

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