How does RTQA impact on clinical Outcome Prof. Dr.med. Damien Charles Weber Paul Scherrer Institut USZ, University of Zürich, Switzerland Inselspital- Hôpital de L’Ile, University of Bern, Switzerland Co Chair, RTQA Strategic, ROG
Objectives • To understand why RTQA is important in/for a intergroup study/trial • What are the levels of RTQA • What is the structure of the RTQA group/platform within EORTC • To see the staffing and equipment of European Centers • To acknowledge the ‘quality’ of RT in Europe (BOA) • Conclusions 2
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• Tissue contamination • Storage containers • Containers filling • Room temperature • Malfunctioning equipment • …. Started in 2007 University of Minnesota- Veterinary Diagnostic Laboratory in St Paul 4
1977 RTOG initiation of QA program Retrospective analysis of RTQA showing 19% rate of major deviations (37/198) Composed of: 1)On study review (First week of RT) 2)Retrospective review 5
Eur J Cancer 1993;29A(2):181-184 Assess Quality through • Assessment of structure (Equipment and Work force) • Measurement of process • Patients’ outcome 6
Specific consideration of RTQA for clinical prospective trials 7
Example of Benchmark Case (BC): EORTC 22043 BC
Example of IMRT: 3D-CRT IMRT Parotid Parotid
26081 – Major # 3 ICR evaluations • Major # 3: Wrong protocol used (declared “no boost = European way”, used “boost = American way”). 10
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The ‘quality’ of RT developed in (EORTC) trials should be guaranteed, so as not to corrupt the endpoints of the trial . Messages: Non adherence to protocol specified RT is associated with potential reduced OS, LC and increased toxicity 14
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Examples of trials where the poor quality of RT did indeed corrupt the primary end point: The Head Start trial. 16
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Facility Questionnaire (FQ) 1 External Reference Dosimetry Audit (ERDA) 2 Dummy Run (DR) 3 Limited Individual Case Review (ICR) 4 Extensive Individual Case Review (ICR) 5 Complex Dosimetry Check 22
Facility Questionnaire (FQ) External Reference Dosimetry Audit (ERDA) 23
Results from Facility Questionnaire • One hundred and fifty-six centers from 22 countries completed a validated FQ. • Over this 6 year period the summed average number of cases treated in these centers increased from 2,011 to 2,377 . 45 40 Percentage of Total Centers 35 30 1992 25 2007 20 2013 15 10 5 0 <=1000 1001-1500 1501-2000 2001-2500 2501-3000 3001-3500 >3500 Number of cases treated per year 24
Results from Facility Questionnaire 40% 35% Percentage of Total Centers 30% 25% 1992 20% 2007 15% 2013 10% 5% 0% <=200 201-250 251-300 301-350 >350 Number of cases treated per radiation oncologist per year 25
Results from Facility Questionnaire 2013 (156 Centers) Mean Median Range SD No cases treated/year 2381.4 1938 (350-12000) 1671.3 No FTE Rad Oncs per dept 10.8 8 (1-41) 7.9 No FTE Physicists per dept 7.4 6 (1-35) 5.3 No RTTs per dept 36.1 23 (3-227) 32.9 No cases per RO 243.2 232 (78-617) 94.7 No cases per Physicists 354.3 320 (114-870) 154.3 No cases per RTT 85.7 77 (7-350) 48.1 No RTT per treatment unit 2.9 3 (2-6) 0.9 2007 (98 Centers) Mean Median Range SD No cases treated/year 2016.0 1696 (470-7300) 1272.3 No FTE Rad Oncs per dept 8.5 7 (2-26) 5.3 No FTE Physicists per dept 5.2 4 (1-22) 3.4 No RTTs per dept 26.1 17 (3-120) 22.2 No cases per RO 258.0 248 (99-480) 84.5 No cases per Physicists 426.0 413 (124-827) 142.8 No cases per RTT 107.0 86 (34-734) 96.0 No RTT per treatment unit 2.4 2 (1-5) 1.0 1992 (50 Centers) Mean Median Range SD No cases treated/year 1452.0 (300-3600) 783.0 No FTE Rad Oncs per dept 6.0 (1-22) No FTE Physicists per dept (1-8) No RTTs per dept No cases per RO 316.0 263 (60-1243) No cases per Physicists 464.0 370 (166-1052 ) No cases per RTT 131.0 100 (36- 420) No RTT per treatment unit 2.8 26
2013 (156 Centers) Mean Median Range SD Questionnaire Results from Facility No. Megavoltage units 5.3 4 (1-16) 3.0 No. cases per Unit per year 468.6 450 (175-1733) 183.6 No. cases per simulator/year 1622.9 1542 (350-7000) 1260.0 % centers with dedicated CT Sim 92 % centres with IMRT capability 94 % centres with SBRT capability 65 2007 (98 centers) Mean Median Range SD No. Megavoltage units 3.9 3 (1-12) 2.1 No. cases per Unit per year 488.0 456 (192-1000) 149.7 No. cases per simulator/year 1117.0 1038 (251-2750) 489.1 % centers with dedicated CT Sim 86 % centres with IMRT capability 79 % centres with SBRT capability 54 1992 (50 centers) Mean Median Range No. Megavoltage units 2.6 No. cases per Unit per year 506.0 (234-1033) No. cases per simulator/year 1192.0 (300-2341) % centers with dedicated CT Sim 22 27
Conclusions (FQ) • The standards set by the EORTC-ROG are met by a continually improving number of centers, particularly in regard to staffing levels, treatment planning and machine use, helping to safeguard use of advanced technologies in EORTC-ROG clinical trials. • Numbers of patients treated by ROs and RTTs decreasing • Numbers of patients planned by Medical physicists decreasing • EORTC centers are treating more patients annually • Improving capacity of IMRT delivery and CT simulations 28
Results of BOA • A total of 465 BOA-reports, performed over a time period of 8.5 years (May 2005 until December 2013) were assessed. • These reports were made for 279 institutions , from 33 countries, which provided at least one BOA-report to EORTC for inclusion in a clinical trial involving RT. • The results of 3171 beams , delivered by 755 different treatment units were assessed. This included 18 results for Co-60 beams, 1790 (56%) for photon beams (of which 11 ‘stereotactic radiosurgery dosimetry’) and 1363 (44%) for electron beams. 29
Results of BOA 30
Results of BOA • On average 4 beams (range, 1-65) and 2 treatment units (range, 1-17) were tested during an audit. • Most of the audits were performed by IROC, EQUAL and different auditing bodies which can be brought back to the common denominator of national organizations. ARPANSA AAPM IAEA 3% 1% 4% Local national bodies ( like PTW Freiburg (Germany), SSRMP Equal (Switzerland) 19% etc.) 38% IROC (RPC) 35% 31
Results of BOA • Fourteen beams (0.4%) , of which 10 electron and 4 photon beams, were out of the range of acceptance of 5%, 8.5% were within the non-optimal range (3-5%) of acceptance and 91.1% of the beams were within the optimal limit of < 3%. 400 photons Electrons Number of beams 300 200 100 0 Measure of discordance between stated and measured dose (%) 32
Results of BOA 120 250 100 Number of BOA-reports 200 80 Number of BOA -reports 60 150 40 100 20 50 0 0 1-3 4-8 9-17 machine(s) machines machines 33
Results of BOA Conclusions: • Our analysis shows that the majority (91.9%) of center present beam output variations within the 3% tolerance cutoff. • Only 0.4% of all beam results were found discrepant in respect to a ± 5% level. Although already over 90% of the beams are within the optimal level of agreement (≤ 3%), ideally these results should be optimized. Unfortunately, no temporal trend for improvement has been observed in our study. 34
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