X Allen Li1, Jennifer Moughan2, Julia R White3, Gary M Freedman4, Douglas W Arthur5, James Galvin6, Ying Xiao4, Susan McNulty6, Janice A Lyons7, Vivek S Kavadi8, Marc T Fields9, Melissa P Mitchell10, Bethany M Anderson11, Michael I Lock12, Kristine E Kokeny13, Jose G Bazan3, Adam D Currey14, Tarek Hijal15, Sally B Cheston16, Frank A Vicini17. 1. Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin. Electronic address: ali@mcw.edu. 2. NRG Oncology Statistics and Data Management Center/ACR, Philadelphia, Pennsylvania. 3. Ohio State University Comprehensive Cancer Center, Columbus, Ohio. 4. Department of Radiation Oncology, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania. 5. Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia. 6. Imaging and Radiation Oncology Core (IROC), Philadelphia, Pennsylvania. 7. Case Western Reserve University, Cleveland, Ohio. 8. Texas Oncology Cancer Center Sugar Land, Sugar Land, Texas. 9. Rohnert Park Cancer Center Kaiser Permanente Medical Group, Rohnert Park, California. 10. University of Kansas Cancer Center. 11. University of Wisconsin Hospital and Clinics, Madison, Wisconsin. 12. London Regional Cancer Program, London, Ontario, Canada. 13. Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah. 14. Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin. 15. Division of Radiation Oncology, McGill University Health Centre, Montreal, Canada. 16. Department of Radiation Oncology, Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, Maryland. 17. 21st Century Oncology MHP - Farmington, Farmington Hills, Michigan.
Abstract
PURPOSE: To investigate patterns of failure in institutional credentialing submissions to NRG/RTOG 1005 with the aim of improving the quality and consistency for future breast cancer protocols. METHODS AND MATERIALS: NRG/RTOG 1005 allowed the submission of 3-dimensional conformal radiation therapy (3DCRT), intensity-modulated radiation therapy (IMRT), and simultaneous integrated boost (SIB) breast plans. Credentialing required institutions to pass a 2-step quality assurance (QA) process: (1) benchmark, requiring institutions to create a plan with no unacceptable deviations and ≤1 acceptable variation among the dose volume (DV) criteria, and (2) rapid review, requiring each institution's first protocol submission to have no unacceptable deviations among the DV criteria or contours. Overall rates, number of resubmissions, and reasons for resubmission were analyzed for each QA step. RESULTS: In total, 352 institutions participated in benchmark QA and 280 patients enrolled had rapid review QA. Benchmark initial failure rates were similar for 3DCRT (18%), IMRT (17%), and SIB (18%) plans. For 3DCRT and IMRT benchmark plans, ipsilateral lung most frequently failed the DV criteria, and SIB DV failures were seen most frequently for the heart. Rapid review contour initial failures (35%) were due to target rather than organs at risk. For 29% of the rapid review initial failures, the planning target volume boost eval volume was deemed an unacceptable deviation. CONCLUSIONS: The review of the benchmark and rapid review QA submissions indicates that acceptable variations or unacceptable deviations for the ipsilateral lung and heart dose constraints were the most commonly observed cause of benchmark QA failure, and unacceptable deviations in target contouring, rather than normal structure contouring, were the most common cause of rapid review QA failure. These findings suggest that a rigorous QA process is necessary for high quality and homogeneity in radiation therapy in multi-institutional trials of breast cancer to ensure that the benefits of radiation therapy far outweigh the risks.
PURPOSE: To investigate patterns of failure in institutional credentialing submissions to NRG/RTOG 1005 with the aim of improving the quality and consistency for future breast cancer protocols. METHODS AND MATERIALS: NRG/RTOG 1005 allowed the submission of 3-dimensional conformal radiation therapy (3DCRT), intensity-modulated radiation therapy (IMRT), and simultaneous integrated boost (SIB) breast plans. Credentialing required institutions to pass a 2-step quality assurance (QA) process: (1) benchmark, requiring institutions to create a plan with no unacceptable deviations and ≤1 acceptable variation among the dose volume (DV) criteria, and (2) rapid review, requiring each institution's first protocol submission to have no unacceptable deviations among the DV criteria or contours. Overall rates, number of resubmissions, and reasons for resubmission were analyzed for each QA step. RESULTS: In total, 352 institutions participated in benchmark QA and 280 patients enrolled had rapid review QA. Benchmark initial failure rates were similar for 3DCRT (18%), IMRT (17%), and SIB (18%) plans. For 3DCRT and IMRT benchmark plans, ipsilateral lung most frequently failed the DV criteria, and SIB DV failures were seen most frequently for the heart. Rapid review contour initial failures (35%) were due to target rather than organs at risk. For 29% of the rapid review initial failures, the planning target volume boost eval volume was deemed an unacceptable deviation. CONCLUSIONS: The review of the benchmark and rapid review QA submissions indicates that acceptable variations or unacceptable deviations for the ipsilateral lung and heart dose constraints were the most commonly observed cause of benchmark QA failure, and unacceptable deviations in target contouring, rather than normal structure contouring, were the most common cause of rapid review QA failure. These findings suggest that a rigorous QA process is necessary for high quality and homogeneity in radiation therapy in multi-institutional trials of breast cancer to ensure that the benefits of radiation therapy far outweigh the risks.
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