Critical impact of radiotherapy protocol compliance and quality in the treatment of advanced head and neck cancer
Source: Stanford University Author: Staff Departments of Radiation Oncology and Medical Oncology, and Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Australia; Department of Radiation Oncology, Princess Margaret Hospital, Toronto, Ontario, Canada; Department of Radiation Oncology, Hospital General Vall d'Hebron, Barcelona, Spain; Department of Radiation Oncology, University of Massachusetts Medical Center, North Worcester, MA; Department of Radiation Oncology, H. Lee Moffitt Cancer Center, Tampa, FL; Department of Radiation Oncology, Genolier Swiss Medical Network, Geneva, Switzerland; Department of Radiation Oncology, Institut Gustave Roussy, Villejuif, France; Quality Assurance Review Center, Providence, RI. PURPOSE To report the impact of radiotherapy quality on outcome in a large international phase III trial evaluating radiotherapy with concurrent cisplatin plus tirapazamine for advanced head and neck cancer. PATIENTS AND METHODS The protocol required interventional review of radiotherapy plans by the Quality Assurance Review Center (QARC). All plans and radiotherapy documentation underwent post-treatment review by the Trial Management Committee (TMC) for protocol compliance. Secondary review of noncompliant plans for predicted impact on tumor control was performed. Factors associated with poor protocol compliance were studied, and outcome data were analyzed in relation to protocol compliance and radiotherapy quality. Results At TMC review, 25.4% of the patients had noncompliant plans but none in which QARC-recommended changes had been made. At secondary review, 47% of noncompliant plans (12% overall) had deficiencies with a predicted major adverse impact on tumor control. Major deficiencies were unrelated to tumor subsite or to T or N stage (if N+), [...]