TY - JOUR
T1 - Critical impact of radiotherapy protocol compliance and quality in the treatment of advanced head and neck cancer
T2 - Results from TROG 02.02
AU - Peters, Lester J.
AU - O'Sullivan, Brian
AU - Giralt, Jordi
AU - Fitzgerald, Thomas J.
AU - Trotti, Andy
AU - Bernier, Jacques
AU - Bourhis, Jean
AU - Yuen, Kally
AU - Fisher, Richard
AU - Rischin, Danny
N1 - Copyright © 2023 American Society of Clinical Oncology
PY - 2010/6/20
Y1 - 2010/6/20
N2 - 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+), but were highly correlated with number of patients enrolled at the treatment center (< five patients, 29.8%; ≥ 20 patients, 5.4%; P < .001). In patients who received at least 60 Gy, those with major deficiencies in their treatment plans (n = 87) had a markedly inferior outcome compared with those whose treatment was initially protocol compliant (n = 502): -2 years overall survival, 50% v 70%; hazard ratio (HR), 1.99; P < .001; and 2 years freedom from locoregional failure, 54% v 78%; HR, 2.37; P < .001, respectively. Conclusion: These results demonstrate the critical importance of radiotherapy quality on outcome of chemoradio-therapy in head and neck cancer. Centers treating only a few patients are the major source of quality problems.
AB - 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+), but were highly correlated with number of patients enrolled at the treatment center (< five patients, 29.8%; ≥ 20 patients, 5.4%; P < .001). In patients who received at least 60 Gy, those with major deficiencies in their treatment plans (n = 87) had a markedly inferior outcome compared with those whose treatment was initially protocol compliant (n = 502): -2 years overall survival, 50% v 70%; hazard ratio (HR), 1.99; P < .001; and 2 years freedom from locoregional failure, 54% v 78%; HR, 2.37; P < .001, respectively. Conclusion: These results demonstrate the critical importance of radiotherapy quality on outcome of chemoradio-therapy in head and neck cancer. Centers treating only a few patients are the major source of quality problems.
UR - http://www.scopus.com/inward/record.url?scp=77954600968&partnerID=8YFLogxK
U2 - 10.1200/JCO.2009.27.4498
DO - 10.1200/JCO.2009.27.4498
M3 - Article
C2 - 20479390
AN - SCOPUS:77954600968
SN - 0732-183X
VL - 28
SP - 2996
EP - 3001
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 18
ER -