TY - JOUR
T1 - Importance of Central Imaging Review in a Pediatric Hodgkin Lymphoma Trial Using Positron Emission Tomography Response Adapted Radiation Therapy
AU - Hoppe, Bradford S.
AU - McCarten, Kathleen M.
AU - Pei, Qinglin
AU - Kessel, Sandy
AU - Alazraki, Adina
AU - Mhlanga, Joyce C.
AU - Lai, Hollie A.
AU - Eutsler, Eric
AU - Hodgson, David C.
AU - Roberts, Kenneth B.
AU - Charpentier, Anne Marie
AU - Keller, Frank G.
AU - Voss, Stephan D.
AU - Wu, Yue
AU - Cho, Steve Y.
AU - Kelly, Kara M.
AU - Castellino, Sharon M.
N1 - Funding Information:
This project was funded by the AHOD1331 Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP) grant; Imaging and Radiation Oncology Core (IROC) grant U24 CA180803; National Clinical Trials Network (NCTN) Operations Center grant U10CA180886; NCTN Statistics & Data Center grant U10CA180899; and St. Baldrick's Foundation. For the patients randomized to the experimental arm, brentuximab vedotin was supplied by Seattle Genetics to the National Cancer Institute under a cooperative research and development agreement. The sponsors of this study had no role in the study design; the collection, analysis, and interpretation of data; the writing of the manuscript; or the decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
This project was funded by the AHOD1331 Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP) grant; Imaging and Radiation Oncology Core (IROC) grant U24 CA180803; National Clinical Trials Network (NCTN) Operations Center grant U10CA180886; NCTN Statistics & Data Center grant U10CA180899; and St. Baldrick's Foundation. For the patients randomized to the experimental arm, brentuximab vedotin was supplied by Seattle Genetics to the National Cancer Institute under a cooperative research and development agreement. The sponsors of this study had no role in the study design; the collection, analysis, and interpretation of data; the writing of the manuscript; or the decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/8/1
Y1 - 2023/8/1
N2 - Purpose: We investigated the effects of central review of the interim fluorodeoxyglucose−positron emission tomography/computed tomography (FDG-PET/CT) scan response (iPET) assessment on treatment allocation in the risk-based, response-adapted, Children's Oncology Group study AHOD1331 (ClinicalTrials.gov identifier: NCT02166463) for pediatric patients with high-risk Hodgkin lymphoma. Methods and Materials: Per protocol, after 2 cycles of systemic therapy, patients underwent iPET, with visual response assessment by 5-point Deauville score (DS) at their treating institution and a real-time central review, with the latter considered the reference standard. An area of disease with a DS of 1 to 3 was considered a rapid-responding lesion, whereas a DS of 4 to 5 was considered a slow-responding lesion (SRL). Patients with 1 or more SRLs were considered iPET positive, whereas patients with only rapid-responding lesions were considered iPET negative. We conducted a predefined exploratory evaluation of concordance in iPET response assessment between institutional and central reviews of 573 patients. The concordance rate was evaluated using the Cohen κ statistic (κ > 0.80 was considered very good agreement and κ > 0.60-0.80, good agreement). Results: The concordance rate (514 of 573 [89.7%]) had a κ of 0.685 (95% CI, 0.610-0.759), consistent with good agreement. In terms of the direction of discordance, among the 126 patients who were considered iPET positive by institutional review, 38 (30.2%) were categorized as iPET negative by central review, preventing overtreatment with radiation therapy. Conversely, among the 447 patients who were considered iPET negative by institutional review, 21 patients (4.7%) were categorized as iPET positive by the central review and would have been undertreated without radiation therapy. Conclusions: Central review is integral to PET response−adapted clinical trials for children with Hodgkin lymphoma. Continued support of central imaging review and education about DS are needed.
AB - Purpose: We investigated the effects of central review of the interim fluorodeoxyglucose−positron emission tomography/computed tomography (FDG-PET/CT) scan response (iPET) assessment on treatment allocation in the risk-based, response-adapted, Children's Oncology Group study AHOD1331 (ClinicalTrials.gov identifier: NCT02166463) for pediatric patients with high-risk Hodgkin lymphoma. Methods and Materials: Per protocol, after 2 cycles of systemic therapy, patients underwent iPET, with visual response assessment by 5-point Deauville score (DS) at their treating institution and a real-time central review, with the latter considered the reference standard. An area of disease with a DS of 1 to 3 was considered a rapid-responding lesion, whereas a DS of 4 to 5 was considered a slow-responding lesion (SRL). Patients with 1 or more SRLs were considered iPET positive, whereas patients with only rapid-responding lesions were considered iPET negative. We conducted a predefined exploratory evaluation of concordance in iPET response assessment between institutional and central reviews of 573 patients. The concordance rate was evaluated using the Cohen κ statistic (κ > 0.80 was considered very good agreement and κ > 0.60-0.80, good agreement). Results: The concordance rate (514 of 573 [89.7%]) had a κ of 0.685 (95% CI, 0.610-0.759), consistent with good agreement. In terms of the direction of discordance, among the 126 patients who were considered iPET positive by institutional review, 38 (30.2%) were categorized as iPET negative by central review, preventing overtreatment with radiation therapy. Conversely, among the 447 patients who were considered iPET negative by institutional review, 21 patients (4.7%) were categorized as iPET positive by the central review and would have been undertreated without radiation therapy. Conclusions: Central review is integral to PET response−adapted clinical trials for children with Hodgkin lymphoma. Continued support of central imaging review and education about DS are needed.
UR - http://www.scopus.com/inward/record.url?scp=85151424514&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2023.02.020
DO - 10.1016/j.ijrobp.2023.02.020
M3 - Article
C2 - 36868525
AN - SCOPUS:85151424514
SN - 0360-3016
VL - 116
SP - 1025
EP - 1030
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 5
ER -