Adherence to Contouring and Treatment Planning Requirements Within a Multicentric Trial: Results of the Quality Assurance of the SAKK 09/10 trial.

Details

Serval ID
serval:BIB_0687223AA24B
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Adherence to Contouring and Treatment Planning Requirements Within a Multicentric Trial: Results of the Quality Assurance of the SAKK 09/10 trial.
Journal
International journal of radiation oncology, biology, physics
Author(s)
Beck M., Sassowsky M., Schär S., Mathier E., Halter M., Zwahlen D.R., Hölscher T., Arnold W., Polat B., Hildebrandt G., Müller A.C., Putora P.M., Papachristofilou A., Hayoz S., Schär C., Li Q., Sumila M., Zaugg K., Guckenberger M., Ost P., Bosetti D.G., Reuter C., Gomez S., Khanfir K., Aebersold D.M., Ghadjar P., Pra A.D.
ISSN
1879-355X (Electronic)
ISSN-L
0360-3016
Publication state
Published
Issued date
01/05/2022
Peer-reviewed
Oui
Volume
113
Number
1
Pages
80-91
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
To evaluate the results of the radiation therapy (RT) quality assurance (QA) program of the phase 3 randomized SAKK 09/10 trial in patients with biochemically recurrent prostate cancer after prostatectomy.
Within the Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung (SAKK) 09/10 trial testing 64-Gy versus 70-Gy salvage RT, a central collection of treatment plans was performed and thoroughly reviewed by a dedicated medical physicist and radiation oncologist. Adherence to the treatment protocol and specifically to the European Organization for the Research and Treatment of Cancer (EORTC) guidelines for target volume definition (classified as deviation observed yes vs no) and its potential correlation with acute and late toxicity (Common Terminology Criteria for Adverse Events version 4.0) and freedom from biochemical progression (FFBP) were investigated.
The treatment plans for 344 patients treated between February 2011 and April 2014 depicted important deviations from the EORTC guidelines and the recommendations per trial protocol. For example, in up to half of the cases, the delineated structures deviated from the protocol (eg, prostate bed in 48.8%, rectal wall [RW] in 41%). In addition, variations in clinical target volume (CTV) and planning target volume (PTV) occurred frequently (eg, CTV and PTV deviations in up to 42.4% and 25.9%, respectively). The detected deviations showed a significant association with a lower risk of grade ≥2 gastrointestinal acute toxicity when the CTV did not overlap the RW versus when the CTV overlapped the RW (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.22-0.85; P = .014), and a higher rate of grade ≥2 late genitourinary (GU) toxicity when the CTV overlapped the RW (OR, 2.58; 95% CI, 1.17-5.72; P = .019). A marginally significant lower risk of grade ≥2 late GU toxicity was observed when the prostate bed did not overlap versus did overlap the RW (OR, 0.51; 95% CI, 0.25-1.03; P = .06). In addition, a marginally significant decrease in FFBP was observed in patients with PTV not including surgical clips as potential markers of the limits of the prostate bed (hazard ratio, 1.44; 95% CI, 0.96-2.17; P = .07).
Despite a thorough QA program, the central review of a phase 3 trial showed limited adherence to treatment protocol recommendations, which was associated with a higher risk of toxicity by means of acute or late gastrointestinal or GU toxicity and showed a trend toward worse FFBP. Data from this QA review might help to refine future QA programs and prostate bed delineation guidelines.
Keywords
Gastrointestinal Diseases/etiology, Humans, Male, Prostatectomy, Prostatic Neoplasms/diagnostic imaging, Prostatic Neoplasms/radiotherapy, Radiotherapy, Intensity-Modulated/methods, Rectum, Salvage Therapy/methods
Pubmed
Web of science
Create date
16/11/2022 17:14
Last modification date
17/11/2022 6:42
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