Critical impact of radiotherapy protocol compliance and quality in the treatment of retroperitoneal sarcomas: Results from the EORTC 62092-22092 STRASS trial.
protocol compliance
quality assurance
radiotherapy
retroperitoneal sarcomas
soft tissue sarcomas
Journal
Cancer
ISSN: 1097-0142
Titre abrégé: Cancer
Pays: United States
ID NLM: 0374236
Informations de publication
Date de publication:
15 07 2022
15 07 2022
Historique:
revised:
19
01
2022
received:
23
08
2021
accepted:
28
01
2022
pubmed:
11
5
2022
medline:
24
6
2022
entrez:
10
5
2022
Statut:
ppublish
Résumé
The European Organization for Research and Treatment of Cancer 22092-62092 STRASS trial failed to demonstrate the superiority of neoadjuvant radiotherapy (RT) over surgery alone in patients with retroperitoneal sarcoma. Therefore, an RT quality-assurance program was added to the study protocol to detect and correct RT deviations. The authors report results from the trial RT quality-assurance program and its potential effect on patient outcomes. To evaluate the effect of RT compliance on survival outcomes, a composite end point was created. It combined the information related to planning target volume coverage, target delineation, total dose received, and overall treatment time into 2 groups: non-RT-compliant (NRC) for patients who had unacceptable deviation(s) in any of the previous categories and RT-compliant (RC) otherwise. Abdominal recurrence-free survival (ARFS) and overall survival were compared between the 2 groups using a Cox proportional hazard model adjusted for known prognostic factors. Thirty-six of 125 patients (28.8%) were classified as NRC, and the remaining 89 patients (71.2%) were classified as RC. The 3-year ARFS rate was 66.8% (95% confidence interval [CI], 55.8%-75.7%) and 49.8% (95% CI, 32.7%-64.8%) for the RC and NRC groups, respectively (adjusted hazard ratio, 2.32; 95% CI, 1.25-4.32; P = .008). Local recurrence after macroscopic complete resection occurred in 13 of 89 patients (14.6%) versus 2 of 36 patients (5.6%) in the RC and NRC groups, respectively. The current analysis suggests a significant benefit in terms of ARFS in favor of the RC group. This association did not translate into less local relapses after complete resection in the RC group. Multidisciplinary collaboration and review of cases are critical to avoid geographic misses, especially for rare tumors like retroperitoneal sarcoma.
Sections du résumé
BACKGROUND
The European Organization for Research and Treatment of Cancer 22092-62092 STRASS trial failed to demonstrate the superiority of neoadjuvant radiotherapy (RT) over surgery alone in patients with retroperitoneal sarcoma. Therefore, an RT quality-assurance program was added to the study protocol to detect and correct RT deviations. The authors report results from the trial RT quality-assurance program and its potential effect on patient outcomes.
METHODS
To evaluate the effect of RT compliance on survival outcomes, a composite end point was created. It combined the information related to planning target volume coverage, target delineation, total dose received, and overall treatment time into 2 groups: non-RT-compliant (NRC) for patients who had unacceptable deviation(s) in any of the previous categories and RT-compliant (RC) otherwise. Abdominal recurrence-free survival (ARFS) and overall survival were compared between the 2 groups using a Cox proportional hazard model adjusted for known prognostic factors.
RESULTS
Thirty-six of 125 patients (28.8%) were classified as NRC, and the remaining 89 patients (71.2%) were classified as RC. The 3-year ARFS rate was 66.8% (95% confidence interval [CI], 55.8%-75.7%) and 49.8% (95% CI, 32.7%-64.8%) for the RC and NRC groups, respectively (adjusted hazard ratio, 2.32; 95% CI, 1.25-4.32; P = .008). Local recurrence after macroscopic complete resection occurred in 13 of 89 patients (14.6%) versus 2 of 36 patients (5.6%) in the RC and NRC groups, respectively.
CONCLUSIONS
The current analysis suggests a significant benefit in terms of ARFS in favor of the RC group. This association did not translate into less local relapses after complete resection in the RC group. Multidisciplinary collaboration and review of cases are critical to avoid geographic misses, especially for rare tumors like retroperitoneal sarcoma.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2796-2805Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2022 American Cancer Society.
Références
Haas RLM, Bonvalot S, Miceli R, Strauss DC, Swallow CJ, Hohenberger P, et al. Radiotherapy for retroperitoneal liposarcoma: report from the Transatlantic Retroperitoneal Sarcoma Working Group. Cancer. 2019;125:1290-1300. doi:10.1002/cncr.31927
Bonvalot S, Gronchi A, Le Pechoux C, et al. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020;21:1366-1377. doi:10.1016/S1470-2045(20)30446-0
Citrin DE. Recent developments in radiotherapy. N Engl J Med. 2017;377:1065-1075. doi:10.1056/NEJMra1608986
Fairchild A, Bar-Deroma R, Collette L, et al. Development of clinical trial protocols involving advanced radiation therapy techniques: the European Organisation for Research and Treatment of Cancer Radiation Oncology Group approach. Eur J Cancer. 2012;48:1048-1054. doi:10.1016/j.ejca.2012.02.008
Bonvalot S, Rivoire M, Castaing M, et al. Primary retroperitoneal sarcomas: a multivariate analysis of surgical factors associated with local control. J Clin Oncol. 2009;27:31-37. doi:10.1200/JCO.2008.18.0802
Jacquet P, Sugarbaker PH. Clinical research methodologies in diagnosis and staging of patients with peritoneal carcinomatosis. In: Sugarbaker PH, ed. Peritoneal Carcinomatosis: Principals of Management. Kluwer Academic Publishers; 1996:359-374.
Bossi A, De Wever I, Van Limbergen E, Vanstraelen B. Intensity modulated radiation-therapy for preoperative posterior abdominal wall irradiation of retroperitoneal liposarcomas. Int J Radiat Oncol Biol Phys. 2007;67:164-170. doi:10.1016/j.ijrobp.2006.08.023
Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481. doi:10.1080/01621459.1958.10501452
Lin DY, Wei LJ, Ying Z. Checking the Cox model with cumulative sums of martingale-based residuals. Biometrika. 1993;80:557-572. doi:10.1093/biomet/80.3.557
Yang JC, Chang AE, Baker AR, et al. Randomized prospective study of the benefit of adjuvant radiation therapy in the treatment of soft tissue sarcomas of the extremity. J Clin Oncol. 1998;16:197-203. doi:10.1200/JCO.1998.16.1.197
van Houdt WJ, Fiore M, Barretta F, et al. Patterns of recurrence and survival probability after second recurrence of retroperitoneal sarcoma: a study from TARPSWG. Cancer. 2020;126:4917-4925. doi:10.1002/cncr.33139
Chouliaras K, Senehi R, Ethun CG, et al. Recurrence patterns after resection of retroperitoneal sarcomas: an eight-institution study from the US Sarcoma Collaborative. J Surg Oncol. 2019;120:340-347. doi:10.1002/jso.25606
Liang Y, Guo T, Hong D, Xiao W, Zhou Z, Zhang X. Time to local recurrence as a predictor of survival in patients with soft tissue sarcoma of the extremity and abdominothoracic wall. Front Oncol. 2020;10:599097. doi:10.3389/fonc.2020.599097
Baldini EH, Abrams RA, Bosch W, et al. Retroperitoneal sarcoma target volume and organ at risk contour delineation agreement among NRG sarcoma radiation oncologists. Int J Radiat Oncol Biol Phys. 2015;92:1053-1059. doi:10.1016/j.ijrobp.2015.04.039
Baldini EH, Wang D, Haas RLM, et al. Treatment guidelines for preoperative radiation therapy for retroperitoneal sarcoma: preliminary consensus of an international expert panel. Int J Radiat Oncol Biol Phys. 2015;92:602-612. doi:10.1016/j.ijrobp.2015.02.013
Weber DC, Tomsej M, Melidis C. QA makes a clinical trial stronger: evidence-based medicine in radiation therapy. Radiother Oncol. 2012;105:4-8. doi:10.1016/j.radonc.2012.08.008
Ohri N, Shen X, Dicker AP, Doyle LA, Harrison AS, Showalter TN. Radiotherapy protocol deviations and clinical outcomes: a meta-analysis of cooperative group clinical trials. J Natl Cancer Inst. 2013;105:387-393. doi:10.1093/jnci/djt001
Blay JY, Honore C, Stoeckle E, et al. Surgery in reference centers improves survival of sarcoma patients: a nationwide study. Ann Oncol. 2019;30:1143-1153. doi:10.1093/annonc/mdz124
Venigalla S, Nead KT, Sebro R, et al. Association between treatment at high-volume facilities and improved overall survival in soft tissue sarcomas. Int J Radiat Oncol Biol Phys. 2018;100:1004-1015. doi:10.1016/j.ijrobp.2017.12.262