Total neoadjuvant therapy for rectal cancer in the CAO/ARO/AIO-12 randomized phase 2 trial

• Verfasst von: Diefenhardt, Markus [VerfasserIn]
• Verfasst von: Schlenska-Lange, Anke [VerfasserIn]
• Verfasst von: Kuhnt, Thomas [VerfasserIn]
• Verfasst von: Kirste, Simon [VerfasserIn]
• Verfasst von: Piso, Pompiliu Ioan [VerfasserIn]
• Verfasst von: Bechstein, Wolf Otto [VerfasserIn]
• Verfasst von: Hildebrandt, Guido [VerfasserIn]
• Verfasst von: Ghadimi, Michael [VerfasserIn]
• Verfasst von: Hofheinz, Ralf-Dieter [VerfasserIn]
• Verfasst von: Rödel, Claus [VerfasserIn]
• Verfasst von: Fokas, Emmanouil [VerfasserIn]
• Titel: Total neoadjuvant therapy for rectal cancer in the CAO/ARO/AIO-12 randomized phase 2 trial
• Titelzusatz: early surrogate endpoints revisited
• Verf.angabe: Markus Diefenhardt, Anke Schlenska-Lange, Thomas Kuhnt, Simon Kirste, Pompiliu Piso, Wolf O. Bechstein, Guido Hildebrandt, Michael Ghadimi, Ralf-Dieter Hofheinz, Claus Rödel and Emmanouil Fokas on behalf of the German Rectal Cancer Study Group
• E-Jahr: 2022
• Jahr: 27 July 2022
• Umfang: 12 S.
• Fussnoten: Gesehen am 13.03.2023
• Titel Quelle: Enthalten in: Cancers
• Ort Quelle: Basel : MDPI, 2009
• Jahr Quelle: 2022
• Band/Heft Quelle: 14(2022), 15, Artikel-ID 3658, Seite 1-12
• ISSN Quelle: 2072-6694
• DOI: doi:10.3390/cancers14153658
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: clinical trial
• Sach-SW: disease-free survival
• Sach-SW: early surrogate endpoints
• Sach-SW: locally advanced rectal cancer
• Sach-SW: tumor regression
• K10plus-PPN: 1838929207

Abstract

Background: Early efficacy outcome measures in rectal cancer after total neoadjuvant treatment are increasingly investigated. We examined the prognostic role of pathological complete response (pCR), tumor regression grading (TRG) and neoadjuvant rectal (NAR) score for disease-free survival (DFS) in patients with rectal carcinoma treated within the CAO/ARO/AIO-12 randomized phase 2 trial. Methods: Distribution of pCR, TRG and NAR score was analyzed using the Pearson’s chi-squared test. Univariable analyses were performed using the log-rank test, stratified by treatment arm. Discrimination ability of non-pCR for DFS was assessed by analyzing the ROC curve as a function of time. Results: Of the 311 patients enrolled, 306 patients were evaluable (Arm A:156, Arm B:150). After a median follow-up of 43 months, the 3-year DFS was 73% in both groups (HR, 0.95, 95% CI, 0.63-1.45, p = 0.82). pCR tended to be higher in Arm B (17% vs. 25%, p = 0.086). In both treatment arms, pCR, TRG and NAR were significant prognostic factors for DFS, whereas survival in subgroups defined by pCR, TRG or NAR did not significantly differ between the treatment arms. The discrimination ability of non-pCR for DFS remained constant over time (C-Index 0.58) but was slightly better in Arm B (0.61 vs. 0.56). Conclusion: Although pCR, TRG and NAR were strong prognostic factors for DFS in the CAO/ARO/AIO-12 trial, their value in selecting one TNT approach over another could not be confirmed. Hence, the conclusion of a long-term survival benefit of one treatment arm based on early surrogate endpoints should be stated with caution.