Clinical outcome after total neoadjuvant treatment (CAO/ARO/AIO-12) versus intensified neoadjuvant and adjuvant treatment (CAO/ARO/AIO-04) a comparison between two multicenter randomized phase II/III trials

• Verfasst von: Diefenhardt, Markus [VerfasserIn]
• Verfasst von: Fleischmann, Maximillian [VerfasserIn]
• Verfasst von: Martin, Daniel [VerfasserIn]
• Verfasst von: Hofheinz, Ralf-Dieter [VerfasserIn]
• Verfasst von: Piso, Pompiliu [VerfasserIn]
• Verfasst von: Germer, Christoph-Thomas [VerfasserIn]
• Verfasst von: Hambsch, Peter [VerfasserIn]
• Verfasst von: Grützmann, Robert [VerfasserIn]
• Verfasst von: Kirste, Simon [VerfasserIn]
• Verfasst von: Schlenska-Lange, Anke [VerfasserIn]
• Verfasst von: Ghadimi, Michael [VerfasserIn]
• Verfasst von: Rödel, Claus [VerfasserIn]
• Verfasst von: Fokas, Emmanouil [VerfasserIn]
• Titel: Clinical outcome after total neoadjuvant treatment (CAO/ARO/AIO-12) versus intensified neoadjuvant and adjuvant treatment (CAO/ARO/AIO-04) a comparison between two multicenter randomized phase II/III trials
• Verf.angabe: Markus Diefenhardt, Maximillian Fleischmann, Daniel Martin, Ralf-Dieter Hofheinz, Pompiliu Piso, Christoph-Thomas Germer, Peter Hambsch, Robert Grützmann, Simon Kirste, Anke Schlenska-Lange, Michael Ghadimi, Claus Rödel, Emmanouil Fokas, on behalf of the German Rectal Cancer Study Group
• E-Jahr: 2023
• Jahr: February 2023
• Umfang: 10 S.
• Illustrationen: Illustrationen
• Fussnoten: Online verfügbar: 23. Dezember 2022, Artikelversion: 4. Januar 2023 ; Gesehen am 01.08.2024
• Titel Quelle: Enthalten in: Radiotherapy and oncology
• Ort Quelle: Amsterdam [u.a.] : Elsevier Science, 1983
• Jahr Quelle: 2023
• Band/Heft Quelle: 179(2023), Artikel-ID 109455
• ISSN Quelle: 1879-0887
• DOI: doi:10.1016/j.radonc.2022.109455
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Clinical trial
• Sach-SW: Oxaliplatin
• Sach-SW: Radiotherapy
• Sach-SW: Rectal cancer
• Sach-SW: Survival
• Sach-SW: TNT
• K10plus-PPN: 1897419562

Abstract

Background - Total neoadjuvant therapy (TNT) can enhance local tumor regression, but its survival benefits compared to intensified chemoradiotherapy (CRT) followed by adjuvant chemotherapy (CT) remain unclear. - Methods - This is a secondary comparison between 607 patients treated with intensified 5-FU/Oxaliplatin neoadjuvant CRT and adjuvant CT within the experimental arm of the CAO/ARO/AIO-04 phase III trial, and 306 patients treated with TNT within the CAO/ARO/AIO-12 phase II trial. Comparison between clinical-pathological characteristics, surgical quality, and post-surgical complications were analyzed using the Pearson’s Chi-squared or Mann-Whitney U test. Oncological outcome was examined with log-rank, Gray’s test, and multivariate cox regression. In addition, further subgroup analyses and propensity score matching were performed to optimize the balance of baseline covariates. - Findings - Patients treated with CRT followed by consolidation CT had a significantly higher rate of pathological complete remission (pCR) compared to patients treated within the experimental arm of the CAO/ARO/AIO-04 trial (25.3 % vs 17.3 %, P = 0.04). Post-surgical complications were less common in the CAO/ARO/AIO-12 trial. After a median follow-up of 46 months, clinical outcome did not differ significantly in the overall cohort, in any subgroup or after propensity score matching. In multivariate analysis, disease-free survival (DFS) was similar between the experimental arm of the CAO/ARO/AIO-04 trial and treatments arms of the CAO/ARO/AIO-12 trial (vs arm A: HR 0.92 [95 % CI 0.62-1.37], P = 0.69; vs arm B: HR 1.06 [95 % CI 0.72-1.58], P = 0.76). - Interpretation - Notwithstanding the limitations of intertrial comparison, TNT did not improve long term oncological outcome in our study compared to the intensified neoadjuvant CRT and adjuvant CT treatment in the CAO/ARO/AIO-04 trial. Improved response rates after TNT offers an attractive option to explore organ preservation in selective patients with locally advanced rectal cancer.