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, ArmB: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.
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa:de:qucosa:87793 |
| Date | 30 October 2023 |
| Creators | Diefenhardt, Markus, Schlenska-Lange, Anke, Kuhnt, Thomas, Kirste, Simon, Piso, Pompiliu, Bechstein, Wolf O., Hildebrandt, Guido, Ghadimi, Michael, Hofheinz, Ralf-Dieter, Rödel, Claus, Fokas, Emmanouil |
| Publisher | MDPI |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | English |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, doc-type:article, info:eu-repo/semantics/article, doc-type:Text |
| Rights | info:eu-repo/semantics/openAccess |
| Relation | 3658 |
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