ArticleClinical and translational radiation oncology2026
De-escalated total neoadjuvant therapy for the non-operative management of rectal cancer: Results of the NOM-3/TNT prospective cohort study.
Article in Clinical and translational radiation oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background and purpose: Total neoadjuvant therapy (TNT) enables non-operative management, although at the cost of increased toxicity. We evaluated a de-escalated TNT-based watch-and-wait (w-w) regimen aimed at reducing toxicity and improving oncological safety through early surgery for poor-responding tumours. Material and methods: Patients with small and intermediate-sized low-lying tumours (cT2-3/T4b N0-2) received short-course radiotherapy followed by 12 weeks of consolidation FOLFOX4. Initial tumour response assessment was performed at the midpoint of chemotherapy (six weeks). Results: Twenty-four patients were included. Based on the initial tumour response assessment, chemotherapy was discontinued in six (25%) patients, including one witha clinical complete response (cCR) and five with a poor response. Grade 3-4 acute toxicity was 17% in the 6-week chemotherapy group and 33% in the 12-week chemotherapy group. Following the initial and second (final) assessments, 16 (66%) patients initiated w-w (eight with cCR and eight with near-cCR), while eight (33%) with a poor-responding/persistent tumour proceeded to total mesorectal excision (TME). Regrowth occurred in seven (44%) patients, including one (13%) of eight who achieved cCR and six (75%) of eight who achieved near-cCR. Five patients with regrowth proceeded to salvage TME, whereas the remaining two refused TME. With a median follow-up of 20 months, sustained cCR at 2 years was 36% (95% confidence interval [CI]: 16-56) and organ preservation adapted disease-free survival 66% (95% CI: 45-87). Conclusion: Our results suggest that the four-tier classification of tumour response (poor response at the midpoint of chemotherapy, persistent tumour, near-cCR and cCR) may reduce toxicity in selected patients.
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