OPRA

Does induction or consolidation sequencing of total neoadjuvant therapy better support organ preservation in stage II–III rectal cancer?

Population and treatment

324 patients with stage II–III rectal adenocarcinoma.

Intervention vs comparator: Induction chemotherapy then chemoradiotherapy vs chemoradiotherapy then consolidation chemotherapy; watch-and-wait for complete/near-complete responders.

Registry: https://pubmed.ncbi.nlm.nih.gov/?term=OPRA+trial+5-year+TME-free+survival

Results

5-year DFS 71% vs 69% (p=0.68). 5-year TME-free survival 39% vs 54% (p=0.012), favouring consolidation. Of 81 regrowths, 94% occurred within 2 years and 99% within 3 years.

TME-free survival · 5 years

NNT: NCT02008656

NNH not calculated without a defensible fixed-time excess-harm risk. Never derive NNT from median survival or HR alone.

Toxicity and treatment burden

54

Full grade 3–5 toxicity, discontinuation, QoL and treatment exposure require primary-report/supplement extraction before full clinical signoff. Missing rates are not imputed.

Interpretation and limitations

DFS was similar while TME-free survival favoured consolidation. Watch-and-wait requires intensive surveillance and timely salvage surgery. Report 15-point absolute difference directly.

Distinguish prespecified from exploratory subgroups, mature from immature endpoints, and superiority from non-inferiority. Verify current guidelines and eligibility.

Primary source

Primary publication / authoritative source ↗

Source-level QoL, discontinuation, full toxicity and guideline currency audit remains a QC requirement.