ORATOR

Background

Phase II, multicenter, international, open-label randomized (ORATOR). N=68 (34/arm), T1–T2 N0–N2 (≤4 cm) OPSCC, 6 centers Canada/Australia 2012–2017, stratified by p16. Compared RT-based management vs transoral robotic surgery (TORS) + neck dissection. Primary endpoint: 1-yr MDADI swallowing QoL.

Interventions and follow up

Arm A: definitive radiotherapy ± chemotherapy
Arm B: transoral robotic surgery (TORS) + neck dissection ± adjuvant (chemo)RT
Primary endpoint: MDADI swallowing-related QoL total score at 1 yr
mFollow up: RT 25 mo; TORS 29 mo

Results

MDADI total at 1 yr: 86.9 (RT) vs 80.1 (TORS), P=.042 — RT superior (higher = better), did not meet prespecified 10-point clinical threshold
Treatment-related death: 0 (RT) vs 1 (TORS; post-op hemorrhage)

Adverse events

Grade ≥3 (RT): neutropenia 18%, hearing loss 38%, tinnitus 35%, mucositis 12%
Grade ≥3 (TORS): dysphagia 26%, trismus 26%, 1 fatal hemorrhage
Adjuvant CRT (TORS): 24% received (positive margins/ECE) — effectively trimodal
Note: swallowing favored RT at 1 yr; trismus dominant TORS-specific long-term concern

Conclusions

RT achieved superior 1-yr swallowing QoL vs TORS + neck dissection for T1–T2 OPSCC, though the 86.9 vs 80.1 difference did not meet the prespecified 10-point clinical threshold; toxicity profiles differed, with TORS showing higher dysphagia/trismus plus one treatment-related death.

Key Limitations

Small phase II (N=68); QoL surrogate primary endpoint, not survival; difference below clinical-meaningfulness threshold; 24% TORS crossover to trimodal therapy; short follow-up.

Clinical Context

First randomized comparison of primary RT vs TORS in early OPSCC; supports definitive RT as a function-preserving option and informs the ongoing surgery-vs-radiation de-intensification debate (ORATOR2 followed).

References