A phase II randomized trial for early-stage squamous cell carcinoma of the oropharynx: Radiotherapy versus trans-oral robotic surgery (ORATOR).
Bibliographic record
Abstract
6006 Background: The incidence of OPSCC has risen rapidly, due to an epidemic of human papillomavirus (HPV) infection. Radiation therapy (RT) has historically been the standard treatment, but transoral robotic surgery (TORS) has surpassed RT in the US as the most common approach, based on assumptions of reduced toxicity or improved quality of life (QOL). No randomized trials have previously compared these treatments. Methods: The ORATOR trial (NCT01590355) enrolled patients with T1-T2 N0-2(≤4 cm) OPSCC amenable to TORS. We randomly assigned patients, stratified by p16 status, to RT (70 Gy/35 fractions, with chemotherapy if N1-2) vs. TORS (± adjuvant [chemo]RT based on pathology). The primary endpoint was a definitive comparison of swallowing QOL at 1-year using the MD Anderson Dysphagia Inventory (MDADI), powered to detect a 10-point improvement (a clinically-meaningful change [CMC]) in the TORS arm. Secondary endpoints included adverse events (AEs), other QOL outcomes [including EORTC scales, the Voice Handicap Index-10, Neck Dissection Impairment Index, and Patient Neurotoxicity Questionnaire], overall- and progression-free survival (OS, PFS). All analyses were pre-specified and intention-to-treat. Results: Between 2012 and 2017, 68 patients were randomized (n = 34 in each arm), in Canada and Australia. Median age was 59 years; 87% were male. Primary tumor sites were palatine tonsil (74%) or base of tongue (26%). Arms were well-balanced for baseline factors, including p16 status (88% in each arm). Median follow-up was 27 months. MDADI scores at 1-year were statistically superior in the RT arm (mean ± SD: 86.9 ± 11.4 vs. 80.1 ± 13.0 in the TORS arm; p = 0.042), but not meeting the definition of a CMC. For the other QOL metrics, outcomes were similar at 1-year. Feeding tube rates at 1-year were 3% (n = 1) vs. 0% respectively. Rates of treatment-related grade ≥2 AEs were similar (91% vs. 100%, p = 0.24), with more neutropenia, constipation and tinnitus in the RT arm and more trismus in the TORS arm (all p < 0.05). There was one TORS bleeding-related death. OS and PFS were similar. Conclusions: RT had superior swallowing QOL scores at 1 year compared to TORS, but the difference was not a CMC. Toxicities differed between the arms. This study provides the first level 1 evidence to inform patients of the QOL impact of both approaches. Clinical trial information: NCT01590355.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.016 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".