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ORATOR was the first randomised comparison of surgery and radiotherapy for early throat cancer; swallowing scores a year later were slightly better after radiotherapy, but the difference was smaller than patients would notice, so both remain reasonable choices.
Transoral robotic surgery had spread rapidly for early oropharyngeal cancer on the assumption that it spares swallowing function compared with radiotherapy, without randomised evidence. The Canadian ORATOR trial randomised 68 patients with T1 to T2, N0 to N2 oropharyngeal squamous cell carcinoma, most of them HPV-positive, to radiotherapy (70 Gy, with concurrent cisplatin for node-positive disease) or to transoral robotic surgery with neck dissection and risk-adapted adjuvant therapy. The primary endpoint was the MD Anderson Dysphagia Inventory score at one year.
Swallowing quality of life was statistically better after radiotherapy but the difference fell short of the threshold regarded as clinically meaningful, and the toxicity profiles differed (more bleeding and pain with surgery, more hearing loss and mucositis with radiotherapy). Oncological outcomes were similar and good. The follow-on ORATOR2 trial compared de-intensified versions of both approaches.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
68 enrolled.
Trial powered for a 10-point, clinically meaningful difference
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| MD Anderson Dysphagia Inventory total score at 1 year (mean)primary | Radiotherapy (70 Gy, with chemotherapy if N1-2) | 34 | 86.9 points | - | 0.042 | link |
| Transoral robotic surgery + neck dissection | 34 | 80.1 points | ||||
| Neutropenia | Radiotherapy (70 Gy, with chemotherapy if N1-2) | 34 | 18% | - | - | link |
| Transoral robotic surgery + neck dissection | 34 | 0% | ||||
| Hearing loss | Radiotherapy (70 Gy, with chemotherapy if N1-2) | 34 | 38% | - | - | link |
| Transoral robotic surgery + neck dissection | 34 | 15% | ||||
| Trismus | Radiotherapy (70 Gy, with chemotherapy if N1-2) | 34 | 3% | - | - | link |
| Transoral robotic surgery + neck dissection | 34 | 26% |
Shares Platinum agents, Cisplatin, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cisplatin, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cisplatin, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cisplatin and the tag subtype-trials.
Shares Cytotoxic chemotherapy and the tag subtype-trials.
Shares Platinum agents, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Platinum agents, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cisplatin and the tag subtype-trials.