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E3311 showed that after robotic surgery for HPV-positive throat cancer, patients at intermediate risk could safely have a lower radiotherapy dose, with about 95 in 100 free of progression at two years, so surgery-first de-escalation became a recognised option.
E3311 enrolled 519 patients with HPV-positive oropharyngeal cancer suitable for transoral surgery. After resection and neck dissection they were assigned by pathology: low-risk patients had no further treatment, intermediate-risk patients were randomised to 50 Gy or the standard 60 Gy of radiotherapy, and high-risk patients (extranodal extension or positive margins) had 66 Gy with cisplatin.
Reported by Robert Ferris in the Journal of Clinical Oncology in 2022, two-year progression-free survival was 96.9 percent with observation, 94.9 percent with 50 Gy, 96.0 percent with 60 Gy and 90.7 percent in the high-risk chemoradiation arm. Swallowing scores were good and the reduced-dose arm had less toxicity. Transoral surgery was safe in experienced hands, with low rates of serious bleeding.
The trial, alongside the phase 2 PATHOS study in Britain, made surgery followed by pathology-guided reduced adjuvant treatment a standard route to de-escalation for HPV-positive disease, in contrast to the definitive chemoradiation setting where reduced doses failed in NRG-HN005.
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.
519 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 2 yearsprimary | Low risk, observation | - | 96.9% | - | - | - |
| Intermediate risk, 50 Gy | - | 94.9% | ||||
| Intermediate risk, 60 Gy | - | 96% | ||||
| High risk, 66 Gy + cisplatin | - | 90.7% |
Shares HPV-positive oropharyngeal cancer, Oropharyngeal cancer (tonsil and base of tongue), Cisplatin, IMRT / IGRT (modern external beam).
Shares HPV-positive oropharyngeal cancer, Oropharyngeal cancer (tonsil and base of tongue), Cisplatin.
Shares HPV-positive oropharyngeal cancer, Oropharyngeal cancer (tonsil and base of tongue), Cisplatin.
Shares HPV-positive oropharyngeal cancer, Oropharyngeal cancer (tonsil and base of tongue), Cisplatin.
Shares HPV-positive oropharyngeal cancer, Oropharyngeal cancer (tonsil and base of tongue), Cisplatin, IMRT / IGRT (modern external beam).
Shares HPV-positive (p16) head and neck cancer, HPV-positive oropharyngeal cancer, IMRT / IGRT (modern external beam).
Shares HPV-positive (p16) head and neck cancer, HPV-positive oropharyngeal cancer, Oropharyngeal cancer (tonsil and base of tongue), IMRT / IGRT (modern external beam).
Shares HPV-positive (p16) head and neck cancer, HPV-positive oropharyngeal cancer, IMRT / IGRT (modern external beam).