ECOG-ACRIN E3311
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.
Overview
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.
- 96.9 vs 94.9 out of 100 alive without the cancer growing at 2 years with Low risk, observation compared with Intermediate risk, 50 Gy; 2 more per 100.
- Roughly one extra person helped for every 50 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Intermediate risk, 60 Gy 96 of 100; High risk, 66 Gy + cisplatin 90.7 of 100.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Resectable HPV-positive oropharyngeal cancer: transoral surgery and neck dissection, then adjuvant treatment by pathological risk, with intermediate-risk patients randomised to 50 or 60 Gy of radiotherapy. People in a different situation may not see the same effect.
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 participants 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% |
Similar pages
not linked directly; found by shared links- TrialDe-ESCALaTE HPV
Shares Oropharyngeal cancer (tonsil and base of tongue), HPV-positive oropharyngeal cancer, Cisplatin, IMRT / IGRT (modern external beam).
- TrialRTOG 1016
Shares Oropharyngeal cancer (tonsil and base of tongue), HPV-positive oropharyngeal cancer, Cisplatin, IMRT / IGRT (modern external beam).
- PairingCaution: de-escalating radiation on HPV status alone
Shares HPV-positive (p16) head and neck cancer, HPV-positive oropharyngeal cancer, IMRT / IGRT (modern external beam).
- TrialNRG-HN002 & NRG-HN005 (HPV+ de-escalation)
Shares HPV-positive (p16) head and neck cancer, Oropharyngeal cancer (tonsil and base of tongue), HPV-positive oropharyngeal cancer, IMRT / IGRT (modern external beam).
- IdeactHPV-DNA-adapted de-escalation of chemoradiation
Shares HPV-positive (p16) head and neck cancer, HPV-positive oropharyngeal cancer, IMRT / IGRT (modern external beam).
- TrialA Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Shares Oropharyngeal cancer (tonsil and base of tongue), HPV-positive oropharyngeal cancer.
- TrialRTOG 0129 (HPV analysis)
Shares HPV-positive (p16) head and neck cancer, HPV-positive oropharyngeal cancer, IMRT / IGRT (modern external beam).
- TrialRRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
Shares Oropharyngeal cancer (tonsil and base of tongue), Cisplatin.