Quality of life after primary TORS vs IMRT for patients with early-stage oropharyngeal squamous cell carcinoma (QoLATI/DAHANCA34): A multicentre, open-label, randomised phase 2 trial

QoLATI

Patient / Population Intervention / Exposure Comparison Outcome

In patients with early-stage oropharyngeal squamous cell carcinoma, TORS-based treatment improved swallowing-related quality of life at 12 months compared with (chemo)radiotherapy, although the difference did not reach the prespecified threshold for clinical relevance.

N

138patients

Design

Multicentre, open-label, parallel-group, randomised phase 2 trial at five Danish hospitals in which patients with T1-2, N0-1, M0 oropharyngeal squamous cell carcinoma were randomly assigned 2:1 to TORS-based treatment incorporating staging neck dissection or (chemo)radiotherapy (NCT04124198).

Endpoint

Swallowing-related quality of life at 12 months assessed with the MD Anderson Dysphagia Inventory (MDADI).

ResultAt 12 months, the adjusted difference in change from baseline MDADI score between groups was 5.1 points favouring TORS (95% CI 0.3-9.9; P = 0.04). This difference did not reach the prespecified threshold for clinical relevance. The primary analysis included 136 patients (92 TORS vs 44 (C-)RT). In the TORS group, 79% were treated with TORS alone, four (4%) received TORS with adjuvant (C-)RT and 15 (16%) were redirected to (C-)RT after staging neck dissection. Objective swallowing, late toxicity, survival and disease control outcomes did not differ between groups. Motor nerve impairment after neck dissection was present in 9 (10%) patients.

Channir HI, Rubek N, Friborg J, et al. Presented at ESMO Congress 2026, abstract LBA45, 25 October. Not yet published.

Discussion & critique

TORS-based treatment gave a statistically significant gain in swallowing-related quality of life at 12 months, but the difference fell short of the authors' own threshold for clinical relevance, so it is a modest effect. The primary endpoint is patient-reported and the trial was open label, which may bias the result in favour of either arm. As a phase 2 trial with 2:1 allocation and only 44 patients in the (C-)RT group, it was not designed to show differences in survival or disease control, and the abstract gives neither the follow-up duration nor event numbers. One in six patients allocated to TORS were redirected to (C-)RT after neck dissection, and the analysis followed a modified rather than full intention-to-treat principle.