KEY POINTS
- DART was a multicentre, prospective, single-arm phase 2 study for patients with inoperable locally advanced non-small cell lung cancer considered ineligible for concurrent chemoradiotherapy because of age, comorbidity or frailty.
- Patients received conventionally fractionated definitive thoracic radiotherapy with concurrent durvalumab, followed by consolidative durvalumab at 1,500 mg every four weeks for up to 12 months, without chemotherapy.
- The study enrolled 58 patients with a median age of 82 years. Eastern Cooperative Oncology Group performance status was 0 in 12%, 1 in 79% and 2 in 14%; 28% had programmed death-ligand 1-negative disease.
- The primary endpoint was met: two-year progression-free survival was 39%, compared with a predefined historical benchmark of 20% for sequential chemoradiotherapy. Two-year overall survival was 54%.
- Better performance status and programmed death-ligand 1 positivity were associated with improved progression-free survival. Better performance status was associated with overall survival, while programmed death-ligand 1 positivity was associated with cancer-specific survival.
- Grade 3–4 treatment-related adverse events occurred in 21% of patients. Four patients (7%) experienced grade 5 events: two radiation-pneumonitis deaths and two cardiac arrests.
- Durvalumab was discontinued early because of adverse events in 31%. The uploaded file contains the published abstract rather than the complete article, so the radiotherapy dose, detailed event attribution and full subgroup analyses could not be independently assessed.
CLINICAL TAKEAWAY
Concurrent and consolidative durvalumab with radiotherapy may offer a treatment option for selected patients unable to receive platinum-based concurrent chemoradiotherapy. The 39% two-year progression-free survival is encouraging, but the absence of a randomized comparator, the 7% grade 5 event rate and frequent treatment discontinuation prevent this regimen from being considered an established standard.