KEY POINTS
- STARLORD is a single-centre prospective phase II study for patients with unresectable stage III NSCLC considered unfit for concurrent chemoradiation because of frailty, comorbidities, limited organ reserve or inability to complete a prolonged conventional RT course.
- This preliminary analysis included 26 consecutive patients, with median age 75.5 years. Stage IIIB disease accounted for 84.6%, stage IIIC for 15.4%, and 57.7% had ECOG performance status 2.
- After induction chemotherapy, SBRT was delivered to both the primary tumor and mediastinal disease in 5 fractions. Median dose was 40 Gy to the primary tumor and 35 Gy to mediastinal disease; 76.9% subsequently received consolidation immunotherapy.
- The primary endpoint was acute grade ≥3 toxicity. Two of 26 patients (7.7%) developed grade 3 dysphagia, both resolving after intravenous steroids. No other acute grade ≥3 toxicity and no grade ≥4 acute events were reported.
- At median follow-up of 17.3 months, there were no grade ≥3 late toxicities. Five grade 2 late events occurred, including two cases of dysphagia and three episodes of transient dyspnea worsening.
- One-year local control was 86.7%. Both in-field failures occurred in mediastinal targets at 11 and 12 months. Median distant progression-free survival was 15.6 months, with a one-year rate of 56.7%.
- Four deaths occurred, producing 90.9% one-year overall survival. These survival data remain immature: the Simon two-stage design plans up to 59 patients, and the current report represents an early 26-patient analysis.
CLINICAL TAKEAWAY
For carefully selected patients with stage III NSCLC who cannot tolerate concurrent chemoradiation, chemotherapy followed by five-fraction SBRT to both primary and mediastinal disease is an intriguing way to shorten treatment substantially. Early safety and local-control results are encouraging, but this small single-centre phase II cohort is not sufficient to replace established sequential chemoradiation.