Role of radiotherapy to the primary lesion in metastatic non-small cell lung cancer patients after first-line systemic therapy — a prospective randomized phase II study
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Abstract
Introduction. Radiation therapy for oligometastatic non-small cell lung cancer (NSCLC) showed overall survival (OS) benefit in phase II clinical trials, with stereotactic body radiation therapy (SBRT) being the main modality for distant metastases. This study aimed to assess the benefit of consolidative irradiation of the primary lesion in patients with partial response or stationary disease after first-line therapy, regardless of their metastatic burden.
Material and methods. Stage IV NSCLC patients without progressive disease after initial systemic therapy were randomly assigned to arm 1 (consolidative primary radiotherapy 45Gy/15 fractions followed by standard treatment) or arm 2 (standard treatment). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were OS and toxicity.
Results. Between September 2020 and January 2023, 75 patients were randomized: 37 to the radiotherapy arm and 38 to the control arm. The median follow-up was 13.50 months (4.50–35.93). Median PFS was 15.37 months in the radiotherapy group versus 10.93 months in the control group (univariate HR = 1.99; 95% CI 1.16–3.41; p = 0.012). Median OS was 18.30 months versus 13.73 months, respectively (HR = 1.84; 95% CI 0.98–3.46; p = 0.057). Except for one patient in the radiotherapy group who experienced grade 3 dysphagia, no grade 3 or higher toxicities were noted.
Conclusions. Primary consolidative radiotherapy in metastatic NSCLC after standard systemic treatment added a benefit for patients who had stationary disease or showed partial response to standard systemic treatment.
Keywords: radiotherapylungmetastaticclinical triallung irradiation
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