Recent findings reveal that stereotactic radiation therapy (SABR) offers long-term survival outcomes comparable to surgery in patients with early non–small cell lung cancer (NSCLC).
Findings from the STARS clinical trial (NCT02357992) demonstrate that stereotactic radiation therapy offers long-term survival outcomes comparable to surgery in patients with small, early-stage non–small cell lung cancer (NSCLC).
This trial, findings from which were presented at the 2025 American Society for Radiation Oncology Annual Meeting in San Francisco, CA, reported 10 years clinical of outcomes and establishes a foundation for future research aimed to reduce recurrence rates further.1,2
Trial Name: Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy
ClinicalTrials.gov ID: NCT02357992
Sponsor: MD Anderson Cancer Center
Completion Date: September 17, 2021
“Surgery historically was the only standard option for early-stage NSCLC, but upwards of 50% of patients experience moderate or severe side effects afterward. And as patients age, many cannot tolerate surgery, so there’s a growing demand for non-invasive options that provide durable local control,” Joe Y. Chang, MD, PhD, FASTRO, senior author of the study and professor of thoracic radiation oncology and director of stereotactic ablative radiotherapy at the University of Texas MD Anderson Cancer Center, said in a news release. “This study offers the clearest picture yet that radiation can also be an appealing option for suitable surgical candidates. It included a larger patient population than previously published randomized studies, and we’ve followed these patients for much longer.”3
STARS is a noninferiority phase 2 clinical trial compared prospectively enrolled patients with early-stage NSCLC treated with stereotactic ablative radiotherapy (SABR) to a matched cohort of patients who were treated with video-assisted thoracoscopic lobectomy with mediastinal lymph node dissection (VATS L-MLND). In their conference abstract, the investigators present long-term clinical outcomes and findings from financial toxicity and quality of life surveys.1,2
In this trial, 80 patients with NSCLC were enrolled to receive SABR, and a matched cohort of 80 patients underwent VATS L-MLND. This prespecified noninferiority analysis compared overall survival (OS) between the 2 treatment cohorts. After 7 years post-SABR, all trial participants received questionnaires assessing the long-term quality of life and the financial impact of treatment.1
Among patients with early-stage NSCLC who were treated with SABR (n = 80) or surgery (n = 80), the median follow-up was about 8.3 years. Endobronchial ultrasound was used for clinical staging in 100% of patients with SABR compared with 25% with surgery (p < .001). Of note, there were no other significant differences in baseline characteristics observed.1
Among patients receiving surgery, approximately 11% had occult lymph node involvement that was discovered on surgical pathology, and 14% received adjuvant therapy. The median OS was about 11.4 years in the surgery group and not yet reached for the SABR cohort. There was no significant difference in OS (HR for SABR vs surgery: 0.77 [95% CI 0.42–1.44]; p = .417, noninferiority met), lung cancer-specific survival (HR: 0.95 [95% CI 0.31–2.94]; p = .928), or recurrence-free survival (HR: 1.17 [95% CI 0.67–2.04]; p = .586) between the 2 treatment cohorts. OS rates at 7-year and 10-year were about 81% (95% CI 73%–91%) and 69% (95% CI 57%–84%) in the SABR group and 70% (95% CI 59%–82%) and 66% (95% CI 55%–78%) in the surgery group, respectively. Among the 60 patients receiving SABR who received long-term quality of life and financial toxicity questionnaires, about 28% responded, and among respondents, 53% denied any financial burden on themselves or their families from radiation-related costs.1
“Our study confirms, based on a decade of data, that stereotactic radiotherapy is a strong alternative to surgery for most patients with operable stage I NSCLC,” Chang said. “This highly targeted, noninvasive treatment achieved the same long-term OS as lobectomy, while offering many patients an easier recovery and potentially better quality of life.”3
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