Radiation Shows Similar 10-Year Outcomes Vs Surgery in Early-Stage NSCLC

Stereotactic ablative radiotherapy (SABR) yielded no significant differences in outcomes such as overall survival (OS), cancer-specific survival, and recurrence-free survival (RFS) vs video-assisted thoracoscopic lobectomy with mediastinal lymph node dissection (VATS L-MLND) among those with early-stage non–small cell lung cancer (NSCLC), according to a presentation on 10-year data from the revised phase 2 STARS trial (NCT02357992) at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting.¹

Data showed a 10-year OS rate of 69% with SABR vs 66% with VATS L-MLND (HR, 0.77; 95% CI, 0.42-1.44; P = .417). In each respective arm, the cancer-specific survival rates were 92% and 89% at 10 years (HR, 0.95; 95% CI, 0.31-2.94; P = .928). Additionally, the 10-year RFS rates were 57% vs 65%, respectively (HR, 1.17; 95% CI, 0.67-2.04; P = .586).

“Surgery, historically, was the only standard option for early-stage NSCLC, but upwards of 50% of patients experience moderate or severe [adverse] 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,” senior study author Joe Y. Chang, MD, PhD, FASTRO, a professor of thoracic radiation oncology and director of Stereotactic Ablative Radiotherapy at The University of Texas MD Anderson Cancer Center, stated in a press release on these findings.² “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. This highly targeted, non-invasive treatment achieved the same long-term [OS] as lobectomy, while offering many patients an easier recovery and potentially better quality of life.”

Investigators of the revised phase 2 STARS trial evaluated whether non-invasive SABR could produce comparable OS rates vs VATS in those with early-stage NSCLC. The study included 80 patients with tumors smaller than 3 cm and no lymph node or distant metastasis who received SABR for 15 minutes each day for 3 to 4 days in an outpatient setting. These patients were matched with 80 others from a VATS surgical cohort based on propensity score matching; investigators used a multivariate logistic regression model accounting for age, tumor size, histology, performance status, and the interaction of age and sex as covariates to match the cohorts.

The study’s primary end point was OS, which included a pre-specified non-inferiority comparison between the radiotherapy and surgical modalities. The hazard ratio margin was 1.965.

Investigators observed that moderate-to-severe short-term complications were more frequent with surgery vs SABR. The short-term complication rates were 1% in the SABR arm and 50% in the VATS L-MLND arm.

Data revealed similar quality of life and financial burden outcomes among survivors after 10-year follow-up. Between the SABR and VATS L-MLND arms, there were no significant differences in SF12v2 physical component scores (P = .4759), SF12v2 mental component scores (P = .5959), and COST total scores (P = .1912).

“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,” Chang stated.²

Regarding potential next steps, the study investigators noted that image biomarker-based personalized SABR guided via artificial intelligence is anticipated to improve clinical outcomes even further and inform other research initiatives.

“While SABR has delivered excellent long-term results, up to a third of patients treated with local therapies still developed locoregional or distant recurrences from this aggressive cancer. Our goal is to find new ways to push survival even higher,” Chang concluded.²

References

1. Kleber T, Hooda Z, Dong W, et al. Ten-year outcomes of the revised STARS trial comparing radiation and surgery for early-stage non-small cell lung cancer. Presented at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting; September 27 – October 1, 2025; San Francisco, CA. Abstract 268.
2. Ten-year clinical trial report finds radiation comparable to surgery for early-stage non-small cell lung cancer. News release. American Society for Radiation Oncology. September 29, 2025. Accessed September 30, 2025. https://tinyurl.com/bdehtuvk