Joe Y. Chang, MD, PhD, FASTRO, FACR
With 10 years of follow-up, no significant difference in survival rates was reported between patients who were treated with stereotactic ablative radiotherapy (SABR) or video-assisted thoracoscopic surgery (VATS) for early-stage non–small cell lung cancer (NSCLC). These findings from the revised STARS trial were presented by Joe Y. Chang, MD, PhD, FASTRO, FACR, Professor, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting.1
“SABR remains an option for operable stage I non–small cell lung carcinoma, with an improved short-term complication rate as compared with the VATS procedure,” said Dr. Chang.
Study Rationale and Methods
As NSCLC has an average age at diagnosis of 71 years, many patients present with comorbidities that may make surgery inadvisable. Additionally, surgical complications may lead to significant side effects for patients who are able to undergo surgery. The investigators sought to determine whether noninvasive radiation with SABR could achieve similar long-term survival rates as VATS in patients with early-stage NSCLC.
The initial STARS trial was closed early due to slow accrual.2 New patients were enrolled into the revised STARS study, which included similar objectives, eligibility, interventions, and methods to the original study.3
In the revised STARS study, 80 patients with early-stage NSCLC, consisting of tumors smaller than 3 cm and no lymph node or distal metastasis, were enrolled. They were treated with SABR using focused radiotherapy in 15 minutes per session per day for 3 to 4 days as an outpatient procedure. The patients given radiotherapy were matched to 80 patients from the surgical cohort through propensity score matching, which was calculated using a multivariable logistic regression model that included age, tumor size, histology, performance status, and interaction between age and sex as covariates. In the surgical cohort, patients underwent VATS lobectomy with mediastinal lymph node dissection.
The primary endpoint was overall survival as a noninferiority comparison, with an expected hazard ratio margin of 1.965.
Survival Outcomes
The long-term overall survival rates showed that SABR was noninferior to VATS lobectomy with lymph node dissection. At 10 years, the overall survival rate was 69% with SABR vs 66% with VATS (hazard ratio [HR] = 0.77; 95% confidence interval [CI] = 0.42–1.44; P = .417).
The cancer-specific survival rate at 10 years was 92% with SABR and 89% with VATS (HR = 0.95; 95% CI = 0.31–2.94; P = .928). Recurrence-free survival rates were 57% and 65% with SABR and VATS, respectively, at 10 years (HR = 1.17; 95% CI = 0.67–2.04; P = .586).
Quality-of-Life Results
The rate of moderate to severe short-term complications of treatment was significantly higher in the surgical cohort than in the radiation cohort, at 50% vs 1%, respectively. “It’s no surprise,” commented Dr. Chang. “One is invasive, and the other is noninvasive.”
Quality-of-life scores for surviving patients at 10 years were comparable between SABR and VATS in terms of physical component score (P = .4759) and mental component score (P = .5959). The financial burden was also comparable in patients alive at year 10 between the cohorts (P = .1912), though there was a slightly higher score for those who underwent VATS.
Dr. Chang stressed that a multidisciplinary discussion with patients is strongly recommended as they weigh their options for early-stage NSCLC. “AI-guided imaging and biomarker-based personalized SABR, plus or minus immunotherapy or targeted therapy, is expected to further improve clinical outcomes and inform future research directions,” he added.
DISCLOSURE: The revised STARS study was supported by funding from Varian Medical Systems and the National Cancer Institute. Dr. Chang has received institutional research grants from BMS, AstraZeneca, and Siemens; and has served on the IBA clinical advisory committee, on the Board of Directors of IASLC, and as Clinical Scientific Program Chair of PTCOG.
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. 2025 ASTRO Annual Meeting. Abstract 268. Presented September 29, 2025.
2. Chang JY, Senan S, Paul MA, et al: Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: A pooled analysis of two randomised trials. Lancet Oncol 16:630-637, 2015.
3. Chang JY, Mehran RJ, Feng L, et al: Stereotactic ablative radiotherapy for operable stage I non-small cell lung cancer (revised STARS): Long-term results of the single-arm, prospective trial with prespecified comparison to surgery. Lancet Oncol 22:1448-1457, 2021.
EXPERT POINT OF VIEW
Invited study discussant, Kenneth Rosenzweig, MD, FASTRO, provided further takeaways for the revised STARS trial from the press briefing at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting. He is Chair of the ASTRO Annual Meeting Scientific Committee and Professor and Chairman of the Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York.
Kenneth Rosenzweig, MD, FASTRO
Dr. Rosenzweig embellished how patients with lung cancer rely on surgery for a possible cure and may lose hope if surgery is not an option. “What this trial, and other trials, have shown us is that there is another option if surgery is not an option, and that’s radiation therapy,” he said. “If there’s a patient for one reason or another who is not a good candidate for surgery, there’s an excellent option that’s going to be equally as effective, so there should not be a sense of desperation to get this patient to surgery no matter what,” he explained.
Dr. Rosenzweig echoed Dr. Chang in advising clinicians to include stereotactic ablative radiotherapy as a possible treatment option in the discussion process with patients who have early-stage non–small cell lung cancer.
DISCLOSURE: Dr. Rosenzweig reported no conflicts of interest related to this presentation.
