268 - Ten-Year Outcomes of the Revised STARS Trial Comparing Radiation and Surgery for Early-Stage Non-Small Cell Lung Cancer
Presenter(s)
T. Kleber1, Z. Hooda2, W. Dong3, Z. Liao4, S. H. Lin1, J. W. Welsh5, M. S. O'Reilly4, P. Balter6, J. Heymach7, R. Mehran2, J. Roth2, R. Rajaram2, and J. Y. Chang1; 1Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 2Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, 3The University of Texas MD Anderson Cancer Center, Houston, TX, 4Department of Thoracic Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 5MD Anderson Cancer Center, Houston, TX, 6Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, 7Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX
Purpose/Objective(s): The revised STARS trial is phase II non-inferiority trial comparing prospectively enrolled patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative radiotherapy (SABR) to a matched cohort of patients treated with video-assisted thoracoscopic lobectomy with mediastinal lymph node dissection (VATS L-MLND). Herein, we report long-term clinical outcomes and findings from financial toxicity and quality of life surveys.
Materials/Methods: Eighty patients with NSCLC were enrolled to receive SABR with the following eligibility criteria: tumor size = 3 cm, the absence of nodal or metastatic disease, and a performance status of 0-2. A matched cohort of 80 patients who underwent VATS L-MLND was selected from an institutional dataset of prospectively registered surgical NSCLC patients during the same time window who met the eligibility criteria. Propensity score matching was performed based on age, gender, histology, tumor size, and performance status. A prespecified noninferiority analysis compared overall survival (OS) between treatment cohorts with a noninferiority margin of 1.965. Clinical outcomes were analyzed using univariate Cox proportional hazards models and are presented with hazard ratios (HR) and 95% confidence intervals (CI). After seven years post-SABR, all trial participants received questionnaires assessing the long-term quality of life and financial impact of treatment.
Results: Among patients with early-stage NSCLC treated with SABR (n = 80) or surgery (n = 80), median follow-up was 8.3 years. Endobronchial ultrasound was used for clinical staging in 100% of patients with SABR compared to 25% with surgery (p < 0.001). No other significant differences in baseline characteristics were found. Among surgery patients, 11% had occult lymph node involvement discovered on surgical pathology, and 14% received adjuvant therapy. The median OS was 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 = 0.417, noninferiority met), lung cancer-specific survival (HR = 0.95, 95% CI = 0.31-2.94, p = 0.928), or recurrence-free survival (HR = 1.17, 95% CI = 0.67-2.04, p = 0.586) between the two treatment cohorts. The OS rates at 7-year and 10-year were 81% (95% CI, 73%-91%) and 69% (95% CI, 57%-84%) in the SABR group compared with 70% (95% CI, 59%-82%) and 66% (95% CI, 55%-78%) in the surgery group, respectively. Of the 60 SABR patients who received long-term quality of life and financial toxicity questionnaires, 28% responded. Among the responders, 53% denied any financial burden on themselves or their families due to radiation-related costs. We will update new data at the meeting.
Conclusion: SABR is not inferior to surgery in OS, with minimal financial toxicity in this phase II clinical study. A multi-disciplinary evaluation is strongly recommended for optimal treatment decision-making for these patients.