Main Session
Sep
29
PQA 07 - Head and Neck Cancer, Lung Cancer/Thoracic Malignancies, and Nursing and Supportive Care
3666 - Prospective Multicenter Evaluation of Stereotactic Body Radiotherapy (SBRT) for Multiple Primary Lung Cancers Following Surgical Resection: The SMILE Study
Presenter(s)
Fang Wu, MD, PhD - The Second xiangya Hospital of Central South University, Changsha, Hunan
F. Wu1,2, D. Fan1, Y. Peng1, Y. Zhang3, X. Sun1, C. Deng1, W. Liu4, M. Peng4, Y. Hu4, C. Hu1, X. Liu1, F. Ma1, Z. Qiu1, Y. Zeng1, S. Yao1, S. Wang1, Y. Zhang1, D. Guo1, A. Liang1, X. Lin1, H. Yang1, and Y. Li1; 1Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China, 2Hunan Key Laboratory of Early Diagnosis and Precision Therapy in Lung Cancer, The Second Xiangya Hospital of Central South University, Changsha, China, 3Department of Radiation Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, China, 4Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University, Changsha, China
Purpose/Objective(s):
With the increasing adoption of low-dose CT screening, multiple primary lung cancers (MPLC) are being detected more frequently. For patients with malignant pulmonary nodules in the residual lung after prior resection who are not candidates for additional surgical resection, management represents a challenging scenario for which standardized treatment is lacking. The SMILE study (Stereotactic body radiotherapy for Multiple prImary Lung cancers following surgical resection: Evaluation of efficacy and safety) was designed to prospectively evaluate SBRT in this population.Materials/Methods:
SMILE is a prospective, multicenter observational clinical study. Eligible patients had previously resected, pathologically confirmed lung cancer and identified malignant pulmonary nodules =3 cm in diameter in the residual lung, confirmed by pathology or multidisciplinary tumor board (MDT) consensus. All patients were node-negative (N0) with no evidence of distant metastasis at enrollment and were deemed unsuitable for or declined further surgical resection following MDT evaluation. SBRT was delivered using hypofractionated regimens to achieve a biologically effective dose (BED) =100 Gy in 3–8 fractions. The primary endpoints were the 2-year local control rate and the 2-year incidence of treatment-emergent adverse events. Secondary endpoints included 2-year progression-free survival (PFS) rate and 2-year overall survival (OS) rate. Toxicities were graded according to CTCAE v5.0. The trial is registered on ClinicalTrials.gov (NCT05113017).Results:
Thirty-six patients with 38 pulmonary lesions were treated. All patients were diagnosed with MPLC, including 13 cases of metachronous disease and 23 cases of synchronous disease. Thirteen patients (36%) had previously undergone multi-lobar or multi-segment pulmonary resections. The median age was 65 years (IQR 57-70, range 47-78), and the median follow-up was 24 months. Among the 34 patients with complete follow-up data, the 2-year local control rate was 100%. At the time of data cutoff (January 2026), one patient developed an intracranial metastasis 18 months after SBRT. All other patients remained progression-free, and no deaths were observed. No grade =3 radiation-related toxicities were observed. Two patients (5.9%) developed grade 2 radiation pneumonitis, both resolving with oral corticosteroids.Conclusion:
SBRT exhibited favorable efficacy and safety profiles in patients with multiple primary lung cancers after surgical resection.