We had conducted a multi-institutional phase II study to evaluate the safety and efficacy of dynamic tumor tracking-stereotactic body radiotherapy (DTT-SBRT) for lung tumors. The primary endpoint was 2-year local control, which was reported to be 95.2%. After the initial evaluation of the primary endpoint, the study was extended as an observational study which was designed to evaluate 5-year survival and late toxicities. We present the long-term results of DTT-SBRT for lung tumors. The main eligibility criteria for the study were as follows: (1) primary or metastatic lung cancer with a diameter of 5 cm or less, and up to 3 lesions without any extrapulmonary lesions; (2) ineligibility to standard surgery, or patient's refusal of surgery; (3) ECOG-PS of 0 to 2; and (4) expected range of respiratory motion of 10 mm or more. The study included 48 patients from four institutions with the median age of 80 years (range, 49-90 years). Forty-two patients had primary non-small-cell lung cancer, and 6 patients had metastatic lung tumors. Forty-eight tumors (median diameter, 23.5 mm; range, 5-47 mm) in 48 patients were targeted for DTT-SBRT using a gimbal-mounted linear accelerator. Prior to treatment planning, spherical gold markers were placed around the tumor to detect internal tumor motion using fluoroscopy. The prescribed dose was 50 Gy in four fractions. Treatment beams were delivered with DTT according to a 4D model that predicts internal tumor motion with abdominal wall motion. DTT-SBRT was successfully delivered to all but one patient who had poor correlation between abdominal wall and tumor motion. Median follow-up period at data cutoff was 5.0 years (interquartile range, 3.1-6.3 years). Twenty-nine patients died; the causes of death were cancer-specific in 10 patients, comorbidity in 14 patients (pulmonary disease, renal failure, cerebral infarction, other malignancies, etc.), and unknown in 5 patients without cancer recurrence. Overall survival at 5 years was 51.5% (95% confidence interval [CI], 36.5-64.6%). Progression-free survival and local control at 5 years were 41.0% (95% CI, 27.0-54.5%) and 92.6% (95% CI, 78.7-97.6%), respectively. There were no grade 4-5 toxicities. One patient (2%) developed grade 3 radiation pneumonitis at 3 months. Grade 2 toxicities were observed in 9 patients (19%), including dyspnea, radiation pneumonitis, pleural effusion, rib fracture, and dermatitis. Dynamic tumor tracking SBRT achieved the long-term efficacy with low incidence of severe toxicities in lung tumors with respiratory motion. In this elderly patient cohort, non-cancer deaths were observed more than cancer-specific deaths.
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