Kenji Suzuki1, Shun-Ichi Watanabe2, Masashi Wakabayashi3, Hisashi Saji4, Keiju Aokage5, Yasumitsu Moriya6, Ichiro Yoshino7, Masahiro Tsuboi5, Shinichiro Nakamura8, Kenichi Nakamura3, Tetsuya Mitsudomi9, Hisao Asamura10. 1. Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan. Electronic address: kjsuzuki@juntendo.ac.jp. 2. Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan. 3. Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan. 4. Department of General Thoracic Surgery, St Marianna University School of Medicine, Kanagawa, Japan. 5. Division of Thoracic Surgery, National Cancer Center Hospital East, Chiba, Japan. 6. Department of Thoracic Surgery, Chiba Rosai Hospital, Chiba, Japan. 7. Department of General Thoracic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. 8. West Japan Oncology Group Data Center, Osaka, Japan. 9. Faculty of Medicine, Department of Surgery, Kindai University, Osaka, Japan. 10. Division of Thoracic Surgery, Keio University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: The optimal mode of surgery for ground-glass opacity dominant peripheral lung cancer defined with thoracic thin-section computed tomography remains unknown. METHODS: We conducted a single-arm confirmatory trial to evaluate the efficacy and safety of sublobar resection for ground-glass opacity dominant peripheral lung cancer. Lung cancer with maximum tumor diameter 2.0 cm or less and with consolidation tumor ratio 0.25 or less based on thin-section computed tomography were registered. The primary end point was 5-year relapse-free survival. The planned sample size was 330 with the expected 5-year relapse-free survival of 98%, threshold of 95%, 1-sided α of 5%, and power of 90%. The trial is registered with University Hospital Medical Information Network Clinical Trials Registry, number University Hospital Medical Information Network 000002008. RESULTS: Between May 2009 and April 2011, 333 patients were enrolled from 51 institutions. Median age was 62 years (interquartile range, 56-68), and 109 were smokers. Median maximum tumor diameter was 1.20 cm (1.00-1.54). Median maximum tumor diameter of consolidation was 0 (0.00-0.20). The primary end point, 5-year relapse-free survival, was estimated on 314 patients who underwent sublobar resection. Operative modes were 258 wide wedge resections and 56 segmentectomies. Median pathological surgical margin was 15 mm (0-55). The 5-year relapse-free survival was 99.7% (90% confidence interval, 98.3-99.9), which met the primary end point. There was no local relapse. Grade 3 or higher postoperative complications based on Common Terminology Criteria for Adverse Effect v3.0 were observed in 17 patients (5.4%), without any grade 4 or 5. CONCLUSIONS: Sublobar resection with enough surgical margin offered sufficient local control and relapse-free survival for lung cancer clinically resectable N0 staged by computed tomography with 3 or fewer peripheral lesions 2.0 cm or less amenable to sublobar resection and with a consolidation tumor ratio of 0.25 or less.
BACKGROUND: The optimal mode of surgery for ground-glass opacity dominant peripheral lung cancer defined with thoracic thin-section computed tomography remains unknown. METHODS: We conducted a single-arm confirmatory trial to evaluate the efficacy and safety of sublobar resection for ground-glass opacity dominant peripheral lung cancer. Lung cancer with maximum tumor diameter 2.0 cm or less and with consolidation tumor ratio 0.25 or less based on thin-section computed tomography were registered. The primary end point was 5-year relapse-free survival. The planned sample size was 330 with the expected 5-year relapse-free survival of 98%, threshold of 95%, 1-sided α of 5%, and power of 90%. The trial is registered with University Hospital Medical Information Network Clinical Trials Registry, number University Hospital Medical Information Network 000002008. RESULTS: Between May 2009 and April 2011, 333 patients were enrolled from 51 institutions. Median age was 62 years (interquartile range, 56-68), and 109 were smokers. Median maximum tumor diameter was 1.20 cm (1.00-1.54). Median maximum tumor diameter of consolidation was 0 (0.00-0.20). The primary end point, 5-year relapse-free survival, was estimated on 314 patients who underwent sublobar resection. Operative modes were 258 wide wedge resections and 56 segmentectomies. Median pathological surgical margin was 15 mm (0-55). The 5-year relapse-free survival was 99.7% (90% confidence interval, 98.3-99.9), which met the primary end point. There was no local relapse. Grade 3 or higher postoperative complications based on Common Terminology Criteria for Adverse Effect v3.0 were observed in 17 patients (5.4%), without any grade 4 or 5. CONCLUSIONS: Sublobar resection with enough surgical margin offered sufficient local control and relapse-free survival for lung cancer clinically resectable N0 staged by computed tomography with 3 or fewer peripheral lesions 2.0 cm or less amenable to sublobar resection and with a consolidation tumor ratio of 0.25 or less.
Authors: Frank C Detterbeck; Vincent J Mase; Andrew X Li; Ulas Kumbasar; Brett C Bade; Henry S Park; Roy H Decker; David C Madoff; Gavitt A Woodard; Whitney S Brandt; Justin D Blasberg Journal: J Thorac Dis Date: 2022-06 Impact factor: 3.005