Runsen Jin1, Yuyan Zheng1, Ye Yuan2, Dingpei Han1, Yuqin Cao1, Yajie Zhang1, Chengqiang Li1, Jie Xiang1, Zhengyuan Zhang1, Zhenyi Niu1, Toni Lerut3, Jules Lin4, Abbas E Abbas5, Alessandro Pardolesi6, Takashi Suda7, Dario Amore8, Stefan Schraag9, Clemens Aigner10, Jian Li11, Jiaming Che1, Junbiao Hang1, Jian Ren1, Lianggang Zhu1, Hecheng Li1. 1. Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. 2. Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. 3. Department of Thoracic Surgery, University Hospital Leuven, Leuven, Belgium. 4. Section of Thoracic Surgery, University of Michigan Medical Center, Ann Arbor, Michigan. 5. Department of Thoracic Medicine and Surgery, Division of Thoracic Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania. 6. Thoracic Surgery Unit, National Cancer Institute, Milan, Italy. 7. Department of Minimally Invasive Thoracic Surgery, Fujita Health University Okazaki Medical Center, Okazaki, Japan. 8. Division of Thoracic Surgery, Monaldi Hospital, Naples, Italy. 9. Department of Perioperative Medicine, Golden Jubilee National Hospital, Clydebank, UK. 10. Department of Thoracic Surgery, Ruhrlandklinik, University Medicine Essen, Essen, Germany. 11. Clinical Research Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Abstract
OBJECTIVE: To determine whether RAL affects perioperative outcomes and long-term efficacy in NSCLC patients, compared with traditional VAL. SUMMARY OF BACKGROUND DATA: RAL is a promising treatment for NSCLC. However, its efficacy has not been fully evaluated. METHODS: A single-center, open-labeled prospective randomized clinical trial was launched in May 2017 to compare the efficacy of RAL and VAL. By May 2020, 320 patients were enrolled. The perioperative results of RAL and VAL were compared. RESULTS: The 320 enrolled patients were randomly assigned to the RAL group (n = 157) and the VAL group (n = 163). Perioperative outcomes were comparable between the 2 groups, including the length of hospital stay (P = 0.76) and the rate of postoperative complications (P = 0.45). No perioperative mortality occurred in either group. The total amount of chest tube drainage {830 mL [interquartile range (IQR), 550-1130 mL] vs 685 mL [IQR, 367.5-1160 mL], P = 0.007} and hospitalization costs [$12821 (IQR, $12145-$13924) vs $8009 (IQR, $7014-$9003), P < 0.001] were significantly higher in the RAL group. RAL group had a significantly higher number of LNs harvested [11 (IQR, 8-15) vs 10 (IQR, 8-13), P = 0.02], higher number of N1 LNs [6 (IQR, 4-8) vs 5 (IQR, 3-7), P = 0.005], and more LN stations examined [6 (IQR, 5-7) vs 5 (IQR, 4-6), P < 0.001]. CONCLUSIONS: Both RAL and VAL are safe and feasible for the treatment of NSCLC. RAL achieved similar perioperative outcomes, together with higher LN yield. Further follow-up investigations are required to evaluate the long-term efficacy of RAL. (ClinicalTrials.gov identifier: NCT03134534).
OBJECTIVE: To determine whether RAL affects perioperative outcomes and long-term efficacy in NSCLC patients, compared with traditional VAL. SUMMARY OF BACKGROUND DATA: RAL is a promising treatment for NSCLC. However, its efficacy has not been fully evaluated. METHODS: A single-center, open-labeled prospective randomized clinical trial was launched in May 2017 to compare the efficacy of RAL and VAL. By May 2020, 320 patients were enrolled. The perioperative results of RAL and VAL were compared. RESULTS: The 320 enrolled patients were randomly assigned to the RAL group (n = 157) and the VAL group (n = 163). Perioperative outcomes were comparable between the 2 groups, including the length of hospital stay (P = 0.76) and the rate of postoperative complications (P = 0.45). No perioperative mortality occurred in either group. The total amount of chest tube drainage {830 mL [interquartile range (IQR), 550-1130 mL] vs 685 mL [IQR, 367.5-1160 mL], P = 0.007} and hospitalization costs [$12821 (IQR, $12145-$13924) vs $8009 (IQR, $7014-$9003), P < 0.001] were significantly higher in the RAL group. RAL group had a significantly higher number of LNs harvested [11 (IQR, 8-15) vs 10 (IQR, 8-13), P = 0.02], higher number of N1 LNs [6 (IQR, 4-8) vs 5 (IQR, 3-7), P = 0.005], and more LN stations examined [6 (IQR, 5-7) vs 5 (IQR, 4-6), P < 0.001]. CONCLUSIONS: Both RAL and VAL are safe and feasible for the treatment of NSCLC. RAL achieved similar perioperative outcomes, together with higher LN yield. Further follow-up investigations are required to evaluate the long-term efficacy of RAL. (ClinicalTrials.gov identifier: NCT03134534).
Authors: Yogita S Patel; Waël C Hanna; Christine Fahim; Yaron Shargall; Thomas K Waddell; Kazuhiro Yasufuku; Tiago N Machuca; Mauricio Pipkin; Jean-Marc Baste; Feng Xie; Andrea Shiwcharan; Gary Foster; Lehana Thabane Journal: PLoS One Date: 2022-02-02 Impact factor: 3.240