Preoperative nivolumab to evaluate pathological response in patients with stage I non-small cell lung cancer: a study protocol of phase II trial (POTENTIAL)

IntroductionRecently, inhibition of programmed cell death 1 or its ligand has shown therapeutic effects on non-small cell lung cancer (NSCLC). However, the effectiveness of preoperative nivolumab monotherapy for stage I NSCLC remains unknown. The present study aimed to investigate the pathological response of preoperative treatment with nivolumab for clinically node negative but having a high risk of NSCLC recurrence.Methods and analysisThe Preoperative Nivolumab (Opdivo) to evaluate pathologic response in patients with stage I non-small cell lung cancer: a phase 2 trial (POTENTIAL) study is a multicentre phase II trial investigating efficacy of preoperative nivolumab for clinical stage I patients at high risk of recurrence. This study includes histologically or cytologically confirmed NSCLC patients with clinical N0 who were found on preoperative high-resolution CT to have a pure solid tumour without a ground-glass opacity component (clinical T1b, T1c or T2a) or a solid component measuring 2–4 cm in size (clinical T1c or T2a). Patients with epidermal growth factor receptor (EGFR) mutation (deletion of exon 19 or point mutation on exon21, L858R), anaplastic lymphoma kinase (ALK) translocation or c-ros oncogene 1 (ROS-1) translocation are excluded from this study. Nivolumab (240 mg/body) is administrated intravenously as preoperative therapy every 2 weeks for three cycles. Afterward, lobectomy and mediastinal lymph node dissection (ND 2a-1 or ND 2a-2) are performed. The primary endpoint is a pathological complete response in the resected specimens. The secondary endpoints are safety, response rates and major pathological response. The planed sample size is 50 patients. Patients have been enrolled since April 2019.Ethics and disseminationThis trial was approved by the Institutional Review Board of Hiroshima University Hospital and other participating institutions. This trial will help examine the efficacy of preoperative nivolumab therapy for clinical stage I NSCLC.Trial registration numberjRCT2061180016.

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A propensity-matched analysis of stereotactic body radiotherapy and sublobar resection for stage I non-small cell lung cancer in patients at high risk for lobectomy: the results in a Chinese population

10.21203/rs.3.rs-15907/v1 ◽

2020 ◽

Author(s):

Wu-Cheng Chen ◽

Xiao-Shuai Yuan ◽

Qing-Ren Lin ◽

Xiao-Jiang Sun ◽

Jin-Shi Liu ◽

...

Keyword(s):

Lung Cancer ◽

High Risk ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Stereotactic Body Radiotherapy ◽

Clinical Stage ◽

Small Cell ◽

Stage I ◽

Sublobar Resection ◽

Small Cell Lung

Abstract Objectives To investigated comparative effectiveness of stereotactic body radiotherapy (SBRT) and sublobar resection (SLR) in patients who had stage I non-small cell lung cancer (NSCLC) and a high risk for lobectomy. Methods From January 2008 to December 2015, patients who underwent SBRT or SLR for clinical stage I NSCLC were examined retrospectively. Propensity score matching (PSM) was performed to reduce selection biases in SBRT and SLR patients. Results 86 SBRT and 79 SLR patients were collected. Median follow-up periods of SBRT and SLR groups were 32 and 37 months, respectively. Patients treated with SBRT exhibited significant increased age, larger tumor diameter, lower FEV1, poorer PS and higher rates of male comparing with SLR. There were no significant differences in terms of 3-year overall survival (OS) (80.3% and 82.3%, P = 0.405), cause-specific survival (CSS) (81.3% and 83.4%, P = 0.383) and local control (LC) (89.7% and 86.0%, P = 0.501) were found in SBRT and SLR patients. 49 patients were identified from each group after performing PSM. The differences of matching factors were balanced based on age, gender, performance status, tumor characteristics and pulmonary function, as no significant differences in terms of 3-year OS (85.4% and 73.3%, P = 0.649), CSS (87.2% and 74.9%, P = 0.637) and LC (95.6% and 82.1%, P = 0.055) in matched SBRT and SLR patients were observed. The rate of grade 3 or the occurrence of worse adverse events was 0 and 10.2% in the matched SBRT and SLR groups (P = 0.056), respectively. Conclusion These results suggest that disease control and survival achieved by SBRT were equivalent to SLR in patients who had clinical stage I NSCLC and were at high risk for lobectomy. SBRT can be an alternative option to SLR in treating patients with a high operative risk.

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A propensity-matched analysis of stereotactic body radiotherapy and sublobar resection for stage I non-small cell lung cancer in patients at high risk for lobectomy: the results in a Chinese population

10.21203/rs.3.rs-15907/v2 ◽

2020 ◽

Author(s):

Wu-Cheng Chen ◽

Xiao-Shuai Yuan ◽

Yuan-Jun Liu ◽

Qing-Ren Lin ◽

Xiao-Jiang Sun ◽

...

Keyword(s):

Lung Cancer ◽

High Risk ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Stereotactic Body Radiotherapy ◽

Clinical Stage ◽

Small Cell ◽

Stage I ◽

Sublobar Resection ◽

Small Cell Lung

Abstract Background: To investigate comparative effectiveness of stereotactic body radiotherapy (SBRT) and sublobar resection (SLR) in patients who had stage I non-small cell lung cancer (NSCLC) and a high risk for lobectomy.Methods: From January 2012 to December 2015, patients who underwent SBRT or SLR for clinical stage I NSCLC were examined retrospectively. Propensity score matching (PSM) was performed to reduce selection biases in SBRT and SLR patients.Results: 86 SBRT and 79 SLR patients were collected. Median follow-up periods of SBRT and SLR groups were 32 and 37 months, respectively. Patients treated with SBRT exhibited significant increased age, larger tumor diameter, lower FEV1, poorer PS and higher rates of male comparing with SLR. There were no significant differences in terms of 3-year overall survival (OS) (80.3% and 82.3%, P = 0.405), cause-specific survival (CSS) (81.3% and 83.4%, P = 0.383) and local control (LC) (89.7% and 86.0%, P = 0.501) were found in SBRT and SLR patients. 49 patients were identified from each group after performing PSM. The differences of matching factors were balanced based on age, gender, performance status, tumor characteristics and pulmonary function, as no significant differences in terms of 3-year OS (85.4% and 73.3%, P = 0.649), CSS (87.2% and 74.9%, P = 0.637) and LC (95.6% and 82.1%, P = 0.055) in matched SBRT and SLR patients were observed. The rate of grade 3 or the occurrence of worse adverse events was 0 and 10.2% in the matched SBRT and SLR groups (P = 0.056), respectively.Conclusion: These results suggest that disease control and survival achieved by SBRT were equivalent to SLR in patients who had clinical stage I NSCLC and were at high risk for lobectomy. SBRT can be an alternative option to SLR in treating patients with a high operative risk.

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