Identification of High-Risk of Recurrence in Clinical Stage I Non-Small Cell Lung Cancer

ObjectiveThis study aimed to identify patients at a high risk of recurrence using preoperative high-resolution computed tomography (HRCT) in clinical stage I non-small cell lung cancer (NSCLC).MethodsA total of 567 patients who underwent screening and 1,216 who underwent external validation for clinical stage I NSCLC underwent lobectomy or segmentectomy. Staging was used on the basis of the 8th edition of the tumor–node–metastasis classification. Recurrence-free survival (RFS) was estimated using the Kaplan–Meier method, and the multivariable Cox proportional hazards model was used to identify independent prognostic factors for RFS.ResultsA multivariable Cox analysis identified solid component size (hazard ratio [HR], 1.66; 95% confidence interval [CI] 1.30–2.12; P < 0.001) and pure solid type (HR, 1.82; 95% CI 1.11–2.96; P = 0.017) on HRCT findings as independent prognostic factors for RFS. When patients were divided into high-risk (n = 331; solid component size of >2 cm or pure solid type) and low-risk (n = 236; solid component size of ≤2 cm and part solid type) groups, there was a significant difference in RFS (HR, 5.33; 95% CI 3.09–9.19; 5-year RFS, 69.8% vs. 92.9%, respectively; P < 0.001). This was confirmed in the validation set (HR, 5.32; 95% CI 3.61–7.85; 5-year RFS, 72.0% vs. 94.8%, respectively; P < 0.001).ConclusionsIn clinical stage I NSCLC, patients with a solid component size of >2 cm or pure solid type on HRCT were at a high risk of recurrence.

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

BMJ Open ◽

10.1136/bmjopen-2020-043234 ◽

2021 ◽

Vol 11 (3) ◽

pp. e043234

Author(s):

Atsushi Kagimoto ◽

Yasuhiro Tsutani ◽

Takahiro Mimae ◽

Yoshihiro Miyata ◽

Norihiko Ikeda ◽

...

Keyword(s):

Lung Cancer ◽

High Risk ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Phase Ii Trial ◽

Clinical Stage ◽

Small Cell ◽

Pathological Response ◽

Stage I ◽

Small Cell Lung

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.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e20076 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e20076-e20076

Author(s):

Wucheng Chen ◽

Qingren Lin ◽

Xiaojiang Sun ◽

Jinshi Liu ◽

Yaping Xu ◽

...

Keyword(s):

Lung Cancer ◽

High Risk ◽

Stereotactic Body Radiotherapy ◽

Wedge Resection ◽

Clinical Stage ◽

Small Cell ◽

Stage I ◽

Sublobar Resection ◽

Small Cell Lung ◽

Better Than

e20076 Background: The aim of this study was to perform a survival comparison between stereotactic body radiotherapy (SBRT) and sublobar resection (SLR) in patients with stage I non-small cell lung cancer (NSCLC) at high risk for lobectomy. Methods: All patients who underwent SBRT or SLR because of medical comorbidities for clinical stage I NSCLC from January 2008 to December 2015 were reviewed retrospectively. Propensity score matching was performed to reduce selection bias between SBRT and SLR patients based on age, gender, performance status, tumour characteristics, pulmonary function. Overall survival (OS) and recurrence-free survival (RFS) were estimated with Kaplan–Meier method. Results: Forty-nine patients were matched into each group of SBRT and SLR (include 27 underwent segmentectomy, 22 underwent wedge resection). There were 32 and 30 men with median age of 67 and 69 years, respectively. Median follow-up was 25 months. In terms of treatment-related mortality, the 30- day mortality rates for the SBRT and SLR groups were 0 and 2.0 %, respectively. Patients treated by SBRT had a tendency to increase 3-year OS compared with SLR (94.0% versus 78.1%; P = 0.064).There was no difference between two groups in 3-year RFS (61.8% versus 65.7%; P = 0.864). In a subanalysis, 3-year OS after SBRT was greatly better than wedge resection subgroup (94.0% versus 67.4%; P = 0.026), but there was no significant difference between SBRT and segmentectomy in 3-year OS (94.0% versus 88.0%; P = 0.212). Conclusions: SBRT had a tendency to increase OS compared with sublobar resection in patients who are not medically fit for lobectomy with clinical stage I NSCLC. However, OS after SBRT was better than wedge resection subgroup. SBRT can be an alternative treatment option to segmentectomy for patients who cannot tolerate lobectomy because of medical comorbidities. A randomized prospective study is necessary to determine survival in compromised SBRT and sublobar resection.

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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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