Local Extension at the Hilum Region Is Associated With Worse Long-Term Survival in Stage I Non-Small Cell Lung Cancers

LungTech, an EORTC Phase II trial of stereotactic body radiotherapy for centrally located lung tumours: a clinical perspective

“…16 In contrast to peripheral tumours, those located centrally often show compression and/or invasion in vessels, major bronchi or other critical mediastinal structures and, therefore, require more extensive surgical procedures associated with higher mortality and morbidity. [17][18][19] Approximately 20% of all patients with NSCLC Stage I are medically inoperable because of poor general condition or coexisting morbidities such as chronic obstructive pulmonary disease and/or heart disease, 20 and ,50% of all patients with early stage NSCLC older than 75 years undergo surgery. 21 It is expected that as the global population ages and lung cancer screening of high-risk populations is implemented, 22 the proportion of inoperable patients with lung cancer with comorbidities will increase.…”

“…Using one-sided 5% Type I error and 80% power, 150 patients (included so far from 23 planned centres in Belgium, France, Germany, Poland, Switzerland and UK) should be sufficient to reject the hypothesis of freedom from the local progression rate at 3 years of #80% under the assumption that SBRT is expected to achieve a freedom from local progression rate of 90%. The trial will also investigate acute and late toxicities as well as patterns of local and distant recurrence, including mediastinal failure, assessed by serial CT scans and confirmed by 18 F-FDG-PET/CT and subsequent repeat imaging or biopsy, if necessary. Moreover, this study offers a unique opportunity to evaluate the role of 18 F-FDG-PET/CT to monitor disease progression and toxicity, as translational research end points, including staging comparison between 3D-and four-dimensional (4D) 18 Recently, the Radiation Therapy Oncology Group (RTOG) has performed a dose-escalation Phase I/II study (RTOG 0813) in centrally located NSCLC.…”

“…The trial will also investigate acute and late toxicities as well as patterns of local and distant recurrence, including mediastinal failure, assessed by serial CT scans and confirmed by 18 F-FDG-PET/CT and subsequent repeat imaging or biopsy, if necessary. Moreover, this study offers a unique opportunity to evaluate the role of 18 F-FDG-PET/CT to monitor disease progression and toxicity, as translational research end points, including staging comparison between 3D-and four-dimensional (4D) 18 Recently, the Radiation Therapy Oncology Group (RTOG) has performed a dose-escalation Phase I/II study (RTOG 0813) in centrally located NSCLC. 56 Derived from the North American standard, the study is based on a five-fraction regime, the results are awaited.…”

“…The primary end point will be freedom from local progression at 3 years as assessed by serial CT scans and confirmed by 18 F-FDG-PET/CT. If still unclear, biopsies or 3 monthly repeated imaging will be performed.…”

Stereotactic radiotherapy for early lung cancer: Evidence-based approach and future directions

“…For patients undergoing surgical resection, more extensive surgery is often required for central tumors, which is associated with increased morbidity and mortality. 21,22 For patients with central tumors undergoing SBRT, a pivotal phase II study reported that a dose of 60-66 Gy in 3 fractions was associated with excessive toxicity and treatment-related death. In this trial of 70 patients with T1 or T2 NSCLC, patients with peripheral tumors had a 2-year freedom from severe toxicity of 83%, compared to only 54% in patients with central tumors.…”