Canadian Phase III Randomized Trial of Stereotactic Body Radiotherapy Versus Conventionally Hypofractionated Radiotherapy for Stage I, Medically Inoperable Non–Small-Cell Lung Cancer – Rationale and Protocol Design for the Ontario Clinical Oncology Group (OCOG)-LUSTRE Trial
“…22 This dose is currently being evaluated for patients with both peripherally and centrally-located NSCLC as part of a randomized trial. 30 We note a recent systematic review by Rim et al 31 also on the topic of SABR for ultra-central lung lesions. In comparison, our search design allowed us to evaluate a larger number of sources and include a significantly higher number of peer-reviewed full-text sources.…”
Introduction: The safety and effectiveness of stereotactic ablative radiotherapy (SABR) in patients with ultra-central lung tumors is currently unclear. We performed a systematic review to summarize existing data and identify trends in treatment-related toxicity and local control following SABR in patients with ultra-central lung lesions. Methods: We performed a systematic review based on the Preferred Reporting Items for Systemic Reviews and Meta-Analyses guidelines using the PubMed and Embase databases. The databases were queried from dates of inception until September 27, 2018. Studies in the English language that reported treatment-related toxicity and local control outcomes post-SABR for patients with ultra-central lung lesions were included. Guidelines, reviews, non-peer reviewed correspondences, studies focused on re-irradiation, and studies with fewer than five patients were excluded. Results: A total of 446 studies were identified, with 10 meeting all criteria for inclusion. The total sample size from the identified studies was 250 ultra-central lung patients and all studies were retrospective in design. Radiotherapy dose and fractionation ranged from 30 to 60 Gy in 3 to 12 fractions, with biologically effective doses (BED 10) ranging from 48 to 138 Gy 10 (median, 78-103 Gy 10). Median treatment-related grade 3 or greater toxicity was 10% (range, 0-50%). Median treatmentrelated mortality was 5% (range, 0-22%), most commonly from pulmonary hemorrhage (55%). High-risk indicators for SABR-related mortality included gross endobronchial disease, maximum dose to the proximal bronchial tree greater than or equal to 180 Gy 3 (BED 3 , corresponding to 45 Gy in 5 fractions or 55 Gy in 8 fractions), peri-SABR bevacizumab use, and antiplatelet/ anticoagulant use. Median 1-year local control rate was 96% (range, 63%-100%) and 2-year local control rate was 92% (range, 57%-100%). Conclusions: SABR for ultra-central lung lesions appears feasible but there is a potential for severe toxicity in patients receiving high doses to the proximal bronchial tree, those with endobronchial disease, and those receiving bevacizumab or anticoagulants around the time of SABR. Prospective studies are required to establish the optimal doses, volumes, and normal tissue tolerances for SABR in this patient population.
“…22 This dose is currently being evaluated for patients with both peripherally and centrally-located NSCLC as part of a randomized trial. 30 We note a recent systematic review by Rim et al 31 also on the topic of SABR for ultra-central lung lesions. In comparison, our search design allowed us to evaluate a larger number of sources and include a significantly higher number of peer-reviewed full-text sources.…”
Introduction: The safety and effectiveness of stereotactic ablative radiotherapy (SABR) in patients with ultra-central lung tumors is currently unclear. We performed a systematic review to summarize existing data and identify trends in treatment-related toxicity and local control following SABR in patients with ultra-central lung lesions. Methods: We performed a systematic review based on the Preferred Reporting Items for Systemic Reviews and Meta-Analyses guidelines using the PubMed and Embase databases. The databases were queried from dates of inception until September 27, 2018. Studies in the English language that reported treatment-related toxicity and local control outcomes post-SABR for patients with ultra-central lung lesions were included. Guidelines, reviews, non-peer reviewed correspondences, studies focused on re-irradiation, and studies with fewer than five patients were excluded. Results: A total of 446 studies were identified, with 10 meeting all criteria for inclusion. The total sample size from the identified studies was 250 ultra-central lung patients and all studies were retrospective in design. Radiotherapy dose and fractionation ranged from 30 to 60 Gy in 3 to 12 fractions, with biologically effective doses (BED 10) ranging from 48 to 138 Gy 10 (median, 78-103 Gy 10). Median treatment-related grade 3 or greater toxicity was 10% (range, 0-50%). Median treatmentrelated mortality was 5% (range, 0-22%), most commonly from pulmonary hemorrhage (55%). High-risk indicators for SABR-related mortality included gross endobronchial disease, maximum dose to the proximal bronchial tree greater than or equal to 180 Gy 3 (BED 3 , corresponding to 45 Gy in 5 fractions or 55 Gy in 8 fractions), peri-SABR bevacizumab use, and antiplatelet/ anticoagulant use. Median 1-year local control rate was 96% (range, 63%-100%) and 2-year local control rate was 92% (range, 57%-100%). Conclusions: SABR for ultra-central lung lesions appears feasible but there is a potential for severe toxicity in patients receiving high doses to the proximal bronchial tree, those with endobronchial disease, and those receiving bevacizumab or anticoagulants around the time of SABR. Prospective studies are required to establish the optimal doses, volumes, and normal tissue tolerances for SABR in this patient population.
“…The comparison to hypofractionated CRT, which is standard Canadian practice, and inclusion of central tumors is unique compared to the aforementioned studies. Accrual is expected to be complete in 3 years (84). These studies may help to address remaining concerns regarding the efficacy and safety of SBRT compared with more conventional or hypofractionated radiation treatment schedules.…”
Section: Sbrt Vs Conventionally Fractionated Radiotherapymentioning
The standard-of-care treatment for early-stage non-small cell lung cancer (NSCLC) continues to be surgery in the form of lobectomy or pneumonectomy. Stereotactic body radiation therapy (SBRT) has evolved as a viable alternative to surgery for medically inoperable patients, achieving excellent local control (LC) with relatively minimal toxicity in standard-risk patients. Nevertheless, the maturation of SBRT has fostered debate regarding its use, technique, dose, and fractionation, particularly in the context of patient- and disease-specific characteristics such as tumor size and location. This review will cover the recent trends and future directions of SBRT as it becomes an increasingly individualized modality in the treatment of early-stage NSCLC.
“…Nonetheless, patients receiving 3D CRT suffered from increased rates of pneumonitis, thought to be secondary to increased irradiated lung due to the larger field sizes typically used in 3D CRT treatments, 21 and as such, SBRT was recommended as compared to 3D CRT. Further randomized trials including the Australian CHISEL trial 22 and Canadian LUSTRE trial 23 will help further clarify the differences in QOL between 3D CRT and SBRT particularly in a modern radiotherapy planning era.…”
Section: Sbrt Versus Conventional Radiotherapy: Convenience and Safetmentioning
confidence: 99%
“… 42 Appropriate dose limitations should still be maintained when using this regimen, including the esophagus to 40 Gy maximum point dose or 20 Gy to 5 cc, and the heart, vessels, and trachea to 64 Gy maximum point dose and 60 Gy to 10 cc (or to 5 cc in the case of the trachea and proximal tree). 23 In most cases, with careful planning and reduced or risk-adapted dose per fraction, SBRT can be delivered safely even in difficult tumor locations, without compromise in local control or survival. 48 …”
Stereotactic body radiation therapy (SBRT) has emerged as a new technology in radiotherapy delivery, allowing for potentially curative treatment in many patients previously felt not to be candidates for radical surgical resection of stage I non-small-cell lung cancer (NSCLC). Several studies have demonstrated very high local control rates using SBRT, and more recent data have suggested overall survival may approach that of surgery in operable patients. However, SBRT is not without unique toxicities, and the balance of toxicity, and effect on patient-reported quality of life need to be considered with respect to oncologic outcomes. We therefore aim to review SBRT in the context of important patient-related factors, including quality of life in several domains (and in comparison to other therapies such as conventional radiation, surgery, or no treatment). We will also describe scenarios in which SBRT may be reasonably offered (i.e. elderly patients and those with severe COPD), and where it may need to be approached with some caution due to increased risks of toxicity (i.e. tumor location, patients with interstitial lung disease). In total, we hope to characterize the physical, emotional, and functional consequences of SBRT, in relation to other management strategies, in order to aid the clinician in deciding whether SBRT is the optimal treatment choice for each patient with early stage NSCLC.
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