Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial

Ball, David; Tao, Gang; Vinod, Shalini; Babington, Scott; Ruben, Jeremy; Kron, Tomas; Chesson, Brent; Herschtal, Alan; Vanevski, Marijana; Rezo, Angela; Elder, Christine; Skala, Marketa; Wirth, Andrew; Wheeler, Greg; Lim, Adeline; Shaw, Margaret; Schofield, Penelope; Irving, Louis; Solomon, Benjamin; Nedev, Nick; Le, Hien

doi:10.1016/s1470-2045(18)30896-9

Cited by 404 publications

(271 citation statements)

References 17 publications

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“…This delivers a higher dose than conventional radical radiotherapy and has better overall survival 27. Several studies attempting to randomise between surgery and SABR have failed to recruit, although one study is ongoing in North America (https://clinicaltrials.gov/ct2/show/NCT02984761).…”

Section: What Are the Latest Management Options?mentioning

confidence: 99%

Lung cancer

Neal

Sun

Emery

et al. 2019

BMJ

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Section: What Are the Latest Management Options?mentioning

confidence: 99%

Lung cancer

Neal

Sun

Emery

et al. 2019

BMJ

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“…Several retrospective studies and prospective trials have also reported that the survival outcomes after SBRT were comparable with those after surgical resection . The phase III randomized trial (CHISEL) of SBRT versus conventional radiotherapy for stage I inoperable NSCLC demonstrated that the two‐year local control (LC) and overall survival (OS) rates improved from 65% and 59% in standard radiotherapy to 89% and 77% in SBRT, respectively …”

Section: Introductionmentioning

confidence: 98%

“…Moreover, investigations have found that a proportion of patients would develop local failure (9%), regional lymph node metastases (1%) or more distant metastasis (9%) after SBRT . Therefore, improved disease outcomes and reduced chances of lung injury can be achieved with individualized treatment .…”

Section: Introductionmentioning

confidence: 99%

“…[5][6][7][8][9] The phase III randomized trial (CHISEL) of SBRT versus conventional radiotherapy for stage I inoperable NSCLC demonstrated that the twoyear local control (LC) and overall survival (OS) rates improved from 65% and 59% in standard radiotherapy to 89% and 77% in SBRT, respectively. 10 Moreover, investigations have found that a proportion of patients would develop local failure (9%), regional lymph node metastases (1%) or more distant metastasis (9%) after SBRT. 10 Therefore, improved disease outcomes and reduced chances of lung injury can be achieved with individualized treatment.…”

Section: Introductionmentioning

confidence: 99%

“…10 Moreover, investigations have found that a proportion of patients would develop local failure (9%), regional lymph node metastases (1%) or more distant metastasis (9%) after SBRT. 10 Therefore, improved disease outcomes and reduced chances of lung injury can be achieved with individualized treatment. [11][12][13] In recent years, medical imaging as a way to predict clinical outcomes and lung injury has become a cornerstone of personalized cancer.…”

Section: Introductionmentioning

confidence: 99%

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Cone‐beam CT radiomics features might improve the prediction of lung toxicity after SBRT in stage I NSCLC patients

et al. 2020

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Background Stereotactic body radiotherapy (SBRT) is the standard care for inoperable early stage non‐small cell lung cancer (NSCLC). The purpose of our study was to investigate whether a prediction model based on cone‐beam CT (CBCT) plus pretreatment CT radiomics features could improve the prediction of tumor control and lung toxicity after SBRT in comparison to a model based on pretreatment CT radiomics features alone. Methods A total of 34 cases of stage I NSCLC patients who received SBRT were included in the study. The pretreatment planning CT and serial CBCT radiomics features were analyzed using the imaging biomarker explorer (IBEX) software platform. Multivariate logistic regression was conducted for the association between progression‐free survival (PFS), lung toxicity and features. The predictive capabilities of the models based on CBCT and CT features were compared using receiver operating characteristic (ROC) curves. Results Five CBCT features and two planning CT features were correlated with disease progression. Six CBCT features and two planning CT features were related to lung injury. The ROC curves indicated that the model based on the CBCT plus planning CT features might be better than the model based on the planning CT features in predicting lung injury. The other ROC curves indicated that the model based on the planning CT features was similar to the model based on the CBCT plus planning CT features in predicting disease progression. Conclusions Both pretreatment CT and CBCT radiomics features could predict disease progression and lung injury. A model with CBCT plus pretreatment CT radiomics features might improve the prediction of lung toxicity in comparison with a model with pretreatment CT features alone. Key points Significant findings of the study: A model with cone‐beam CT radiomics features plus pre‐treatment CT radiomics features might improve the prediction of lung toxicity after SBRT in stage I NSCLC patients. What this study adds: In the prediction of PFS and lung toxicity in early‐stage NSCLC patients treated with SBRT, CBCT radiomics could be another effective method.

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Individualized Stereotactic Ablative Radiotherapy for Lung Tumors

Gensheimer,

Gee,

Shirato

et al. 2023

JAMA Oncol

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ImportanceStereotactic ablative radiotherapy (SABR) is used for treating lung tumors but can cause toxic effects, including life-threatening damage to central structures. Retrospective data suggested that small tumors up to 10 cm3 in volume can be well controlled with a biologically effective dose less than 100 Gy.ObjectiveTo assess whether individualizing lung SABR dose and fractionation by tumor size, location, and histological characteristics may be associated with local tumor control.Design, Setting, and ParticipantsThis nonrandomized controlled trial (the iSABR trial, so named for individualized SABR) was a phase 2 multicenter trial enrolling participants from November 15, 2011, to December 5, 2018, at academic medical centers in the US and Japan. Data were analyzed from December 9, 2020, to May 10, 2023. Patients were enrolled in 3 groups according to cancer type: initial diagnosis of non–small cell lung cancer (NSCLC) with an American Joint Committee on Cancer 7th edition T1-3N0M0 tumor (group 1), a T1-3N0M0 new primary NSCLC with a history of prior NSCLC or multiple NSCLCs (group 2), or lung metastases from NSCLC or another solid tumor (group 3).InterventionUp to 4 tumors were treated with once-daily SABR. The dose ranged from 25 Gy in 1 fraction for peripheral tumors with a volume of 0 to 10 cm3 to 60 Gy in 8 fractions for central tumors with a volume greater than 30 cm3.Main outcomePer-group freedom from local recurrence (same-lobe recurrence) at 1 year, with censoring at time of distant recurrence, death, or loss to follow-up.ResultsIn total, 217 unique patients (median [IQR] age, 72 [64-80] years; 129 [59%] male; 150 [69%] current or former smokers) were enrolled (some multiple times). There were 240 treatment courses: 79 in group 1, 82 in group 2, and 79 in group 3. A total of 285 tumors (211 [74%] peripheral and 74 [26%] central) were treated. The most common dose was 25 Gy in 1 fraction (158 tumors). The median (range) follow-up period was 33 (2-109) months, and the median overall survival was 59 (95% CI, 49-82) months. Freedom from local recurrence at 1 year was 97% (90% CI, 91%-99%) for group 1, 94% (90% CI, 87%-97%) for group 2, and 96% (90% CI, 89%-98%) for group 3. Freedom from local recurrence at 5 years ranged from 83% to 93% in the 3 groups. The proportion of patients with grade 3 to 5 toxic effects was low, at 5% (including a single patient [1%] with grade 5 toxic effects).Conclusions and RelevanceThe results of this nonrandomized controlled trial suggest that individualized SABR (iSABR) used to treat lung tumors may allow minimization of treatment dose and is associated with excellent local control. Individualized dosing should be considered for use in future trials.Trial RegistrationClinicalTrials.gov Identifier: NCT01463423

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Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial

Cited by 404 publications

References 17 publications

Lung cancer

Lung cancer

Cone‐beam CT radiomics features might improve the prediction of lung toxicity after SBRT in stage I NSCLC patients

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors

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