The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials.
Clin Radiol
; 76(2): 155.e25-155.e34, 2021 Feb.
Article
in En
| MEDLINE
| ID: mdl-33268083
ABSTRACT
AIM:
To report on the multidisciplinary approach, focusing specifically on the role of the interventional radiologist (IR), used to support the Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) and BATTLE-2 trials. MATERIALS ANDMETHODS:
Patients who underwent percutaneous image-guided biopsy for the BATTLE and BATTLE-2 trials were reviewed. A radiology-based, three-point, lesion-scoring system was developed and used by two IRs. Lesions were given a score of 3 (most likely to yield sufficient material for biomarker analysis) if they met the following criteria size >2 cm, solid mass, demonstrated imaging evidence of viability, and were technically easy to sample. Lesions not meeting all four criteria were scored 2 with the missing criteria noted as negative factors. Lesions considered to have risks that outweighed potential benefits receive a score of 1 and were not biopsied. Univariate and multivariate analyses were performed to evaluate the score's ability to predict successful yield for biomarker adequacy.RESULTS:
A total of 555 biopsies were performed. The overall yield for analysis of the required biomarkers was 86.1% (478/555), and 84% (268/319) and 88.9% (210/236) for BATTLE and BATTLE-2, respectively (p=0.09). Lesions receiving a score of 3 were adequate for biomarker analysis in 89% of cases. Lesions receiving a score of 2 with more than two negative factors were adequate for molecular analysis in 69.2% (IR1, p=0.03) and 74% (IR2, p=0.04) of cases. The two IRs scored 78.4% of the lesions the same indicating moderate agreement (kappa=0.55; 95% confidence interval [CI] 0.48, 0.61).CONCLUSIONS:
IRs add value to clinical trial teams by optimising lesions selected for biopsy and biomarker analysis.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Radiology, Interventional
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Carcinoma, Non-Small-Cell Lung
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Lung Neoplasms
Type of study:
Prognostic_studies
Limits:
Aged
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Female
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Humans
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Male
/
Middle aged
Language:
En
Journal:
Clin Radiol
Year:
2021
Document type:
Article