EARL: a multicentre phase III randomised trial to evaluate the efficacy of endobronchial electrocautery with autofluorescence bronchoscopy (AFB) surveillance versus AFB surveillance alone in high-grade bronchial dysplasia
Kalinke, L. Thakrar, R. Daniels, H. Rintoul, R. Booton, R. Hackshaw, Allan Janes, S.
Kalinke, L.
Thakrar, R.
Daniels, H.
Rintoul, R.
Booton, R.
Hackshaw, Allan
Janes, S.
Citations
Altmetric:
Abstract
Introduction: Bronchial pre-invasive lesions are precursors of
squamous cell cancer. However, not every pre-invasive lesion is
destined to this; some lesions may remain stable or even regress to
normal epithelium. Performing surveillance with autofluorescence
bronchoscopy (AFB), we have shown that 50% of high-grade lesions (HGLs), i.e. severe dysplasia/carcinoma in-situ, progress to cancer
(unpublished). Their treatment remains controversial. Guidelines
advocate surgical management. This carries inherent risk and its
benefit has not been proven in a randomised trial; new lesions also
develop, so a tissue-sparing strategy is needed.
Methods: We are conducting a Cancer Research UK-funded,
international multi-centre randomised trial to examine whether
thermal ablation using bronchoscopic electrocautery of HGLs
prevents their progression to cancer. Participants will be randomised
to electrocautery and AFB surveillance or AFB surveillance alone. The
trial will run across four centres (University College London Hospital,
Wythenshawe, Papworth and VUmc, Amsterdam)and opens in
December 2019. We aim to recruit 106 participants within 3 years.
Referral criteria are: 1. Individuals with HGLs found incidentally
on bronchial biopsy or at resection margins post-operatively
(even if found up to one year previously) 2. Individuals with
abnormal sputum cytology, but normal CT and/or bronchoscopy All
participants will have a chest CT, pulmonary function tests and AFB
at baseline, and then AFB at 6, 12, 24 and 36 months. Participants
can receive two electrocautery treatments per year over the 3-year
trial period.
Results: The primary endpoint is the time to progression of any
HGL in a patient to invasive lung cancer. Secondary outcomes are (i)
cancer-free and overall survival, (ii) health-related quality of life and
(iii) cost-effectiveness.
Conclusion: The EARL trial is the first Phase III randomised trial
of an endobronchial therapy for the prevention of lung cancer.
If successful, it will address the unmet clinical need for a proven
tissue-sparing therapy for this high-risk population.
Description
Date
2020
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Kalinke L, Thakrar R, Daniels H, Rintoul R, Booton R, Hackshaw A, et al. EARL: a multicentre phase III randomised trial to evaluate the efficacy of endobronchial electrocautery with autofluorescence bronchoscopy (AFB) surveillance versus AFB surveillance alone in high-grade bronchial dysplasia. Lung Cancer. 2020;139:S92-S3