HALT: targeted therapy with or without dose-intensified radiotherapy in oligo-progressive disease in oncogene addicted lung tumours
McDonald, F. Guckenberger, M. Popat, S. Faivre-Finn, Corinne Andratschke, N. Riddell, A. Hanna, G. Prakash, V. Nair, A. Diez, P.
McDonald, F.
Guckenberger, M.
Popat, S.
Faivre-Finn, Corinne
Andratschke, N.
Riddell, A.
Hanna, G.
Prakash, V.
Nair, A.
Diez, P.
Citations
Altmetric:
Abstract
Background: Following initial response to TKI, advanced NSCLC
patients with actionable mutations ultimately develop treatment
resistance. In a proportion of patients (15-40%), initial, limited
pro gression (≤3 lesions) is observed, termed oligoprogressive
disease (OPD). SBRT offers hypofractionated, targeted radiotherapy
treatment hypothesised to prolong clinical benefit from TKI prior to widespread disease development. The potential benefit offered
by SBRT to ablate OPD sites prior to change in systemic therapy is
an important question to address, particularly during the current
pandemic, where reducing clinic visits is particularly advantageous.
Method: HALT is a randomised, multi-centre, phase II/III
international trial with seamless transition to phase III incorporated.
Eligible patients (stage IV NSCLC, actionable mutation, TKI response
prior to OPD) are randomised 2:1 to SBRT/continued TKI or continued
TKI alone. Eligibility is confirmed by a virtual MDT comprising
trial clinicians and radiologists (OPD, SBRT suitability). Follow-up
assessments aligned with routine care at 3-monthly intervals until
change in systemic therapy is clinically indicated, imaging and
toxicity assessment at each visit.
Current status: Recruitment commenced November 2017; 27
centres (16 UK; 11 non-UK) open to date (09/03/2021), 94 patients
registered and 50 randomised. Because of the COVID-19 pandemic,
recruitment was temporarily paused on 20/03/2020 and restarted in
accordance with national guidelines on 16/06/2020. Of 94 patients
registered, vMDT review performed for 74 patients (18 screen fails
prior to vMDT); 50 randomised, 22 confirmed ineligible via vMDT
(inc. >3 lesions, lesion >5cm, intracranial disease identified).
Conclusion: The vMDT remains an important, novel aspect of the
trial, ensuring robust patient selection ahead of randomisation.
As the first randomised trial assessing SBRT benefit in this patient
population, HALT will provide valuable treatment efficacy and safety
information, informing subsequent trial design and contribute to
the development of international guidelines for the identification
and clinical management of oligoprogression in mutation positive
lung cancer.
Affiliation
Description
Date
2021
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
McDonald F, Guckenberger M, Popat S, Faivre-Finn C, Andratschke N, Riddell A, et al. HALT: targeted therapy with or without dose-intensified radiotherapy in oligo-progressive disease in oncogene addicted lung tumours. Lung Cancer . 2021 Jun;156:S70–1