HALT - Targeted Therapy with or without Dose-Intensified Radiotherapy in Oligo-Progressive Disease in Oncogene Addicted Lung Tumours
Journal of Thoracic Oncology
; 17(9):S492, 2022.
Article
in English
| EMBASE | ID: covidwho-2031528
ABSTRACT
Introduction:
Following initial response to TKI, advanced NSCLC patients with actionable mutations ultimately develop treatment resistance. In a proportion of patients (15-40%), initial, limited progression (≤5 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. With limited evidence to date, and poor clinical/biological selection criteria, the potential benefit offered by SBRT to ablate OPD sites prior to change in systemic therapy is an important question to address.Methods:
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 21 to SBRT/continued TKI or continued TKI alone. Eligibility is confirmed by a virtual MDT (vMDT) comprising trial clinicians and radiologists (confirmation of OPD, SBRT suitability). Follow-up assessments are aligned with routine care at 3-monthly intervals until change in systemic therapy is clinically indicated, with imaging and toxicity assessment at each visit.Results:
Recruitment commenced November 2017 with 25 centres (17 UK;8 non-UK) open to date. Following the COVID-19 pandemic, recruitment is recovering with 129 registered and 74 randomised patients. Over the last 4 years, little evidence has emerged to confirm any potential benefit of SBRT in this patient group and the impact on patient toxicity remains unknown. Therefore, with persisting questions around clinical equipoise, HALT remains highly relevant. With an 18-month extension and a recent amendment to the HALT inclusion criteria (≤5 OPD lesions, ≤7cm and OPD assessments by PET-avidity), the target of 110 randomised patients remains achievable.Conclusions:
As the first randomised trial assessing SBRT benefit in this mutation-positive NSCLC 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. Keywords Stereotactic body radiotherapy, NSCLC, Phase II
endogenous compound; adult; cancer patient; cancer radiotherapy; cancer staging; conference abstract; controlled study; coronavirus disease 2019; disease assessment; eligibility; equipoise; female; follow up; genetic susceptibility; human; major clinical study; male; molecularly targeted therapy; non small cell lung cancer; oncogene; pandemic; phase 2 clinical trial; phase 3 clinical trial; practice guideline; radiologist; radiotherapy; randomized controlled trial; stereotactic body radiation therapy; surgery; systemic therapy; tumor volume
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Language:
English
Journal:
Journal of Thoracic Oncology
Year:
2022
Document Type:
Article
Similar
MEDLINE
...
LILACS
LIS