2110 - Primary and Complete Clinical Outcome Results from the TROG 17.03 Liver Ablative Radiotherapy with KIM (LARK) Trial
Presenter(s)
Y. Y. Lee1,2, D. T. Nguyen3, T. Moodie4, L. Inskip4, B. Tacon5, B. Zwan5,6, S. C. Tang5, K. Van Gysen7, J. Luo7, K. Au7, P. Ramachandran1, E. Brown1, J. Chu8,9, N. Hardcastle8,10, J. Booth11,12, R. O'Brien3, H. Thomas13, V. Gebski13, T. W. Wang2,4, and P. Keall3; 1Princess Alexandra Hospital, Brisbane, QLD, Australia, 2University of Sydney, Sydney, NSW, Australia, 3Image X Institute, University of Sydney, Sydney, NSW, Australia, 4Department of Radiation Oncology, The Crown Princess Mary Cancer Centre, Westmead, NSW, Australia, 5Central Coast Cancer Centre, Gosford, NSW, Australia, 6School of Informatics and Physical Sciences, University of Newcastle, Newcastle, NSW, Australia, 7Nepean Cancer & Wellness Centre, Kingswood, NSW, Australia, 8Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia, 9Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia, 10Physical Sciences, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia, 11Northern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia, 12Institute of Medical Physics, School of Physics, University of Sydney, Sydney, NSW, Australia, 13NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia
Purpose/Objective(s): A systematic review and meta-analysis stated that effective liver cancer SABR requires accurate dose delivery with accuracy depending on liver tumor motion. Kilovoltage Intrafraction Monitoring, (KIM), is a real-time IGRT implemented for liver cancer SABR patients for the first time in the TROG 17.03 Liver Ablative Radiotherapy with KIM (LARK) trial. This study reports the primary and complete clinical outcome results from the LARK trial.
Materials/Methods: SABR-eligible patients with hepatocellular carcinoma (HCC) or oligometastatic liver disease (OMD) were recruited to receive KIM real-time guidance in the LARK multi-institutional phase II study. When KIM detected target motion =~3-5 mm, the beam was paused and the patient shifted. Delivered dose accuracy was assessed by comparing dosimetry for treatment delivered with and without KIM guidance. The treatment outcomes of overall survival, disease control, toxicity, and quality of life were analyzed on an intent-to-treat basis.
Results: 32 patients, 11 with HCC and 21 with OMD, were recruited across six institutions in Australia. 25 (78%) had a single lesion, median dose was 50 Gy in 5 fractions (range 27.5 – 51 Gy in 3–5 fractions). 27 patients were treated with KIM guidance (84%); 5 patients were treated without KIM due to technical challenges (3), incorrect markers (1), and linac upgrade (1). 97 couch shifts occurred for 20 of 27 patients. KIM guidance led to dosimetric improvement in 15 patients with a mean PTV D95 improvement of 3.0% (range 0.2 – 10.6%).
The median follow up was 25 months. Overall survival: 12 patients (38%) died, 9 from disease progression. Disease control: Local failure was observed in 6 of 32 patients (19%); distant failure in 19 of 32 patients (59%). Toxicity: 3 unrelated grade 3 toxicities. Two patients (6%) developed RILD. The QoL completion rates were =75% at 1.5, 3 and 6 months. Symptom burden, measured by the QLQ-C30, moderately increased over time, including fatigue and insomnia, while nausea and vomiting scores remained low. Symptom burden, measured by the QLQ-HCC18, showed improvement in the domains of pain, jaundice, and abdominal swelling.Conclusion: The implications for practice are the multi-institutional demonstration of a real-time IGRT system for liver cancer patients that can be deployed on the majority of radiation therapy systems. Low toxicity and encouraging quality of life scores were observed. This clinical achievement demonstrates the benefit of the KIM technology, and derisks the KIM technology for broader implementation.