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Clinical Trial
. 2022 May:170:14-20.
doi: 10.1016/j.radonc.2021.06.005. Epub 2021 Jun 6.

Ablative radiotherapy for liver tumors using stereotactic MRI-guidance: A prospective phase I trial

Ritchell van Dams  1 , Trudy C Wu  1 , Amar U Kishan  1 , Ann C Raldow  1 , Fang-I Chu  1 , Jackie Hernandez  1 , Minsong Cao  1 , James M Lamb  1 , Argin Mikaeilian  1 , Daniel A Low  1 , Michael L Steinberg  1 , Percy Lee  2
Affiliations
Clinical Trial

Ablative radiotherapy for liver tumors using stereotactic MRI-guidance: A prospective phase I trial

Ritchell van Dams et al. Radiother Oncol. 2022 May.

Abstract

Background and purpose: To prospectively determine the feasibility, safety, and efficacy of stereotactic body radiation therapy (SBRT) to primary and secondary liver tumors with MR-guided radiation therapy (MRgRT).

Materials and methods: Treatment plans with a conventional CT-guided linear accelerator and a MRI-guided tri-60Co teletherapy unit (MR-Co) were generated and compared for patients undergoing liver-directed SBRT from 2015 to 2017. If dosimetric parameters were met on MR-Co, patients were treated with MRgRT. The highest priority constraint was >1000 cc or >800 cc of normal liver receiving <15 Gy for single- or multiple-lesion treatments, respectively. Treatment was delivered every other day.

Results: Of 23 patients screened, 20 patients (8 primary, 12 secondary) and 25 liver tumors underwent MR-guided SBRT to a median dose of 54 Gy (range 11.5-60) in a median of 3 fractions (range 1-5). With a median follow up of 18.9 months, the 1- and 2-year estimate of local control were 94.7% and 79.6%, respectively. A difference in local control between single and multiple lesions or BED ≥ 100 Gy10 and BED < 100 Gy10, respectively, was observed. The 2-year estimate of overall survival (OS) was 50.7% with a median OS of 29 months. There were no acute grade ≥ 3 toxicities and one late grade 3/4 toxicity from a single patient whose plan exceeded an unrecognized dose constraint at the time.

Conclusion: MR-guided SBRT is a viable and safe option in the delivery of ultrahypofractionated ablative radiation treatment to primary and secondary liver tumors resulting in high rates of local control and very favorable toxicity profiles.

Keywords: Ablative radiotherapy; Clinical trial; Liver tumors; MR-guided.

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Conflict of interest statement

Conflicts of interest Dr. Kishan reports personal fees from Varian Medical Systems, Inc., grants and personal fees from ViewRay, Inc., personal fees from Intelligent Automation Inc., advisory board for Janssen Pharmaceuticals Inc., outside the submitted work; Dr. Raldow reports grants and personal fees from ViewRay, Inc., outside the submitted work; Dr. Cao reports personal fees from ViewRay Inc.,outside the submitted work; Dr. Lamb reports grants and personal fees from ViewRay, Inc., outside of the submitted work; Dr. Steinberg reports personal fees from ViewRay Inc., outside the submitted work; Dr. Lee is a consultant and reports speaking honorarium for Varian Medical Systems, Inc., advisory board member and clinical trial funding from AstraZeneca Inc., medical advisory board member for ViewRay, Inc., co-Principal Investigator of the SMART Trial outside the submitted work; All other authors: None.

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