Document Type
Article
Publication Date
12-20-2023
Abstract
BACKGROUND AND PURPOSE: Radiation dose escalation may improve local control (LC) and overall survival (OS) in select pancreatic ductal adenocarcinoma (PDAC) patients. We prospectively evaluated the safety and efficacy of ablative stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) for borderline resectable (BRPC) and locally advanced pancreas cancer (LAPC). The primary endpoint of acute grade ≥ 3 gastrointestinal (GI) toxicity definitely related to SMART was previously published with median follow-up (FU) 8.8 months from SMART. We now present more mature outcomes including OS and late toxicity.
MATERIALS AND METHODS: This prospective, multi-center, single-arm open-label phase 2 trial (NCT03621644) enrolled 136 patients (LAPC 56.6 %; BRPC 43.4 %) after ≥ 3 months of any chemotherapy without distant progression and CA19-9 ≤ 500 U/mL. SMART was delivered on a 0.35 T MR-guided system prescribed to 50 Gy in 5 fractions (biologically effective dose
RESULTS: Mean age was 65.7 years (range, 36-85), induction FOLFIRINOX was common (81.7 %), most received elective coverage (57.4 %), and 34.6 % had surgery after SMART. Median FU was 22.9 months from diagnosis and 14.2 months from SMART, respectively. 2-year OS from diagnosis and SMART were 53.6 % and 40.5 %, respectively. Late grade ≥ 3 toxicity definitely, probably, or possibly attributed to SMART were observed in 0 %, 4.6 %, and 11.5 % patients, respectively.
CONCLUSIONS: Long-term outcomes from the phase 2 SMART trial demonstrate encouraging OS and limited severe toxicity. Additional prospective evaluation of this novel strategy is warranted.
Recommended Citation
Chuong, Michael; Lee, Percy; Low, Daniel; Kim, Joshua; Mittauer, Kathryn; Bassetti, Michael; Glide-Hurst, Carri; Raldow, Ann; Yang, Yingli; Portelance, Lorraine; Padgett, Kyle; Zaki, Bassem; Zhang, Rongxiao; Kim, Hyun; Henke, Lauren; Price, Alex; Mancias, Joseph; Williams, Christopher; Ng, John; Pennell, Ryan; Raphael Pfeffer, M; Levin, Daphne; Mueller, Adam; Mooney, Karen; Kelly, Patrick; Shah, Amish; Boldrini, Luca; Placidi, Lorenzo; Fuss, Martin; and Jitendra Parikh, Parag, "Stereotactic MR-Guided On-Table Adaptive Radiation Therapy (SMART) for Borderline Resectable and Locally Advanced Pancreatic Cancer: A Multi-Center, Open-Label Phase 2 Study" (2023). Department of Radiation Oncology Faculty Papers. Paper 187.
https://jdc.jefferson.edu/radoncfp/187
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
Supplementary data 1
Univariable and multivariable analysis for 2-year overall survival from diagnosis.docx (30 kB)
Supplementary data 2
Incidence of individual acute and late grade 3 or higher adverse events possibly, probably, or definitely attributed to radiation therapy.docx (30 kB)
PubMed ID
38135187
Language
English
Comments
This article is the author's final published version in Radiotherapy and Oncology, Volume 191, February 2024, Article number 110064.
The published version is available at https://doi.org/10.1016/j.radonc.2023.110064.
Copyright © 2023 The Author(s).