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
Recommended Citation
Chuong MD, Lee P, Low DA, Kim J, Mittauer KE, Bassetti MF, Glide-Hurst CK, Raldow AC, Yang Y, Portelance L, Padgett KR, Zaki B, Zhang R, Kim H, Henke LE, Price AT, Mancias JD, Williams CL, Ng J, Pennell R, Raphael Pfeffer M, Levin D, Mueller AC, Mooney KE, Kelly P, Shah AP, Boldrini L, Placidi L, Fuss M, and Jitendra Parikh P. 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. Radiother Oncol 2023; 191:110064.
Document Type
Article
Publication Date
2-1-2024
Publication Title
Radiotherapy and oncology
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(10) [BED(10)] = 100 Gy). Elective coverage was optional. Surgery and chemotherapy were permitted after SMART.
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.
Medical Subject Headings
Humans; Aged; Pancreatic Neoplasms; Antineoplastic Combined Chemotherapy Protocols; Radiotherapy Planning, Computer-Assisted; Radiosurgery
PubMed ID
38135187
Volume
191
First Page
110064
Last Page
110064
