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

Michael D. Chuong, Percy Lee, Daniel A. Low, Joshua Kim, Kathryn E. Mittauer, Michael F. Bassetti, Carri K. Glide-Hurst, Ann C. Raldow, Yingli Yang, Lorraine Portelance, Kyle R. Padgett, Bassem Zaki, Rongxiao Zhang, Hyun Kim, Lauren E. Henke, Alex T. Price, Joseph D. Mancias, Christopher L. Williams, John Ng, Ryan PennellM. Raphael Pfeffer, Daphne Levin, Adam C. Mueller, Karen E. Mooney, Patrick Kelly, Amish P. Shah, Luca Boldrini, Lorenzo Placidi, Martin Fuss, Parag Jitendra Parikh

Research output: Contribution to journalArticlepeer-review

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 dose10 [BED10] = 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.

Original languageEnglish
Article number110064
JournalRadiotherapy and Oncology
Volume191
DOIs
StatePublished - Feb 2024

Keywords

  • Adenocarcinoma
  • Induction chemotherapy
  • Pancreatic neoplasms
  • Radiotherapy

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