A Multi-Institutional Phase 2 Trial of Ablative 5-Fraction Stereotactic Magnetic Resonance-Guided On-Table Adaptive Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer

Parag Jitendra Parikh, 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, Michael D. Chuong

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

Purpose: Magnetic resonance (MR) image guidance may facilitate safe ultrahypofractionated radiation dose escalation for inoperable pancreatic ductal adenocarcinoma. We conducted a prospective study evaluating the safety of 5-fraction Stereotactic MR-guided on-table Adaptive Radiation Therapy (SMART) for locally advanced (LAPC) and borderline resectable pancreatic cancer (BRPC). Methods and Materials: Patients with LAPC or BRPC were eligible for this multi-institutional, single-arm, phase 2 trial after ≥3 months of systemic therapy without evidence of distant progression. Fifty gray in 5 fractions was prescribed on a 0.35T MR-guided radiation delivery system. The primary endpoint was acute grade ≥3 gastrointestinal (GI) toxicity definitely attributed to SMART. Results: One hundred thirty-six patients (LAPC 56.6%, BRPC 43.4%) were enrolled between January 2019 and January 2022. Mean age was 65.7 (36-85) years. Head of pancreas lesions were most common (66.9%). Induction chemotherapy mostly consisted of (modified)FOLFIRINOX (65.4%) or gemcitabine/nab-paclitaxel (16.9%). Mean CA19-9 after induction chemotherapy and before SMART was 71.7 U/mL (0-468). On-table adaptive replanning was performed for 93.1% of all delivered fractions. Median follow-up from diagnosis and SMART was 16.4 and 8.8 months, respectively. The incidence of acute grade ≥3 GI toxicity possibly or probably attributed to SMART was 8.8%, including 2 postoperative deaths that were possibly related to SMART in patients who had surgery. There was no acute grade ≥3 GI toxicity definitely related to SMART. One-year overall survival from SMART was 65.0%. Conclusions: The primary endpoint of this study was met with no acute grade ≥3 GI toxicity definitely attributed to ablative 5-fraction SMART. Although it is unclear whether SMART contributed to postoperative toxicity, we recommend caution when pursuing surgery, especially with vascular resection after SMART. Additional follow-up is ongoing to evaluate late toxicity, quality of life, and long-term efficacy.

Original languageEnglish
Pages (from-to)799-808
Number of pages10
JournalInternational Journal of Radiation Oncology Biology Physics
Volume117
Issue number4
DOIs
StatePublished - Nov 15 2023

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