MIAMI, FL – February 15, 2024 – A study co-led by researchers at Miami Cancer Institute, part of Baptist Health South Florida, found that ablative stereotactic magnetic resonance (MR)-guided adaptive radiation therapy may improve local control (LC) and overall survival (OS) in patients with borderline resectable (BRPC) and locally advanced pancreas cancer (LAPC). Long-term outcomes from the Phase 2 SMART trial demonstrate encouraging OS and limited toxicity as published recently in Radiotherapy & Oncology (“The Green Journal”).
“Pancreatic ductal adenocarcinoma is a leading cause of cancer death. Surgery is the only known curative treatment, although most newly diagnosed patients are not surgical candidates due to locally extensive and/or distant metastatic disease,” said Michael D. Chuong, M.D., vice chair and medical director of proton therapy and photon therapy in the department of radiation oncology at Miami Cancer Institute, and senior author of the study. “Ablative radiation therapy may benefit patients with advanced pancreatic ductal adenocarcinoma by improving LC, reducing pain, and enhancing quality-of-life.”
This first prospective, multi-center, single-arm open-label Phase 2 trial enrolled 136 patients at thirteen centers in three countries after ≥3 months of any chemotherapy without distant progression and a serum carbohydrate antigen (CA 19-9) tumor marker level of £500 U/mL. Stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) was delivered on a 0.35T MR-guided system prescribed to 50 Gy in 5 fractions. Surgery and chemotherapy were permitted after SMART. Median OS from diagnosis and SMART was 22.8 months and 14.2 months, respectively. Two-year OS for the entire cohort from diagnosis and SMART was 53.6 % and 40.5 %, respectively, which is significantly higher than what is expected after chemotherapy +/- standard radiation therapy. Two-year estimated OS for resected vs. unresected patients from SMART was 67 % vs. 26 % respectively. Two-year LC from diagnosis and SMART for the entire cohort was 77.7 % and 78.2 %, respectively, and was higher for resected vs. unresected patients (90 % vs. 71 %; p = 0.019).
“The SMART trial is the first to prospectively demonstrate the safety of delivering ablative radiation dose for advanced pancreas cancer, which resulted in excellent long-term LC even among patients who did not have surgery,” added Dr. Chuong. “We are especially excited by the potential for ablative radiation therapy to also prolong OS. A Phase 3 randomized trial evaluating whether OS is definitely improved with addition of ablative SMART to chemotherapy versus chemotherapy alone for advanced pancreas cancer is warranted,” said Dr. Chuong.
About Miami Cancer Institute
Miami Cancer Institute brings to South Florida access to personalized clinical treatments and comprehensive support services delivered with unparalleled compassion. No other cancer program in the region has the combination of cancer-fighting expertise and advanced technology—including the first proton therapy center in South Florida, Latin America and the Caribbean, and one of the only radiation oncology programs in the world with each of the newest radiation therapies in one place—to diagnose and deliver precise cancer treatments that achieve the best outcomes and improve the lives of cancer patients. The Institute offers an impressive roster of established community oncologists and renowned experts, clinical researchers and genomic scientists recruited from the nation’s top cancer centers. Selected as Florida’s only member of the Memorial Sloan Kettering Cancer (MSK) Alliance, Miami Cancer Institute is part of a meaningful clinical collaboration that affords patients in South Florida access to innovative treatments and ensures that the standards of care developed by their multidisciplinary disease management teams match those at MSK. For more information, please visit https://cancer.baptisthealth.net/miami-cancer-institute.
Miami Cancer Institute is part of Baptist Health Cancer Care, the largest cancer program in South Florida, with locations from the Florida Keys to the Palm Beaches.
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Journal
Radiotherapy and Oncology
Method of Research
Randomized controlled/clinical trial
Subject of Research
People
Article Title
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
Article Publication Date
20-Dec-2023
COI Statement
Corresponding author: Parag Jitendra Parikh, BSE, MD.; E-mail: PParikh2@hfhs.org This research has been supported by ViewRay, Inc. This protocol is registered with ClinicalTrials.gov and may be viewed online at https://clinicaltrials.gov/ct2/show/NCT03621644. Disclosures: P.J.P. reports research grants, consulting fees, and honoraria from ViewRay, Inc, and grants from Galera, is a stock owner for Nuvaira, and is supported by Elizabeth, Allan & Warren Shelden Fund outside of submitted work. P.L. reports personal fee from ViewRay, Inc, grants and personal fees from AstraZeneca, personal fees and nonfinancial support from Varian, and personal fees from Genentech, Inc, outside the submitted work. D.A.L. reports consulting fees, honoraria, and travel support from ViewRay, Inc, grants from Varian and Triplet State, patents with UCLA, SAB membership for TAE Life Sciences, and leadership roles at Jewish Sacred Music Foundation, AAPM, and American Society for Radiation Oncology. J.K. reports consulting and travel support from ViewRay, Inc, travel support from Varian, and honoraria from University of Washington and Roswell Park Cancer Institute. K.E.M. reports personal fees from ViewRay, Inc, is a cofounder of MR Guidance LLC, and reports grants from ViewRay, Inc, outside of submitted work. M.F.B. reports institutional support for clinical trial from AstraZeneca, honoraria from University of Virginia, and honoraria and travel reimbursement from University of Calgary (Edmonton Health Services). C.K.G.-H. reports research funding from the National Institutes of Health (R01CA204189, R01HL153720, and R01CA236857) and research agreements with Modus Medical Devices and GE Healthcare outside of submitted work. A.C.R. reports consulting fees from ViewRay, Inc, and grant funding from ViewRay, Inc, Joseph Drown Foundation, and Intelligent Automation, Inc, outside of submitted work. Y.Y. reports research support, honoraria, and consulting for ViewRay, Inc, outside of submitted work. L.P. reports study and advisory funding from ViewRay, Inc. H.K. reports research funding and honoraria from ViewRay, Inc, and Varian. L.E.H. reports research funding from Varian, consulting fees from Varian and Radialogica, honoraria from Varian, LusoPalex, and ViewRay, Inc, and ViewRay consortium membership. A.T.P. reports speaker fees from ViewRay Technologies, Inc, and speaker and travel fees from SunNuclear Corp. C.L.W. reports prior research grant support and speaker honoraria from ViewRay, Inc. R.P. reports consulting fees from ViewRay, Inc, outside of the submitted work. A.C.M. reports RSNA Research Scholar Grant, W. Kim Foster Foundation Research Grant, and research funding from ViewRay, Inc, outside of submitted work. M.R.P. reports board membership with ISCORT (Israel Society for Clinical Oncology and Radiotherapy). K.E.M. reports honoraria from ViewRay, Inc. P.K. reports research grant support from ViewRay, Inc, Mevion, and Varian outside of submitted work. A.P. S. reports research funding from ViewRay, Inc, Varian, and CIRS, Inc, consulting for ViewRay, Inc, and honoraria from Varian. L.B. reports speaker honoraria and research and travel support from ViewRay, Inc, consulting for Varian and Medipass srl, patents with Universita Cattolica del Sacro Cuore, advisory board membership for IBA, and a leadership role with AIRO. L.P. reports research grant support from ViewRay, Inc. M.F. reports employment by ViewRay, Inc, and stock ownership. M.D.C. reports consulting, honoraria, advisory board, research funding, and travel support from ViewRay, Inc, honoraria from Sirtex, researchfunding from Novocure, research funding from StratPharma, honoraria from IBA, and honoraria from GenesisCare. No other disclosures were reported. Research data are stored in an institutional repository and will be shared upon request to the corresponding author. Acknowledgments—The authors thank Scott Dill, PhD, Aine Duffy, PhD (NAMSA, New York, NY), Teresa Yurik (NAMSA, Minneapolis, MN), and Stewart Richmond, PhD (NAMSA, Selby, United Kingdom) for their assistance in the preparation of this article.