دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Parikh PJ; Henry Ford Health - Cancer, Detroit, Michigan. Electronic address: PParikh2@hfhs.org., Lee P; City of Hope National Medical Center, Los Angeles, California., Low DA; Department of Radiation Oncology, University of California, Los Angeles, California., Kim J; Henry Ford Health - Cancer, Detroit, Michigan., Mittauer KE; Miami Cancer Institute, Baptist Health South Florida, Miami, Florida., Bassetti MF; Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin., Glide-Hurst CK; Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin., Raldow AC; Department of Radiation Oncology, UCLA David Geffen School of Medicine, Los Angeles, California., Yang Y; Department of Radiation Oncology, UCLA David Geffen School of Medicine, Los Angeles, California., Portelance L; Sylvester Comprehensive Cancer Center, Miller School of Medicine, Miami, Florida., Padgett KR; Sylvester Comprehensive Cancer Center, Miller School of Medicine, Miami, Florida., Zaki B; Section of Radiation Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire., Zhang R; Section of Radiation Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire., Kim H; Washington University School of Medicine in St. Louis, St. Louis, Missouri., Henke LE; Washington University School of Medicine in St. Louis, St. Louis, Missouri., Price AT; Washington University School of Medicine in St. Louis, St. Louis, Missouri., Mancias JD; Department of Radiation Oncology, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts., Williams CL; Department of Radiation Oncology, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts., Ng J; Weill Cornell Medicine Sandra and Edward Meyer Cancer Center, New York, New York., Pennell R; Weill Cornell Medicine Sandra and Edward Meyer Cancer Center, New York, New York., Pfeffer MR; Assuta Medical Center, Tel Aviv, Israel., Levin D; Assuta Medical Center, Tel Aviv, Israel., Mueller AC; Department of Radiation Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania., Mooney KE; Department of Radiation Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania., Kelly P; Orlando Health Cancer Institute, Orlando, Florida., Shah AP; Orlando Health Cancer Institute, Orlando, Florida., Boldrini L; Department of Radiology, Radiation Oncology and Hematology, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy., Placidi L; Department of Radiology, Radiation Oncology and Hematology, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy., Fuss M; ViewRay, Inc, Denver, Colorado., Chuong MD; Miami Cancer Institute, Baptist Health South Florida, Miami, Florida. |
| المصدر: | International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2023 Nov 15; Vol. 117 (4), pp. 799-808. Date of Electronic Publication: 2023 May 19. |
| نوع المنشور: | Multicenter Study; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-355X (Electronic) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New York, NY : Elsevier, Inc Original Publication: Elmsford, N. Y., Pergamon Press. |
| مواضيع طبية MeSH: | Pancreatic Neoplasms*/diagnostic imaging , Pancreatic Neoplasms*/radiotherapy , Pancreatic Neoplasms*/drug therapy , Radiosurgery*/methods, Humans ; Aged ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Prospective Studies ; Radiotherapy Planning, Computer-Assisted ; Quality of Life ; Pancreas ; Magnetic Resonance Spectroscopy ; Pancreatic Neoplasms |
| مستخلص: | 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. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.) |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03621644 |
| تواريخ الأحداث: | Date Created: 20230520 Date Completed: 20231023 Latest Revision: 20231213 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.ijrobp.2023.05.023 |
| PMID: | 37210048 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1879-355X |
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| DOI: | 10.1016/j.ijrobp.2023.05.023 |