دورية أكاديمية

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.

التفاصيل البيبلوغرافية
العنوان: 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.
المؤلفون: Chuong MD; Miami Cancer Institute, Baptist Health South Florida, Miami, FL, United States. Electronic address: michaelchu@baptisthealth.net., Lee P; City of Hope National Medical Center, Los Angeles, CA, United States., Low DA; UCLA Department of Radiation Oncology, Los Angeles, CA, United States., Kim J; Henry Ford Health - Cancer, Detroit, MI, United States., Mittauer KE; Miami Cancer Institute, Baptist Health South Florida, Miami, FL, United States., Bassetti MF; University of Wisconsin-Madison, Department of Human Oncology, Madison, WI, United States., Glide-Hurst CK; University of Wisconsin-Madison, Department of Human Oncology, Madison, WI, United States., Raldow AC; Department of Radiation Oncology, UCLA David Geffen School of Medicine, Los Angeles, CA, United States., Yang Y; Department of Radiation Oncology, UCLA David Geffen School of Medicine, Los Angeles, CA, United States., Portelance L; Sylvester Comprehensive Cancer Center, Miller School of Medicine, Miami, FL, United States., Padgett KR; Sylvester Comprehensive Cancer Center, Miller School of Medicine, Miami, FL, United States., Zaki B; Section of Radiation Oncology Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Zhang R; Section of Radiation Oncology Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Kim H; Washington University School of Medicine in St. Louis, St. Louis, MO, United States., Henke LE; Washington University School of Medicine in St. Louis, St. Louis, MO, United States., Price AT; Washington University School of Medicine in St. Louis, St. Louis, MO, United States., Mancias JD; Brigham and Women's Hospital, Department of Radiation Oncology, Dana-Farber Cancer Institute, Department of Radiation Oncology, Harvard Medical School, Boston, MA, United States., Williams CL; Brigham and Women's Hospital, Department of Radiation Oncology, Dana-Farber Cancer Institute, Department of Radiation Oncology, Harvard Medical School, Boston, MA, United States., Ng J; Weill Cornell Medicine Sandra and Edward Meyer Cancer Center, New York, NY, United States., Pennell R; Weill Cornell Medicine Sandra and Edward Meyer Cancer Center, New York, NY, United States., Raphael Pfeffer M; Assuta Medical Center, Tel Aviv, IL, United States., Levin D; Assuta Medical Center, Tel Aviv, IL, United States., Mueller AC; Department of Radiation Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States., Mooney KE; Department of Radiation Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States., Kelly P; Orlando Health Cancer Institute, Orlando, FL, United States., Shah AP; Orlando Health Cancer Institute, Orlando, FL, United States., 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, CO, United States., Jitendra Parikh P; Henry Ford Health - Cancer, Detroit, MI, United States.
المصدر: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology [Radiother Oncol] 2024 Feb; Vol. 191, pp. 110064. Date of Electronic Publication: 2023 Dec 20.
نوع المنشور: Multicenter Study; Clinical Trial, Phase II; Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Scientific Publishers Country of Publication: Ireland NLM ID: 8407192 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0887 (Electronic) Linking ISSN: 01678140 NLM ISO Abbreviation: Radiother Oncol Subsets: MEDLINE
أسماء مطبوعة: Publication: Limerick : Elsevier Scientific Publishers
Original Publication: Amsterdam : Elsevier Science Publishers, c1983-
مواضيع طبية MeSH: Pancreatic Neoplasms*/pathology , Radiosurgery*/adverse effects, Humans ; Aged ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Radiotherapy Planning, Computer-Assisted
مستخلص: 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.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
فهرسة مساهمة: Keywords: Adenocarcinoma; Induction chemotherapy; Pancreatic neoplasms; Radiotherapy
تواريخ الأحداث: Date Created: 20231222 Date Completed: 20240223 Latest Revision: 20240223
رمز التحديث: 20240223
DOI: 10.1016/j.radonc.2023.110064
PMID: 38135187
قاعدة البيانات: MEDLINE
الوصف
تدمد:1879-0887
DOI:10.1016/j.radonc.2023.110064