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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.
Chuong, Michael D; Lee, Percy; Low, Daniel A; Kim, Joshua; Mittauer, Kathryn E; Bassetti, Michael F; Glide-Hurst, Carri K; Raldow, Ann C; Yang, Yingli; Portelance, Lorraine; Padgett, Kyle R; Zaki, Bassem; Zhang, Rongxiao; Kim, Hyun; Henke, Lauren E; Price, Alex T; Mancias, Joseph D; Williams, Christopher L; Ng, John; Pennell, Ryan; Raphael Pfeffer, M; Levin, Daphne; Mueller, Adam C; Mooney, Karen E; Kelly, Patrick; Shah, Amish P; Boldrini, Luca; Placidi, Lorenzo; Fuss, Martin; Jitendra Parikh, Parag.
Afiliación
  • 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.
Radiother Oncol ; 191: 110064, 2024 02.
Article en En | MEDLINE | ID: mdl-38135187
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Radiocirugia Límite: Aged / Humans Idioma: En Revista: Radiother Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Irlanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Radiocirugia Límite: Aged / Humans Idioma: En Revista: Radiother Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Irlanda