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.

Journal

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

ISSN: 1879-0887

Titre abrégé: Radiother Oncol

Pays: Ireland

ID NLM: 8407192

Informations de publication

Date de publication:
20 Dec 2023

Historique:

received: 12 09 2023

revised: 03 12 2023

accepted: 11 12 2023

medline: 23 12 2023

pubmed: 23 12 2023

entrez: 22 12 2023

Statut: aheadofprint

Résumé

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. 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 0.35T MR-guided system prescribed to 50 Gy in 5 fractions (biologically effective dose 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 fwas 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. 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.

Sections du résumé

BACKGROUND AND PURPOSE OBJECTIVE

MATERIALS AND METHODS 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 0.35T MR-guided system prescribed to 50 Gy in 5 fractions (biologically effective dose

RESULTS 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 fwas 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 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.

Identifiants

DOI: 10.1016/j.radonc.2023.110064 PMID: 38135187

pubmed: 38135187

pii: S0167-8140(23)09371-4

doi: 10.1016/j.radonc.2023.110064

pii:

doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

110064

Informations de copyright

Déclaration de conflit d'intérêts

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.