Results of a phase II trial of short-course radiation and TASOX [trifluridine/tipiracil (TAS-102) plus oxaliplatin] chemotherapy in operable rectal cancer.

Publication Title

ESMO Gastrointest Oncol

Document Type

Article

Publication Date

9-1-2025

Keywords

TASOX; rectal cancer; short course radiation; total neoadjuvant therapy; trifluridine/tipiracil.; oregon; portland; chiles

Abstract

BACKGROUND: Trifluridine/tipiracil (FTD/TPI) is approved for metastatic colorectal cancer as monotherapy or in combination with bevacizumab, though dosing in combination with oxaliplatin has not yet been established. The objective of the phase II SHORT trial (NCT04417699) was to determine the efficacy of short-course radiation (SC RT) followed by 3 months of FTD/TPI + oxaliplatin (TASOX) as a condensed total neoadjuvant therapy (TNT) regimen for intermediate-risk rectal cancer.

METHODS: Eligible patients with clinical T3N0 or T1-3N1 nonlow rectal tumors and negative radial tumor margins (>1 mm) were enrolled. The primary endpoint was reduction in neoadjuvant response (NAR) score compared with historic controls. Patients received 25 Gy in five 5 Gy fractions of conformal pelvic radiation followed by six planned 14-day cycles of TASOX: FTD/TPI (35 mg/m

RESULTS: Between 2020 and 2023, 13 patients with stage II (

CONCLUSIONS: SC RT and 3 months of TASOX can be safely delivered to patients with intermediate-risk rectal cancer, offering a convenient regimen that should be further explored for rectal cancer treatment. The TASOX regimen may be of particular relevance for patients with suspected dihydropyrimidine dehydrogenase deficiency who require oxaliplatin-based therapy.

Area of Special Interest

Cancer

Area of Special Interest

Digestive Health

Specialty/Research Institute

Oncology

Specialty/Research Institute

Gastroenterology

Specialty/Research Institute

Pharmacy

DOI

10.1016/j.esmogo.2025.100215

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