Efficacy of TAS-102 in Fluoropyrimidine-Refractory PC

June, 06, 2024 | Gastrointestinal Cancer, Pancreatic Cancer


  • The study aimed to investigate the efficacy and safety of TAS-102 in patients with fluoropyrimidine-refractory PC.
  • The primary endpoint was to determine the PFS rate.
  • Researchers noticed the promising efficacy and acceptable safety of TAS-102; further investigation is ongoing.

Patients with refractory pancreatic cancer (PC) have limited therapeutic options and dismal prognoses. Trifluridine/tipiracil (FTD/TPI) has demonstrated activity in PC and fluoropyrimidine-resistant tumors in pre-clinical studies. However, no clinical data exists to date.

Chi Leung Chiang and the team aimed to evaluate the efficacy and safety of TAS-102 in patients with fluoropyrimidine-refractory PC.

They performed an inclusive analysis in this single-arm phase II trial. Patients with advanced, metastatic PC, with ECOG PS 0-1 and adequate organ function, who had progressed after one or more lines of chemotherapy, were enrolled. Patients were treated with TAS-102 at a dose of 35 mg/m² twice daily on days 1-5 and 8-12 of a 28-day cycle until disease progression or unacceptable toxicity. The primary endpoint was the 16-week progression-free survival (PFS) rate. Secondary endpoints included median PFS, median overall survival (OS), disease control rate (DCR), and toxicities.

About 28 patients were enrolled between March 2021 and June 2023. The median age was 64 years (range: 49-80) and 16 (57.1%) were male. All 28 patients (100%) received prior chemotherapy regimens containing fluoropyrimidine. Twenty-three patients (82.1%) received 2 or more lines of chemotherapy. After a median follow-up of 4.8 months, the 16-week PFS rate was 53.6% (15/28; 95% CI, 37.4-69.8%). The median PFS was 3.7 months (95% CI, 2.1-5.3 months) and the median OS was 4.5 months (95% CI, 3.6-5.4 months).

The median number of treatment cycles was 2 (range: 1-12). The DCR was 50% (14/28; 95% CI, 30.7-69.4%). The most common grade 3 or worse adverse events were neutropenia (n=9, 32.1%), anemia (n=4, 14.3%), and increase in bilirubin level (n=4, 14.3%) without new safety signals. Neutrophil to lymphocyte ratio (NLR) > 5 was associated with worse PFS ( HR: 7.6; 95% CI, 2.5-23.4) and OS (HR: 7.4; 95% CI, 2.5-21.4).

The study concluded that TAS-102 demonstrates promising efficacy and acceptable safety in patients with PC refractory to fluoropyrimidine. Further randomized trials are warranted.

The trial was sponsored by The University of Hong Kong.


Clnical Trial:

Chiang C.L., Chan S.K., Lee A.S., et al. (2024). “Trifluridine/tipiracil (FTD/TPI) in patients with fluoropyrimidine refractory advanced pancreatic adenocarcinoma: A single-arm phase II trial.” Presented at ESMO-GI 2024 (Abstract 328P).

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