Novel oral neoadjuvant therapy shows promising phase II results

The novel neoadjuvant therapy (Nac) S-1, an oral fluoropyrimidine agent containing tegafur, gimeracil, and oteracil potassium, yields promising survival outcomes in high-risk patients with resectable pancreatic ductal adenocarcinoma (R-PDAC), a recent study has found.

Forty-nine R-PDAC patients participated in the present analysis of whom 31 completed two cycles of preoperative S-1 Nac and proceeded to surgery. Overall, 28 patients completed Nac and surgery and subsequently initiated four more cycles of postoperative S-1 adjuvant therapy.

The primary outcome was 2-year progression-free survival (PFS), which was found to be 58.1 percent in the 31 patients who completed per-protocol preoperative Nac and surgery. This was higher than he expected 2-year PFS of 48.6 percent, and the threshold value of 28.9 percent.

Meanwhile, the 2-year, 3-year, and 5-year per-protocol overall survival rates were 80.7 percent, 54.8 percent, and 44.0 percent, respectively, while the median survival time was 49.2 months.

Eighteen patients (58.1 percent) ultimately saw disease recurrence, commonly arising in the liver (25.8 percent). In patients who failed Nac, the rate of distant metastasis was high.

In terms of safety, preoperative S-1 therapy was well-tolerated as reflected by haematological markers. However, cases of diarrhoea, nausea, and vomiting eventually led to trial discontinuation.

“S-1 monotherapy can be used as neoadjuvant therapy for patients with R-PDAC. However, well-designed, randomized controlled trials are required to better understand the safety profile and efficacy of this approach,” the researchers said.