NIPS regimen improves OS in gastric cancer with peritoneal metastasis

Among patients with gastric cancer and peritoneal metastasis, treatment with neoadjuvant intraperitoneal–systemic (NIPS) regimen, which consists of intraperitoneal (IP) and intravenous (IV) paclitaxel plus S-1, significantly improved overall survival (OS) compared with IV paclitaxel plus S-1 only (PS regimen), according to the DRAGON-01 trial presented at ASCO GI 2025.

At a median follow-up of 60.2 months, patients who received NIPS had a significantly longer median OS than those who received PS regimen (19.4 vs 13.9 months), which translated to a 34-percent reduction in the risk of death (hazard ratio [HR], 0.66; p=0.056). [ASCO GI 2025, abstract 327]

Moreover, the 1-, 3-, and 5-year OS rates were improved by 69.6 percent, 24.3 percent, and 11.4 percent, respectively, with NIPS vs 54.1 percent, 12.2 percent, and 7.9 percent with PS alone.

In a subgroup analysis, NIPS showed consistent benefits over PS across patient subgroups, except for those with an ECOG performance status of 1 (HR, 1.03; p=0.914). “This reinforces the overall effectiveness of NIPS treatment in improving outcomes for patients with gastric cancer and peritoneal metastasis,” said lead author Dr Chao Yan from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

“This is the first positive phase III, multicentre randomized controlled trial to definitively show the survival advantage of IP chemotherapy, providing robust evidence to support changes in current clinical practices,” he noted.

This trial involved 222 patients with histologically confirmed gastric cancer with peritoneal metastasis who were randomly assigned in a 2:1 ratio to receive either NIPS* (n=148, median age 60 years) or PS** (n=74, median age 56 years) regimen. Baseline characteristics were similar between the treatment groups.

Secondary endpoints

Patients in the NIPS group achieved a significantly higher conversion surgery rate than those in the PS group (50.7 percent vs 35.1 percent; p=0.028).

NIPS-treated patients with conversion success had a longer median survival time of 33.1 months compared with 11.1 months in those with conversion failure (HR, 0.24; p<0.0001). “[With this remarkable survival outcome with conversion surgery, this result supports] the role of NIPS combined with conversion surgery in carefully selected patients,” Yan said.

Safety endpoints

A similar incidence of grade 3–4 adverse events (AEs) was observed between the NIPS and PS groups (38.4 percent vs 42.5 percent). Leukopenia, neutropenia, and fatigue were the most commonly reported AEs in both treatment groups.

“Both treatments were well tolerated with manageable side effects, highlighting the feasibility of the NIPS regimen in clinical practice,” said Yan.