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TOPLINE:

Adding intraperitoneal paclitaxel to intravenous paclitaxel plus oral S-1 improved overall survival in patients with gastric cancer and peritoneal metastasis, extending median survival to 19.4 months compared with 13.9 months for intravenous paclitaxel plus S-1 alone. The intraperitoneal paclitaxel approach also improved progression-free survival and conversion surgery rates without increasing the rates of severe adverse events.

METHODOLOGY:

• Gastric cancer with peritoneal metastasis has a poor prognosis, with prior studies reporting median overall survival of roughly 5-11 months with systemic therapy.
• Researchers conducted a multicenter, open-label, randomized phase 3 superiority trial (DRAGON-01) at nine hospitals in China to assess whether adding intraperitoneal paclitaxel to intravenous paclitaxel plus S-1 can improve survival outcomes in this patient population.
• Overall, 222 adults with gastric cancer and confirmed peritoneal metastasis were randomized 2:1 to receive intraperitoneal plus intravenous paclitaxel with oral S-1, or intravenous paclitaxel with S-1 alone.
• The primary endpoint was overall survival, defined as the time from randomization to death from any cause, with secondary endpoints including progression-free survival and safety.
• Median follow-up was 72.2 months, and conversion surgery was considered after meeting prespecified protocol criteria, including negative peritoneal cytology and confirmation by CT and diagnostic laparoscopy.

TAKEAWAY:

• Patients who received intraperitoneal paclitaxel had significantly longer median overall survival — 19.4 months vs 13.9 months (hazard ratio [HR], 0.67).
• The intraperitoneal paclitaxel group also had significantly longer median progression-free survival — 11.2 months vs 7.2 months (HR, 0.72).
• Significantly more patients in the intraperitoneal paclitaxel group underwent conversion surgery — 50.7% vs 35.1%; among those undergoing surgery, R0 resection rates were similar between groups (84.0% vs 84.6%).
• Slightly fewer grade 3 or 4 adverse events occurred in the intraperitoneal paclitaxel group — 38.5% vs 41.9% — with no treatment-related deaths in either group.

IN PRACTICE:

“The results of this randomized clinical trial of patients with gastric cancer with peritoneal metastasis suggest that adding intraperitoneal paclitaxel to intravenous paclitaxel plus S-1 significantly improved overall survival without increasing severe toxic effects, potentially providing an encouraging signal for [intraperitoneal paclitaxel] therapy in first-line treatment of gastric cancer with peritoneal metastasis,” the authors of the study concluded.

SOURCE:

The study was led by Chao Yan, MD, Shanghai Jiao Tong University School of Medicine, and Kai Yin, MD, First Affiliated Hospital of Naval Medical University, Shanghai, China, and was published online on May 21 in JAMA Oncology.

LIMITATIONS:

The open-label design may have influenced clinical decisions such as the threshold for second-look laparoscopy, though it is less likely to bias overall survival. The trial was conducted only in Chinese centers, limiting generalizability to Western populations. Center-level variability in surgical decision-making, peritoneal cancer index scoring, and timing of second-look laparoscopy was not controlled, and region-specific peritoneal cancer index subscores were not recorded, limiting assessment of anatomic distribution of peritoneal disease between groups. Baseline microsatellite instability and PD-L1 data were not available, limiting characterization in the current biomarker-directed era. The modified intention-to-treat analysis excluded 16 patients who withdrew before treatment, and continued intraperitoneal paclitaxel chemotherapy in second-line treatment is a potential confounder of overall survival outcomes.

DISCLOSURES:

The study received support from the Multicenter Clinical Research Project Program of Shanghai Jiao Tong University School of Medicine (grant DLY201602). The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.