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Intraperitoneal and Intravenous Paclitaxel Plus S-1 for Gastric Cancer With Peritoneal Metastasis: A Phase 3
Chao Yan1, Zhongyin Yang1, Zheng Shi2
1Department of General Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Adding intraperitoneal paclitaxel to intravenous paclitaxel plus S-1 significantly improved overall survival for patients with gastric cancer and peritoneal metastasis. This combination therapy offers a promising new treatment option without increasing severe toxic effects.
Area of Science:
- Oncology
- Gastroenterology
- Clinical Trials
Background:
- Gastric cancer with peritoneal metastasis has a poor prognosis.
- Current treatment regimens like intravenous paclitaxel plus S-1 offer limited survival benefits.
Purpose of the Study:
- To evaluate if adding intraperitoneal paclitaxel to intravenous paclitaxel plus S-1 improves overall survival.
- To assess the efficacy and safety of this combination therapy in a phase 3 clinical trial.
Main Methods:
- A multicenter, open-label, randomized phase 3 superiority trial (DRAGON-01) was conducted.
- Adults with gastric adenocarcinoma and peritoneal metastasis received either intraperitoneal and intravenous paclitaxel plus S-1 (IP group) or intravenous paclitaxel plus S-1 (PS group).
- The primary endpoint was overall survival; secondary endpoints included progression-free survival and safety.
Main Results:
- Median overall survival was significantly longer in the IP group (19.4 months) compared to the PS group (13.9 months) (HR, 0.67; P=.01).
- Median progression-free survival was also improved in the IP group (11.2 months) versus the PS group (7.2 months) (HR, 0.72).
- Grade 3 or 4 adverse events occurred in 38.5% of the IP group and 41.9% of the PS group, with no treatment-related deaths.
Conclusions:
- Adding intraperitoneal paclitaxel to intravenous paclitaxel plus S-1 significantly improves overall survival in patients with gastric cancer and peritoneal metastasis.
- This combination therapy is a potentially encouraging first-line treatment option, demonstrating improved survival without increased severe toxicity.
- Further research may explore the broader application of intraperitoneal chemotherapy in advanced gastric cancer.
