Abstract
BackgroundThere is no currently available treatment for peritoneal metastasis of gastric cancer. This phase II study aimed to evaluate the efficacy and safety of neoadjuvant systemic chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) combined with cytoreductive surgery (CRS) for the treatment of these patients.MethodsNeoadjuvant chemotherapy comprised two cycles of HIPEC and four cycles of S-1 plus paclitaxel. HIPEC was administered intraperitoneally with paclitaxel (75 mg/m2). For systemic chemotherapy, paclitaxel was administered intravenously(150 mg/m2) on day 1, and S-1 was administered orally(80 mg/m2/day)on days 1–14 of a 3-week cycle. Another two cycles of HIPEC and four cycles of S-1 plus paclitaxel were administered after second diagnostic staging laparoscopy or CRS. The primary endpoints were treatment efficiency and safety; the secondary endpoint was 3-year overall survival (OS).ResultsA total of 40 patients were enrolled and 38 patients have been analyzed. Of these, 18 (47.4%) patients received neoadjuvant systemic chemotherapy, HIPEC and CRS (conversion therapy group), while 20 patients received only chemotherapy and HIPEC (palliative chemotherapy group). Median OS was markedly improved in the conversion therapy group (21.1 months, 95% confidence interval [CI] 16.7–25.6 months) in comparison with the palliative chemotherapy group(10.8 months, 95%CI 7.3–14.2 months, p = 0.002). After neoadjuvant systemic chemotherapy and HIPEC, a second laparoscopic exploration was performed, and the prognosis of patients with low peritoneal cancer index (PCI) (PCI < 6) was significantly better than that of patients with high PCI (PCI ≥ 6)(20.1 vs.11.3 months, p = 0.006).ConclusionNeoadjuvant systemic chemotherapy and HIPEC combined with CRS is safe and feasible, and could potentially improve the prognosis of gastric cancer patients with limited peritoneal metastasis. However, further clinical trials are still warranted.Trial registrationThis study has been registered with ClinicalTrials.gov as NCT02549911. Trial registration date: 15/09/2015.
Highlights
There is no currently available treatment for peritoneal metastasis of gastric cancer
Recent retrospective studies have reported that the primary tumor and peritoneal metastasis can be well controlled in some patients by comprehensive treatment including systemic and local chemotherapy
This study aimed to assess the efficacy and safety of neoadjuvant systemic chemotherapy and HIPE C combined with cytoreductive surgery for the treatment of advanced Gastric cancer (GC) with limited peritoneal metastasis, so as to develop a reasonable treatment strategy for these patients
Summary
There is no currently available treatment for peritoneal metastasis of gastric cancer. This phase II study aimed to evaluate the efficacy and safety of neoadjuvant systemic chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) combined with cytoreductive surgery (CRS) for the treatment of these patients. Palliative chemotherapy is the main treatment strategy for peritoneal metastasis of gastric cancer, the response rate is low with a median survival time less than 6 months [5]. Recent retrospective studies have reported that the primary tumor and peritoneal metastasis can be well controlled in some patients by comprehensive treatment including systemic and local chemotherapy. Cytoreductive surgery (CRS) of the primary tumor and peritoneal metastasis can be achieved and survival time is significantly improved [6, 7]
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