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Bidirectional chemotherapy in patients with gastric cancer and peritoneal metastasis.

ABSTRACT: Gastric cancer is a lethal malignancy due to the combination of late-stage presentation, propensity for early metastasis, and lack of effective systemic therapies. Given the high rates of gastric peritoneal metastasis, both macro- and microscopic, regional therapy represents both an attractive and rational treatment option for patients given its success in other peritoneal surface malignancies. Bidirectional chemotherapy (intraperitoneal and intravenous) for treatment of metastatic gastric cancer has not been evaluated prospectively in a contemporary North American cohort. Here we present the rationale and design of a phase II clinical trial of intraperitoneal paclitaxel in combination with intravenous paclitaxel and oral capecitabine. We hypothesize that the combination of systemic and regional chemotherapy may result in improved progression free survival (PFS) for patients with gastric adenocarcinoma and peritoneal-only metastasis. In addition to studying clinical outcomes associated with this treatment regimen, both basic and translational science efforts are planned to better understand this complex malignancy.

SUBMITTER: Martin SP

PROVIDER: S-EPMC7052767 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Bidirectional chemotherapy in patients with gastric cancer and peritoneal metastasis.

Martin Sean P SP Drake Justin A JA Hernandez Jonathan M JM Davis Jeremy L JL

Journal of gastrointestinal oncology 20200201 1

Gastric cancer is a lethal malignancy due to the combination of late-stage presentation, propensity for early metastasis, and lack of effective systemic therapies. Given the high rates of gastric peritoneal metastasis, both macro- and microscopic, regional therapy represents both an attractive and rational treatment option for patients given its success in other peritoneal surface malignancies. Bidirectional chemotherapy (intraperitoneal and intravenous) for treatment of metastatic gastric cance ...[more]

PMID: 32175112

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Project description:BACKGROUND: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. METHODS:Neoadjuvant 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). RESULTS:A 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). CONCLUSION:Neoadjuvant 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 REGISTRATION:This study has been registered with ClinicalTrials.gov as NCT02549911 . Trial registration date: 15/09/2015.

Dataset Information

Bidirectional chemotherapy in patients with gastric cancer and peritoneal metastasis.

Publications

Bidirectional chemotherapy in patients with gastric cancer and peritoneal metastasis.

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