Bidirectional chemotherapy in gastric cancer with peritoneal metastasis combining intravenous XELOX with intraperitoneal chemotherapy with low-dose cisplatin and Doxorubicin administered as a pressurized aerosol: an open-label, Phase-2 study (PIPAC-GA2)
| Autor: | Andrey Ryabov, Anna Utkina, Vladimir Khomyakov, N. N. Volchenko, Larisa Bolotina, Andrey A. Ivanov, Andrey Kaprin |
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| Rok vydání: | 2016 |
| Předmět: |
Cisplatin
Oncology Chemotherapy medicine.medical_specialty business.industry medicine.medical_treatment Phases of clinical research Combination chemotherapy Clinical trial 03 medical and health sciences 0302 clinical medicine 030220 oncology & carcinogenesis Laparotomy Internal medicine Conventional PCI Internal Medicine medicine 030211 gastroenterology & hepatology Doxorubicin business medicine.drug Research Article |
| Zdroj: | Pleura and peritoneum. 1(3) |
| ISSN: | 2364-768X |
| Popis: | BackgroundPeritoneal metastasis (PM) develop in more than 50 % of gastric cancer (GC) patients. Median survival without treatment is not more than 3–7 months, and 8–12 months after modern combination chemotherapy. Innovative therapeutic approaches are urgently needed.MethodsPhase-2, open label prospective clinical trial assessing safety and efficacy of bidirectional chemotherapy for treating peritoneal metastasis of gastric cancer (PMGC). Treatment protocol included initial staging laparoscopy or laparotomy, 3–4 courses of systemic chemotherapy (XELOX) followed by Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) procedures every 6 weeks until progression of disease or death. Primary endpoints were overall survival and histological peritoneal regression grading score after rebiopsy.Results31 patients were included (9 men, 22 women, mean age 52 years), 24 with synchronous PM at diagnosis, 7 with metachronous PM after previous chemotherapy. Mean PCI was 13.8 (min-max 6–34). XELOX was administered in all patients and combined with 56 PIPAC procedures. Complete and partial pathological response was found in 60 % of the 15 patients eligible for tumor response assessment (4 and 5 patients, respectively). Median survival was 13 months.ConclusionsBidirectional chemotherapy combining XELOX with PIPAC with cisplatin and doxororubicin is well tolerated, can induce objective tumor regression and is associated with a promising survival in PMGC. |
| Databáze: | OpenAIRE |
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