Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study
Abstract Background Gastric cancer (GC) remains among the most common and most lethal cancers worldwide. Peritoneum is the most common site for distant dissemination. Standard treatment for GC peritoneal metastases (PM) is a systemic therapy, but treatment outcomes remain very poor, with median over...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-023-11549-z |
| _version_ | 1797452291161194496 |
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| author | Martynas Luksta Augustinas Bausys Klaudija Bickaite Rokas Rackauskas Marius Paskonis Raminta Luksaite-Lukste Anastasija Ranceva Rokas Stulpinas Birute Brasiuniene Edita Baltruskeviciene Nadezda Lachej Rasa Sabaliauskaite Rimantas Bausys Skaiste Tulyte Kestutis Strupas |
| author_facet | Martynas Luksta Augustinas Bausys Klaudija Bickaite Rokas Rackauskas Marius Paskonis Raminta Luksaite-Lukste Anastasija Ranceva Rokas Stulpinas Birute Brasiuniene Edita Baltruskeviciene Nadezda Lachej Rasa Sabaliauskaite Rimantas Bausys Skaiste Tulyte Kestutis Strupas |
| author_sort | Martynas Luksta |
| collection | DOAJ |
| description | Abstract Background Gastric cancer (GC) remains among the most common and most lethal cancers worldwide. Peritoneum is the most common site for distant dissemination. Standard treatment for GC peritoneal metastases (PM) is a systemic therapy, but treatment outcomes remain very poor, with median overall survival ranging between 3-9 months. Thus, novel treatment methods are necessary. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is the most novel technique for intraperitoneal chemotherapy. Some preliminary data suggest PIPAC can achieve improved long-term outcomes in patients with GC PM, especially when used in combination with systemic chemotherapy. However, there is a lack of data from well-design prospective studies that would confirm the efficacy of PIPAC and systemic therapy combination for first-line treatment. Methods This study is an investigator-initiated single-arm, phase II trial to investigate the efficacy of PIPAC combined with systemic FOLFOX (5-fluorouracil, oxaliplatin, leucovorin) as a first-line treatment for GC PM. The study is conducted in 2 specialized GC treatment centers in Lithuania. It enrolls GC patients with histologically confirmed PM without prior treatment. The treatment protocol consists of PIPAC with cisplatin (10.5 mg/m2 body surface in 150 mL NaCl 0.9%) and doxorubicin (2.1 mg/m2 in 50 mL NaCl 0.9%) followed by 2 cycles of FOLFOX every 6–7 weeks. In total 3 PIPACs and 6 cycles of FOLFOX will be utilized. The primary outcome of the study is the objective response rate (ORR) according to RECIST v. 1.1 criteria (Eisenhauer et al., Eur J Cancer 45:228–47) in a CT scan performed 7 days after the 4th cycle of FOLFOX. Secondary outcomes include ORR after all experimental treatment, PIPAC characteristics, postoperative morbidity, histological and biochemical response, ascites volume, quality of life, overall survival, and toxicity. Discussion This study aims to assess PIPAC and FOLFOX combination efficacy for previously untreated GC patients with PM. Trial registration NCT05644249. Registered on December 9, 2022. |
| first_indexed | 2024-03-09T15:06:35Z |
| format | Article |
| id | doaj.art-24c3cffac9e64767989adeada837e132 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-09T15:06:35Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-24c3cffac9e64767989adeada837e1322023-11-26T13:37:25ZengBMCBMC Cancer1471-24072023-10-012311910.1186/s12885-023-11549-zPressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II studyMartynas Luksta0Augustinas Bausys1Klaudija Bickaite2Rokas Rackauskas3Marius Paskonis4Raminta Luksaite-Lukste5Anastasija Ranceva6Rokas Stulpinas7Birute Brasiuniene8Edita Baltruskeviciene9Nadezda Lachej10Rasa Sabaliauskaite11Rimantas Bausys12Skaiste Tulyte13Kestutis Strupas14Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius UniversityDepartment of Abdominal Surgery and Oncology, National Cancer InstituteClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius UniversityClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius UniversityClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius UniversityDepartment of Radiology, Nuclear Medicine and Medical Physics, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius UniversityHematology, Oncology, and Transfusion Medicine Center, Vilnius University Hospital Santaros KlinikosNational Center of Pathology, Affiliate of Vilnius University Hospital Santaros KlinikosDepartment of Medical Oncology, National Cancer InstituteDepartment of Medical Oncology, National Cancer InstituteDepartment of Medical Oncology, National Cancer InstituteLaboratory of Genetic Diagnostic, National Cancer InstituteClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius UniversityHematology, Oncology, and Transfusion Medicine Center, Vilnius University Hospital Santaros KlinikosClinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius UniversityAbstract Background Gastric cancer (GC) remains among the most common and most lethal cancers worldwide. Peritoneum is the most common site for distant dissemination. Standard treatment for GC peritoneal metastases (PM) is a systemic therapy, but treatment outcomes remain very poor, with median overall survival ranging between 3-9 months. Thus, novel treatment methods are necessary. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is the most novel technique for intraperitoneal chemotherapy. Some preliminary data suggest PIPAC can achieve improved long-term outcomes in patients with GC PM, especially when used in combination with systemic chemotherapy. However, there is a lack of data from well-design prospective studies that would confirm the efficacy of PIPAC and systemic therapy combination for first-line treatment. Methods This study is an investigator-initiated single-arm, phase II trial to investigate the efficacy of PIPAC combined with systemic FOLFOX (5-fluorouracil, oxaliplatin, leucovorin) as a first-line treatment for GC PM. The study is conducted in 2 specialized GC treatment centers in Lithuania. It enrolls GC patients with histologically confirmed PM without prior treatment. The treatment protocol consists of PIPAC with cisplatin (10.5 mg/m2 body surface in 150 mL NaCl 0.9%) and doxorubicin (2.1 mg/m2 in 50 mL NaCl 0.9%) followed by 2 cycles of FOLFOX every 6–7 weeks. In total 3 PIPACs and 6 cycles of FOLFOX will be utilized. The primary outcome of the study is the objective response rate (ORR) according to RECIST v. 1.1 criteria (Eisenhauer et al., Eur J Cancer 45:228–47) in a CT scan performed 7 days after the 4th cycle of FOLFOX. Secondary outcomes include ORR after all experimental treatment, PIPAC characteristics, postoperative morbidity, histological and biochemical response, ascites volume, quality of life, overall survival, and toxicity. Discussion This study aims to assess PIPAC and FOLFOX combination efficacy for previously untreated GC patients with PM. Trial registration NCT05644249. Registered on December 9, 2022.https://doi.org/10.1186/s12885-023-11549-zGastric cancerPeritoneal metastasesPIPAC |
| spellingShingle | Martynas Luksta Augustinas Bausys Klaudija Bickaite Rokas Rackauskas Marius Paskonis Raminta Luksaite-Lukste Anastasija Ranceva Rokas Stulpinas Birute Brasiuniene Edita Baltruskeviciene Nadezda Lachej Rasa Sabaliauskaite Rimantas Bausys Skaiste Tulyte Kestutis Strupas Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study BMC Cancer Gastric cancer Peritoneal metastases PIPAC |
| title | Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study |
| title_full | Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study |
| title_fullStr | Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study |
| title_full_unstemmed | Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study |
| title_short | Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study |
| title_sort | pressurized intraperitoneal aerosol chemotherapy pipac with cisplatin and doxorubicin in combination with folfox chemotherapy as a first line treatment for gastric cancer patients with peritoneal metastases single arm phase ii study |
| topic | Gastric cancer Peritoneal metastases PIPAC |
| url | https://doi.org/10.1186/s12885-023-11549-z |
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