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
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
Affiliations
Martynas Luksta
Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University
Augustinas Bausys
Department of Abdominal Surgery and Oncology, National Cancer Institute
Klaudija Bickaite
Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University
Rokas Rackauskas
Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University
Marius Paskonis
Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University
Raminta Luksaite-Lukste
Department of Radiology, Nuclear Medicine and Medical Physics, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius University
Anastasija Ranceva
Hematology, Oncology, and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos
Rokas Stulpinas
National Center of Pathology, Affiliate of Vilnius University Hospital Santaros Klinikos
Birute Brasiuniene
Department of Medical Oncology, National Cancer Institute
Edita Baltruskeviciene
Department of Medical Oncology, National Cancer Institute
Nadezda Lachej
Department of Medical Oncology, National Cancer Institute
Rasa Sabaliauskaite
Laboratory of Genetic Diagnostic, National Cancer Institute
Rimantas Bausys
Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University
Skaiste Tulyte
Hematology, Oncology, and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos
Kestutis Strupas
Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University
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.
