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Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with Oxaliplatin, Cisplatin, and Doxorubicin in Patients with Peritoneal Carcinomatosis: An Open-Label, Single-Arm, Phase II Clinical Trial

1
Candiolo Cancer Institute, Unit of Surgical Oncology, FPO-IRCCS, 10060 Candiolo, Italy
2
Department of Drug Science and Technology, University of Turin, 10125 Turin, Italy
3
Department of Clinical and Biological Sciences, University of Turin, 10126 Turin, Italy
4
Candiolo Cancer Institute, Pathology Unit, FPO-IRCCS, 10060 Candiolo, Italy
*
Author to whom correspondence should be addressed.
Biomedicines 2020, 8(5), 102; https://doi.org/10.3390/biomedicines8050102
Received: 27 March 2020 / Revised: 27 April 2020 / Accepted: 28 April 2020 / Published: 30 April 2020
(This article belongs to the Section Therapeutic Strategies in Different Diseases)
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is an innovative approach for treating peritoneal carcinomatosis that applies chemotherapeutic drugs into the peritoneal cavity as an under-pressure airflow. It improves local bioavailability of cytostatic drugs as compared to conventional intraperitoneal chemotherapy. The aim of this study is to prove feasibility, efficacy and safety of this new treatment. Patients included in the analysis underwent at least two single port PIPAC procedures; drugs used were Oxaliplatin for colorectal cancers and Cisplatin + Doxorubicin for ovarian, gastric, and primary peritoneal cancers. The primary endpoint was the Disease Control Rate according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Secondary significant endpoints were overall and progression free survival, tumor regression on histology, and quality of life. Safety and tolerability were assessed according to the Common Terminology Criteria for Adverse Events 4. Sixty-three patients were enrolled in this trial. Forty patients (100 PIPAC) were eligible for analysis. Twenty patients were undergoing systemic chemotherapy. Fourteen patients reported an objective response (35%). Median overall survival was 18.1 months; median progression-free survival was 7.4 months. Minor morbidity was observed in seven procedures. Grade 3 complications occurred in two patients, and grade 4 in one patient submitted to reoperation. Single-port PIPAC is feasible, safe, and easy to perform. The combined treatment based on systemic chemotherapy and PIPAC does not induce significant hepatic and renal toxicity and can be considered a valid therapeutic option in patients with advanced peritoneal disease. Further studies on the use of PIPAC alone, possibly with different drug dosages, may define the real effectiveness of the procedure. View Full-Text
Keywords: peritoneal carcinomatosis; chemotherapy; aerosol; cancer peritoneal carcinomatosis; chemotherapy; aerosol; cancer
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De Simone, M.; Vaira, M.; Argenziano, M.; Berchialla, P.; Pisacane, A.; Cinquegrana, A.; Cavalli, R.; Borsano, A.; Robella, M. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with Oxaliplatin, Cisplatin, and Doxorubicin in Patients with Peritoneal Carcinomatosis: An Open-Label, Single-Arm, Phase II Clinical Trial. Biomedicines 2020, 8, 102.

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