De Simone Michele, Vaira Marco, Argenziano Monica, Berchialla Paola, Pisacane Alberto, Cinquegrana Armando, Cavalli Roberta, Borsano Alice, Robella Manuela
Candiolo Cancer Institute, Unit of Surgical Oncology, FPO-IRCCS, 10060 Candiolo, Italy.
Department of Drug Science and Technology, University of Turin, 10125 Turin, Italy.
Biomedicines. 2020 Apr 30;8(5):102. doi: 10.3390/biomedicines8050102.
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.
腹腔内加压气雾化疗（PIPAC）是一种治疗腹膜癌病的创新方法，它通过负压气流将化疗药物注入腹腔。与传统的腹腔内化疗相比，它提高了细胞毒性药物的局部生物利用度。本研究的目的是证明这种新治疗方法的可行性、有效性和安全性。纳入分析的患者至少接受了两次单孔PIPAC手术；使用的药物为用于结直肠癌的奥沙利铂以及用于卵巢癌、胃癌和原发性腹膜癌的顺铂+阿霉素。主要终点是根据实体瘤疗效评价标准（RECIST）的疾病控制率。次要显著终点是总生存期和无进展生存期、组织学上的肿瘤消退以及生活质量。根据不良事件通用术语标准4评估安全性和耐受性。63名患者纳入本试验。40名患者（100次PIPAC）符合分析条件。20名患者正在接受全身化疗。14名患者报告有客观缓解（35%）。中位总生存期为18.1个月；中位无进展生存期为7.4个月。7例手术观察到轻微并发症。2例患者发生3级并发症，1例接受再次手术的患者发生4级并发症。单孔PIPAC可行、安全且易于实施。基于全身化疗和PIPAC的联合治疗不会引起显著的肝毒性和肾毒性，可被视为晚期腹膜疾病患者的有效治疗选择。关于单独使用PIPAC（可能采用不同药物剂量）的进一步研究可能会确定该手术的实际有效性。
