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Published in: Annals of Surgical Oncology 11/2013

Open Access 01-10-2013 | Gastrointestinal Oncology

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC): Occupational Health and Safety Aspects

Authors: Wiebke Solaß, MD, Urs Giger-Pabst, MD, Jürgen Zieren, Marc A. Reymond

Published in: Annals of Surgical Oncology | Issue 11/2013

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Abstract

Background

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel approach for treating peritoneal carcinomatosis. First encouraging results have been obtained in human patients. However, delivering chemotherapy as an aerosol might result in an increased risk of exposure to health care workers, as compared with other administration routes.

Methods

PIPAC was applied in two human patients using chemotherapeutic drugs (doxorubicin and cisplatin), and air contamination levels were measured under real clinical conditions. Air was collected on a cellulose nitrate filter with a flow of 22.5 m3/h. To exclude any risk for health care workers, both procedures were remote controlled. Toxicological research of cisplatin was performed according to NIOSH 7300 protocol. Sampling and analysis were performed by an independent certification organization.

Results

The following safety measures were implemented: closed abdomen, laminar airflow, controlled aerosol waste, and protection curtain. No cisplatin was detected in the air (detection limit < 0.000009 mg/m3) at the working positions of the surgeon and the anesthesiologist under real PIPAC conditions.

Conclusions

For the drugs tested, PIPAC is in compliance with European Community working safety law and regulations. Workplace contamination remains below the tolerance margin. The safety measures and conditions as defined above are sufficient. Further protecting devices, such as particulate (air purifying) masks, are not necessary. PIPAC can be used safely in the clinical setting if the conditions specified above are met. However, a toxicological workplace analysis must be performed to confirm that the procedure as implemented complies with local regulations.
Literature
1.
go back to reference Markman M. Intraperitoneal antineoplastic drug delivery: rationale and results. Lancet Oncol. 2003;4:277–83.PubMedCrossRef Markman M. Intraperitoneal antineoplastic drug delivery: rationale and results. Lancet Oncol. 2003;4:277–83.PubMedCrossRef
2.
go back to reference Alberts DS, Young L, Mason N, et al. In vitro evaluation of anticancer drugs against ovarian cancer at concentrations achievable by intraperitoneal administration. Semin Oncol. 1985;12(Suppl 4):38–42.PubMed Alberts DS, Young L, Mason N, et al. In vitro evaluation of anticancer drugs against ovarian cancer at concentrations achievable by intraperitoneal administration. Semin Oncol. 1985;12(Suppl 4):38–42.PubMed
3.
go back to reference Verwaal VJ, Bruin S, Boot H, et al. 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol. 2008;15:2426–32.PubMedCrossRef Verwaal VJ, Bruin S, Boot H, et al. 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol. 2008;15:2426–32.PubMedCrossRef
4.
go back to reference Trédan O, Galmarini CM, Patel K, et al. Drug resistance and the solid tumor microenvironment. J Natl Cancer Inst. 2007;99:1441–54.PubMedCrossRef Trédan O, Galmarini CM, Patel K, et al. Drug resistance and the solid tumor microenvironment. J Natl Cancer Inst. 2007;99:1441–54.PubMedCrossRef
5.
go back to reference Solaß W, Hetzel A, Nadiradze G, et al. Description of a novel approach for intraperitoneal drug delivery and the related device. Surg Endosc. 2012;26:1849–55.PubMedCrossRef Solaß W, Hetzel A, Nadiradze G, et al. Description of a novel approach for intraperitoneal drug delivery and the related device. Surg Endosc. 2012;26:1849–55.PubMedCrossRef
6.
go back to reference Laube BL. The expanding role of aerosols in systemic drug delivery, genetherapy, and vaccination. Respir Care. 2005;50:1161–76.PubMed Laube BL. The expanding role of aerosols in systemic drug delivery, genetherapy, and vaccination. Respir Care. 2005;50:1161–76.PubMed
7.
8.
go back to reference Jacquet P, Stuart OA, Chang D, et al. Effects of intra-abdominal pressure on pharmacokinetics and tissue distribution of doxorubicin after intraperitoneal administration. Anticancer Drugs. 1996;7:596–603.PubMedCrossRef Jacquet P, Stuart OA, Chang D, et al. Effects of intra-abdominal pressure on pharmacokinetics and tissue distribution of doxorubicin after intraperitoneal administration. Anticancer Drugs. 1996;7:596–603.PubMedCrossRef
9.
go back to reference Esquis P, Consolo D, Magnin G, et al. High intra-abdominal pressure enhances the penetration and antitumor effect of intraperitoneal cisplatin on experimental peritoneal carcinomatosis. Ann Surg. 2006;244:106–12.PubMedCrossRef Esquis P, Consolo D, Magnin G, et al. High intra-abdominal pressure enhances the penetration and antitumor effect of intraperitoneal cisplatin on experimental peritoneal carcinomatosis. Ann Surg. 2006;244:106–12.PubMedCrossRef
10.
go back to reference Solass W, Herbette A, Schwarz T, et al. Therapeutic approach of human peritoneal carcinomatosis with Dbait in combination with capnoperitoneum: proof of concept. Surg Endosc. 2012;26:847–52.PubMedCrossRef Solass W, Herbette A, Schwarz T, et al. Therapeutic approach of human peritoneal carcinomatosis with Dbait in combination with capnoperitoneum: proof of concept. Surg Endosc. 2012;26:847–52.PubMedCrossRef
11.
go back to reference Canis M, Matsuzaki S, Bourdel N, et al. Peritoneum and laparoscopic environment. Bull Cancer. 2007;94:1043–51.PubMed Canis M, Matsuzaki S, Bourdel N, et al. Peritoneum and laparoscopic environment. Bull Cancer. 2007;94:1043–51.PubMed
12.
go back to reference Zytostatika im Gesundheitsdienst. Informatiuon zur sicheren Handhabung von Zytostatika. GUV-I 8533. Berlin: Deutsche Gesetzliche Unfallversicherung; 2008. Zytostatika im Gesundheitsdienst. Informatiuon zur sicheren Handhabung von Zytostatika. GUV-I 8533. Berlin: Deutsche Gesetzliche Unfallversicherung; 2008.
13.
go back to reference Wittgen BP, Kunst PW, Perkins WR, et al. Assessing a system to capture stray aerosol during inhalation of nebulized liposomal cisplatin. J Aerosol Med. 2006;19:385–91.PubMedCrossRef Wittgen BP, Kunst PW, Perkins WR, et al. Assessing a system to capture stray aerosol during inhalation of nebulized liposomal cisplatin. J Aerosol Med. 2006;19:385–91.PubMedCrossRef
14.
go back to reference Otterson GA, Villalona-Calero MA, Sharma S, et al. Phase I study of inhaled doxorubicin for patients with metastatic tumors to the lungs. Clin Cancer Res. 2007;13:1246–52.PubMedCrossRef Otterson GA, Villalona-Calero MA, Sharma S, et al. Phase I study of inhaled doxorubicin for patients with metastatic tumors to the lungs. Clin Cancer Res. 2007;13:1246–52.PubMedCrossRef
15.
go back to reference Lemarie E, Vecellio L, Hureaux J, et al. Aerosolized gemcitabine in patients with carcinoma of the lung: feasibility and safety study. J Aerosol Med Pulm Drug Deliv. 2011;24:261–70.PubMedCrossRef Lemarie E, Vecellio L, Hureaux J, et al. Aerosolized gemcitabine in patients with carcinoma of the lung: feasibility and safety study. J Aerosol Med Pulm Drug Deliv. 2011;24:261–70.PubMedCrossRef
16.
go back to reference Jakubowski M. Biological monitoring versus air monitoring strategies in assessing environmental-occupational exposure. J Environ Monit. 2012;14:348–52.PubMedCrossRef Jakubowski M. Biological monitoring versus air monitoring strategies in assessing environmental-occupational exposure. J Environ Monit. 2012;14:348–52.PubMedCrossRef
Metadata
Title
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC): Occupational Health and Safety Aspects
Authors
Wiebke Solaß, MD
Urs Giger-Pabst, MD
Jürgen Zieren
Marc A. Reymond
Publication date
01-10-2013
Publisher
Springer US
Published in
Annals of Surgical Oncology / Issue 11/2013
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-013-3039-x

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