Prospective, single-center implementation and response evaluation of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for peritoneal metastasis

Martin Graversen, Sönke Detlefsen, Jon Kroll Bjerregaard, Claus Wilki Fristrup, Per Pfeiffer, Michael Bau Mortensen, Martin Graversen, Sönke Detlefsen, Jon Kroll Bjerregaard, Claus Wilki Fristrup, Per Pfeiffer, Michael Bau Mortensen

Abstract

Background: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a laparoscopy-guided administration of aerosolized chemotherapy. PIPAC seems to improve objective tumor response, survival and quality of life in patients with peritoneal metastasis. We assessed feasibility and efficacy of PIPAC in patients with peritoneal metastasis (PM).

Methods: Patients were included in a prospective PIPAC protocol. Patients with colorectal PM were treated with oxaliplatin, patients with other primary tumors were treated with cisplatin and doxorubicin. Any chemotherapy exposure for healthcare workers was monitored by environmental and biological sampling. Feasibility was quantified by completion and complication rates. Response evaluation was documented by the peritoneal regression grading score (PRGS) and by peritoneal lavage cytology. Biopsy sites were marked by clips. Quality of life questionnaires were collected at baseline and after 60, 120 and 180 days.

Results: A total of 35 patients with PM were treated with a median of three PIPAC procedures (range 1-9). Intraperitoneal access and completion of PIPAC was achieved in all patients. Few complications and adverse events were noted. There was no risk of chemotherapy exposure for healthcare workers. The mean PRGS was reduced significantly and a reduction of the PRGS was seen in 67% of the patients. Conversion from positive to negative cytology was achieved in 23% of the patients. Quality of life was stabilized from baseline to day 60.

Conclusions: PIPAC is feasible and well tolerated, may stabilize the quality of life in patients with end-stage PM and may induce histological and cytological regression.This study is registered at www.clinicaltrials.gov [ClinicalTrials.gov identifier: NCT02320448].

Keywords: aerosol; carcinomatosis; intraperitoneal; metastasis; palliative treatment; peritoneum.

Conflict of interest statement

Conflict of interest statement: The authors declare that there is no conflict of interest.

Figures

Figure 1.
Figure 1.
Patient flow during PIPAC therapy. CT, computed tomography; CRS, cyto-reductive surgery; ECOG PS, Eastern Cooperative Oncology Group performance status; EORTC-QLQC30, European Organisation for Research and Treatment of Cancer quality of life questionnaire; HIPEC, hyperthermic intraperitoneal chemotherapy.
Figure 2.
Figure 2.
(a) Punch biopsy of a PM. (b) The biopsy sites are marked by clips.
Figure 3.
Figure 3.
Adverse events. CTCAE, Common Terminology Criteria for Adverse Events.
Figure 4.
Figure 4.
Global quality of life at baseline (day 0) and after 60 days according to EORTC-QLQC30. EORTC-QLQC30, European Organisation for Research and Treatment of Cancer quality of life questionnaire.

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