A systematic review on quality of life (QoL) of patients with peritoneal metastasis (PM) who underwent pressurized intraperitoneal aerosol chemotherapy (PIPAC).
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ABSTRACT: Background
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) has recently emerged as a palliative alternative for patients with unresectable peritoneal metastasis (PM). Quality of life (QoL) has increasingly been used as an endpoint to evaluate treatment outcomes. This review aims to identify evidence on how PIPAC would impact the QoL of PM patients.Content
A systematic review was performed on articles identified from Medline, EMBASE, PsycInfo, and Web of Sciences. A meta-analysis was conducted on further selected studies. ACROBAT-NRSI was attempted to assess the risk of bias (RoB).Summary
Nine studies using the EORTC QLQ-C30 questionnaire to assess QoL after repeated PIPAC cycles were identified. Majority was found to be moderately biased and a great extent of heterogeneity was observed. Four studies on PM from either gastric cancer (GC) or epithelial ovarian cancer (EOC) were included for meta-analysis. In 31 GC patients and 104 EOC patients, QoL remained stable in 13/14 and 11/14 EORTC QLQ-C30 scales. PIPAC was inferior to cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) in global QoL and functioning but superior in symptom reduction.Outlook
PIPAC is a well-tolerated option for most GC and EOC patients with irresectable PM. Future trials are warranted to confirm the findings.
SUBMITTER: Li Z
PROVIDER: S-EPMC9166188 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPeritoneal carcinomatosis (PC) is a common endpoint in both gastrointestinal and non-gastrointestinal cancers, and PC is treated as other systemic metastases - unfortunately with disappointing results and considerable side-effects. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a new method of applying traditional chemotherapy, and preliminary data indicate that PIPAC is safe, able to stabilize or improve quality of life, and can induce an objectively measurable reduction in disease burden in PC.MethodsPIPAC-OPC2 is a prospectively controlled Phase II, single center, one-arm, open-label clinical trial investigating the treatment effect of PIPAC in patients with histological or cytological proven PC from gastrointestinal, ovarian or primary peritoneal cancer. Eligible patients will receive PIPAC in series of three using a combination of doxorubicin (1.5 mg/m2) and cisplatin (7.5 mg/m2) for non-colorectal cancer patients (PIPAC C/D), and oxaliplatin (92 mg/m2) in patients with PC of colorectal origin (PIPAC OX). Patients are monitored by: (1) repeated measurements of the Peritoneal Regression Grading Score (PRGS) in biopsies obtained from metal clips marked areas, (2) Quality-of-Life (QoL) questionnaires, (3) Magnetic Resonance Imaging (MRI) and (4) Prognostic Nutritional Index (PNI). Adverse events and surgical complications will be recorded according to the 30 days definition.ResultsThe primary outcome of PIPAC-OPC2 is to evaluate if PIPAC can induce major or complete response (PRGS 1 or 2) within a series of three PIPAC procedures. Secondarily this study investigates changes in QoL and MRI as a staging and response evaluation tool. The secondary outcomes will be used to create a model that may predict which of the patients will benefit from PIPAC treatment.ConclusionsIt is expected that PIPAC directed therapy can induce major or complete response in 50 % of patients with PC of colorectal origin and in 30 % of patients with PC of non-colorectal origin - and at the same time stabilize or even improve quality of life. This trial may provide data regarding the utility of MRI as a staging and response evaluation tool in patients with PC.Trial registrationThe study is registered with ClinicalTrials.gov Identifier NCT03287375 and the European Clinical Trials Database (EudraCT) number 2016-003394-18.
| S-EPMC6404994 | biostudies-literature
Project description:Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel technique of intraperitoneal chemotherapy. First results obtained with PIPAC in patients with advanced peritoneal metastasis (PM) from gastric cancer (GC) are presented.Retrospective analysis: Sixty PIPAC were applied in 24 consecutive patients with PM from GC. 67 % patients had previous surgery, and 79 % previous platinum-based systemic chemotherapy. Mean Peritoneal Carcinomatosis Index (PCI) of 16?±?10 and 18/24 patients had signet-ring GC. Cisplatin 7.5 mg/m(2) and doxorubicin 1.5 mg/m(2) were given for 30 min at 37 °C and 12 mmHg at 6 week intervals. Outcome criteria were survival, adverse events, and histological tumor response.Median follow-up was 248 days (range 105-748), and median survival time was 15.4 months. Seventeen patients had repeated PIPAC, and objective tumor response was observed in 12 (12/24?=?50 %): no vital tumor cells?=?6, major pathological response?=?6, minor response?=?3. Postoperative adverse events?>?CTCAE 2 were observed in 9 patients (9/24, 37.5 %). In 3/17 patients, a later PIPAC could not be performed due to non-access. Two patients (ECOG 3 and 4) died in the hospital due to disease progression.PIPAC with low-dose cisplatin and doxorubicin was safe and induced objective tumor regression in selected patients with PM from recurrent, platinum-resistant GC. First survival data are encouraging and justify further clinical studies in this indication.
| S-EPMC4722080 | biostudies-literature
Project description:BACKGROUND:Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is used in the palliative treatment of peritoneal metastasis. The combination of intraperitoneal and systemic chemotherapy seems rational, and the aim of this systematic review was to compare PIPAC directed monotherapy with a bidirectional treatment approach (PIPAC in combination with systemic chemotherapy). Main outcomes were survival and quality of life. METHODS:A systematic literature search in Medline, Embase, Cochrane and the "Pleura and Peritoneum" was conducted and analyzed according to PRISMA guidelines. Studies in English reporting on bidirectional treatment with PIPAC and systemic chemotherapy and published before April 2019 were included. RESULTS:Twelve studies with a total of 386 patients were included. None were specifically designed to compare mono- versus bidirectional treatment, but 44% of the patients received bidirectional treatment. This was more frequent in women (non-gynecological cancers) and one-third of the bidirectional treated patients had received no prior chemotherapy. Data from the included studies provided no conclusions regarding survival or quality of life. CONCLUSION:Bidirectional treatment with PIPAC and systemic chemotherapy is practised and feasible, and some patients are enrolled having received no prior systemic chemotherapy for their PM. The difficulty in drawing any conclusions based on this systematic review has highlighted the urgent need to improve and standardize reports on PIPAC directed therapy. We have, therefore, constructed a list of items to be considered when reporting on clinical PIPAC research. TRIAL REGISTRATION:International Prospective Register of Systematic Reviews, PROSPERO. Registration number: 90352, March 5, 2018.
| S-EPMC7011374 | biostudies-literature
Project description: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].
| S-EPMC5985602 | biostudies-literature
Project description:IntroductionPressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system with superior pharmacological properties for treating peritoneal metastasis (PM). Safety and efficacy results of PIPAC with cisplatin/doxorubicin or oxaliplatin from a registry cohort are presented.MethodsIRB-approved registry study. Retrospective analysis. No predefined inclusion criteria, individual therapeutic recommendation by the interdisciplinary tumor board. Safety assessment with CTCAE 4.0. Histological assessment of tumor response by an independent pathologist using the 4-tied peritoneal regression grading system (PRGS). Mean PRGS and ascites volume were assessed at each PIPAC.ResultsA total of 142 PIPAC procedures were scheduled in 71 consecutive patients with PM from gastric (n = 26), colorectal (n = 17), hepatobiliary/pancreatic (n = 9), ovarian (n = 6), appendiceal (n = 5) origin, pseudomyxoma peritonei (n = 4), and other tumors (n = 3). Mean age was 58 ± 13 years. Patients were heavily pretreated. Mean PCI was 19 ± 13. Laparoscopic nonaccess rate was 11/142 procedures (7.7%). Mean number of PIPAC/patient was 2. All patients were eligible for safety analysis. There was no procedure-related mortality. There were 2.8% intraoperative and 4.9% postoperative complications. 39 patients underwent more than one PIPAC and were eligible for efficacy analysis, and PRGS could be assessed in 36 of them. In 24 patients (67%), PRGS improved or remained unchanged at PIPAC#2, reflecting tumor regression or stable disease. Ascites was present in 24 patients and diminished significantly under therapy. Median survival was 11.8 months (95% CI: 7.45-16.2 months) from PIPAC#1.ConclusionPIPAC is feasible, safe, and well-tolerated and can induce histological regression in a significant proportion of pretreated PM patients. This trial is registered with NCT03210298.
| S-EPMC6220392 | biostudies-literature
Project description:Purpose:Gastric cancer (GC) patients with peritoneal metastasis (PM) have poor prognosis. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in combination with systemic chemotherapy is a novel treatment option for patients in stage IV of the disease. Materials and Methods:Between November 2015 and June 2018, prospective data collection was performed in 24 patients with GC and PM (median age, 57; range, 44-75 years). These patients underwent 46 PIPAC procedures with a median number of 2 interventions per patient (range, 1-6). A laparoscopic access was used and a combined therapy of cisplatin and doxorubicin aerosol was administered. Results:The median peritoneal carcinomatosis index before the 1st PIPAC was 14 (range, 2-36), and the median ascites volume in patients before the 1st PIPAC was 100 mL (range, 0-6 mL, 300 mL). Eleven patients, who received 2 or more PIPAC procedures, had decreased and stable volumes of ascites, while only 3 patients displayed increasing volume of ascites. The median overall survival was 121 days (range, 66-625 days) after the 1st PIPAC procedure, while 8 patients who received more than 3 PIPAC procedures had a median survival of 450 days (range, 206-481 days) (P=0.0376). Conclusions:Our data show that PIPAC is safe and well tolerated, and that the production of ascites can be controlled by PIPAC in GC patients. Patients, who received 2 or more PIPAC procedures, reported a stable overall quality of life. Further studies are required to document the significance of PIPAC as a palliative multimodal therapy. Trial Registration:ClinicalTrials.gov Identifier: NCT03100708.
| S-EPMC6310762 | biostudies-literature
Project description:BackgroundPressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) represents a novel approach to intraperitoneal chemotherapy. Hereby results, obtained with PIPAC in patients with advanced peritoneal metastasis (PM) from colorectal cancer (CRC), are presented.MethodsData from CRC patients (n = 24) included in the prospective PIPAC-OPC1 and PIPAC-OPC2 trials are reported. Oxaliplatin 92 mg/m2 was administered at 4-6-week intervals. A CE certified nebulizer was used to aerosolize the chemotherapeutics. Outcome criteria were objective tumor response, survival and adverse events.ResultsRetrospective analysis of 74 PIPAC procedures carried out in 24 consecutive patients with PM from CRC included from October 2015 to February 2019. Five patients had still the primary tumor in situ, and 22 patients had received palliative systemic chemotherapy. Nineteen patients completed more than two PIPAC procedures, and objective tumor response according to the histological Peritoneal Regression Grading Score (PRGS) was observed in 67% of the patients, while 21% had stable disease. Four patients (21%) had complete response (mean PRGS = 1 and negative cytology). We recorded a median survival of 37.6 (range 7.3-48.9) months from the time of PM diagnosis, whereas it was 20.5 (range 0.13-34.7) months following the first PIPAC session. Minor postoperative complications were noted, and few were considered causally related to the PIPAC treatment. However, two cases of severe postoperative complications were recorded (urosepsis and iatrogenic bowel perforation).ConclusionsPIPAC with low-dose oxaliplatin can induce objective tumor regression in selected patients with advanced PM from colorectal cancer.
| S-EPMC7292236 | biostudies-literature
Project description:BackgroundPressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a drug-delivery method for patients with peritoneal metastasis (PM). The study objective was to investigate whether PIPAC is possible in an outpatient setting.MethodsData was extracted from the prospective PIPAC-OPC2 study (ClinicalTrials.gov NCT03287375). Patients with PM were treated by cisplatin and doxorubicin (PIPAC C/D), except patients with colorectal PM, who were treated by oxaliplatin (PIPAC OX). Patients were evaluated concerning the suitability for carrying out the PIPAC procedure in an out- patient setting. The preconditions for outpatient surgery were that the patient should be (1) freely mobilized, (2) adequately pain-relieved, (3) have untroubled urination and (4) without anxiety or discomfort caused by leaving the hospital.ResultsDuring the study period, 106 PIPAC procedures (79 PIPAC C/D, 27 PIPAC OX) were performed in 41 patients with gastrointestinal or ovarian PM. Ninety percent (37/41) of the patients were pretreated with systemic chemotherapy. Eight patients (20%) received bidirectional chemotherapy. Twenty-four percent (10/41) of the first PIPAC procedures were completed in an outpatient setting, which increased to 65% (13/20) in PIPAC no 3 (p=0.008). In the PIPAC C/D cohort, 28% and 80% of the PIPACs were performed in the outpatient setting at PIPAC 1 and 3 respectively, contrasting to only 11% and 20% in the PIPAC OX group. No readmissions after outpatient care. Postoperative morphine administration was more frequent in the PIPAC OX group.ConclusionsThe PIPAC procedure can be performed in an outpatient setting. The critical component for success is pain control.
| S-EPMC6405001 | biostudies-literature
Project description:Background:Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is an innovative technique for intraperitoneal drug delivery. This study investigates the efficacy of the occupational health safety measures taken to prevent exposition of healthcare workers to the toxic chemotherapy aerosol. Methods:Air samples were taken at the working place of the surgeon and of the anesthetist during 2 PIPAC procedures and analyzed for content of platinum by inductively coupled plasma mass spectrometry (ICP-MS). Airborne particles were quantified in real time. Biological monitoring was performed in two surgeons after 50 PIPAC by examining blood samples for possible traces of platinum. Analysis was performed by an independent company. Results:Safety measures included tightly closed abdomen, operating room (OR), ventilation meeting requirements of ISO norm 14644-1 class 5, closed aerosol waste system and remote control of PIPAC administration. No traces of platinum were found in the air of the OR (detection limit of 0.0001?mg/filter). No specific rise in particle concentration was detected in the air during the PIPAC procedure, patient closure and removal of the sterile drapes. Blood samples of the surgeons showed no traces of platinum. Conclusions:After implementation of adequate safety measures, no signs of environmental contamination or biological exposure of the surgeons were detected during PIPAC.
| S-EPMC6386395 | biostudies-literature
Project description:BackgroundPatients with recurrent malignant epithelioid mesothelioma (MM) after surgery and standard chemotherapy with cisplatin and pemetrexed have limited treatment options.MethodsWe performed a retrospective cohort study of patients with recurrent MM undergoing Pressurized IntraPeritoneal/Thoracal Aerosol Chemotherapy (PIPAC/PITAC) with doxorubicin 1.5 mg/m2 and cisplatin 7.5 mg/m2. Data were retrospectively collected in a prospective registry of patients undergoing PIPAC/PITAC. Study outcomes were microscopic tumor regression grade (TRG), survival and adverse events (v4.0 CTCAE).ResultsA total of 29 patients (m/f = 17/12) with MM with a mean age of 62.4 (range: 42 to 84) years were analyzed. A total of 74 PIPAC and 5 PITAC procedures were performed. The mean number of PIPAC applications was 2.5 (range: 0 to 10) per patient. Twenty patients (69%) had > 2 PIPAC procedure and were eligible for TRG analysis. TRG 1 to 4 was observed in 75% (15/20) of patients. Major regression (TRG 3) or complete regression (TRG 4) was observed in 20% and 10%, respectively. PIPAC induced significant tumor regression in 51.7% (15/29) of patients with a cumulative effect after repetitive PIPACs (PIPAC #1 vs. PIPAC #2: p = 0.001; PIPAC #1 vs. PIPAC #3: p = 0.001; PIPAC #1 vs. PIPAC #4: p = 0.001). Postoperative CTCAE grade 4 complications were observed in two patients (6.9%) who had cytoreductive surgery (CC2) and intraoperative PIPAC. One patient (3.4%) died due to postoperative kidney insufficiency. After a follow up of 14.4 (95% CI: 8.1 to 20.7) months after the last PIPAC/PITAC application, median overall survival was 26.6 (95% CI: 9.5 to 43.7) months (from the first application).ConclusionAfter prior abdominal surgery and systemic chemotherapy, repetitive PIPAC applications are feasible and safe for patients with end-stage MM. Furthermore, PIPAC induces significant histological regression of malignant mesothelioma in the majority of patients. PITAC is feasible, but its safety and efficacy to control malignant pleural effusion remain unclear.
| S-EPMC5907219 | biostudies-literature